Reverse pharmacology is an approach to drug discovery that begins with clinical observations of traditional medicines and then uses exploratory and experimental studies to validate efficacy and safety. It reverses the conventional path of discovery from the laboratory to clinics. Key advantages include starting with clinically tested botanicals, reducing costs and time, and leveraging an experiential database of traditional medicines. Challenges include few success stories adopted by industry. Increased awareness and innovative solutions inspired by traditional knowledge may help accelerate discovery through the reverse pharmacology approach.
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.
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.
This document discusses clinical pharmacy, including definitions, the status of clinical pharmacy in India, the scope and history of clinical pharmacy, activities of clinical pharmacists, clinical pharmacy practice areas, guidelines for pharmacotherapy specialists, clinical pharmacokinetics, drugs that can be monitored through therapeutic drug monitoring, reasons to request TDM, and the responsibilities of clinical pharmacists. It outlines how clinical pharmacy aims to optimize drug therapy for patients through various roles like consulting, drug information provision, and patient monitoring.
The document discusses the process of drug discovery and development. It has 5 main stages: drug discovery, pre-clinical testing, clinical trials (phases I-III), regulatory approval, and post-marketing surveillance. Drug discovery involves screening compounds for pharmacological activity through random testing, serendipitous findings, or rational drug design. Pre-clinical testing involves extensive animal studies to evaluate safety, efficacy, and adverse effects. Clinical trials in humans have 3 phases to further assess these factors before regulatory approval and marketing of the drug. Post-approval monitoring continues to study long-term safety and efficacy.
Reverse pharmacology is an approach to drug discovery that begins with clinical observations of traditional medicines and then uses exploratory and experimental studies to validate efficacy and safety. It reverses the conventional path of discovery from the laboratory to clinics. Key advantages include starting with clinically tested botanicals, reducing costs and time, and leveraging an experiential database of traditional medicines. Challenges include few success stories adopted by industry. Increased awareness and innovative solutions inspired by traditional knowledge may help accelerate discovery through the reverse pharmacology approach.
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.
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.
This document discusses clinical pharmacy, including definitions, the status of clinical pharmacy in India, the scope and history of clinical pharmacy, activities of clinical pharmacists, clinical pharmacy practice areas, guidelines for pharmacotherapy specialists, clinical pharmacokinetics, drugs that can be monitored through therapeutic drug monitoring, reasons to request TDM, and the responsibilities of clinical pharmacists. It outlines how clinical pharmacy aims to optimize drug therapy for patients through various roles like consulting, drug information provision, and patient monitoring.
The document discusses the process of drug discovery and development. It has 5 main stages: drug discovery, pre-clinical testing, clinical trials (phases I-III), regulatory approval, and post-marketing surveillance. Drug discovery involves screening compounds for pharmacological activity through random testing, serendipitous findings, or rational drug design. Pre-clinical testing involves extensive animal studies to evaluate safety, efficacy, and adverse effects. Clinical trials in humans have 3 phases to further assess these factors before regulatory approval and marketing of the drug. Post-approval monitoring continues to study long-term safety and efficacy.
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 GPHF-Minilab is a mobile mini-laboratory developed by the Global Pharma Health Fund to allow for quick and reliable testing of medicines in developing countries. It contains equipment and reagents to test for 90 active pharmaceutical ingredients using physical inspection and thin layer chromatography. Over 800 Minilabs have been distributed across 97 countries. The Minilab aims to address the problem of counterfeit medicines and lack of drug quality testing facilities in many areas. It provides a portable, inexpensive way to screen for substandard or falsified drugs.
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.
Basic aspects of Pharmacovigilance (Clinical Research & Pharmacovigilance).pptxDureshahwar khan
The slides in this presentation mainly focus on History and Progress of Pharmacovigilance, significance of safety monitoring and Pharmacovigilance in India & International aspects.
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.
This document discusses the process of new drug development. It begins with basic research to understand disease pathways and identify potential drug targets. Promising compounds are identified through screening and optimized in preclinical testing, which evaluates safety and effectiveness in animals. If preclinical results are satisfactory, an Investigational New Drug Application is submitted to regulators to seek approval for clinical trials in humans. The drug development process is long and rigorous, aiming to bring safe and effective medications to market while meeting regulatory guidelines.
This document provides an overview of an orientation lecture for pharmacy students. It discusses key topics including the definition of pharmacy and drugs, the scope of pharmacy practice, naming conventions for drugs, pharmacy career paths, pharmacy education, ethics, and good dispensing practices. The lecture defines pharmacy as the art and science of preparing and dispensing medications and providing drug information to the public. It outlines the roles of pharmacists in areas like interpreting prescriptions, compounding, labeling, dispensing, and educating patients. Community pharmacists, hospital pharmacists, and other career paths are also summarized.
