The document discusses the role of hospital pharmacists in managing medical gases in Italy. It outlines the regulatory requirements that designate pharmacists as responsible for overseeing medical gases, which include therapeutic oxygen as well as other gases used for various medical purposes. The document then describes a practical experience where the author, as a hospital pharmacist, successfully managed medical gases at a hospital from 2013 to 2018 in accordance with quality, cost, risk, and time standards. It concludes that while pharmacists may not be engineers, the role requires strong chemistry and management skills to adequately oversee complex hospital medical gas systems, as mandated by current regulations.
This document summarizes the role of hospital pharmacists in managing medicinal gases in hospitals based on a practical experience in an advanced country. Hospital pharmacists are responsible for the logistics and quality control of medicinal gases, which are classified as drugs or medical devices according to European regulations. They ensure proper storage, distribution, and use of gases like oxygen, nitrous oxide, carbon dioxide, and others used for therapies, diagnostics, and research. Pharmacists work with a multidisciplinary team on gas management procedures, safety, cost containment, and training regarding therapeutic gases. Their roles include quality testing, vigilance reporting, emergency planning, and participating in procurement and accreditation processes related to medicinal gases.
This document summarizes the role of hospital pharmacists in managing medicinal gases in hospitals based on a practical experience in an advanced country. Hospital pharmacists are responsible for the logistics and quality control of medicinal gases, which are classified as drugs or medical devices according to European regulations. They oversee the production, storage, distribution, and use of oxygen, nitrous oxide, carbon dioxide, and other gases used in therapies and diagnostics. Pharmacists also collaborate with other professionals on safety procedures, staff training, quality testing, emergency preparedness, and documentation regarding medicinal gas management.
This document summarizes the role of clinical pharmacists in diagnostic imaging procedures that utilize contrast agents or radiopharmaceuticals. It discusses how clinical pharmacists are experts in drug management and can help ensure proper use and monitoring of contrast agents and radiopharmaceuticals. The document also reviews literature showing that involvement of clinical pharmacists in imaging procedures can improve patient outcomes and safety while reducing costs.
The document summarizes updates from the Pharmacy and Therapeutics Committee, including approval of new non-formulary and formulary drugs. Fingolimod and teriflunomide were approved as non-formulary drugs for treating multiple sclerosis. Anidulafungin was approved as a formulary antifungal drug. The document also provides information on pharmacy services, guidelines, new medications added to the formulary, and efforts to minimize medication errors.
The document discusses the role of hospital pharmacists in managing medical gases in Italy. It outlines the regulatory requirements that designate pharmacists as responsible for overseeing medical gases, which include therapeutic oxygen as well as other gases used for various medical purposes. The document then describes a practical experience where the author, as a hospital pharmacist, successfully managed medical gases at a hospital from 2013 to 2018 in accordance with quality, cost, risk, and time standards. It concludes that while pharmacists may not be engineers, the role requires strong chemistry and management skills to adequately oversee complex hospital medical gas systems, as mandated by current regulations.
This document summarizes the role of hospital pharmacists in managing medicinal gases in hospitals based on a practical experience in an advanced country. Hospital pharmacists are responsible for the logistics and quality control of medicinal gases, which are classified as drugs or medical devices according to European regulations. They ensure proper storage, distribution, and use of gases like oxygen, nitrous oxide, carbon dioxide, and others used for therapies, diagnostics, and research. Pharmacists work with a multidisciplinary team on gas management procedures, safety, cost containment, and training regarding therapeutic gases. Their roles include quality testing, vigilance reporting, emergency planning, and participating in procurement and accreditation processes related to medicinal gases.
This document summarizes the role of hospital pharmacists in managing medicinal gases in hospitals based on a practical experience in an advanced country. Hospital pharmacists are responsible for the logistics and quality control of medicinal gases, which are classified as drugs or medical devices according to European regulations. They oversee the production, storage, distribution, and use of oxygen, nitrous oxide, carbon dioxide, and other gases used in therapies and diagnostics. Pharmacists also collaborate with other professionals on safety procedures, staff training, quality testing, emergency preparedness, and documentation regarding medicinal gas management.
This document summarizes the role of clinical pharmacists in diagnostic imaging procedures that utilize contrast agents or radiopharmaceuticals. It discusses how clinical pharmacists are experts in drug management and can help ensure proper use and monitoring of contrast agents and radiopharmaceuticals. The document also reviews literature showing that involvement of clinical pharmacists in imaging procedures can improve patient outcomes and safety while reducing costs.
The document summarizes updates from the Pharmacy and Therapeutics Committee, including approval of new non-formulary and formulary drugs. Fingolimod and teriflunomide were approved as non-formulary drugs for treating multiple sclerosis. Anidulafungin was approved as a formulary antifungal drug. The document also provides information on pharmacy services, guidelines, new medications added to the formulary, and efforts to minimize medication errors.
This document discusses self-medication in Croatia, including an overview of self-medication worldwide and in Croatia specifically. It notes that over-the-counter (OTC) drugs make up 27% of drugs used in Croatia by unit. The role of pharmacists is expanding to include health consultation to help patients practice responsible self-medication. Future goals include increasing education of both medical professionals and patients about responsible OTC drug use and the differences between OTC drugs and dietary supplements.
Thông báo về chuyển ngữ sang tiếng Việt CSDS STABILISHA VO THI
This newsletter provides summaries of recent developments in Stabilis and stability studies:
1) Stabilis has added Vietnamese as its 29th language, allowing more users in Vietnam to access the database.
2) Recent conferences included posters on compatibility studies and stability studies of drugs like azacitidine, phenylephrine, and naloxone.
3) A new textbook on practical pharmaceutics includes a chapter on stability and is now available for order.
1) Hospital pharmacists play an important role in managing medical gas systems in hospitals. They contribute to ensuring proper pharmacological therapies using gases, prevent emergencies, and ensure quality, safety, and cost containment.
2) Pharmacists' competencies in medicinal chemistry and management are key to their role in overseeing medical gas logistics and distribution, quality control testing, staff training, and emergency procedures in compliance with regulations.
3) As the responsible parties for medical gases, pharmacists collaborate with various teams to write procedures, manage risks, store documentation, and provide clinical pharmacy services regarding gases' use in hospitals.
1) Hospital pharmacists play an important role in managing medical gas systems in hospitals. They contribute to ensuring proper pharmacological therapies using gases, prevent emergencies, and ensure quality, safety, and cost containment.
2) Pharmacists' competencies in medicinal chemistry and management are crucial for their role in overseeing medical gas logistics and distribution, quality control testing, staff training, and emergency procedures.
3) Pharmacists are responsible for regulatory compliance, quality assurance of gases from production and distribution systems, proper storage of tanks, and documentation according to various standards and norms.
The document summarizes the historical development of clinical pharmacy and pharmaceutical care from 1928 to 2016. It outlines key steps such as pharmacists beginning to participate in patient rounds in 1928. It also reviews studies showing the positive impact of clinical pharmacists on patient outcomes when included as part of the medical team. This includes reduced mortality, readmission rates, and healthcare costs. The conclusion is that incorporating clinical pharmacy expertise into medical care through a flexible team-based approach is essential for improving clinical outcomes, especially with new complex drug formulations.
1) The introduction of pharmaceutical care and clinical pharmacy practices in the 1920s positively impacted patient outcomes.
2) Over time from the 1920s-2016, clinical pharmacy evolved as its own discipline and pharmacists increasingly participated in direct patient care as part of medical teams.
3) Studies found the involvement of clinical pharmacists on medical teams generally had favorable effects on various outcomes across different healthcare settings and disease states.
This document discusses the role of clinical pharmacists in medical teams. It argues that pharmacists are experts in pharmacology and drug therapy who can improve clinical outcomes when working alongside physicians. The document outlines studies that found clinical pharmacist involvement on medical wards reduced drug errors, adverse drug reactions, morbidity and mortality rates, and healthcare costs. It advocates for pharmacists to take a more active role in multidisciplinary teams to aid physicians and help ensure the best and safest drug therapy for patients. Pharmacists' expertise in areas like drug interactions, delivery systems, and monitoring could benefit patient care and outcomes across many medical disciplines if their contributions were utilized more fully.
Pharmacology is the study of drugs and their actions within the body. It overlaps with other sciences like pharmacy and biochemistry. The document outlines the history and development of pharmacology from ancient times using herbal remedies to the modern era of drug development involving clinical trials. It discusses the scope and branches of pharmacology as well as the process of developing new drugs which goes through preclinical and clinical testing to ensure safety and efficacy before regulatory approval and marketing.
The document provides a history of pharmaceutical quality and regulations, beginning with tragic events in the early 20th century that led to the first drug safety laws. It describes key milestones in GMP development and implementation, from the 1938 FD&C Act to modern ICH guidelines. The current pharmaceutical quality system aims to ensure safety, efficacy and conformity through elements like quality control, assurance programs, documentation standards, and change management processes across the product lifecycle.
Pharmacology is the study of drugs and their actions within the body. It deals with how drugs are absorbed, distributed, metabolized and excreted by the body, as well as their physiological effects. The document provides a brief historical overview of pharmacology and important discoveries. It discusses the development process for new drugs, which includes preclinical testing in animals followed by clinical trials in humans in four phases. Stringent regulations and guidelines govern the development and approval of new drugs to ensure safety and efficacy.
The document provides an overview of the field of pharmacy, including:
- Pharmacy is defined as the science of preparing, dispensing, and reviewing drugs and providing additional clinical services to ensure safe and effective medication use.
- Key areas of pharmacy practice are described, including hospital pharmacy, retail pharmacy, industrial pharmacy, and forensic pharmacy.
- The roles and responsibilities of pharmacists are outlined, emphasizing their role in optimizing patient outcomes through medication management.
- Pharmacy education and the various specializations within the field are summarized.
The International Pharmaceutical Federation (FIP) first adopted the guidelines for Good Pharmaceutical Practice in 1993. These guidelines were developed as a reference to be used by national pharmaceutical organisations, governments, and international pharmaceutical organizations to set up nationally accepted standards of Good Pharmacy Practice.
A revised version of this document was endorsed by WHO in 1997 and subsequently approved by the FIP Council in 1997.
In 2011, FIP and WHO adopted an updated version of Good Pharmacy Practice entitled "Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services".
Full reference: Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services. WHO Technical Report Series, No. 961, 2011. Geneva: World Health Organization, 2011.
In this document, the aim of pharmacy practice aim is defined as to "contribute to health improvement and to help patients with health problems to make the best use of their medicines."
GPP is defined as "the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal, evidence-based care. To support this practice it is essential that there be an established national framework of quality standards and guidelines."
The 2011 GPP document underlines the requirements of Good Pharmacy Practice and how to set standards required for GPP, (which also imply a quality management framework and a strategic plan for developing services).
GPP are organised around 4 major roles for pharmacists
Role 1: Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medical products
Role 2: Provide effective medication therapy management
Role 3: Maintain and improve professional performance
Role 4: Contribute to improve effectiveness of the health-care system and public health
Each function is structured in several roles, and for each role, a list of minimum national standards to be established have been set.
WHO/FIP GPP should serve as a guidance document for the development of specific standards of GPP at national levels by national pharmacists associations and other related stakeholders.
When establishing minimum standards on GPP, it is important to define the roles played by pharmacists, as expected
by patients and society. Secondly, relevant functions for which pharmacists have direct responsibility and accountability need to be determined within each role. Thirdly, minimum national standards should then be established, based upon the need to demonstrate competency in a set of activities supporting each function and role.
Source of info: http://www.fip.org/good_pharmacy_practice
This document discusses the need to refocus clinical pharmacology (CP) activities to address new challenges. It argues that CP must expand its scope to include new areas like protein therapeutics, epigenetics, and systems pharmacology. It also needs to refocus its research on drug safety and integrated biological systems. CP must adapt its teaching methods to changing medical school curriculums. Overall, CP must constantly refocus its activities to improve patient care, increase knowledge, and disseminate information as the fields of medicine and pharmacology rapidly advance.
This document discusses the growing field of cell-based therapies and efforts to standardize their production and use. It notes that while there are currently less than 40 cell therapies approved for commercial use, the field is growing rapidly with over 300 therapies in clinical trials. New technologies are being developed to streamline and automate cell therapy production in order to minimize variability and human error. These technologies could also help standardize biomedical research practices and improve reproducibility. The document argues that as tools for standardization move from industry into academic labs, they will change the way biomedical research is conducted.
