This PPT would be helpful to retail pharmacist for drug product stability. It contains various factors those are responsible for drug degradation and improve drug product stability. So it would be highly used in the field of registered retail pharmacist and pharmacy graduate in diploma pharmacy graduate.
The document discusses guidelines from the International Council for Harmonization (ICH) regarding stability testing of drug substances and products. It provides an overview of the ICH Q1 series of guidelines, which address stability testing, including specifications for testing protocols, storage conditions and minimum data requirements. The guidelines provide recommendations for conducting long-term, intermediate and accelerated stability studies to evaluate the impact of various stress conditions like temperature, humidity and light on drug substances and products. The goal is to ensure quality, safety and efficacy over the proposed shelf-life.
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 is an industrial training report submitted by Rohit Yadav to partially fulfill the requirements of a B.Pharma degree. It summarizes Rohit's one month internship at NAVKAR LIFESCIENCE Pvt. Ltd, including an overview of the company and acknowledgements. The report then describes the various sections and processes involved in pharmaceutical manufacturing, with a focus on tablet and capsule production processes, equipment used, and quality control procedures.
The FDA regulates food, drugs, medical devices and other products. It oversees the drug approval process which involves preclinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy and side effects. If approved, the drug can be marketed and is monitored for side effects. The document outlines the drug approval process and regulations around generic drugs, biologics, manufacturing and product changes.
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the g...John Blue
This document discusses antibiotic use and regulation in animal agriculture. It notes that while antibiotics are an important tool for veterinarians, their overuse and misuse has led to concerns about antibiotic resistance in bacteria. New FDA guidance aims to curb antibiotic overuse by restricting medically important antibiotics to uses overseen by veterinarians, requiring veterinary oversight for all antibiotic use, and improved record keeping. The document advocates for judicious antibiotic use according to principles of using the right drug, at the right time, dose and duration, with proper withdrawal times and record keeping. It outlines programs like PQA Plus that promote responsible antibiotic use and judicious use principles for veterinarians.
FDA Guidelines for Drug Development & Approvalrahimbrave
The document discusses the drug development and approval process in the United States. It describes the roles and responsibilities of the Food and Drug Administration (FDA) in regulating drugs, medical devices, and other products. It then outlines the various phases of clinical trials (Phases I-IV) that drugs must go through to test for safety and efficacy before FDA approval. It also discusses the processes for approving generic drugs, biological products, and modifications to approved drugs.
The document discusses guidelines from the International Council for Harmonization (ICH) regarding stability testing of drug substances and products. It provides an overview of the ICH Q1 series of guidelines, which address stability testing, including specifications for testing protocols, storage conditions and minimum data requirements. The guidelines provide recommendations for conducting long-term, intermediate and accelerated stability studies to evaluate the impact of various stress conditions like temperature, humidity and light on drug substances and products. The goal is to ensure quality, safety and efficacy over the proposed shelf-life.
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 is an industrial training report submitted by Rohit Yadav to partially fulfill the requirements of a B.Pharma degree. It summarizes Rohit's one month internship at NAVKAR LIFESCIENCE Pvt. Ltd, including an overview of the company and acknowledgements. The report then describes the various sections and processes involved in pharmaceutical manufacturing, with a focus on tablet and capsule production processes, equipment used, and quality control procedures.
The FDA regulates food, drugs, medical devices and other products. It oversees the drug approval process which involves preclinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy and side effects. If approved, the drug can be marketed and is monitored for side effects. The document outlines the drug approval process and regulations around generic drugs, biologics, manufacturing and product changes.
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the g...John Blue
This document discusses antibiotic use and regulation in animal agriculture. It notes that while antibiotics are an important tool for veterinarians, their overuse and misuse has led to concerns about antibiotic resistance in bacteria. New FDA guidance aims to curb antibiotic overuse by restricting medically important antibiotics to uses overseen by veterinarians, requiring veterinary oversight for all antibiotic use, and improved record keeping. The document advocates for judicious antibiotic use according to principles of using the right drug, at the right time, dose and duration, with proper withdrawal times and record keeping. It outlines programs like PQA Plus that promote responsible antibiotic use and judicious use principles for veterinarians.