This document presents information about pharmacovigilance from Nilesh Jawalkar, including definitions, aims and objectives, types of adverse drug reactions, importance of pharmacovigilance, partners in pharmacovigilance like WHO and national regulatory authorities, how pharmacovigilance works in drug regulation and clinical practice, and the RaPID program. It also discusses contributions that can be made at the levels of clinicians, pharmacists, pharmacologists, and students through activities like reporting adverse drug reactions, creating drug alerts and bulletins, and presenting information through animations. The conclusion emphasizes thinking more about patient safety, using and reacting to concerns, and considering the impact of decisions.
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 provides an overview of Schedule Y, which establishes requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. Schedule Y aims to frame guidelines for clinical research in line with global standards. It outlines application procedures, ethics committee requirements, pre-clinical and clinical data to be submitted, protocol elements, and other rules to ensure safety and efficacy of investigational products. The objectives of Schedule Y are to regulate clinical trials and new drugs in India according to current scenarios and integrate the country into global drug development while improving clinical trial quality.
The document discusses new and old pharmacological anticoagulant strategies. It notes that while new anticoagulant molecules have been introduced to improve strategies for certain conditions, they are often more expensive than older molecules. The document questions whether these new strategies truly provide benefits to public healthcare systems given their high costs compared to older drugs that may have tolerable safety profiles. It argues that a clinical pharmaceutical care approach involving multidisciplinary medical teams can help rationalize costs by aiding the appropriate selection and use of both new and old pharmacological instruments for patients.
Clinical pharmacology is a multidisciplinary science that studies the relationship between drugs and humans. It has a long history dating back to the 18th century. Clinical pharmacologists play important roles in patient care, teaching, and research. Their goals are to improve patient outcomes through rational drug use and the development of safer and more effective medicines. They conduct research studies in humans to better understand pharmacokinetics, pharmacodynamics, and pharmacogenetics which can help optimize drug therapy for individuals.
The document discusses World Pharmacists Day, which is celebrated annually on September 25th. It was established by the International Pharmaceutical Federation in 2009 to recognize pharmacists' role in improving health worldwide. This year's theme is "Transforming Global Health" to highlight how pharmacists develop medicines, provide patient care and ensure access to healthcare. Pharmacists are very accessible as over 90% of Americans live within 5 miles of a pharmacy. The day aims to appreciate pharmacists and their important work, especially during the difficult times of the COVID-19 pandemic.
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.
This document provides information about an investigational drug project submitted by Tashi Choezom for her B.Pharmacy degree. It discusses the various phases of drug development including drug discovery, characterization of investigational drugs, formulation, pharmacokinetics, preclinical toxicity studies, the Investigational New Drug application process, bioanalytical and clinical trials. The project is supervised by Kriti Bhadoria and submitted to Veer Madho Singh Bhandari Uttarakhand Technical University.
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.
Rat models of acute inflammation: a randomized controlled study on the effect...home
The discrepancies between single-blind and double-blind methods in animal pharmacological research are
noteworthy and should be better investigated, also in non-homeopathic research.
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 GPHF-Minilab is a mobile mini-laboratory developed by the Global Pharma Health Fund to allow for quick and reliable testing of medicines in developing countries. It contains equipment and reagents to test for 90 active pharmaceutical ingredients using physical inspection and thin layer chromatography. Over 800 Minilabs have been distributed across 97 countries. The Minilab aims to address the problem of counterfeit medicines and lack of drug quality testing facilities in many areas. It provides a portable, inexpensive way to screen for substandard or falsified drugs.
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.
Basic aspects of Pharmacovigilance (Clinical Research & Pharmacovigilance).pptxDureshahwar khan
The slides in this presentation mainly focus on History and Progress of Pharmacovigilance, significance of safety monitoring and Pharmacovigilance in India & International aspects.
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.
This document discusses the process of new drug development. It begins with basic research to understand disease pathways and identify potential drug targets. Promising compounds are identified through screening and optimized in preclinical testing, which evaluates safety and effectiveness in animals. If preclinical results are satisfactory, an Investigational New Drug Application is submitted to regulators to seek approval for clinical trials in humans. The drug development process is long and rigorous, aiming to bring safe and effective medications to market while meeting regulatory guidelines.
This document provides an overview of an orientation lecture for pharmacy students. It discusses key topics including the definition of pharmacy and drugs, the scope of pharmacy practice, naming conventions for drugs, pharmacy career paths, pharmacy education, ethics, and good dispensing practices. The lecture defines pharmacy as the art and science of preparing and dispensing medications and providing drug information to the public. It outlines the roles of pharmacists in areas like interpreting prescriptions, compounding, labeling, dispensing, and educating patients. Community pharmacists, hospital pharmacists, and other career paths are also summarized.
This document presents information about pharmacovigilance from Nilesh Jawalkar, including definitions, aims and objectives, types of adverse drug reactions, importance of pharmacovigilance, partners in pharmacovigilance like WHO and national regulatory authorities, how pharmacovigilance works in drug regulation and clinical practice, and the RaPID program. It also discusses contributions that can be made at the levels of clinicians, pharmacists, pharmacologists, and students through activities like reporting adverse drug reactions, creating drug alerts and bulletins, and presenting information through animations. The conclusion emphasizes thinking more about patient safety, using and reacting to concerns, and considering the impact of decisions.