The document discusses new technologies that are helping to standardize and streamline the commercial production of cell-based therapies. These tools are now being applied back in the lab to advance biomedical research. Some of the key technologies mentioned include automated tissue culture systems, cell processing workstations that provide contained cleanroom environments, and high-throughput systems for characterizing cells. Adopting these standardized approaches and technologies in research labs has the potential to improve reproducibility and help push the frontiers of cell-based research.
The document discusses strategies for improving hospital pharmacy services through centralized logistics and increased clinical pharmaceutical care. Centralized logistics systems can reduce drug and medical device costs by increasing bulk purchasing power. This allows hospitals to reduce on-site stock and rely on just-in-time delivery from central warehouses. Implementing information and communication technologies helps coordinate these systems. The role of clinical pharmacists is also emphasized - through multidisciplinary teams, they can help reduce medical errors and costs while improving outcomes. Studies show the presence of clinical pharmacists on medical teams can lower costs by 35% through optimizing treatments and preventing errors.
This document provides an overview of herbal monographs and guidelines for herbal drugs. It discusses the purpose and importance of herbal monographs in authenticating herbal materials. It describes different types of monographs, including standards monographs, therapeutic monographs, and combined monographs. The document also compares the content and format of monographs from various pharmacopoeias and authoritative sources, such as the Indian Pharmacopoeia, United States Pharmacopoeia, Ayurvedic Pharmacopoeia of India, and World Health Organization.
The Pharmacy and Therapeutic Committee (PTC) is a policy-making body that advises the hospital administration on matters related to drug therapy. The PTC assists in developing policies around drug procurement, distribution, use, and safety. It is composed of physicians, pharmacists, nurses, and administrators. The PTC's functions include establishing drug policies and procedures, preventing unnecessary drug use, promoting rational prescribing guidelines, and monitoring for medication errors and adverse drug reactions. It also plays roles in ensuring drug safety, reviewing drug utilization, developing emergency drug lists, and conducting training programs.
The document provides information on the International Conference on Harmonization (ICH), including:
- ICH aims to harmonize technical requirements for pharmaceutical registration across regions to ensure safety and efficacy.
- It involves regulators and industry from the EU, Japan, and USA.
- The goals are to establish common guidelines and make information available globally.
- ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics for drug development and review.
- The document then focuses on specific ICH guidelines related to quality, including stability testing, analytical method validation, and impurities.
The document discusses the changing role of pharmacists and the benefits of integrating pharmacists into medical teams. It presents several studies that show pharmacists improving clinical outcomes when involved in patient care. The rationale is that pharmacists can help physicians optimize drug therapy and patient safety by providing expertise in areas like monitoring treatments, detecting interactions and adverse reactions, and managing costs. The conclusion is that applying pharmaceutical care principles can both improve health outcomes and reduce healthcare costs.
This document discusses self-medication in Croatia, including an overview of self-medication worldwide and in Croatia specifically. It notes that over-the-counter (OTC) drugs make up 27% of drugs used in Croatia by unit. The role of pharmacists is expanding to include health consultation to help patients practice responsible self-medication. Future goals include increasing education of both medical professionals and patients about responsible OTC drug use and the differences between OTC drugs and dietary supplements.
Thông báo về chuyển ngữ sang tiếng Việt CSDS STABILISHA VO THI
This newsletter provides summaries of recent developments in Stabilis and stability studies:
1) Stabilis has added Vietnamese as its 29th language, allowing more users in Vietnam to access the database.
2) Recent conferences included posters on compatibility studies and stability studies of drugs like azacitidine, phenylephrine, and naloxone.
3) A new textbook on practical pharmaceutics includes a chapter on stability and is now available for order.
1) Hospital pharmacists play an important role in managing medical gas systems in hospitals. They contribute to ensuring proper pharmacological therapies using gases, prevent emergencies, and ensure quality, safety, and cost containment.
2) Pharmacists' competencies in medicinal chemistry and management are key to their role in overseeing medical gas logistics and distribution, quality control testing, staff training, and emergency procedures in compliance with regulations.
3) As the responsible parties for medical gases, pharmacists collaborate with various teams to write procedures, manage risks, store documentation, and provide clinical pharmacy services regarding gases' use in hospitals.
1) Hospital pharmacists play an important role in managing medical gas systems in hospitals. They contribute to ensuring proper pharmacological therapies using gases, prevent emergencies, and ensure quality, safety, and cost containment.
2) Pharmacists' competencies in medicinal chemistry and management are crucial for their role in overseeing medical gas logistics and distribution, quality control testing, staff training, and emergency procedures.
3) Pharmacists are responsible for regulatory compliance, quality assurance of gases from production and distribution systems, proper storage of tanks, and documentation according to various standards and norms.
The document summarizes the historical development of clinical pharmacy and pharmaceutical care from 1928 to 2016. It outlines key steps such as pharmacists beginning to participate in patient rounds in 1928. It also reviews studies showing the positive impact of clinical pharmacists on patient outcomes when included as part of the medical team. This includes reduced mortality, readmission rates, and healthcare costs. The conclusion is that incorporating clinical pharmacy expertise into medical care through a flexible team-based approach is essential for improving clinical outcomes, especially with new complex drug formulations.
1) The introduction of pharmaceutical care and clinical pharmacy practices in the 1920s positively impacted patient outcomes.
2) Over time from the 1920s-2016, clinical pharmacy evolved as its own discipline and pharmacists increasingly participated in direct patient care as part of medical teams.
3) Studies found the involvement of clinical pharmacists on medical teams generally had favorable effects on various outcomes across different healthcare settings and disease states.
This document discusses the role of clinical pharmacists in medical teams. It argues that pharmacists are experts in pharmacology and drug therapy who can improve clinical outcomes when working alongside physicians. The document outlines studies that found clinical pharmacist involvement on medical wards reduced drug errors, adverse drug reactions, morbidity and mortality rates, and healthcare costs. It advocates for pharmacists to take a more active role in multidisciplinary teams to aid physicians and help ensure the best and safest drug therapy for patients. Pharmacists' expertise in areas like drug interactions, delivery systems, and monitoring could benefit patient care and outcomes across many medical disciplines if their contributions were utilized more fully.
Pharmacology is the study of drugs and their actions within the body. It overlaps with other sciences like pharmacy and biochemistry. The document outlines the history and development of pharmacology from ancient times using herbal remedies to the modern era of drug development involving clinical trials. It discusses the scope and branches of pharmacology as well as the process of developing new drugs which goes through preclinical and clinical testing to ensure safety and efficacy before regulatory approval and marketing.
The document provides a history of pharmaceutical quality and regulations, beginning with tragic events in the early 20th century that led to the first drug safety laws. It describes key milestones in GMP development and implementation, from the 1938 FD&C Act to modern ICH guidelines. The current pharmaceutical quality system aims to ensure safety, efficacy and conformity through elements like quality control, assurance programs, documentation standards, and change management processes across the product lifecycle.
Pharmacology is the study of drugs and their actions within the body. It deals with how drugs are absorbed, distributed, metabolized and excreted by the body, as well as their physiological effects. The document provides a brief historical overview of pharmacology and important discoveries. It discusses the development process for new drugs, which includes preclinical testing in animals followed by clinical trials in humans in four phases. Stringent regulations and guidelines govern the development and approval of new drugs to ensure safety and efficacy.
The document provides an overview of the field of pharmacy, including:
- Pharmacy is defined as the science of preparing, dispensing, and reviewing drugs and providing additional clinical services to ensure safe and effective medication use.
- Key areas of pharmacy practice are described, including hospital pharmacy, retail pharmacy, industrial pharmacy, and forensic pharmacy.
- The roles and responsibilities of pharmacists are outlined, emphasizing their role in optimizing patient outcomes through medication management.
- Pharmacy education and the various specializations within the field are summarized.
The International Pharmaceutical Federation (FIP) first adopted the guidelines for Good Pharmaceutical Practice in 1993. These guidelines were developed as a reference to be used by national pharmaceutical organisations, governments, and international pharmaceutical organizations to set up nationally accepted standards of Good Pharmacy Practice.
A revised version of this document was endorsed by WHO in 1997 and subsequently approved by the FIP Council in 1997.
In 2011, FIP and WHO adopted an updated version of Good Pharmacy Practice entitled "Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services".
Full reference: Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services. WHO Technical Report Series, No. 961, 2011. Geneva: World Health Organization, 2011.
In this document, the aim of pharmacy practice aim is defined as to "contribute to health improvement and to help patients with health problems to make the best use of their medicines."
GPP is defined as "the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal, evidence-based care. To support this practice it is essential that there be an established national framework of quality standards and guidelines."
The 2011 GPP document underlines the requirements of Good Pharmacy Practice and how to set standards required for GPP, (which also imply a quality management framework and a strategic plan for developing services).
GPP are organised around 4 major roles for pharmacists
Role 1: Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medical products
Role 2: Provide effective medication therapy management
Role 3: Maintain and improve professional performance
Role 4: Contribute to improve effectiveness of the health-care system and public health
Each function is structured in several roles, and for each role, a list of minimum national standards to be established have been set.
WHO/FIP GPP should serve as a guidance document for the development of specific standards of GPP at national levels by national pharmacists associations and other related stakeholders.
When establishing minimum standards on GPP, it is important to define the roles played by pharmacists, as expected
by patients and society. Secondly, relevant functions for which pharmacists have direct responsibility and accountability need to be determined within each role. Thirdly, minimum national standards should then be established, based upon the need to demonstrate competency in a set of activities supporting each function and role.
Source of info: http://www.fip.org/good_pharmacy_practice
This document discusses the need to refocus clinical pharmacology (CP) activities to address new challenges. It argues that CP must expand its scope to include new areas like protein therapeutics, epigenetics, and systems pharmacology. It also needs to refocus its research on drug safety and integrated biological systems. CP must adapt its teaching methods to changing medical school curriculums. Overall, CP must constantly refocus its activities to improve patient care, increase knowledge, and disseminate information as the fields of medicine and pharmacology rapidly advance.
This document discusses the growing field of cell-based therapies and efforts to standardize their production and use. It notes that while there are currently less than 40 cell therapies approved for commercial use, the field is growing rapidly with over 300 therapies in clinical trials. New technologies are being developed to streamline and automate cell therapy production in order to minimize variability and human error. These technologies could also help standardize biomedical research practices and improve reproducibility. The document argues that as tools for standardization move from industry into academic labs, they will change the way biomedical research is conducted.
The document discusses new technologies that are helping to standardize and streamline the commercial production of cell-based therapies. These tools are now being applied back in the lab to advance biomedical research. Some of the key technologies mentioned include automated tissue culture systems, cell processing workstations that provide contained cleanroom environments, and high-throughput systems for characterizing cells. Adopting these standardized approaches and technologies in research labs has the potential to improve reproducibility and help push the frontiers of cell-based research.
The document discusses strategies for improving hospital pharmacy services through centralized logistics and increased clinical pharmaceutical care. Centralized logistics systems can reduce drug and medical device costs by increasing bulk purchasing power. This allows hospitals to reduce on-site stock and rely on just-in-time delivery from central warehouses. Implementing information and communication technologies helps coordinate these systems. The role of clinical pharmacists is also emphasized - through multidisciplinary teams, they can help reduce medical errors and costs while improving outcomes. Studies show the presence of clinical pharmacists on medical teams can lower costs by 35% through optimizing treatments and preventing errors.
This document provides an overview of herbal monographs and guidelines for herbal drugs. It discusses the purpose and importance of herbal monographs in authenticating herbal materials. It describes different types of monographs, including standards monographs, therapeutic monographs, and combined monographs. The document also compares the content and format of monographs from various pharmacopoeias and authoritative sources, such as the Indian Pharmacopoeia, United States Pharmacopoeia, Ayurvedic Pharmacopoeia of India, and World Health Organization.
The Pharmacy and Therapeutic Committee (PTC) is a policy-making body that advises the hospital administration on matters related to drug therapy. The PTC assists in developing policies around drug procurement, distribution, use, and safety. It is composed of physicians, pharmacists, nurses, and administrators. The PTC's functions include establishing drug policies and procedures, preventing unnecessary drug use, promoting rational prescribing guidelines, and monitoring for medication errors and adverse drug reactions. It also plays roles in ensuring drug safety, reviewing drug utilization, developing emergency drug lists, and conducting training programs.
The document provides information on the International Conference on Harmonization (ICH), including:
- ICH aims to harmonize technical requirements for pharmaceutical registration across regions to ensure safety and efficacy.