FDA Guidelines for Drug Development & Approvalrahimbrave
The document discusses the drug development and approval process in the United States. It describes the roles and responsibilities of the Food and Drug Administration (FDA) in regulating drugs, medical devices, and other products. It then outlines the various phases of clinical trials (Phases I-IV) that drugs must go through to test for safety and efficacy before FDA approval. It also discusses the processes for approving generic drugs, biological products, and modifications to approved drugs.
Formulation Development and in Vitro Evaluation of Capecitabine Immediate Rel...ijtsrd
The aim of this study is to formulate and significantly improve the bioavailability and reduce the side effects of immediate release tablets Capecitabine. The precompression blends of Capecitabine were characterized with respect to angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. The precompression blend of all the batches indicates good to fair flowability and compressibility. Immediate release tablets were prepared with various disintegrants like PEG 6000, Croscarmellose sodium and Sodium starch glycolate at different concentration ratios and were compressed into tablets. The formulated tablets were evaluated for various quality control parameters. The tablets were passed all tests. Among all the formulations F7 formulation containing, drug and Croscarmellose sodium showed good result that is 98.12 in 45 min. Hence from the dissolution data it was evident that F7 formulation is the better formulation. Dr. G. Jagadish | Dr. Vibhor Kumar Jain | Rama Shukla "Formulation Development and in Vitro Evaluation of Capecitabine Immediate Release Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55058.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/pharmaceutics/55058/formulation-development-and-in-vitro-evaluation-of-capecitabine-immediate-release-tablets/dr-g-jagadish
Generic drugs provide the same clinical benefits as their brand-name counterparts at a lower cost. The document discusses the definition of generic drugs and the regulatory process for approval, including how generics are proven to be bioequivalent to the original drug but do not need to repeat clinical trials. It also addresses India's policies promoting generic drugs, the TRIPS agreement and its implications for international drug access, and initiatives like the Doha Declaration aimed at balancing intellectual property protections with public health needs.
A Little Bit of Everything, Quick & Snappy: Probiotics to Advances in the Car...PASaskatchewan
As pharmacists, you are rarely faced with a consistent patient population with similar problems and questions. More likely, each patient you interact with has unique and varied concerns that you must be ready to address in an instant. This session reflects the diversity of patients a pharmacist will face in day-to-day practice and covers a range of topics in a quick and snappy format. This session will cover the evidence as it relates to concurrent probiotic and antibiotic use, second line treatment for patients with type 2 diabetes, and explore new utilization strategies of using drugs traditionally used in the treatment of type 2 diabetes for patients with type 1 diabetes.
dispensing pharmacy note to administrationbaharbarree
Abgabekategorie regulates which kinds of drugs can be dispensed by the pharmacist, and whether a prescription is necessary. Swiss medic, the Swiss authority for approving drugs, classifies the drugs under the appropriate category
The document discusses extemporaneous compounding by pharmacists. It defines extemporaneous compounding as the modification of manufactured products to supply customized dosage forms. Dermatological products are most commonly compounded. Reasons for compounding include unavailable commercial products and customized strengths/dosages. Risks include lack of stability data and standardized protocols. The document also discusses compounding environments, equipment, and the need for more pharmacists and pharmacy services in Pakistan's hospitals.
A NSW partnership has been established with GW Pharmaceuticals to conduct the world's first clinical trials using medicinal cannabis products for children with severe epilepsy. The trials will test cannabidivarin (CBDV) in a phase 2 trial and cannabidiol (CBD) in a phase 4 trial and compassionate access scheme. Researchers at Sydney Children's Hospitals Network will lead the trials to evaluate CBDV and CBD as treatments for drug-resistant epilepsy and determine their safety and effectiveness. The goal is to understand which children may benefit from cannabis-derived medicines and identify any side effects.