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 provides an overview of Schedule Y, which establishes requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. Schedule Y aims to frame guidelines for clinical research in line with global standards. It outlines application procedures, ethics committee requirements, pre-clinical and clinical data to be submitted, protocol elements, and other rules to ensure safety and efficacy of investigational products. The objectives of Schedule Y are to regulate clinical trials and new drugs in India according to current scenarios and integrate the country into global drug development while improving clinical trial quality.
The document discusses new and old pharmacological anticoagulant strategies. It notes that while new anticoagulant molecules have been introduced to improve strategies for certain conditions, they are often more expensive than older molecules. The document questions whether these new strategies truly provide benefits to public healthcare systems given their high costs compared to older drugs that may have tolerable safety profiles. It argues that a clinical pharmaceutical care approach involving multidisciplinary medical teams can help rationalize costs by aiding the appropriate selection and use of both new and old pharmacological instruments for patients.
Clinical pharmacology is a multidisciplinary science that studies the relationship between drugs and humans. It has a long history dating back to the 18th century. Clinical pharmacologists play important roles in patient care, teaching, and research. Their goals are to improve patient outcomes through rational drug use and the development of safer and more effective medicines. They conduct research studies in humans to better understand pharmacokinetics, pharmacodynamics, and pharmacogenetics which can help optimize drug therapy for individuals.
The document discusses World Pharmacists Day, which is celebrated annually on September 25th. It was established by the International Pharmaceutical Federation in 2009 to recognize pharmacists' role in improving health worldwide. This year's theme is "Transforming Global Health" to highlight how pharmacists develop medicines, provide patient care and ensure access to healthcare. Pharmacists are very accessible as over 90% of Americans live within 5 miles of a pharmacy. The day aims to appreciate pharmacists and their important work, especially during the difficult times of the COVID-19 pandemic.
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.
This document provides information about an investigational drug project submitted by Tashi Choezom for her B.Pharmacy degree. It discusses the various phases of drug development including drug discovery, characterization of investigational drugs, formulation, pharmacokinetics, preclinical toxicity studies, the Investigational New Drug application process, bioanalytical and clinical trials. The project is supervised by Kriti Bhadoria and submitted to Veer Madho Singh Bhandari Uttarakhand Technical University.
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.
Rat models of acute inflammation: a randomized controlled study on the effect...home
The discrepancies between single-blind and double-blind methods in animal pharmacological research are
noteworthy and should be better investigated, also in non-homeopathic research.
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
2. Archives of Pharmacy & Pharmacology Research Volume 4-Issue 1
Citation: Luisetto M*, Khaled Edbey, Fiazza C, Mashori Gulam Rasool, Nili B Ahmadabadi, Cabianca L and Oleg Yurevich. Non-Sterile Clinical
GALENIC LABORATORY: A Scientific Discipline Between Laboratory Practice Clinical Pharmacy and Personalized Pharmacological Therapy.
Arch Phar & Pharmacol Res. 4(1): 2024. APPR.MS.ID.000579. DOI: 10.33552/APPR.2024.04.000579.
Page 2 of 8
Introduction
Starting from the consideration that in history of the remedy for
the pathology of human’s great contribution was obtained with the
introduction of GALENIC principle and methods. From GALENUS
form Pergamon (Greek) 129 dc-201 comes the term GALENIC art of
the pharmacist to produce drugs inside in the pharmacy. He codified
the preparation of drugs using multiple kinds of ingredients.
(active principle added with excipients). For many centuries these
methods were used in the laboratory to produce remedy to treat
many human pathologies. Federico II Svevia 1194 – 1250 knowed
as “STUPOR MUNDI “related his open mind concepts introduced In
Europe and in Italy the need to have specific rules for regulation
the activity of drugs production in the pharmacy laboratory from
the prescription activity of the physicians. This in order to avoid
conflict of interest between this prescriptive function form the
pharmacy practice: this produced the mandatory separation
between medicine and pharmacy: to the physicians the role in
therapy and for pharmacist the production and sell of the drugs.
But during the illuministic period, the industrial revolution, the
success of medicinal chemistry since 1800 and 1900 many forces
make possible to shift the drugs production form the pharmacy
to the more complex industry. During all this periods many
FORMULARIES and then PHARMACOPOEIA in various countries
was introduced and adopted to make possible to get adequate
quality of the drugs produced, safety and reproducibility of the
procedure. (monography, methods of analysis, table et other) This
text becomes mandatory by healthcare law in the various contests
(FU Italian, FU European, US pharmacopeia and many other
examples). Also, the competencies of who were involved in remedy
preparation increased over centuries: from botanic expertise
(SCUOLASALERNITANAVIIeVIIIcentury)totheIATROCHEMISTRY
principle (PARACELSUS from XVI century). Before the pharmacists,
apothecariesthatworkedalongsidepriestsandphysiciansinregard
to the patient care. The history of pharmaceutical history is well
known from introduction of the first SULFAMIDICS since the Actual
the last antivirals (for covid-19 treatment). But related the last
industrial pharmaceutical revolution, some problem arosed: not all
pharmaceuticals’ industries produce drugs for all subpopulation
(pediatric patients, swallowing problems in geriatrics). There is
the needs of personalized dosages or personalized pharmaceutical
form (for pediatric or geriatric patients) needs to introduce drugs
in enteral nutrition, drugs not available form national or foreign
producers (national or international shortcomings), orphan drugs
for some rare disease, dermatologic products, cannabis preparate,
some disinfectants band antiseptics formula, some antidotes
(galenics), some laboratory reagents and solutions, some contrast
agents, odontoiatric galenics and many other So due to this failure
of industry to cover all this situation the galenic laboratory is a real
opportunity.