- It involves regulators and industry from the EU, Japan, and USA.
- The goals are to establish common guidelines and make information available globally.
- ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics for drug development and review.
- The document then focuses on specific ICH guidelines related to quality, including stability testing, analytical method validation, and impurities.
The document discusses the changing role of pharmacists and the benefits of integrating pharmacists into medical teams. It presents several studies that show pharmacists improving clinical outcomes when involved in patient care. The rationale is that pharmacists can help physicians optimize drug therapy and patient safety by providing expertise in areas like monitoring treatments, detecting interactions and adverse reactions, and managing costs. The conclusion is that applying pharmaceutical care principles can both improve health outcomes and reduce healthcare costs.
Similar to 2 -BOOK -complete version GALENIC- EXTENDED 2 nd edition.pdf (20)
Order : Trombidiformes (Acarina) Class : Arachnida
Mites normally feed on the undersurface of the leaves but the symptoms are more easily seen on the uppersurface.
Tetranychids produce blotching (Spots) on the leaf-surface.
Tarsonemids and Eriophyids produce distortion (twist), puckering (Folds) or stunting (Short) of leaves.
Eriophyids produce distinct galls or blisters (fluid-filled sac in the outer layer)
Hariyalikart Case Study of helping farmers in Biharrajsaurav589
Helping farmers all across India through our latest technologies of modern farming like drones for irrigation and best pest control For more visit : https://www.hariyalikart.com/case-study
Sexuality - Issues, Attitude and Behaviour - Applied Social Psychology - Psyc...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Discovery of Merging Twin Quasars at z=6.05Sérgio Sacani
We report the discovery of two quasars at a redshift of z = 6.05 in the process of merging. They were
serendipitously discovered from the deep multiband imaging data collected by the Hyper Suprime-Cam (HSC)
Subaru Strategic Program survey. The quasars, HSC J121503.42−014858.7 (C1) and HSC J121503.55−014859.3
(C2), both have luminous (>1043 erg s−1
) Lyα emission with a clear broad component (full width at half
maximum >1000 km s−1
). The rest-frame ultraviolet (UV) absolute magnitudes are M1450 = − 23.106 ± 0.017
(C1) and −22.662 ± 0.024 (C2). Our crude estimates of the black hole masses provide log 8.1 0. ( ) M M BH = 3
in both sources. The two quasars are separated by 12 kpc in projected proper distance, bridged by a structure in the
rest-UV light suggesting that they are undergoing a merger. This pair is one of the most distant merging quasars
reported to date, providing crucial insight into galaxy and black hole build-up in the hierarchical structure
formation scenario. A companion paper will present the gas and dust properties captured by Atacama Large
Millimeter/submillimeter Array observations, which provide additional evidence for and detailed measurements of
the merger, and also demonstrate that the two sources are not gravitationally lensed images of a single quasar.
Unified Astronomy Thesaurus concepts: Double quasars (406); Quasars (1319); Reionization (1383); High-redshift
galaxies (734); Active galactic nuclei (16); Galaxy mergers (608); Supermassive black holes (1663)
BIRDS DIVERSITY OF SOOTEA BISWANATH ASSAM.ppt.pptxgoluk9330
Ahota Beel, nestled in Sootea Biswanath Assam , is celebrated for its extraordinary diversity of bird species. This wetland sanctuary supports a myriad of avian residents and migrants alike. Visitors can admire the elegant flights of migratory species such as the Northern Pintail and Eurasian Wigeon, alongside resident birds including the Asian Openbill and Pheasant-tailed Jacana. With its tranquil scenery and varied habitats, Ahota Beel offers a perfect haven for birdwatchers to appreciate and study the vibrant birdlife that thrives in this natural refuge.
Evaluation and Identification of J'BaFofi the Giant Spider of Congo and Moke...MrSproy
ABSTRACT
The J'BaFofi, or "Giant Spider," is a mainly legendary arachnid by reportedly inhabiting the dense rain forests of
the Congo. As despite numerous anecdotal accounts and cultural references, the scientific validation remains more elusive.
My study aims to proper evaluate the existence of the J'BaFofi through the analysis of historical reports,indigenous
testimonies and modern exploration efforts.
SDSS1335+0728: The awakening of a ∼ 106M⊙ black hole⋆Sérgio Sacani
Context. The early-type galaxy SDSS J133519.91+072807.4 (hereafter SDSS1335+0728), which had exhibited no prior optical variations during the preceding two decades, began showing significant nuclear variability in the Zwicky Transient Facility (ZTF) alert stream from December 2019 (as ZTF19acnskyy). This variability behaviour, coupled with the host-galaxy properties, suggests that SDSS1335+0728 hosts a ∼ 106M⊙ black hole (BH) that is currently in the process of ‘turning on’. Aims. We present a multi-wavelength photometric analysis and spectroscopic follow-up performed with the aim of better understanding the origin of the nuclear variations detected in SDSS1335+0728. Methods. We used archival photometry (from WISE, 2MASS, SDSS, GALEX, eROSITA) and spectroscopic data (from SDSS and LAMOST) to study the state of SDSS1335+0728 prior to December 2019, and new observations from Swift, SOAR/Goodman, VLT/X-shooter, and Keck/LRIS taken after its turn-on to characterise its current state. We analysed the variability of SDSS1335+0728 in the X-ray/UV/optical/mid-infrared range, modelled its spectral energy distribution prior to and after December 2019, and studied the evolution of its UV/optical spectra. Results. From our multi-wavelength photometric analysis, we find that: (a) since 2021, the UV flux (from Swift/UVOT observations) is four times brighter than the flux reported by GALEX in 2004; (b) since June 2022, the mid-infrared flux has risen more than two times, and the W1−W2 WISE colour has become redder; and (c) since February 2024, the source has begun showing X-ray emission. From our spectroscopic follow-up, we see that (i) the narrow emission line ratios are now consistent with a more energetic ionising continuum; (ii) broad emission lines are not detected; and (iii) the [OIII] line increased its flux ∼ 3.6 years after the first ZTF alert, which implies a relatively compact narrow-line-emitting region. Conclusions. We conclude that the variations observed in SDSS1335+0728 could be either explained by a ∼ 106M⊙ AGN that is just turning on or by an exotic tidal disruption event (TDE). If the former is true, SDSS1335+0728 is one of the strongest cases of an AGNobserved in the process of activating. If the latter were found to be the case, it would correspond to the longest and faintest TDE ever observed (or another class of still unknown nuclear transient). Future observations of SDSS1335+0728 are crucial to further understand its behaviour. Key words. galaxies: active– accretion, accretion discs– galaxies: individual: SDSS J133519.91+072807.4
Presentation of our paper, "Towards Quantitative Evaluation of Explainable AI Methods for Deepfake Detection", by K. Tsigos, E. Apostolidis, S. Baxevanakis, S. Papadopoulos, V. Mezaris. Presented at the ACM Int. Workshop on Multimedia AI against Disinformation (MAD’24) of the ACM Int. Conf. on Multimedia Retrieval (ICMR’24), Thailand, June 2024. https://doi.org/10.1145/3643491.3660292 https://arxiv.org/abs/2404.18649
Software available at https://github.com/IDT-ITI/XAI-Deepfakes
The Limited Role of the Streaming Instability during Moon and Exomoon FormationSérgio Sacani
It is generally accepted that the Moon accreted from the disk formed by an impact between the proto-Earth and
impactor, but its details are highly debated. Some models suggest that a Mars-sized impactor formed a silicate
melt-rich (vapor-poor) disk around Earth, whereas other models suggest that a highly energetic impact produced a
silicate vapor-rich disk. Such a vapor-rich disk, however, may not be suitable for the Moon formation, because
moonlets, building blocks of the Moon, of 100 m–100 km in radius may experience strong gas drag and fall onto
Earth on a short timescale, failing to grow further. This problem may be avoided if large moonlets (?100 km)
form very quickly by streaming instability, which is a process to concentrate particles enough to cause gravitational
collapse and rapid formation of planetesimals or moonlets. Here, we investigate the effect of the streaming
instability in the Moon-forming disk for the first time and find that this instability can quickly form ∼100 km-sized
moonlets. However, these moonlets are not large enough to avoid strong drag, and they still fall onto Earth quickly.
This suggests that the vapor-rich disks may not form the large Moon, and therefore the models that produce vaporpoor disks are supported. This result is applicable to general impact-induced moon-forming disks, supporting the
previous suggestion that small planets (<1.6 R⊕) are good candidates to host large moons because their impactinduced disks would likely be vapor-poor. We find a limited role of streaming instability in satellite formation in an
impact-induced disk, whereas it plays a key role during planet formation.
Unified Astronomy Thesaurus concepts: Earth-moon system (436)
2 -BOOK -complete version GALENIC- EXTENDED 2 nd edition.pdf
1. BOOK
TIITLE : GALENIC LABORATORY: STATE OF THE ART –-INNOVATION AND MANAGEMENT
A SCIENTIFIC AND TECHNOLOGICAL DISCIPLINE
2nd. EDITION
The semplified normative rules ( NBP NORME DI BUONA PREPARAZIONE) ) in Italy : An Useful tools also
for non advanced country
The innovative 3D Printing system technology for cps and tablets .
AUTHORS
1 ) Luisetto M, IMA MARIJNSKAYA academy , applied pharmacologist , high professionality hospital
pharmacist manager , member of ITALIAN GALENIST UNION , Galenic lab PC AREA , italy
2) Naserr Almukthar Professor Physiology Babilon university Iraq
3) Khaled EDBEY , professor of physical chemistry , Libyan Authority for Scientific Research
4) Mashori Gulam Rasool, Professor, Department of Medical & Health Sciences for Woman, Peoples
University of Medical and Health Sciences for Women, Pakistan
5)Benzi Cipelli R . IMA Marijnskaya academy italy
6) Fiazza C medical pharmacologist , hospital pharmacist manager , independent researcher PC area italy
7)Cabianca L medical lab turin italy Citta’ della Salute
8)Oleg Yurevich latyshew IMA president RU
2. Corresponding author : Luisetto mauro maurolu65@gmail.com PC italy 29121 +393402479620
Tables of contents :
abstract
introduction
material and methods
results
discussion
conclusion
refarences
KEYWORDS
Physiology ,Galenic laboratory , magistral formula, clinical pharmacy , pharmaceutical care , personalized
pharmacy, pediatry, drug shortage ,NBP , semplified rules, official pharmacopeia, control process, quality
management system, Rare disease, 3d PRINTING systems, management.
CHAPTHER 1 ABSTRACT
The term galenic imply a scientific and technical matter but also an art.
Related the hospital practice the future of pharmacy pass trought the innovation of the galenic lab.
Observing the today hospital practice HP in many countries and the international literature involved it is
clear How clinical pharmacy is linked to the galenic lab practice LP.
Today more then recent past due to the various kinds of magistral formula requested by the clinicians
It is necessary that the clinical pharmacist CP perpesctive must to be added to the classic GALENIC lab
competencies : this make possible to complete the profile of efficacy and safety of this fundamental and
crucial Drugs like the magistral formula and officinal and their use .
Aim of this ancient discipline and art is today to provide efficacy and safe drugs for the need of single
patient when it is not possibile to use the industrial product.
The clinical galenic activity can be divided into sterile and Non sterile .
3. ( Total parenteral nutrition TPN bags, Pain therapy, oncological parenteral drugs lab UFA , radio drugs and
diagnostics and non the sterile galenics) .
Aim of this work is to deeply investigate this relevant link ( CLINICAL PHARMACY CP with LAB PRACTICE LP)
in order to get the really best clinical results for the patiens and healthcare org need.
Clinical pharmacy CP principle , PHARMACEUTICAL care PC , the managerial competencies and
personalized pharmacy added to the best knowledge and competencies in the galenic lab. make the
difference in order to obtain the right final clinical results.
The same in this work are submitted to the international pharmacy practioner , directors , researcher or
students the Normatives rules operating in an advanced country like Italy : the semplified NBP , example
that can be applied also in the non advanced nations.
In italy pharmacist can follow or the full NBP rules of the official pharmacopeia or the semplified according
DM Salute 18.nov.2003. ( related the kind of galenic formula prepared if sterile or not).
The NBP ( good manifacturing rules) introduce an QUALITY CQ SYSTEM MANAGEMENT.
The full NBP are more used in more complex labs in ex. involved in specialistic products (Like oncologic or
radio drugs, sterile colliria and other ).
This rules guarantee the quality, security and the efficacy of a drug prepared in galenic lab.