Ranveer Sharma from the Department of Biotech at Bcet Gurdaspur presented on Panacea Biotec. Panacea Biotec is an Indian healthcare company focused on pharmaceuticals, biopharmaceuticals, vaccines and natural products. It has a global footprint in over 30 countries. Key highlights included its #4 ranking in vaccines in India, state-of-the-art manufacturing facilities approved by US FDA and WHO, and strategic collaborations with companies like Serum Institute of India and Apotex. Recent updates discussed a collaboration with Serum Institute on a hexavalent vaccine and a settlement agreement with Celgene regarding patents on Panacea's generic version of Abraxane.
Pharmacovigilance in Special Populations: Considerations for Pediatric and Ge...ClinosolIndia
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. When it comes to special populations, such as pediatric and geriatric patients, there are specific considerations that need to be taken into account in pharmacovigilance efforts. Here are some key points regarding pharmacovigilance in these population
This document discusses veterinary drug delivery systems and formulations. It provides an introduction to veterinary medicine and the importance of new drugs. It then summarizes various drug delivery systems used in veterinary medicine including oral, injectable, topical, and other dosage forms. The document reviews some marketed veterinary products and updates on new drugs approved by the FDA. It concludes by noting challenges in developing new veterinary drugs and the importance of research in this area.
One mans supergeneric is anothers life cycle managementMalcolm Ross
This document discusses the potential for generic pharmaceutical companies to develop "supergeneric" or value-added generic drug products. It provides examples of how simple reformulations or new delivery methods for off-patent drugs could create differentiated products with improved efficacy or compliance compared to existing generics. Developing combination products or modified release formulations are presented as opportunities requiring relatively little investment that leverage existing technical skills at generic companies.
This document describes quality control tests that are performed on tablets to ensure they meet specifications. It discusses tests like physical examination, thickness, diameter, weight variation, hardness, friability, disintegration and dissolution. The physical examination checks for defects, thickness and diameter tests uniformity, weight variation tests content uniformity, hardness tests strength, friability tests fragility, disintegration tests breakdown into particles and dissolution tests release of drug in fluid. The document provides details on the principles, procedures, requirements and reports for each of these quality control tests performed on tablets.
Good Manufacturing Practice (GMP) regulations ensure that pharmaceutical products are consistently produced and controlled according to quality standards. GMP has regulations for facilities, equipment, personnel, sanitation, testing of raw materials and finished products, manufacturing, packaging, quality control, records, and stability. Following GMP procedures guarantees high quality products for consumers by minimizing risks of contamination and ensuring correct labeling and potency. Key aspects of GMP include written procedures, process validation, environmental monitoring, and record keeping. Strict adherence to GMP is important for producing safe, effective medicines.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Fabrication and Characterization of Edible Jelly Formulation of Stevioside: A...Debarshi123456789
Based on the fact that stevioside, a glycoside obtained from Stevia rebaudiana Bert has the chief characteristic of
regulating hyperglycemic episodes. The present nutraceutical research describes an innovation that stevia product containing
jelly based formulations have not yet designed as hypoglycemic aids for over-the-counter (OTC) prospective. The main
objectives of this study involved the development of edible jelly formulations containing stevioside which will impart glucose
lowering as well as artificial sweetening characteristics, just like edible jelly brand products such as Juzt Jelly®, Jelly Belly®,
Boleto®, Jolly Candy®, FrutBite® in India. Therefore, the diabetic patients will get a better hypoglycemic control, non-calorific
product, will also enjoy the sweetness, patient-friendly, convenient, without specific dose and frequency and will be much
cheaper than existing market products. The formulation was prepared by the heating method which comprises of stevioside,
HPMC K100, HPMC K15, sodium metabisulphite, ascorbic acid, glycerine, propylene glycol, triethanolamine along with essence
and colors. The organoleptic properties and physicochemical parameters (like stickiness, texture, grittiness, viscosity, drug
content and pH) of the formulations were determined. Techniques like FT-IR analysis, differential scanning calorimetry analysis,
X-Ray diffraction, etc were studied exhaustively to determine the characteristics of the optimized formulation (F9). In-vitro
dissolution study was carried out in simulated gastric fluid without enzyme. The hypoglycemic potential of the optimized
formulation (F9) was studied on Swiss albino rat and the results were compared with standard drug metformin. This research
opened new doors for nutraceutical research that have perspectives of commercialization as OTC products in near future.