Today also many pharmaceutical industries not like more to
produce classic drugs as many cardioactive products and other and
the magistral product make possible to overcome this problem.
(especially today whit actual economic crisis). Also, a great number
of galenic formulas are in use commonly in the hospital: corrosive
products for dermatologist, alcohol solution for laboratory, various
reactive, phytotherapy derivates and so on. Galenic Pharmacy also
provides educational, scientific and research activities in the profile
discipline-pharmaceutical technology to the pharmacy student
or under specialization programs. But observing international
literature it is possible to see that the best clinical results are
obtained when the laboratory activity in production magistral
formula by the physicians is completed when available the clinical
pharmacist and managerial competencies in the same team.
Galenics is the laboratory process that turns an active ingredient
(API) into a ready-to-use medicine that can be dosed as required for
various patients. This optimizes their absorption. It is the discipline
(or science) of dosage form design.
According Review
Braz. J. Pharm. Sci. 56 2020 https://doi.org/10.1590/s2175-
97902019000418358
Preparation of extemporaneous oral liquid in the hospital
pharmacy
Márcio Robert Mattos da Silva Letícia Pereira Dysars Elisabete
Pereira dos Santos Eduardo Ricci Júnior
“At the hospital, the pharmacist is constantly challenged to
prepare extemporaneous solutions ES from tablets, capsules or
drug powder for patients unable to swallow, such as pediatric,
elderly and patients that use nasoenteric and nasogastric tubes. The
preparation of extemporaneous solutions ES from capsules, tablets
and drug powder requires stability studies analysis” (Figures 1,2).
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 DM 18 NOV
2003. An practical experimental study is reported with results
from 2008 to 2023 . Finally a global conclusioni is submitted to the
researcher related also innovations in fields of Galenic laboratory.
From Literature
J Pharm Pract. 2021 Jun 15;8971900211023643. doi:
10.1177/08971900211023643.
Check on the final products:
Following the procedure, aspects, packaging, and its closure. According to NBP the laboratory must be separated (or it must be separable)
from the pharmacy and a second pharmacist (that is different from the pharmacist that prepares) must check the final preparation. The locals must
be according to strictly environmental condition to make possible to prepare in safety way the drugs. And it is mandatory must to follow written
procedure. (Instruments verify, training of the pharmacist cleaning procedure, significations). Raw material certifications, technical sheet, safety
sheet. Working sheet is mandatory. The pharmacist can follow these two options related the kind of drugs produced and the characteristic of the
laboratory. It is not the main focus of this work to produce a literal translation of DM 18/11/03 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 non-advanced countries.
3. Citation: Luisetto M*, Khaled Edbey, Fiazza C, Mashori Gulam Rasool, Nili B Ahmadabadi, Cabianca L and Oleg Yurevich. Non-Sterile Clinical
GALENIC LABORATORY: A Scientific Discipline Between Laboratory Practice Clinical Pharmacy and Personalized Pharmacological Therapy.
Arch Phar & Pharmacol Res. 4(1): 2024. APPR.MS.ID.000579. DOI: 10.33552/APPR.2024.04.000579.
Archives of Pharmacy & Pharmacology Research Volume 4-Issue 1
Page 3 of 8
Figure 1: Manual Encapsulator.
Figure 2: Galenic Laboratory.
Hospital Pharmacy Response to Covid-19 Pandemic in Italy:
What We Learned from the First Outbreak Wave Vera Damuzzo,
Riccardo Bertin, Daniele Mengato, Marco Chiumente, Melania
Rivano,AngeloClaudioPalozzoDOI:10.1177/08971900211023643
“When COVID-19 pandemic started, Italian hospital pharmacists
faced multiple challenges and change their work practices.
The aim of this study was to describe the impact of the
COVID-19 emergency on pharmaceutical care (PC) provided by
pharmacists during the first wave of the pandemic. Issues related
to pharmacist’s involvement in the pandemic management
were changes in activities, support received by authorities and
pharmacists’ own perceived role in the Health System HS. A cross-
sectional study based on a web survey was conducted between May
and June 2020 collecting information from pharmacists, members
of Italian Society of Clinical Pharmacy and Therapeutics SCPT. 113
(11.4%) completed the questionnaire. The cohort was divided into
2 arms: pharmacists who worked in severely COVID-19 affected
areas (High Spread Regions) and those employed in the less affected
areas (Low Spread Regions).