This are based on the resonsability principles, plan, documentation of all activity.( QUALITY SYSTEM OF
INSURANCE CQ ).
All the phases of the preparation are under the responsability of the pharmacist.
The final quality of the products depends on the correct use of API and eccipients, on the right calculations
operation, right volume measure or weight operation and the Check on the final products:
-following of the procedure , aspects, pakaging and closing system and other request by ITALIAN FU
related the specific pharmaceutical form.
According NBP the lab. must to be separated (or it must to be separable ) form the rest of pharmacy and
a second pharmacist ( that is different form the pharmacist that prepare ) must to check the final
preparation.
The locals must to be according striclty enviromental condition required normative rules by to make
possible to prepare in safety way drugs.
And it is mandatory to follow the written procedure : instrument verify, training of the pharmacists
Cleaning procedure, sanifications.
For Raw materials: it is needed to have certifications, technical sheet , safety sheet, data of the first use ,
expiry data
Working sheet is mandatory to testify the operations.
4. The pharmacist can follow this 2 option related the kind of drugs produced and the characteristic of the
lab.
It is not the main focus of this work to produce a literal translation of the DM 18/nov /2003 only to submit
its general meanings.
This can be considered for the authors useful to be added also to the normative rules in force in other
non advanced countries.
In order to make more interesting this book some useful concepts of physiology of the stomach and GI
tract are reported .
The same some relevant pharmaceutical concepts and technique with a focus on the capsules CPS as
pharmaceutical form ( gastro resistance, delayed release), some oral suspension , gels and other few
preparation.
This work is produced whit a non conventional approach : it is not a book of pharmaceutical technique .
Innovation and management of the system make possible to increase the power of the galenic laboratories
In the hospital or in private pharmacy.
This work is produced only for international purpose.
CHAPTHER 2 INTRODUCTION
in hystory to treat the humans pathology great contribute was obtained with the introduction of GALENIC
principle and methods.
From GALENUS form Pergamon ( Greek) 129 dc – 201 comes the word GALENIC art of the pharmacist to
produce drugs inside in the pharmacy .
Fig. n 1 Galenus form Perganom
5. He codified the preparation of drugs using multiple kinds of ingredients. ( active principle API added with
excipients).
For many times (centuries) this methods was used in the lab to produce remedy to treat many human
pathology .
Federico II of Svevia 1194 – 1250 knowed as “ STUPOR MUNDI “ related his open mind concepts
introduced
Fig. n 2 Federico II Svevia
In europe and in italy the need to have specific rules for regulation the activity of drugs production in the
pharmacy lab. This In separate way from the prescription activity of the physicians.
All in order to avoid risk of conflic of interest between the prescrictive funtion from the pharmacy practice
this produced the mandatory separation between the medicine and the pharmacy discipline : to the
physicians - role in prescription of drugs and therapy and – to the pharmacyst the production and sell of
the drugs .
But during the illuministic period , in the industrial revolution , the succes of medicinal chemistry MC since
1800 - 1900 make possible to shift the drugs production form the pharmacy to the more complex industry.
During all this periods many FORMULARY and then PHARMACOPEIA in various countries was introduced
and adopted To make possible to get the adeguate quality of drugs produced, safety , reproducibility of
the procedure. ( monography, methods of analisys ,table et other reported ).
This texts becomes mandatory by healthcare normative law in the various contests ( FU italian, FU
european, USP, BP and many other examples ).
Also the competencies of who was involved in remedy preparation increased during the various centuries :
from botanic experties ( SCUOLA SALERNITANA in the VII -VIII century ) to the IATROCHEMISTRY principle
( PARACELSUS in XVI century ) since last 2 century with the born of the modern pharmacy and medicinal
chemistry.
6. Fig. n 3 Paracelsus
Before the pharmacists, apothecaries that worked alongside with priests and physicians in regard to the
patient care.
The history of pharmaceutical industry is well knowed starting form the introduction of the first
SULFAMIDICS since the Actual last antivirals drugs ( for c-19 treatement).
But , related the last industrial pharmaceutical revolution ,various problem arosed :
not all pharmaceuticals industries produce drgus for all kind of subpopulation ( pediatric patients ,
swallowing problems in geriatrics, drug shortages).
So There is a needs for personalized dosages or personalized pharmaceutical form PPP ( for pediatric or
geriatric patients) or to produce officinal formula: various reason are involved.
needs to introduce drugs in enteral nutrition NE
drugs not available form national or foreign producers ( in example due by national or international
shortcomings )
some orphan drugs OD for some rare disease RD
specific needs of specific dermatologic products ( not produced by industry, not in the market )
Emergency products : in example lat gel , calcium gel, cardioactive oral suspension stokes for pediatry
cannabis preparates : CBD,THC ( various formulations)
some disinfectants and antiseptics formula
some antidothes ( galenics) , in ex Activated charcoal AC, calcium gel, KI cps and other
galenics and magistral for pediatry : Phenobarbital bs , caffeina bs, cardioactive and other API ( cps, oral
suspension or bs ).
galenics for the metabolic urgencies in pediatry, rare disease .
7. some lab. reagents and solutions , buffers
some contrast agents for radiology ( sodium bicarbonate cps , citric acid )
odontoiatric galenics : like ipoclorite solutions, toluidin solutions
otorino solutions : lidocaine solutions , alcool boric solutions
solution used in ginecologic ambulatory : acetic acid 5% and strong lugol
and many other useful products.
Due to the failure of industry to cover all this situation the galenic lab. Is crucial and real opportunity.
Today also many pharmaceutical industry PI not like more to produce classic drugs as many cardioactive
products and other registered drugs and the magistral product make possible to overcome this problem.
( expecially today whit actual economic crisis some producers are no more interested to produce registered
drugs if the price is highly reduced for various kind of reason ) .
Also a great number of galenic formula GF are in use and currently in the hospital or in private pharmacy:
corrosive products for dermatologist,, lugol, acetic acid solutions, alcool solution for lab, various reactives ,
phytotherapic derivates and so on .
Galenic Pharmacy GP also provides educational, scientific and research activities in the profile discipline –
pharmaceutical technology to the pharmacy students or under specilization programs course SPC.
But observing international literature IL it is possible to see that the best clinical results are obtained when
the lab. activity in production magistral formula by the phyicians is completed when available the clinical
pharmacist and managerial competecies in the same team.
Galenics is the lab.process that turns an active ingredient (API) into a ready-to-use medicine that can be
dosed as required for the various kinds of patients .
This to optimise their absorption.
It is knowed as the discipline (or science) of the dosage form design.
According Review Braz. J. Pharm. Sci. 56 2020
Preparation of extemporaneous oral liquid in the hospital pharmacy
Márcio Robert ,M. da Silva ,L.Pereira Dysars, E.Pereira dos Santos, E. Ricci Júnior
“At the hospital, the pharmacist is constantly challenged to prepare the extemporaneous solutions ES from
tablets, capsules or drug powder DP for patients unable to swallow, Like as pediatric, elderly or patients
that use nasoenteric NE or nasogastric tubes. The preparation of extemporaneous solutions ES from
capsules, tablets and drug powder requires stability studies analysis”
8. Figure n 4 manual encapsulator
Fig. n 5 Fig. n 5 from j Mallik ,useful table to verify the volume for filling a capsula
9. Fig n. 6 usefultable to choose what size is to be used accordin amount of API is to be filled inside.
Figure n 7 cilinder use to measure volumes
10. Fig. n 8 mortar and pestel
Fig. n 9 right method for measure of volume ( liquids) with cilinder
11. Fig. n 10 instruments and glases for galenic lab.
Fig. n 11
12. Fig. n 12
The measure are crucial for API and eccipients :
In example if tecnical Balance with sensibility 2 mg and admitted error 5% the minimum amount that
can be measured :
2x100/5= 40 mg
Aliquot Weighted method : for measure of API under the precision level of the instrument :
1) Choose a multiple of the powder to be measured
2) Diluite with inert eccipient
3) Measure an aliquot of the diluited API + Eccipient
In example if needed 15 mg to be weighted:
15 mg x 20 = 300 mg ( multiplied for factor 20 )
Mix with eccipient 19 x 300 mg = 5700 gr
The global mixture is = 6000 mg
So it is necessary to weight a measure of 1/20 =300 mg that contain 15 mg of API
13. CHAPTHER 3 MATERIAL AND METHODS
With and observational point of view an review of relevant article related the topics of this work is
performed .
It is produced the meaning translation of an Italian normative rule: Decreto M 18 NOV 2003
And are then reported some innovation in galenic field .
Finally a global conclusioni is submitted to the researcher related also innovations .
CHAPTHER 4 RESULTS
FROM LITERATURE
J Pharm Pract. 2021 Jun 15;
Hospital Pharmacy Response to Covid-19 Pandemic in Italy: What We Learned From the First Outbreak
Wave
Vera Damuzzo et al
“ When C-19 pandemic started, the Italian hospital pharmacists faced multiple challenges and change their
work practices.
The aim of this study work was to describe the impact of the C-19 emergency on the pharmaceutical care
(PC) provided by pharmacists during the 1 th wave of the pandemic. Issues related to pharmacist's
involvement in the pandemic management PM were: changes in activities, support received by authorities
and pharmacists' own perceived role in the Health care System HS .
A cross-sectional study work based on a web survey was conducted between May - Jun 2020 collecting
information from the pharmacists, members of the Italian Soc. of Clinical Pharmacy and Therapeutics
SCPT. 113 (11.4%) completed the questionnaire. The cohort was divided in 2 arms: pharmacists who
worked in severely C-19 affected areas (High Spread Regions) and those employed in the less affected
areas (Low Spread Regions).
14. The changes in the pharmacy work settings PWS reflected the increase of logistics area and non-sterile
clinical galenic NSG, and reduction of clinical tasks. The most demanding challenge was referred to
shortages of medical devices MD and drugs, 61/113 pharmacists reported difficulty in obtaining products
compliant to quality standards. National Instit. and Regional Governments provided a greater perceived
support. More than about 50% of participants felt that their role did not change if compared to other
healthcare professionals HP .
Despite some limitations related to their clinical activity, pharmacists played a crucial role in supplying
personal protective equipment PE, medical devices MD and medications to improve health outcomes
during this emergency. The results may guide pharmacists in future actions to improve the management of
the pandemic. “(6)
Croat Med J. 2014 Dec;
Establishment of galenic laboratories in developing countries to produce high quality medicines: results of
Aid Progress Pharmacist Agreement (A.P.P.A.®) Project
Francesca Baratta et al
“Aid Progress Pharmacist Agreement Project: aims in developing countries
Aid Progress Pharmacist Agreement is a non-profit NP association based on a voluntary work and its main
activity is the A.P.P.A.® Project. The Project started in the 2005 as a result of the cooperation between the
Pharmacy Faculty Turin and Italian community pharmacists. Its main task is the establishment of galenic
laboratories (GLs) in hospitals of developing countries according to the principles of international health
cooperation.
Aims of this Project:
- establishing GLs in DCs with the aim of preparing medicinal products MP that comply with the quality
requirements, first of all to fight the widespread counterfeiting of medicines in DCs;
-tailoring the dosages and pharmaceutical forms PF according to the actual patient needs PN;
-employing the local staff, teaching them a kind of a “new job,” and opening a suitable school;
-minimizing the costs necessary to prepare these medicines formula MF
There are various relevant and important reasons why galenics should be used:
i) a low cost of the production system and simple kind of operative procedures OP;
ii) the possibility to adapt the dosages and pharmaceutical forms PF to the patients’ needs and medical
prescriptions;
iii) reduction in use of counterfeit medicines CM in the settings where the GL is located. “(7)
15. Study protocol 08 January 2018
Impact of collaborative pharmaceutical care on in-patients’ medication safety: study protocol for a stepped
wedge cluster randomized trial (MEDREV study)
Géraldine Leguelinel-Blache et al
“The clinical pharmacist CP will have a collaborative meeting with both the prescriber and the nurse in
order to notify any possible medication errors ME and suggest any proposals to optimize the AMO
according to the medical history MH , the clinical status CS , and the therapeutic adherence .