1. FDA's Medwatch program allows reporting of adverse events from medical products to help identify safety concerns, with reports on Zyvox and Levoxine/LANOXIN leading to label changes.
2. It is important to report serious adverse events, therapeutic failures, use errors, and product quality issues to the FDA to maintain the Medwatch system.
3. The iPLEDGE program imposed stricter controls on isotretinoin due to depression and suicide risks, requiring registration of prescribers, pharmacies, patients.
This document outlines standards for good pharmacy practice (GPP) as established by the International Pharmaceutical Federation (FIP). It discusses the underlying philosophy of patient-centered pharmaceutical care. The main elements of GPP are outlined as health promotion, supply of medicines, self-care, and influencing prescribing. Specific standards are provided for premises, dispensing, containers, labeling, patient instructions, records, health information, and self-medication. Adherence to these standards helps pharmacists provide quality care that complies with GPP.
1. The document discusses the process of generic drug product development. It defines a generic drug as a drug that is comparable to a brand name drug in dosage, strength, quality and performance, and intended use.
2. The key steps in generic drug development include selecting a product, addressing legislative and regulatory requirements like bioequivalence studies, seeking approval via an Abbreviated New Drug Application (ANDA) by demonstrating bioequivalence to the branded reference drug, and referencing patent and approval information in sources like the Orange Book.
3. Generic drugs can be approved and marketed after relevant patents for the branded counterpart expire. The ANDA process allows generic drugs to avoid duplicating preclinical and clinical trials
Formulation Development and in Vitro Evaluation of Capecitabine Immediate Rel...ijtsrd
The aim of this study is to formulate and significantly improve the bioavailability and reduce the side effects of immediate release tablets Capecitabine. The precompression blends of Capecitabine were characterized with respect to angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. The precompression blend of all the batches indicates good to fair flowability and compressibility. Immediate release tablets were prepared with various disintegrants like PEG 6000, Croscarmellose sodium and Sodium starch glycolate at different concentration ratios and were compressed into tablets. The formulated tablets were evaluated for various quality control parameters. The tablets were passed all tests. Among all the formulations F7 formulation containing, drug and Croscarmellose sodium showed good result that is 98.12 in 45 min. Hence from the dissolution data it was evident that F7 formulation is the better formulation. Dr. G. Jagadish | Dr. Vibhor Kumar Jain | Rama Shukla "Formulation Development and in Vitro Evaluation of Capecitabine Immediate Release Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55058.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/pharmaceutics/55058/formulation-development-and-in-vitro-evaluation-of-capecitabine-immediate-release-tablets/dr-g-jagadish
Generic drugs provide the same clinical benefits as their brand-name counterparts at a lower cost. The document discusses the definition of generic drugs and the regulatory process for approval, including how generics are proven to be bioequivalent to the original drug but do not need to repeat clinical trials. It also addresses India's policies promoting generic drugs, the TRIPS agreement and its implications for international drug access, and initiatives like the Doha Declaration aimed at balancing intellectual property protections with public health needs.
A Little Bit of Everything, Quick & Snappy: Probiotics to Advances in the Car...PASaskatchewan
As pharmacists, you are rarely faced with a consistent patient population with similar problems and questions. More likely, each patient you interact with has unique and varied concerns that you must be ready to address in an instant. This session reflects the diversity of patients a pharmacist will face in day-to-day practice and covers a range of topics in a quick and snappy format. This session will cover the evidence as it relates to concurrent probiotic and antibiotic use, second line treatment for patients with type 2 diabetes, and explore new utilization strategies of using drugs traditionally used in the treatment of type 2 diabetes for patients with type 1 diabetes.
dispensing pharmacy note to administrationbaharbarree
Abgabekategorie regulates which kinds of drugs can be dispensed by the pharmacist, and whether a prescription is necessary. Swiss medic, the Swiss authority for approving drugs, classifies the drugs under the appropriate category
The document discusses extemporaneous compounding by pharmacists. It defines extemporaneous compounding as the modification of manufactured products to supply customized dosage forms. Dermatological products are most commonly compounded. Reasons for compounding include unavailable commercial products and customized strengths/dosages. Risks include lack of stability data and standardized protocols. The document also discusses compounding environments, equipment, and the need for more pharmacists and pharmacy services in Pakistan's hospitals.