The changes in the pharmacy work settings reflected the
increase of logistics area and non-sterile clinical galenic, and
reduction of clinical tasks. The most demanding challenge was
referred to shortages of medical devices and drugs, 61/113
pharmacists reported difficulty in obtaining products compliant
to quality standards. National Institutions and the Regional
Governments provided a greater perceived support. More than
50% of participants felt that their role did not change if compared
to other healthcare professionals. Despite some limitations related
to their clinical activity, pharmacists played a crucial role in
supplying personal protective equipment, 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; doi: 10.3325/cmj.2014.55.662
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, Antonio Germano, Gaetano Di Lascio,
Richard Petieau, and Paola Brusa
Aid Progress Pharmacist Agreement Project: aims in
developing countries
Aid Progress Pharmacist Agreement (A.P.P.A.®) is a non-profit
association based on 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 of Turin (TO) and
Italian community pharmacists.Its main task istheestablishment of
galeniclaboratories(GLs)inhospitalsofdevelopingcountries(DCs)
4. Archives of Pharmacy & Pharmacology Research Volume 4-Issue 1
Citation: Luisetto M*, Khaled Edbey, Fiazza C, Mashori Gulam Rasool, Nili B Ahmadabadi, Cabianca L and Oleg Yurevich. Non-Sterile Clinical
GALENIC LABORATORY: A Scientific Discipline Between Laboratory Practice Clinical Pharmacy and Personalized Pharmacological Therapy.
Arch Phar & Pharmacol Res. 4(1): 2024. APPR.MS.ID.000579. DOI: 10.33552/APPR.2024.04.000579.
Page 4 of 8
according to the principles of international health cooperation.
Aims of the Project:
• establishing GLs in DCs with the aim of preparing
medicinal products MP that comply with 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.
• -employing local staff, teaching them a “new job,” and
opening a suitable school.
• -minimizing costs necessary to prepare these medicines.
There are relevant and important reasons why galenics should
be used:
i) low cost of the production system and simple operative
procedures.
ii) the possibility to adapt dosages and pharmaceutical forms
PF to the patients’ needs and medical prescriptions.
iii) reduction in the use of counterfeit medicines CM in the
settings where the GL is located [7].
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,
Christel Castelli, Clarisse Roux-Marson, Sophie Bouvet, Sandrine
Andrieu, Philippe Cestac, Rémy Collomp, Paul Landais, Bertrice
Loulière, Christelle Mouchoux, Rémi Varin, Benoit Allenet, MEDREV
Working Group, Pierrick Bedouch & Jean-Marie Kinowski
“The clinical pharmacist CP will have a collaborative meeting
with both the prescriber and the nurse in order to notify any
possible medication errors and suggest any proposals to optimize
the AMO according to the medical history, the clinical status, and the
therapeutic adherence. (change of galenic form due to swallowing
problem, dose adjustment to renal function). After the collaborative
meeting, the clinical pharmacist will check whether the prescriber
has accepted his/her suggestion(s) and modified the AMO. All
the pharmaceutical interventions, the medication errors detected
and the pharmaceutical suggestions of order 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
Johannes Wohlrab 23 November 2016 https://doi.
org/10.1111/ddg.13151
“The choice of a pharmaceutical (galenic) concept is primarily
based on the requirements of the physico-chemical properties of
the active ingredient to be applied. The fixed combination of active
pharmaceutical ingredients API in topical preparations is suitable
for only a limited number 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 Marija Dj. Jovović, Maja M. Ribar
“Compliance with national legislation, like as establishing
compliance prescribed by the European legislation in the field of
drug development is binding. All manufacturers of drugs and/or
active pharmaceutical ingredients must apply quality standards
prescribed by the European Pharmacopoeia 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
countryispermanentlydonebyharmonizingnationallegislationNL
inordertoimproveconditionsforthepreparationandproductionof
galenic drugs GD in terms of inpatient health institutions performed
in a manner that is prescribed by international regulations. Th is
requiring the adaptation of institutions, including fundamental
changes in competence as national professional and administrative
and regulatory rules that apply to state- and private sectors “(10)
Original Article
DOI: 10.1016/j.rppede.2016.02.012
Magistral drugs in hospitalized newborns and children
Medicamentos magistrais em recém-nascidos e crianças
hospitalizados
Agueda Cabral de Souza Pereira, Elaine Silva Miranda, Selma
Rodrigues de Castilho, Débora Omena Futuro, Lenise Arneiro
Teixeira, Geraldo Renato de Paula
Universidade 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 for such preparations as a pediatric therapeutic
alternative in this hospital.” (11)
Dooms, M., Carvalho, M. Compounded medication for patients
with rare diseases. Orphanet J Rare Dis 13, 1 (2018). https://doi.
org/10.1186/s13023-017-0741-y
04 January 2018 “When there is no on-label or even no off-
label treatment for patients with rare diseases pharmacists have to
compound the medication” [12].
Pharmaceutics. 2021 Apr.