( change of galenic form due to swallowing problem, dose adjustment to the renal function RF ). After the
collaborative meeting, the clinical pharmacist will check whether the prescriber has accepted his
suggestions and modified the AMO. All the pharmaceutical interventions, the medication errors ME
detected and the pharmaceutical suggestions of order kind of modification, will be collected and
characterized in a standardized form according to the French Society of Clinical Pharmacy FSCP “ (8)
JDDG: Journal der Deutschen Dermatologischen Gesellschaft
Topical preparations and their use in dermatology
J. Wohlrab 23 Nov 2016
“The choice of a pharmaceutical (galenic) concept is primarily based on the requirements of the physico-
chemical properties PCP of the active ingredient API to be applied.
The fixed combination of API in topical preparations is suitable for only a limited numb. of clinical
treatment scenarios.” (9)
Hospital Pharmacology. 2015;
Information on the Quality of Substance for the Preparation of Pharmaceutical Drugs in Terms of
Hospital Pharmacy M. Dj. Jovović et al
“Compliance with the national legislation, like as establishing compliance prescribed by the
Eu legislation EL in the field of drug development is binding.
16. All manufacturers of drugs and/or API must apply quality standards prescribed by the European Pharm.
EP in order to develop, manufacture and sales of
medicines. When it comes to the quality of pharmaceutical ingredients PI for the production
of drugs in the pharmacy, pharmacies especially in residential institutions in our country
is permanently done by the harmonizing national legislation NL in order to improve conditions for
the preparation and production of galenic drugs GD in terms of inpatient health institutions HI
performed in a manner that is prescribed by international regulations IR . Th is requires the adaptation of
institutions, including the fundamental changes in competence as national professional and administrative
and regulatory rules that apply to state- and private sectors “(10)
ORIGINAL ARTICLE
Magistral drugs in hospitalized newborns and children
Medicamentos magistrais em recém-nascidos e crianças hospitalizados
A. Cabral de Souza Pereira et al
Univ. Federal Fluminense (UFF), Niterói, RJ, Brazil
“The constant consumption of magistral oral solutions MOS and suspensions by newborns and children of
the assessed hospital indicates the need forthis such preparations as a pediatric therapeutic alternative
PTA in this hospital.”(11)
Dooms, M., Carvalho, M. Compounded medication for patients with rare diseases. Orphanet J Rare Dis 13,
1 (2018).
04 January 2018
“When there is no on-label or even no off-label treatment for the patients with rare diseases RD
pharmacists have to compound the medication needed.”(12)
17. Pharmaceutics. 2021 Apr;
2021 Mar 26.
Medicine Shortages in Serbia: Pharmacists’ Standpoint and Potential Solutions for a Non-EU Country
Nataša J. Lješković et al
“Backup manufacturing on a small scale (magistral and galenical) could be a good way to overcome some
kind of drugs shortages.”(13)
Pharmaceuticals (Basel). 2022 Jan
Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics
Guendalina Zuccari et al
“In treatment of pediatric diseases PD , mass-produced dosage forms are often not suitable for children.
Commercially available medicines CAM are commonly manipulated- mixed with food by caregivers at
home, or extemporaneous kinds of medications are routinely compounded in the hospital pharmacies HP
to treat hospitalized children. Despite considerable efforts by regulatory agencies RA, the pediatric
population is still exposed to questionable and potentially harmful practices. When designing medicines for
children, the ability to fine-tune the dosage while ensuring safety of the ingredients is of paramount and
crucial relevance . For these kind of scope solid formulations SF may represent a valid alternative to liquid
formulations for their simpler formula and more stability, and, to overcome the problem of swelling ability,
mini-tablets could be a practicable option. This research work deals with the different approaches that
may be applied to develop mini-tablets MT intended for pediatrics with a focus on safety of the
excipients. Alongside the various conventional method of compression, 3D printing system appeared
particularly appealing, as it allows to reduce the number of ingredients and to avoid both the mixing of
powders and intermediate steps like as granulation. this technique could be well adaptable to the daily
galenic preparations of a hospital pharmacy HP, thus leading to a reduction of the common practice of off-
label preparations. “(14)
18. Volume 174, July 2021
Advanced Drug Delivery Reviews
Translating 3D printed pharmaceuticals: From hype to real-world clinical applications
Seoane-Viaño et al
“Three-dimensional (3D) printing offers the potential to revolutionise the production of pharmaceuticals
targeted to the gastrointestinal GI tract by offering a flexible drug product manufacturing platform that
can adapt readily to changing market and the patient needs . By using a digital computer-aided design
software to produce medicines in a layer-by-layer manner, 3D printing enables the on-demand production
of drug products DP with personalised dosages PD , drug combinations , geometries and release
characteristics ; a concept which is currently unattainable and cost inefficient with conventional
manufacturing technologies CMT ( tabletting, encapsulation). This kind of technology has been forecast to
disrupt a wide range of pharma applications, ranging from expediting the drug development process DDP
and providing benefits for pharmaceutical manufacture, to on demand printing of personalised medicines
PM on the front-line and in hard-to-reach areas . “(15)
International Jour. of Pharmaceutics
Volume 569, 5 October 2019
Feasibility study into the potential use of fused-deposition modeling to manufacture 3D-printed enteric
capsules in compounding pharmacies
Christoph Nober et al
“The purpose of this research sudy work was to investigate the feasibility to manufacture enteric capsules
EC, which could be used in compounding pharmacies CP , by fused-deposition modeling. It is well-known
that conventional enteric dip coating of capsules CPS in community pharmacies CP or hospitals is a time-
consuming process which is characterized by an erratic efficacy. Fused-deposition FD modeling was
selected as a potential 3D printing system method due its ease and low-cost implementation LCI . Before
starting to print the capsules CPS , an effective sealing system was designed via a computer-aided design
program. Hot melt extrusion HME was used to make printable enteric filaments. They were made of the
enteric polymer, a plasticizer and a thermoplastic polymer: Eudragit® L100-55, PEG 400 and polylactic
acid, respectively.
Riboflavine-5′-phosphate was selected like as a coloured drug model to compare the efficacy of the 3D
printed cps to that of enteric dip coated capsules as they are currently produced in community
pharmacies and hospitals HP .
19. Different parameters of fabrication which could influence the dissolution profile of the model drug, such as
the layer thickness or post-processing step, were studied. It was demonstrated that our 3D printed enteric
capsules EC did not release the drug for 2 hours in acid medium (pH 1.2). They completely dissolved within
45 min at pH 6.8 which allowed the release of a minimal amount of 85% w/w of drug as it was
recommended by the Eur.Pharmacopoeia EP 9th Edition for enteric products.”(16)
Can Fam Physician. 2017 Aug; 63(8): 607–609.
Acetylsalicylic acid for children with Kawasaki disease
Teeranai Sakulchit, S. M. Benseler, and Ran D. Goldman
“Intravenous immunoglobulin IVIG with high-dose ASA should be the treatment of choice for children with
Kawasaki disease until fever subsides, and low-dose ASA should be given for 6 to 8 weeks thereafter. The
role and effectiveness of ASA in children with Kawasaki disease during the acute phase has been called into
question recently, especially in regards to anticipated reduction in the incidence of coronary artery
abnormalities” (17)
Review 30 August 2018
Kawasaki disease: guidelines of the Italian Society of Pediatrics, part I - definition, epidemiology,
etiopathogenesis, clinical expression and management of the acute phase
Alessandra Marchesi, Isabella Tarissi de Jacobis, Donato Rigante, Alessandro Rimini, Walter Malorni,
Giovanni Corsello, Grazia Bossi, Sabrina Buonuomo, Fabio Cardinale, Elisabetta Cortis, Fabrizio De
Benedetti, Andrea De Zorzi, Marzia Duse, Domenico Del Principe, Rosa Maria Dellepiane, Livio D’Isanto,
Maya El Hachem, Susanna Esposito, Fernanda Falcini, Ugo Giordano, Maria Cristina Maggio, Savina
Mannarino, Gianluigi Marseglia, Silvana Martino, Giulia Marucci, Rossella Massaro, Christian Pescosolido,
Donatella Pietraforte, Maria Cristina Pietrogrande, Patrizia Salice, Aurelio Secinaro, Elisabetta Straface &
Alberto Villani Show fewer authors
Italian Journal of Pediatrics volume 44, Article number: 102 (2018)
“Dosage
Associated with IVIG in the initial treatment, ASA anti-inflammatory dosage varies from 80 to 100
mg/kg/day in the USA to 30–50 mg/kg/day in Japan, subdivided into four doses [136]. Then, 48 h after
defervescence, aspirin can be used at an antiplatelet dosage: 3–5 mg/kg/day. The duration of treatment is
6–8 weeks in KD patients without CAA. However, in patients with CAA, antiplatelet therapy is continued
until resolution of the lesions or indefinitely in case of persistence.”
20. METABOLIC EMERGENCY pediatry : active principle example
arginine cloridrate
Sodium benzoate
Sodium fenilacetate – sodium fenilbutirrate
carnitin
Examples of some pharmacetucial forms prepared in pharmacy galenic lab ( non sterile ):
Fig. n 13 envelope of prescripetd powders
Fig. n 14 cartine-ENVELOPE containing a dose of drug ( as pharmaceutical form)
Eccipients: amido mais, lattose or other
21. Fig. n 15 Phb ( pediatric envelopes)
Preparation ( only for registered pharmacist): calculate the API needed for requested number of envelopes
add with the eccipient needed.
Mixing well ( with geometric diluition methods )in mortar with pestel for the time needed to get a really
mixed powder ( it can be used a little part of alimetar colour to veryfy the procedure).
The divide into the all encelopes : weighing every single one.
Verify also watching the all envelope before close : to verify the amount in visual method.
Close the envelope, label, add the prases : narcotics, and put at distance form children.
Other kinds of preparation:
Powders :Activated charcoal sachets 30 gr -5 gr -1 gr as antidothes for emergiencies department.
Procedure : weight the AC for single sachets , fill, close , label
Other example : caffeine envelopes for newborn
Fig n 16
22. Paediatr Drugs. 2001
Caffeine citrate: a review of its use in apnoea of prematurity
A M Comer , C M Perry, D P Figgitt
“Caffeine citrate was generally well tolerated by neonates in clinical trials and it decreased the incidence of
apnoea of prematurity compared with placebo. It has demonstrated similar efficacy to theophylline, but is
generally better tolerated and has a wider therapeutic index TI . Caffeine citrate should, therefore, be
considered the drug of choice when pharmacological treatment of apnoea of prematurity is required”
Fig. n 17 example of cps Flecainide pediatry
23. Fig. n 18 Tiopronin cps chelant agent, remove cistineexcess from urine
Fig. n 19 Lutein 20% cps antioxidant for retinite pigmentosa
Fig. 20 pediatric cps or oral solution
Fig. n 21 oral solution
24. Fig. n 22 Omeprazole
Of interest the profile related PPI : related the gastroresistance needed:
Omeprazole
Neal Shah; W. Gossman. Feb 7, 2023.
Continuing Education Activity
“Omeprazole should be ingested 30 to 60 minutes before meals. It may be taken with an antacids. When
taken twice daily, the first dose should be before breakfast and the 2nd dose before dinner. The cps and
tablet should be swallowed whole, not crushed or chewed.”
Related stomach Physiology it is of interest to read :
Neurogastroenterol Motil. 2019 Apr
Advances in the physiology of gastric emptying
Raj K. Goyal, Y. Guo, H. Mashimo
“GASTRIC EMPTYING IN THE INTER‐DIGESTIVE PERIOD
In the inter‐digestive (fasting) period, gastric motility designed to clear the stomach of undigestible
residues. It is characterized by a cyclical motor activity called the migrating motor complex (MMC). The
MMC is divided into 4 phases. Phase 1 lasts approximately 45‐60 minutes, during which the peristaltic
pump exhibits electrical slow waves that are not associated with the muscle contractions. Motor
quiescence is due to tonic inhibition of the motor activity. Phase 2 is associated with slow waves associated
with frequent phasic contractions. Phase 3 (also called “activity front”) is characterized by a front of large
amplitude contractions, lasting 5‐15 minutes that march toward the pyloric sphincter. The phase III of the
MMC is neurally mediated and is independent of the slow waves.”
25. GASTRO -RESISTANCE rigid capsules and DELAY RELEASE
Some API are gastro lesive ( fans) and some other are inactivated at PH gastric ( omeprazol and other PPI,
pancreatin).
Budesonide for example need an intestinal release.
Fig. n 23
Fig. n 24 nitrazepam pediatric cps
Related the Capsule as pharmaceutical form in pharmacy :
very used in galenic labs , this can mask odour and taste of various API
This can dissolve themselves in GI tract , and can be easlity prepared in pharmacy also with manual
ecapsulators.( low cost even if imply pharmacist time to produce) .