A NSW partnership has been established with GW Pharmaceuticals to conduct the world's first clinical trials using medicinal cannabis products for children with severe epilepsy. The trials will test cannabidivarin (CBDV) in a phase 2 trial and cannabidiol (CBD) in a phase 4 trial and compassionate access scheme. Researchers at Sydney Children's Hospitals Network will lead the trials to evaluate CBDV and CBD as treatments for drug-resistant epilepsy and determine their safety and effectiveness. The goal is to understand which children may benefit from cannabis-derived medicines and identify any side effects.
Ranveer Sharma from the Department of Biotech at Bcet Gurdaspur presented on Panacea Biotec. Panacea Biotec is an Indian healthcare company focused on pharmaceuticals, biopharmaceuticals, vaccines and natural products. It has a global footprint in over 30 countries. Key highlights included its #4 ranking in vaccines in India, state-of-the-art manufacturing facilities approved by US FDA and WHO, and strategic collaborations with companies like Serum Institute of India and Apotex. Recent updates discussed a collaboration with Serum Institute on a hexavalent vaccine and a settlement agreement with Celgene regarding patents on Panacea's generic version of Abraxane.
Pharmacovigilance in Special Populations: Considerations for Pediatric and Ge...ClinosolIndia
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. When it comes to special populations, such as pediatric and geriatric patients, there are specific considerations that need to be taken into account in pharmacovigilance efforts. Here are some key points regarding pharmacovigilance in these population
This document discusses veterinary drug delivery systems and formulations. It provides an introduction to veterinary medicine and the importance of new drugs. It then summarizes various drug delivery systems used in veterinary medicine including oral, injectable, topical, and other dosage forms. The document reviews some marketed veterinary products and updates on new drugs approved by the FDA. It concludes by noting challenges in developing new veterinary drugs and the importance of research in this area.
One mans supergeneric is anothers life cycle managementMalcolm Ross
This document discusses the potential for generic pharmaceutical companies to develop "supergeneric" or value-added generic drug products. It provides examples of how simple reformulations or new delivery methods for off-patent drugs could create differentiated products with improved efficacy or compliance compared to existing generics. Developing combination products or modified release formulations are presented as opportunities requiring relatively little investment that leverage existing technical skills at generic companies.
This document describes quality control tests that are performed on tablets to ensure they meet specifications. It discusses tests like physical examination, thickness, diameter, weight variation, hardness, friability, disintegration and dissolution. The physical examination checks for defects, thickness and diameter tests uniformity, weight variation tests content uniformity, hardness tests strength, friability tests fragility, disintegration tests breakdown into particles and dissolution tests release of drug in fluid. The document provides details on the principles, procedures, requirements and reports for each of these quality control tests performed on tablets.
Good Manufacturing Practice (GMP) regulations ensure that pharmaceutical products are consistently produced and controlled according to quality standards. GMP has regulations for facilities, equipment, personnel, sanitation, testing of raw materials and finished products, manufacturing, packaging, quality control, records, and stability. Following GMP procedures guarantees high quality products for consumers by minimizing risks of contamination and ensuring correct labeling and potency. Key aspects of GMP include written procedures, process validation, environmental monitoring, and record keeping. Strict adherence to GMP is important for producing safe, effective medicines.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Fabrication and Characterization of Edible Jelly Formulation of Stevioside: A...Debarshi123456789
Based on the fact that stevioside, a glycoside obtained from Stevia rebaudiana Bert has the chief characteristic of
regulating hyperglycemic episodes. The present nutraceutical research describes an innovation that stevia product containing
jelly based formulations have not yet designed as hypoglycemic aids for over-the-counter (OTC) prospective. The main
objectives of this study involved the development of edible jelly formulations containing stevioside which will impart glucose
lowering as well as artificial sweetening characteristics, just like edible jelly brand products such as Juzt Jelly®, Jelly Belly®,
Boleto®, Jolly Candy®, FrutBite® in India. Therefore, the diabetic patients will get a better hypoglycemic control, non-calorific
product, will also enjoy the sweetness, patient-friendly, convenient, without specific dose and frequency and will be much
cheaper than existing market products. The formulation was prepared by the heating method which comprises of stevioside,
HPMC K100, HPMC K15, sodium metabisulphite, ascorbic acid, glycerine, propylene glycol, triethanolamine along with essence
and colors. The organoleptic properties and physicochemical parameters (like stickiness, texture, grittiness, viscosity, drug
content and pH) of the formulations were determined. Techniques like FT-IR analysis, differential scanning calorimetry analysis,
X-Ray diffraction, etc were studied exhaustively to determine the characteristics of the optimized formulation (F9). In-vitro
dissolution study was carried out in simulated gastric fluid without enzyme. The hypoglycemic potential of the optimized
formulation (F9) was studied on Swiss albino rat and the results were compared with standard drug metformin. This research
opened new doors for nutraceutical research that have perspectives of commercialization as OTC products in near future.