2021 Mar 26. doi: 10.3390/pharmaceutics13040448
Medicine Shortages in Serbia: Pharmacists’ Standpoint and
Potential Solutions for a Non-EU Country
Nataša Jovanović Lješković, Aleksandra Jovanović Galović,
Svetlana Stojkov, Nikola Jojić, and Slobodan Gigov
Umberto Musazzi. “Backup manufacturing on a small scale
(magistral and galenical) could be a good way to overcome some
kind of shortages” [13].
5. Citation: Luisetto M*, Khaled Edbey, Fiazza C, Mashori Gulam Rasool, Nili B Ahmadabadi, Cabianca L and Oleg Yurevich. Non-Sterile Clinical
GALENIC LABORATORY: A Scientific Discipline Between Laboratory Practice Clinical Pharmacy and Personalized Pharmacological Therapy.
Arch Phar & Pharmacol Res. 4(1): 2024. APPR.MS.ID.000579. DOI: 10.33552/APPR.2024.04.000579.
Archives of Pharmacy & Pharmacology Research Volume 4-Issue 1
Page 5 of 8
Pharmaceuticals (Basel). 2022 Jan
Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety
in Pediatrics
Guendalina Zuccari, Silvana Alfei, Danilo Marimpietri, Valentina
Iurilli, Paola Barabino, Leonardo Marchitto
DOI: 10.3390/ph15010108
“In the treatment of pediatric diseases, mass-produced dosage
forms are often not suitable for children. Commercially available
medicines CAM are commonly manipulated and mixed with food by
caregivers at home, or extemporaneous medications are routinely
compounded in the hospital pharmacies 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 the
safety of the ingredients is of paramount importance. For these
purposes solid formulations 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 review work deals with the
different approaches that may be applied to develop mini tablets
intended for pediatrics with a focus on the safety of excipients.
Alongside the conventional method of compression, 3D printing
appeared particularly appealing, as it allows to reduce the number
of ingredients and to avoid both the mixing of powders and
intermediate steps such 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].
Volume 174, July 2021
Advanced Drug Delivery Reviews
Translating 3D printed pharmaceuticals: From hype to real-
world clinical applications
Seoane-Viaño, Sarah J. Trenfield , Abdul W. Basit , Alvaro
Goyanes
https://doi.org/10.1016/j.addr.2021.05.003
“Three-dimensional (3D) printing offers the potential to
revolutionize the production of pharmaceuticals targeted to
the gastrointestinal tract by offering a flexible drug product
manufacturing platform that can adapt readily to changing
market and patient needs. By using 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 personalized dosages, drug combinations, geometries and
release characteristics; a concept which is currently unattainable
and cost inefficient with conventional manufacturing technologies
(tableting and encapsulation). This technology has been forecast
to disrupt a wide range of pharmaceutical applications, ranging
from expediting the drug development process DDP and providing
benefits for pharmaceutical manufacture, to on demand printing
of personalized medicines on the front-line and in hard-to-reach
areas” [15].
International Journal 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 Author links open overlay panel
Christoph Nober a, Giuseppe Manini a, Emeric Carlier a, Jean-Marie
Raquez b, Samira Benali b, Philippe Dubois b, Karim Amighi a,
Jonathan Goole a c
https://doi.org/10.1016/j.ijpharm.2019.118581
“The purpose of this research work was to investigate the
feasibility of manufacturing enteric capsules, which could be used
in compounding pharmacies, by fused-deposition modeling. It
is well-known that conventional enteric dip coating of capsules
in community pharmacies CP or hospitals is a time-consuming
process which is characterized by erratic efficacy. Fused-deposition
modeling was selected as a potential 3D printing method due to its
ease and low-cost implementation LCI. Before starting to print the
capsules, an effective sealing system was designed via a computer-
aided design program. Hot melt extrusion was used to make
printable enteric filaments. They were made of the enteric polymer,
a plasticizer and a thermoplastic polymer, namely Eudragit® L100-
55, polyethylene glycol 400 and polylactic acid, respectively.
Riboflavine-5′-phosphate was selected as a colored drug model
to compare the efficacy of the 3D printed capsules to that of enteric
dip coated capsules as they are currently produced in community
pharmacies and hospitals HP. 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 did not
release the drug for 2 h 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 European Pharmacopoeia EP 9th Edition for enteric products”
[16] (Figure 3).
Practical project
In this part are analyzed the Italian normative rules named
NBP and simplified as DM Salute 18.11.2003 normed di buona
preparazione” applied by law as mandatory in the galenic
laboratory setting inside the pharmacy (public or private – hospital
and community).
NBP or GMP good manufacturing practice
The GMP philosophy are based on:
documentation of the process, registrations, every phase of the
process, activity and single operations.
- team must receive adeguate training
-responsibility clearly identified
-Quality of API and excipients
6. Archives of Pharmacy & Pharmacology Research Volume 4-Issue 1
Citation: Luisetto M*, Khaled Edbey, Fiazza C, Mashori Gulam Rasool, Nili B Ahmadabadi, Cabianca L and Oleg Yurevich. Non-Sterile Clinical
GALENIC LABORATORY: A Scientific Discipline Between Laboratory Practice Clinical Pharmacy and Personalized Pharmacological Therapy.