About in 15 minutes the hard gelatine capsule dissolves in the stomach.
There are 3 kinds of gelatine cps : hard cps, gastro resistence cps, prolonged or delayed release cps.
There are cps of gelatin or idrossipropilmetilcellulose (HPMC = ipromellosa) (V-caps), plus colorant and
mattifying.
This can be filled with API and eccipient particle acido resistance coated or covering the capsules after
filling the API+ eccipient with specific acido resistance treatement.
26. In every way It is necessary to consider that :
acido resistance cps are not gastro resistance , because the acido resistence cps dissolve themseves in
about 30 minutes at PH acid like the stomach.
Delay release capslues are diffrent from gastro resistance .
For this reason it is necessary to consider some concept:
In the GI tract there are various PH environment :
gastric PH 1-3
duodenum 5,6-8
Small intestine 7,2-7,5
Colon 7,9-8,5
In article : Dan Med Bull. 1999 Jun
Intraluminal pH of the human gastrointestinal tract
J Fallingborg
Is reported :
“The intraluminal pH is rapidly changed from highly acid into the stomach to about pH 6 into duodenum.
The pH gradually increases in the small intestine from a pH 6 to about pH 7.4 in the terminal ileum. The pH
drops to 5.7 in the caecum, but again gradually increases, reaching a pH 6.7 in rectum.”
So the ACIDO RESITENCE caps are not to be considered as gastro resistence because in 30 minutes this
start to realese API in gastric environment .
The italian pharmacopea for gastro resistance require AT LEAST 1 hour of integrity in HCL 0,1 N solution
under mixing.
Then in phosfate buffer at 6,8 ph they must to disaggregate in 1 hour.
The classic hard gelatine capsule start to disaggregate in 15 minutes about.
27. For preparation of gastro resistance capsules can be used according National italy tariffary in use :
a) capsule in other capsules method : prepare normal gelatin capsules with inside API and eccipients
then put inside this into other acido resistance capsules of superior measure
CPS acido resistance HPMC : 30 minutes resistance in acid environent + 15 minutes normal
resistance of hard gelatine = tot 45 minutes
There are experimental proof about efficacy of this method
b) Prepare a normal gelatin capsule with API and eccipient inside and then, after closing threat with
cellulose acetoftalate 8% in aceton ( there are instrument to do this . This proceure Must to be
repeated at least 2 times : for 30-40 sec in the first step and 20 sec in the second then filtered with
gauze ).
Doi: 10.4025/actascihealthsci.v35i2.14581
Acta Scientiarum. Health Sciences Maringá, July-Dec., 2013
The importance of coating standardization in gastro-resistant capsules produced in magistral pharmacy
Suelen Cristina Franco, Flávia Cristina da Silva, Marcela Maria Baracat, Rúbia Casagrande
Janice Aparecida Rafael and Daniela Cristina de Medeiros
“it was observed that the cps coated with cellulose acetate phthalate 10% complied with the
pharmacopeia’s disintegration specifications required”
Fig n 25 from Santarelli E.
28. Other interesting method:
using an ACIDO RESITANCE capusle but using as eccipient METOLOSE 90SH hydroxipropil metil
cellulose HPMC at high viscosity ( at 10%) in order to increase the global acido resistance ( see
Bettiol) or metilcellulose with similar viscosity.
This because in the acido resistence cps the closing system is not able to stop the acid entrance in
the capsule.
And in article : Enteric Dissolution Enhancement of Engineered Gastro Resistant Omeprazole
Tablets usingHydroxypropyl Methylcellulose Acetate Succinate 2021
Sagar Kumar Mohapatra , Rudra Narayan Sahoo, S.Mallick , Rajaram Mohapatra : is reported
“Omeprazole gets degraded in the stomach;to prevent this enteric coating was done employing
HPMC. This formulatory approach can be transferred to the local pharmaceutical industries.”
dealyed release capules : is used EUDRAGIT type RL to cover capsules produced.
In article : Study of a delayed-release system for hard and soft capsules coated with eudragit® s100
acrylic polymers
Luciana Arantes , Soares Eduardo Crema Universidade Federal do Triângulo Mineiro, Brasil
Acta Scientiarum. Health Sciences, vol. 42, 2020
Is reported :“The findings demonstrate the pharmaceutical application of the Eudragit. S100 in the
modification of the coating and the preparation of a delayed-release system of hard and soft
capsules, thus enabling ileal release of active ingredients.”
Fig. n 26 From T.QUINTEN
29. Pancreatin cps : is needed gastroresistance to avoid inactivation of the API
(Units UI for mgr)
It is necessary to verify in the composiyion of requested CPS to verify the composition in
AMILASE, PROTEASE, LIPASE.
Eritromicin cps : because eritromicin base is gastro sensible it is necessary to use gastro resistance
cps.
Other kind of cps : Veg caps , for consumers that have dietary restrictions against the consumption
of animal byproducts
Procedure to prepare hard cps in galenic lab ( only for registerd pharmacist ) :
according the amount of API in one single cps use the righy size of cps , verify if needed a normal
hard gelatine cps or gastro resistance or delay release based on the API .
Calculate the global API neded for all the cps required , Based on the number of cps asked by
physician
Using the volume method : volume filling for 1 cps X total n. cps to be prepared ( V TOTAL)
Add eccipients ( in example cellulose microcristalline or other ) to the API since volume total with a
cilinder .
Mix very well for the time needed.
Using encapsulator , after charging the empty gelatin cps , open and fill the cps with the really
mixed powder ( API + eccipients): use the method at fall.
Verify all cps are equally filled then close them according the procedure .
Perform the quality control required by pharmacopeia : number of dosis forme, mass units
uniformity and all required , then label.
In is important to SIEVING of the powders : API and eccipients, in order to avoid aggregates
For Volume tipe 0 cps = 0,68 ml for 1 cps 100 cps = 68 ml capacity
Mix THE POWDERS: mortar and pestel, V type automatic mixer, Container shaked manually
30. Between the Eccipients for hard gelatin capsules :is is possible to see :
diluents
glidants
lubrificants
disgregants
tensioactives
for igroscopic API ( es ammonio clorure ) it is used colloidal silice
Fig .n 27 eccipient
Right MIXING procedure of the powders : API and eccipients : using the geometric method
diluition
Mortar and pestle or mechanical powder automatic systems ( 3D type or V typer o other )
Fig n 28
31. Fig n 29
Use of alimentar colour to chek the level of mixing
Filling procedure of cps : to be used the volume methods (or weight method if already
validated).
This because the variuos powders and API used have different apparent density.
It is needed to beat the cilinder with the powder three time before read the level.
Saggi previsti dalla FU XII edizione
Capsule
Uniformità delle unità di dosaggio 2.9.40
Uniformità di contenuto 2.9.6
Uniformità di massa 2.9.5
Dissoluzione 2.9.3
Disaggregazione 2.9.1
Conservation of the cps : in dry and fresh environment , no more then 30 grades
Other examples of cps for radiology : cps of sodium bicarbonate and cps of citric acid as MDC.
32. Spatolated cp: in example sildenafil 25 mg , API is first accurately mixed with a specific base , then
moistened with other specific product then spatolated into the apposite instrument.
Innovations: the 3 D printing systems
c)
Fig n . 30 from https://doi.org/10.1016/j.ijpharm.2019.118581
33. Some lab glassware or instrument :
Fig. n 31 glass beker
Fig n 32 cilinder
Fig. n 33 graduated pipett
34. Fig. n 34 cream jar
Fig n 35 spatule for cream and ungents
Fig n 36 alluminion tube for gel
35. Fig n 37 suppositories moulds
Fig. n 38 sieves for powders
From 39 2012 Chemical & Pharmaceutical Bulletin DOI: 10.1248/cpb.60.624
36. Fig n . 40 solutions
In example : acetic acid solution 5% for ginecologic ambulatory
Preparation : add the water then the acid needed , then mix well , fill the bottle and label
Write : external use, corrosive .
KOH solution and TCA solutions for dermatologic use
Boric alchool 3% in ETOH at 60%
In example DTT solution for trasfusional wards :
Fig n 41 ditio treitol
Preparation : PREPARE BEFORE pbs buffer with water required , then measure the amount of DTT
necessary and add to the PBS buffer. Fill the bottle and label , to be stoked at 2-8 centigrades.
Fig n 42 strong lugol solutions- composition: iodine sublimate, potassium iodure and purified water
37. Fig. n 43 peroxide of hydrogen solution
Ipoclorite solutions : ex 0,05% for wound disinfections
Fig. n 44
Other example of solution preparation : Toluidin 1% solution for detect oral lesion, Ipoclorite solution in
water for dentistry
Fig n 45 Toluidin blue
38. Fig n 46
Fig. n 47 Acetic acid : used in ginecology ambulatory
JOULIE SOL ORAL: sodium fosfate bibasic dodecaidrate 17,04 gr , ac fosforic 85% 5,68 gr , water qb 100ml
For ipofosfatemia and ipercalcemia
TCA solution : tricloro acetic solution 50 % in dermatology
39. J Clin Pharm Ther. 1992 Jun;17(3):185-9. doi: 10.1111/j.1365-2710.1992.tb01291.x.
Stability of captopril in some aqueous systems
Y Pramar , V Das Gupta, C Bethea
“Captopril solution prepared in water using tablets was stable for about 20 days when stored at 5 degrees
C, and that prepared using powder in water was stable for about 27 days.”
Captopril 1 mg/mL Oral Solution
Amanda Ye, RPh, PharmD Medical Director–Health Professional Digital Education
Staten Island, New YorkUS Pharm. 2024;49(2):59-60.
“Stability: The USP default beyond-use date for preserved aqueous oral liquids is 35 days. However,
according to captopril stability studies, this formulation is stable for 14 days at controlled room
temperature and for 56 days when refrigerated.”
GTT : in example nifedipin gtt
SHOSHL’S SOLUTION WITH OR WITHOUT POTASSIUM for nephropatica patients
40. Fig. n 48 suspensions
Suspension as pharmaceutical form : dispersion of a solid (size from 0,5-1 to 100 micrometer ) in a liquid
( the solids particle are Insoluble).
This pharmaceutical form are easy to be swallowed, mask unpleasant taste , viscosity adeguate .
The oral suspension with API powders are mixed i mortar and pestes with an suspendig agent then added
the acqueous phases ( with the rest of idrosoluble eccipients) to get the final volume .
In use Flocculants agents ( repulsion force ): elettrolites, tensioactives , polimers ( cellulose derivates,
gomme adragante, arabica, gelatina)
Other eccipients used can be preservatives , antioxidants, aroma and edulcorants.
Are available ready for use basis for oral suspension whit right stability during time.
Crucial to label the preparation adding the phrase: “ shake before the use “
Fig. n 49 propranolol beta bloker - pediatric cps or oral suspension or solution
(It is possible to use ready for use basis for oral suspension available in commerce )
Quality control for suspensions:
Granulometry, sedimentation and re- suspendibility, viscosity, density ,accelerated aging, API tituli
41. Other example SULFADIAZINE ORAL SUSPENSION : use the API in cp , mortar and peste, then add water
To better solve API ( ex 40 ml ) , mix well and add base ready for use to the final volume .
Verify there are not aggreates before fill the bottle.
SILDENAFIL orasl sup. 2mg/ml in pediatry for pulmunary artery ipertension
Fig n 50
Bosentan oral solution : pediatric pulmonary arterious ipertension
42. Fig n 51 Captopril oral suspension : generally stable 14 days
PEDIATRIC PHARMACOTHERAPY
A Monthly Newsletter for Health Care Professionals from the
University of Virginia Children’s Hospital Volume 15 Number 2 February 2009
Use of Ursodiol in Infants and Children
“Ursodiol was approved by the Food and Drug Administration (FDA) in 1987 for
the prevention and treatment of gallstones and for the treatment of primary biliary cirrhosis in
adults. Although not approved by the FDA for use in pediatric patients, ursodiol has been used
for two decades as adjunctive therapy in the management of children with hepatobiliary
disease.
Ursodiol is marketed as Actigall ® (Watson) and as a generic product in 300 mg capsules. It is
also available from Axcan Pharma in 250 mg tablets (URSO 250®) and 500 mg tablets (URSO
Forte®).1,3 Several extemporaneous formulations for oral suspensions have been published, with
ursodiol concentrations ranging from 10 to 60 mg/mL.