1. FDA's Medwatch program allows reporting of adverse events from medical products to help identify safety concerns, with reports on Zyvox and Levoxine/LANOXIN leading to label changes.
2. It is important to report serious adverse events, therapeutic failures, use errors, and product quality issues to the FDA to maintain the Medwatch system.
3. The iPLEDGE program imposed stricter controls on isotretinoin due to depression and suicide risks, requiring registration of prescribers, pharmacies, patients.
This document outlines standards for good pharmacy practice (GPP) as established by the International Pharmaceutical Federation (FIP). It discusses the underlying philosophy of patient-centered pharmaceutical care. The main elements of GPP are outlined as health promotion, supply of medicines, self-care, and influencing prescribing. Specific standards are provided for premises, dispensing, containers, labeling, patient instructions, records, health information, and self-medication. Adherence to these standards helps pharmacists provide quality care that complies with GPP.
1. The document discusses the process of generic drug product development. It defines a generic drug as a drug that is comparable to a brand name drug in dosage, strength, quality and performance, and intended use.
2. The key steps in generic drug development include selecting a product, addressing legislative and regulatory requirements like bioequivalence studies, seeking approval via an Abbreviated New Drug Application (ANDA) by demonstrating bioequivalence to the branded reference drug, and referencing patent and approval information in sources like the Orange Book.
3. Generic drugs can be approved and marketed after relevant patents for the branded counterpart expire. The ANDA process allows generic drugs to avoid duplicating preclinical and clinical trials
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Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
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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Role of Retail Pharmacist for Product Stability.ppt
1. GSPC REFRESHER COURSE- AUGUST 2022 1
Role of Retail Pharmacist for Product Stability
Prof. Vishnu M. Patel
APMC College of Pharmaceutical Education and Research,
Himatnagar, Gujarat, INDIA
2. • Retail pharmacist is a licensed pharmacist who works
in a retail pharmacy to provide the services to patients
on prescribed and non-prescribed (OTC) medicines.
• Retail pharmacy means any pharmacy where drugs are
compounded, dispensed, stored or sold or where
prescriptions are filled or dispensed to the general
public.
GSPC REFRESHER COURSE- AUGUST 2022 2
Retail Pharmacist
3. Retail Pharmacist’ responsibility
3
PRODUCT STABILITY
To Retain medicine’s strength,
quality, and purity when it is
stored according to its labeled
storage conditions till its shelf
life.
COMPOUNDING
The process of providing
information, advice and
assistance to help patients
use their medicines
appropriately
PATIENT COUNCELLING DISPENSING
preparation, mixing, labeling and
packing of medicines as per need of
individual patient.
Giving already available packed
medicines manufactured by
pharmaceutical companies to patient
on evaluation of prescription.
4. Retail pharmacist’s Responsibility
for drug stability
• Maintain the quality and integrity of
medicines till their shelf life in medical store.
• Maintain recommended storage conditions of
each medicines.
• Get updated with the proper storage conditions
for new drug formulations.