Arch Phar & Pharmacol Res. 4(1): 2024. APPR.MS.ID.000579. DOI: 10.33552/APPR.2024.04.000579.
Page 6 of 8
- cleaning and sanitization procedure
-Regular check of the instruments
- process validation
- NC nonconformity management
Figure 3:
So, in Italy by law the pharmacist that work in a galenic
laboratory according to DM 22/06/05 must follow or the FULL
NBP of ITALIAN FU (more complex) or DM Salute 18.11.2003
(if not sterile magistral preparations or officinal reduced scale)
Pharmacy that prepares nonsterile magistral formula or officinal
reduced scale can follow or full NBP or simplified NBP. Instead, if
prepared sterile products, or toxic preparate, anticancer drugs
and radio drugs, it must be used biological hood: it is mandatory
to follow full NBP. For non-sterile products it is possible in Italy
to deviate from full NBP and to follow the simplified rules if it is
possible to keep under control all the process, proving it. (quality
efficacy, safety depends on organization and consistent control).
First NBP was introduced in (FU IX ed.) in 1989. In the chapter 795
USP, pharmaceutical compounding of non-sterile products, related
the difficulty of the preparations, its stability, storage conditions,
dosage form, complexity in calculations, systemic, topic use,
risk level for pharmacist, damage risk for patients are classified
3 situations: simple compounding, moderate and complex
compounding. It is requested to produce the master formulation
records and the compounding record. Like NBP the USP rules are
based on the quality of final products and on the documentation
of all process. Some preparations at high microbiological quality
need to be prepared in zone with HEPA FILTER. A translation of
Simplified NBP and its philosophy (DM Salute 18.11.2003) and
their meaning are reported
Results
Translation of the meaning of the NBP procedure simplified
DM 18/11/2003 Application field :( nonsterile magistral and
officinal forms reduced lots) for hospital and community pharmacy
medical prescription for magistral formula and Pharmacopeia for
Officinal reduced scale production) Preliminary evaluation about
opportunity -possibility to prepare the galenic requested or needed
definitions: magistral formula, officinal, reduced batch laboratory
hygienic written procedure, frequency (provided by director of the
pharmacy or lab. Responsible). lab area: it must be adequate for
the kind of galenic products produced, ceiling and walls wahable.
It can be in a separate room, separate or not separate inside the
pharmacy. Instruments: mandatory according PHARMACOPEA
uff. ITALIAN table n. 6, the measure instrument must be verified
in regular way. The refrigerator must be cleaned. Containers (and
related certificate of conformity to pharmacopeia requirement of
the primary containers). Raw material: chemical denomination,
date of arrive in pharmacy, batch number, expiration date or date
of reticulation, certificate of analysis signed by producer (according
to pharmacopeia quality requirement), conservation condition
or use, date of first use. (necessary a register of raw materials,
excipients and API, with a progressive numeration). The empty
7. Citation: Luisetto M*, Khaled Edbey, Fiazza C, Mashori Gulam Rasool, Nili B Ahmadabadi, Cabianca L and Oleg Yurevich. Non-Sterile Clinical
GALENIC LABORATORY: A Scientific Discipline Between Laboratory Practice Clinical Pharmacy and Personalized Pharmacological Therapy.
Arch Phar & Pharmacol Res. 4(1): 2024. APPR.MS.ID.000579. DOI: 10.33552/APPR.2024.04.000579.
Archives of Pharmacy & Pharmacology Research Volume 4-Issue 1
Page 7 of 8
container of raw material must be kept for 6 months after final
use. Fulfillments (preventive and after setup) to the preparations.
Prescription verifies, normative requirement, sign of the physician,
iperdosages verify (according to table n. 8 pharmacopeia Italy),
Incompatibility verify, the possibility to prepare in lab. After setup:
to be written on the prescription the progressive number of the
preparation, date of the preparation, expiration date, excipients
used, precautions and cautions, label must be attached. Sign of
the pharmacist in the label, on the prescription or on the working
sheet Labeling etcetera – batch number and expiration date,
composition qualitative quantitative, API Excipients, date limits for
use, precautions, Price (community pharmacy) Documents storage
-conservation documentation (time), empty bottle. The written
prescription must be kept in the pharmacy for 6 months and the
same working sheet. (working sheet). The prescription of narcotics
must be kept in pharmacy for the time required by normative rules.
Quality control: right following of the procedure, organoleptic
characteristics, control of the packaging, sealing of the container,
right label copilation, mass uniformity, acceptation limits. A copy
of the label must be attached to the working sheet Documentation:
of the working space, instruments, raw materials Expiration time
of the drugs prepared: according to FU requirement: 30 days
that can be prolonged to 6 months according chemical -physical
microbiological stability documented by official information’s.
Mandatory equipment and tools utensil in pharmacy a (TABLE N 6
pharmacopeia Italian in force)
1. balance sensitivity to the mg, scale = 0,001 g, loading
capacity at least 500 g or in alternative way two different
balances, one with sensitivity at the mg (d=0,001g) with
loading capacity at least 50 g and the other with sensitivity at
0,50 g (d=0,50 g) with carry load at least of 2 kg.