As described previously, it is essential that all care providers, including family
members, be aware of the need to check the suspension concentration to ensure that the
correct dose is being administered.”
43. Fig. n 52 Acid ursodesossicholic
Fig. n 53 emulsions ( methods ENGLISH and Continental)
Emulsions as pharmaceutical form : a liquid , dispersed phase into other liquid , disperdent phase not
mixable whit it
Use : oral and external : emulsion of olea of castor oil, bases for skin emulsion
Preparation : set the tensioactive and its concentration, dispersion of the phases, dissolution of idrosolubile
component in water phase and the liposoluble in olea phase, dissolution of tensioactive in acqueso phase
or oleous .
Are used mechanical mixer, ultasonic, omogeneators
Modifications: creaming, flocculation, coalescence and rupture
44. Fig n 54
Fig. n 55 tensioactive
Fig n 56 gel
GELS in galenic labs:
colloidal dispersion,the disperse phase impeded in the movement hold the disperdent phase inside.
(Gel idrophila or idrofobic)
Gelificat used at 0,5-2% , the methods of preparation depends on the kind of gelificant used
Carbopol must to be slowly added in water under mixing, gelatin need hot water, metilcellulose need hot
water and mixing.
Polimer used: gomma guar, pectine, alginate, carragenine, gomma xantano, gelatina , amido, carbopol,
natrosol ( idrossietil cellulosa), HMPC
45. Are needed preservants to avoid microbial contaminations.
Es.of formulation LAT GEL for wounds is a topical anesthetic : of Lidocaine, Epinefrine, , Tetracaine that is
used in conjunction with suturing patients in hospital emergency rooms, CALCIUM GEL ( used in hospital
emergency ,antidote for fluoridic acid burns ).
Calcium gel composition- ingredietnts : calcium gluconate , lidocaine cloridrate , propile glicole , idrossietil
cellulose
Nipagine, PPI water
Other example : xylocain viscose oral gel 2% for oncological patient ( after radiotherapy or other )
API at 2% , eccipient idrossetil cellulose in preserved water .
Creams:
multiphases, 2 phases lipofilic and acqueous
2 types : water in oil or idrofobe , occlusive , greasy and oil in water or idrofilic , washable with water
Ex cetomacrogol base cream : vaselin, paraffin, alchool cetosterilic,macrogol 1000 ,water
Fusion first of the 4 component then emulsioning of the water at the same temperature, mix well.
Unguents :
semisolids, that melt at body temperature
They can be idrophobe ( for dry skin or lesions , increase idratation, are emollient ,occlusive) this are more
persistency then cream , or hydrophil (in ex PEG based , non occlusive)
Hydrofobe: vaselin, paraffin, vegetal oil, cere
Unguent that absorbe water : emollient , occlusive : lanolin, sorbitan ester
Ex macrogol base unguent FUXII ED peg 4000 40 gr + peg 400 60 gr, heat at fusion temp then mix since
solidification
Benzil benzoate 20% unguent for SCABBIA
46. Fig n 57
Benzil benzoate
Ittiol unguent
PASTE
Usually this contain at least 20% of solids. Generally are used oleose basis and it is required to heat up
LASSAR PASTE : use mortar and pestle, micronizate well the powders , sieve ,melt vaselin and incorporate
in portion the mix of the powder , mix well since cooling dawn. Used in eczema
SUPPOSITORY : ex glicerole supp , 2,5 gr - glicerolo 85% 90% and ecc. 10%
OVULA: in ex lattic acid ovula, composition ac lattic, gelatin, glicerin , water
RECTAL MICROCLISM : diazepam , anticonvulsivant in emergency pediatry
Ex of formulation API needed plus clisma base ready for use.
COLLIRIA :
this preparates need sterility , so it ca be prepared only if the lab meet the normative rules prescriptions.
Are used specific software for the calculation, is needed a bilance with precision of centesime of mg
Needed white chamber or isolator according full NBP and GMP, whit ZONE A,B,C,D, in sovrapression,
closing system that avoid simultaneous opening of the doors. Needed chesk system for Pressure .
( It must to be verified regularly ) , in a HEPA hood vertical flux .
Before the hood use and after : treat with ETOH 70 % the inside of the the working environment.
47. (Used also wood UV ligth ).
The pharmacist must use mask ffp3 , sterile sovra shirt, sterile gloves and all is required.
All operation are performed in sterile conditions, with final filtration with filter 0,2 micron.
Are used sterile final bottle opened under the hood.
Conservation of the final product 2-8 grades.
They need strictly sterility, specific tonicity ,PH, viscosity adeguate, preservation for microbial
contamination
Es cyclosporine colliria 1%
Fig. n 58
Diluition of the resitered drug , in artificial tears. Conservation 30 days at 2-8 grades
Amfotericine B colliria 2,5 ml / ml
Fig. n 59
Reconstituition of the drugs Fungizon 50 mg with 2 ml Water PI , then remove in sterile way 1 ml
And diluite this solution with 9 ml PI water. ( see SIFO formulation)
48. To better understand the need of strictly sterile conditions to be followed for this kind of pharmaceutical
form it is Interesting to read this article : Wolters Kluwer HEALTHMAY 29, 2015
Sterile Compounding Oversight Changes Since the 2012 Meningitis Outbreak
In 2012, contaminated injections made by a compounding pharmacy in Massachusetts sickened 751 people
in 20 states and led to the death of 64.
“Since then, new laws and increased regulations have tightened oversight of compounding pharmacies to
provide greater protection of patients and limit the possibility of another outbreak.”
Other device and instrument used in galenic labs:
Fig n 60 fusion point
Fig. n 61 baign marie
49. Fig. n 62 classic chemical hood
Fig n 63 Sieves for powders
CHAPTHER 5 Practical project
In this part are analyzed the italian normative rules ( NBP ( NORME DI BUONA PREPARAZIONE) ) and the
semplified as DM Salute 18.nov.2003 norme di buona preparazione” applied by law as mandatory in the
galenic lab setting inside the pharmacy ( public, private – hospital , comunity ).
(NBP or GMP good manifacturing practice)
The GMP philosophy are based essentially on :
documentation of all the process , registrations, every phases of the process, activity , since the single
operations.
50. - team must receive an adeguate practical training , formalized , WRITTEN REPORT
-responsability must to be clearly identified and documented, under the responsability of the director
-Quality of thte API and eccipients must to be certified
- cleaning and sanitization procedure ( lab, instruments, glassware)
-Regular check of the instruments, documentation
- process validation, procedure of
- NC non conformity :management of this
So In italy by law the pharmacist that work in a galenic lab. according DM 22/06/05 must to follow or
the FULL NBP of ITALIAN FU ( more complex) or DM Salute 18.nov.2003 ( if not sterile magistral
preparations or officinal reduced scale )
The pharmacy that prepare non sterile magistral formula NSMF or officinal reduced scale can follow or full
NBP or semplified NBP .
Instead if prepared the sterile products , toxic preparates , poison molecule , anticancer drugs and
radiodrugs, it must to be used biological hood : it is mandatory to follow full NBP .
For non sterile products NSP it is possible in italy to deviate from full NBP and to follow the semplified
rules if it is possible to keep under control all the process , prooving it. ( quality efficacy , safety depends on
organization and consistent control) .
First NBP was introduced in (FU IX ed.)1989.
In the chapter 795 of USP, pharmaceutical compounding of non sterile products NSP , related the
difficulty of the preparations, its stability , storage conditions, dosage form FF, complexity in
calculations,sistemic, topic use, risk level for pharmacist, damage risk for patients are classified 3 general
situations :simple compounding , moderate and complex compounding .
It is request to produce the master formulation records and also the compounding record.
Like NBP the USP rules are based on the quality of the final products and on the documentation of all the
process.
Some preparations at high microbiological quality need to be prepared in zone with HEPA FILTER HF
according the regulatory rules in force .
A translation of Semplified NBP an its phylosophy (DM Salute 18.nov.2003 ) and their meaning are
reported
Results :
translation of the meaning of the NBP procedure semplified DM 18/nov /2003
Application field :( non sterile magistral NSM and officinal forms reduced lots) for hospital and comunity
pharmacy
51. medical prescription for magistral formula MF and Pharmacopeia for Officinal reduced scale production
Preliminar evaluation about opportunity -possibility to prepare the galenic requested or needed
( avaiability of API and eccipients)
definitions: magistral formula, officinal, reduced batch RB
lab hygienic written procedure, frequency of this ( provided by director of the pharmacy or lab.
Responsible).
lab area: it must to be adequate to the kind of the galenic products produced, ceiling and walls wahable
it can be in a separate room or not separate inside the pharmacy.
Instruments: mandatory list according PHARMACOPEA uff. ITALIAN table n. six , the measure insntrument
must to be verified in regular way. The refrigerator must to be cleaned.
Containers ( and related certificate of conformity to pharmacopeia requirement of the primary
contaniners PC).
Raw material RM : chemical denomination, date of arrive into the pharmacy lab , batch number ,
expiration date or date of retitulation, certificate of analisys CA signed by producer ( according
pharmacopeia quality requirement), conservation condition or use, date of first use . ( it is necessary a
register of raw materials , eccipients and API, with a progressive numeration).
The empty container of the raw material must to be keeped for SIX month after final use.
Fulfillments ( preventive and after setup ) to the preparations .
Prescription verify, according the normative requirement , sign of phisician, iperdosages verify (
according table n. 8 pharmacopeia italy), Incompatibility verify , the possibility to prepare into the lab.
After setup: to be writed on the prescription the progressive number of the preparation, date of the
praparation, expiration date, the eccipients used, precautions and cautions, then label must to be attached.
Sign of the pharmacist in the label , on the prescription or in the working sheet
Labeling – batch numb. and expiration date, composition qualitative quantitative , API
Eccipients , date limits for use, precautions, storage condition
Price ( for comunity pharmacy)
Douments storage - ( time ) , emplty bottle .
The written prescritption must to be keeped into the pharmacy for 6 month and the same working sheet.
(working sheet).
The prescription of narcotics must to be keeped in pharmacy for the time required by normative rules NR.
Quality control CQ : right following of the procedure, organolectic characteristics, control of the pakaging,
sealing of the container , right label compilation, mass uniformity accordinf the FU acceptation limits
52. A copy of the label must to be attached to the working sheet WS for the documentation
Documentation : of the working space, instruments, raw materials RM
Expiration time ET of the drugs prepared : accordin FU requirement : 30 days that can be prolonged to 6
month acording chemico -phisical microbiological stability documentated by official informations.
Mandatory equipment and tools in pharmacy a ( TABLE N 6 pharmacopea italian in force)
1. balance sensitivity to the mg , scale = 0,001 g, loading capacity at least 500 g or in alternative way 2
different balances , 1 with a sensitivity at the mg (d=0,001g) with a loading capacity at least 50 g and the
other with sensitivity at level SL of 0,50 g (d=0,50 g) with carry load at least of 2 kg.
2. Bain marie BM or other equipement that can assure ,in heating , temperature since to 100 °C.
3. Fridge able to assure the right storage conditions SC according the pharmacopeia requirement
4. Point of fusion equipement . ( to test raw material)
5. chemical glassware, graduated, sufficient for the normal execution of the preparation.
6. percolator – at empty Concentrator (1).
7. an encapsulator (2)
8. a Tablet press (3).
9. a powder Aspiration system AS (4).
10. moulds or plastic valve for ovules - suppositories (5).
11.tools and devices necessary to guaranteee sterility of the preparation (6)
Beyond the reported lab instruments , the pharmacy must have all other instruments,equipements ,tools
materials, products and reactive adequate to the number end to the nature of the preparations usually
performed and of suitable tools for their check to be done according the Pharmacopeia FU indications.
Pharmacy that execute injectable preparations IP must have also materials, equipements, and tools
essential to this kind of preparations an for all the control expected by pharmacopeia for this specific kind
of preparation.
53. Note:
1)– mandatory for pharmacy that prepare extracts . they must to be of marterials and adequate dimension
to the volume and related the preparation that must to be executed .
(2) - mandatory for the pharmacy that prepare the capsules CPS
(3) – mandatory for the pharmacy that prepare the tablets .
(4) – mandatory for pharmacy that prepare tablets, capsules ,CPS, teas sachets .
(5) – mandatory for pharmacy that prepare the suppositories or ova .
(6) - for pharmacy that prepare the sterile products.
CHAPTHER 6 DISCUSSION
As reported in this work are clear the advantages to produce some kinds of drugs in a galenic lab.