• Give advise to patients about storage condition,
advice patients on the safe use of medicines and
their potential side effects, if drug is not stored
properly. GSPC REFRESHER COURSE- AUGUST 2022 4
Retail Pharmacist
5. Product/drug Stability
• Product stability means the ability of the
pharmaceutical dosage form to maintain the
physical, chemical, therapeutic and microbial
properties during the time of storage and usage.
• Drug stability affects the safety and efficacy of
the drug product; degradation impurities may
cause a loss of efficacy and generate possible
adverse effects. Therefore, achieving the
chemical and physical stability of drugs is
essential to ensure their quality and safety.
5
GSPC REFRESHER COURSE- AUGUST 2022
Product stability
6. Product Expiry
In any medicine, 10% drug is degraded, this
medicine is called expired medicine. So after drug
expiry 90% drug is remained in medicine and
upto 10% drug was degraded. This medicine is
not suitable for use.
So ,medicine must have more than 90% of label
claimed potency during its shelf-life.
Any product after opening of primary packaging,
not suitable for potency claim.
6
GSPC REFRESHER COURSE- AUGUST 2022
Product stability
7. Early Drug expiry
Reasons for early expiration of drug products:
• Storage condition is not proper as per label during shelf-
life.
• Some drugs are more sensitive to light, temp, humidity.
• Incompatible formulation due to chemical reactions like
oxidation, hydrolysis, isomerization, polymerization.
• container and closure are not appropriate to product
stability standards. eg. Leakage, sorption, temper-proof,
air tight, well-closed,
• Opening of packaging makes the product non sterile:
e.g. Multi dose injection, multi dose tablet bottle, eye
drops etc. After opening the package, the product is
more susceptible to atmospheric oxygen and
microorganisms. 7
GSPC REFRESHER COURSE- AUGUST 2022
Product stability
8. Short expiry dates
Some medicines are given a short expiry date, such as:
• prepared antibiotic mixtures: when the pharmacist
adds water to powdered antibiotic, it changes the
stability of the product, and the pharmacist will give it
an expiry date of 1 or 2 weeks, depending on the
product
• eyedrops: these are usually given an expiry date of 4
weeks after first opening the container, because your
eyes are particularly sensitive to any bacteria that
might get into the eyedrops. Preservatives gets
degraded rapidly after opening the container.
GSPC REFRESHER COURSE- AUGUST 2022 8
Product stability
9. 9
25% of vaccines go waste due to lack of cold chain
Sushmi Dey | TNN | Jul 1, 2016, 10.00 AM IST
GSPC REFRESHER COURSE- AUGUST 2022
Published Articles
Most vaccines are heat sensitive and remain
potent between 2 degree Celsius and 8 degree
Celsius. Thus maintaining a cold chain becomes
critical to their efficacy.
January 5, 2022
Packaging Update Announced for Rybelsus Tablets
Rybelsus is a glucagon-like peptide (GLP-1) receptor agonist indicated as an
adjunct to diet and exercise to improve glycemic control in adults with type 2
diabetes mellitus.
10. 10
Poor storage lowers quality of TB drugs
Ekatha Ann John | TNN | Mar 7, 2014, 06.24 AM IST
GSPC REFRESHER COURSE- AUGUST 2022
Even though India is the largest supplier of vaccines
globally, producing 62 per cent of the global
demand, the wastage rate is high.
Written by Editorial Team | Updated : May 12, 2022 4:01 PM IST
High Vaccine Wastage In India: Robust Medical
Cold Chain Set Up Needed To Address The Issue
Published Articles
11. GSPC REFRESHER COURSE- AUGUST 2022 11
Indian Express
Drug regulation: 27 medicines sold by top firms ‘fail’
quality tests in seven states
Face charges of false labelling, wrong quantity of ingredients.
• Written by Deepak Patel | New Delhi |
Updated: November 28, 2016 4:30:53 pm
In a major crackdown since March,2016 , then year, the drug
regulators of seven states have alleged that 27 medicines — sold
by 18 major drug companies in India including Abbott India, GSK
India, Sun Pharma, Cipla and Glenmark Pharma — are of
“substandard” quality, citing discolouration, moisture
formation, failing dissolution test and failing disintegration test.