2. Bain Marie or other equipment that can assure, in heating,
temperature since to 100 °C.
3. Fridge able to assure the right storage conditions
according pharmacopeia requirement
4. Point of fusion equipment. (to test the raw material)
5. chemical glassware, also graduated sufficient for the
execution of the preparation.
6. percolator – at empty Concentrator (1).
7. encapsulate (2)
8. Tablet press (3).
9. powder Aspiration system (4).
10. molds or plastic valves for ovules and suppositories (5).
11. 11.tools and devices necessary to guarantee sterility of
the preparation (6)
Beyond the reported instruments, the pharmacy must have
all other instruments, equipment’s, 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 to the Pharmacopeia indications. Pharmacy
that executes injectable preparations must have also materials,
equipment, and tools essential to these preparations and for all
the control expected by pharmacopeia for this specific kind of
preparation.
Note:
1. mandatory for pharmacy that prepare extracts. They
must be of materials and adequate dimension to the volume
and related the preparation to be executed.
2. mandatory for the pharmacy that prepares capsules.
3. mandatory for the pharmacy that prepares tablets.
4. mandatory for pharmacy that prepare tablets, capsules,
capsule, teas or sachets.
5. mandatory for pharmacy that prepare suppositories and
ova.
6. for pharmacy that prepares sterile products.
Experimental Project
In order to evaluate the application of REDUCED NBP in an
hosp. galenic lab PC AREA are reported All official nonconformity
registered from 2008 to 2023. (the internal production) Results: no
major nonconformity registered related to the preparation activity.
(for the non serile galenic activity), only 2 secondary- minor NC due
by an excipient to be modified to increase solubility of an API and
related a closing system for an oral power.
Discussion
As reported in this work are clear the advantages to produce
some kinds of drugs in a galenic laboratory. Even the industrial
epoca, with the pharmaceutical industry increase, the industrial
production of drugs Was rapidly developed and so reduced or
stopped the production in the galenic laboratory: this process
was due to the complexity process to produce with high quality
the finished drugs in the amount requested by the hospital and
the patient. But the same some condition needed to manteign this
procedure: for magistral prescription single patient based and for
the production of disinfectants, reagents or other product. It must
also to be remembered that during LAST COVID-19 PANDEMIA one
of the main producers of antiseptic gel hands and alcoholic solution
was the hospital pharmacy in their lab as well as in the private
pharmacy. The industry in this situation was not able to provide
ready to use great amount of this product in few times as needed for
the public safety. (3) The galenic hospital laboratory in the public
hospital was able to guarantee this production and the safety of
the patient and healthcare professional. The results of practical
experience reported show also in a specific setting the goodness
of this rules NBP even if simplified. The technological innovation
makes possible to better cover the need for drugs shortcomings.
Comparing full NBP to the reduced DM 10nov 2003 it is possible
to verify that NBP requires separate or separable locals, check by
another pharmacist vs the one that prepares the drug in lab. and
required as mandatory written procedures accredited. For DM it is
not mandatory to have complex quality checks on the final products,
8. Archives of Pharmacy & Pharmacology Research Volume 4-Issue 1
Citation: Luisetto M*, Khaled Edbey, Fiazza C, Mashori Gulam Rasool, Nili B Ahmadabadi, Cabianca L and Oleg Yurevich. Non-Sterile Clinical
GALENIC LABORATORY: A Scientific Discipline Between Laboratory Practice Clinical Pharmacy and Personalized Pharmacological Therapy.
Arch Phar & Pharmacol Res. 4(1): 2024. APPR.MS.ID.000579. DOI: 10.33552/APPR.2024.04.000579.
Page 8 of 8
no mandatory written procedure is needed (even if suggested). In
this work it is also submitted a new technology useful in galenical
laboratory: the 3D PRINTING SYSTEM As an innovation for quality
and efficiency of the process.
Conclusion
As conclusion it is possible to say that observing the Italian
Reduced NBP rules in an advanced country can be applied also
in non-advanced countries with great benefit for healthcare of
the patients. Related to the specific preparation requested by the
clinicians. These rules report general behavior and procedure to
be followed to be sure that the drugs produced are safe and useful
for the patients. Not all laboratories in the world have the same
instruments or complex laboratory, but in every laboratory. It is
crucial to know the responsibility as well as procedure adopted
(quality control of raw material, active substantive, qualification of
the pharmacist, traceability of the lots and other). For this reason,
it is opinion of the author that these rules must be translated
in their general meaning from Italian to English languages as
reported in this work. The authors submit to the researchers and
pharmacists a new innovative tool: the 3D PRINTING systems for
galenic laboratory use: a system to increase global efficiency of
the preparation of capsules or other pharmaceutical form during a
period of drug shortages.
Acknowledgement
None.
Conflict Of Interest
No conflict of interest.
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Feasibility study into the potential use of fused-deposition modeling to
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International Journal of Pharmaceutics: 569(5).