Even the industrial epoca , with the pharmaceutical industry PI increase , the industrial production of
drugs Was rapidly developed and so was reduced or stopped the production in the pharmacy galenic labs
this process was due to The complexity of the process to produce with an high quality the finished drugs in
the amonut requested by the hospital and by the patient need .
But the same some condition need to mantein this procedure : for magistral formula MF prescription
(single patient based) and for the production of officinals reduced scale , disinfectants, reagents or other
kind of product into the hospital or asked in private pharmacy.
It must also to be remembered that during the LAST C-19 PANDEMIA one of the main producers of
antispetic gel hands and alcoolic solution was the hospital pharmacy in their lab as well as in the private
pharmacy.
The industry in fact ,in this situation , was not able to provide ready to use a great amount of this
product needed in few time for the public safety. (3)
The galenic hospital lab in the public hospital guarantee this production and the safety of the patient and
healtchare professional HP.
But novelty in filed of galenic lab are crucial even if an ancient origin discipline :
Today The technological innovation (TI) make possible to better cover the need for today drugs
shortcomings.
54. In this BOOK it is submitted a new technology usefull in galenic labs : the 3D PRINTING SYSTEM As an
innovation for quality and global efficiency of the process.
About the normative rules in galenic laboratory :
Comparing full NBP to the reduced DM 18 .11, 2003 it is possible to verify that NBP require separate or
separable locals , chek by other pharmacist vs the one that prapare the drug in lab., and required as
mandatory the written procedures WP accreditated .
For the cited Decreto instead it is not mandatory complex quality check on final products, no mandatory
written procedure are needed ( even if suggested): this last are more easy to be followed also for lab that
not prepare the sterile products.
It is clear that innovation in field of galnic imply a great management system to cover the cost of
instrument.
The same a managerial method make possible to rule the pharmacist involved related
The formative programs, continous updating of the knowledge , API and eccipient ordering activity
Monitoring of the costs .
About SAFETY :
It is clear that all galenic lab activities must to be performed observing the chemical risk safety rules as well
as safety law for the pharmacist lab worker, using individual DPI and collective PROTECTIONS DISPOSITIVE
CPD and other needed .
Are To be Followed all procedure related.
Before start the preparation it is necessary read techincal and safety sheet of materials used.
Use anti split kit if accident.
Formative course are fundamental .(it must to be documented), CHEMICAL RISK course .
See italy law 81/2008 abour safety for workers.
55. Here are reported Some Simply rules in lab :
prepare one magistral formula or an officinal formula one at time .
use DPI needed
use collective protection system as needed
before start the preparation study the components and procedure , literature or technical texts, normative
rules, professional website and org.
Verify pharmaceutical form and dosage
Verify compatibility between API and eccipient , related way of subministration
Attention to acronimus and abbreviations
Verify that the magistral formula are signed by physician authorized
Verify errors in the prescription or data incomplete
Verify age or weight or body surface if needed
ask to other pharmacist information also if possible.
look at the safety and technical sheet of ingredients
verify instruments
verify dropper = 20 gtt water for millilter
repeat the calculation two times
not error in volume measure level or in weighting
attention to the limits accepted by pharmacopea ( ex + - 10%)
not interruption
keep calm
write data of first use for eccipients and API
verify instrument of measure and other instruments used, chemical hood and other
register the lavoration steps
perform quality control
not give drink to the strong acid
pay attention to electric instruments
56. right hygiene procedure ( hands) and sanification of enviroment
pay attention to drugs with narrow therapeutic index ( where the pharmacological effect are near to the
toxic ones)
pay attentions at maximum doses for adults and children ( tab 8 FU XII ED and accordin pediatric manuals
like BNF for childrens)
in mixing powder use the geometric method
in mixing PAI and eccipient use alimentar colour to veryfy the complete mixing expecially for very active
drugs
in oral dispersione ans syrup of very active drugs : crucial to add label with the phrases: needed to mix
before the use .
Similia similibus solvuntur
Pay attention to the microbial contamination risk, preservative use
Pay attention to the poison raw material, caustic or corrosive or strong acid.
Pay attention to the dosage of narcotics
Pay attentions to the flamable substantie and free flame
Related stability verify FU , literature , or stability proof
API : this can be used as pharmacetutical powder or from registered drugs ( tablets, cps and other ) ,
fitoterapic extract
Related the Raw materials:
EU reg. REACH registration evaluation , authorizationand restriction of chemicals and CLP classification
labeling of chemicals.
Register the raw material arrived , label with the first use, keep empy jars for six month
Verify certificate of analisys , or measure fusion point .
Drug containers: according normative rules, compatible with API and eccipients , verify closing system, use
safety caps for children
57. Of interest the new list classification of Technological operation in galenic lab of pharmacy ( italy ) :
according new italian tariffario Decreto min. salute 22 sept 2017 and Decreto 13 dec 2017: weighed,
heating, filtration, volumetric measure, grinding, dissolution, mixing, ripartition, sterilization,trituration,
pulverization, sieving, analytical test, PH measure, gelification, concentration, extraction, filling cps, and
other.
And about Concentration and other measure or chemico physical factors:
% p/p gr/100 gr % p/ v gr/100 ml % v/v ml/100 ml
Molarity = n. moli/ liter micromol millimol
Normality gr equivalent milliequivalent
Equivalent weight = atomic weight/ valence
Ratio strenght part/part ex 1:20
Unity : in example for sodium eparine ex 250 UI/5 ML
ppm part for milion
Density = m/ vol = gr/ml to search volume V= gr/density
Weight = vol x density
Water density 1 gr/1ml
Solubility: concentration of a solute in saturated solution at a determinate temperature.
Solubility, velocity of ( increased by shaking, increase in temperature and molecular size, PH)
The temperature increase molecular mobility
HLB balance- hydrophilicity -lipophilicity
polarity
Cristalline status : amorphus or cristalline
58. PH= -Log ( conc. H+)
Fig. n. 53 litmus paper
Buffer solutions, acid solutions, basic solutions ( to set PH range )
Temperature( ATTENTION TO TERMOLABILE API), attention to API to be conserved 2-8 grades
Boiling point ( water) , fusion temperature ( suppository eccipients )
Storage temperature TA, < 25 grades , 2-8 grades
Humidity content, dry
Cristallization water
Size of powder, porosity, apparent volume
State of materia: solid, liquid, gases
Granulometry ( powders)
Velocity of dissolution
Flocculation -deflocculation suspension , sedimentation status
59. Tonicity, isotonicity ( 0,9% nacl P/V) , ipo ( ex 0,45% nacl ), ipertonicity ( ex 3% nacl) , osmotic property
Plasma osmolality = 280 mOsm/kg
Viscosity
Surface tension
Additive presence: tensioactive, complexant
Vapour pressor
Sobstitution factor : for suppository : 1 gr of API shift f gr of eccipient
Where f= density eccipient/drug density
About UDM measure units: SI international system
Gr, centigr , milligram, kilogram
Ml , liter , centiliter
Grades
kind of Water in galenic lab:
Depurated
PPI water , sterility, pyrogen remove
Parenteral : pyrogen, endotoxins ( LAL test )
1 ml water = 20 gtt
60. Alchoolic grade : % v/v
alchool diluition
Fig. n 54
Liquid diluition :
dil 1:10 = 1 part + 9 part diluent
other example :
500 ml at 15% solution to be diluited to 1500 ml , how will be % final of the diluited solution?
Volume initial x % initial = vol final x % finale
500 ml x 15% = 1500 ml x X X= 5%
61. Symple syrup FU
Saccarose 66,5% p/p water 33,5%
An example of medicated syrup :Niaprazin syrup :
API, K sorbate, tartaric acid , water PI, Saccarose , aroma
(Or using ready for use basis)
Heat PI water then solve Ksorbate and tartaric acid ,coll dawn, add API an aroma and mix well.
So add the simple syrup to final volume .
Fig. n 55 niaprazin
The Calculation: crucial step in laboratory
ratio strenght , proportion, conversion of measure unit, %
Significant digit, rounding
Prefix: milli gr , centi, deci , gr ,deca gr, hetto gr, kg and milliter ,centilt, decilt, liter
62. Other to be take in consideration :
Simbols , acronimus , abbreviation
Pediatric dosage : weight based, body surface , age based
Narcotics free basis and salts : transformation calculations
Prescriptions: physicians, specialist, veterinary, in label , off label, orphan drugs
Repeable prescription , not repeteable, limitative prescription, narcotics , poison substantie , officinal
formula
Reduced scale production, limits
Type of products: narcotics , poison substantie based, doping , corrosive, caustic, acid, flamable products
It must to be followed the specific normative rules
63. Fig. n 56
About “POISON ” in lab galenic : substantie that are listed in Tab n. 3 F.U.I. XII IT, and also substantie
classified as “letal” = labeled H300, 310 e 330.
64. General Labeling Attention phrases :
keep not accessible to children , mix before use, poison, under narcotics rules, keep in refrigerator ,
veterinary use, doping et other
Galenic exception rule : in Italy state council sententia n. 4257/2015 make possible to unpak registerd
drugs to prepare magistral formula ( for different dosages and for therapeutic need )
Kinds of Eccipients:
diluents,adsorbent,disgregants, polimer for release, wet eccipients, sweeteners, lubrificants, glidants ,
binders, tensioactives, humectants, viscosifying, antimicrobials ,chelants, antioxidant et other.
They must to be inert vs API, Organism and vs pakaging.
Sterilization methods:
filtration, heat ( humid and dry), radiations( UV, ionizant ), chemical methods.
Indicators of sterilization( chemical, biological)
Tecnical Balance characteristic : max payload , sensibility ( the smaller value that can be measured ),
precision( reporducibility ) , accuracy ( mrasured value vs real)
Innovation in galenic field : trends
Oral suspension : introduced in the market of already for use basis products ( or for syrup): various
producers into the market ( also for gatrosensible principle active )
Excipient basis ( powders) redy for use, for humans and also for veterinary
Ready for use Bases for spatulated tablets
Shifting ,when possible, pediatric prescription of capsules into oral suspension
Ready Basis for cp
Topical veiculy ready for use , transdermal
Introduction into the market of Estract already titolated of cannabis CBD THC (no more needed HPLC
titulation of the final preparation whit complex analytical intruments ). The extract is diluited with vegetal
oils. The amount of extract is weighted ( gr ) then bring at final volume with a cilinder.
65. Vaporizators
Micronizzators, mixer
V type powders mixers
Introduction of spatolated cp methodology
Dose unit systems, Robots: for sterile galenics
3D printing Systems for capsules and cp
Advanced software for lab. Management( order, calculi , labels, raw material management, working sheet)
Procedure for Shorteness of registered drugs , orphan drugs
Software for global management of the galenic lab
Sterile products : colliria and ophtalmic vitreal injections ( only uder strictly rules), introduced normative
rules for pharmacy
Academy on line
CHAPTHER 7 CONCLUSION
As conclusion of this Book it is possible to say that observing the Italian Reduced NBP rules in an
advanced countries like Italy can be applietd also in the non advanced countries with great benefit for
healthcare of the various kinds of patients.
This rules report general behavior and procedure to be followed by the pharmacist to be sure that the
durgs produced are safe and useful for the patiens or for healthcare org.
Not all labs in the world have the same intruments or level of complex lab ( due by economic avaiability)
but in every lab It is crucial to know the responsability as well as procedure adopeted ( quality control of
raw material RM ,active substantie API , qualification of the pharmacist , traceability of the lots , API,
eccipients and other.)
For this reason it is opinion of the authors that this rules must to be translated in their general meaning
from the italian to the english languages as reported in this work.
The authors submit to the reseachers and pharmacists a new innovative tool : the 3D PRINTING systems
for galenic lab. use : a system that make possible to increase global efficiency of the preparation of
capsules CPS or other pharmaceutical form during a period of drug shortages as today situation.
66. A managerial government of the innovation in galenic field added to the clinical competencies
( clinical pharmacy and pharmaceutica care ) Make possible to provide in healthcare system a great
contribution also in this years.
DISCLAIMER: this work has no any terapeutic intent , only to submit to the international researcher and
reader some interesting concept.
CONFLICT OF INTEREST: no
ETICAL IMPLICATION : considered all rules
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during COVID-19 emergency: A practical experience in an advanced country. Int J Clin
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WASHINGTON STATE UNIVERSITY LIBRARY INDEXED
Kuster -thiel tabelle
Stechiometria Bertini mani
Elementi essenziali farmacocinetica Piccin Birkett
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