Published Articles
12. GSPC REFRESHER COURSE- AUGUST 2022 12
Gujarat’s drug regulator, which claimed Emcure Pharma’s antibiotic
drug Rifampin was substandard in August, said in its report:
“Almost all vials received for analysis show lumps formation of
the contents of the vials.”
Pentids-400: Abbott received information from the Kerala drug
controller in May 2016 about some tablets of Pentids-400 being
discoloured and having moisture. Testing performed for a portion
of the collected samples by a government laboratory confirmed that
the product met all specifications. Control samples and batch
records of the same batch were also found satisfactory, and we
have not received any other complaints from this batch. This
isolated event was caused by inappropriate storage and handling
in the marketplace. We have shared these details with the state
drug authorities, explaining why there was no need to recall the
said batch.
Published Articles
13. GSPC REFRESHER COURSE- AUGUST 2022 13
May 11, 2021
Insulin Product Samples Recalled Due to Improper
Storage Temperature Conditions
Novo Nordisk is voluntarily recalling 1468 product samples of
Levemir® (insulin detemir [rDNA origin]), Tresiba® (insulin degludec),
Fiasp® (insulin aspart), Novolog® (insulin aspart [rDNA origin]) and
Xultophy® (insulin degludec) to the consumer level due to the
products being stored at temperatures below storage requirements.
Published Articles
Govt Shuts 34 Medicine Outlets For Non-Compliance
Channels Television
Updated December 10, 2021
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14. 14
GSPC REFRESHER COURSE- AUGUST 2022
Published Articles
Lucknow: Over 2 lakh expired medicines in
Lohia hospital’s store, DyCM Brajesh Pathak
orders probe
TNN / Updated: May 13, 2022, 14:33 IST
Expired drugs seized from medical store in
Patna
VK Tripathi / TNN / Updated: Aug 4, 2021, 13:03 IST
15. 15
GSPC REFRESHER COURSE- AUGUST 2022
Published Articles
Affecting quality: A pharmacy in south Delhi.
(photograph by Rajeev Dabral / MINT)
3 min read . Updated: 11 Aug 2008, 12:24 AM IST C.H. Unnikrishnan
Improper storage at retail stores reduces drug
potency: study
Drugs in India lose 3-4% of their potency at
chemists’ shops because they are not stored
properly, results of a recent study show.
16. 16
GSPC REFRESHER COURSE- AUGUST 2022
Published Articles
Poor storage: Your pharmacy is probably
spoiling medicines
The medicines you consume probably aren’t
working as effectively as they should, because
pharmacies often don’t adhere to the
specified storage conditions.
Published: 29th August 2019 03:45 AM | Last Updated: 29th
August 2019 08:59 AM
17. 17
GSPC REFRESHER COURSE- AUGUST 2022
Published Articles
Jammu: Operations of 36 medical
stores suspended for ...
https://medicaldialogues.in › ... › Pharma News 07-Mar-2021
— The reasons for suspension ranged from
non-maintenance of sales records,
impersonation, unhygienic and improper
storage conditions, ...
18. GSPC REFRESHER COURSE- AUGUST 2022 18
Health Risk from Improper Medication Storage
Antibiotics–if they decay, they can cause stomach or kidney damage.
Aspirin–can cause stomach upset (more than the usual).
Hydrocortisone cream–can separate and become useless in the
heat.
Diagnostic test strips–like those used to test for blood sugar
levels, pregnancy or ovulation, are extremely sensitive to humidity. If
moisture sticks to the strips, it will dilute the test liquid and possible
give a false reading.
Hormone pills–thyroid, birth control and others, are especially
susceptible to temperature changes. These are often protein-based,
and when protein gets hot it changes properties.
Insulin, seizure medicines and anticoagulants–small changes in
doses in some medicines like these can make a big difference to your
health.
Published Articles
19. • physical instability problems
Oral solutions
Loss of flavour
Change in taste
Presence of off flavours due to
interaction with plastic bottle
Precipitation
discoloration
Effects Change in smell or feel or
taste
19
GSPC REFRESHER COURSE- AUGUST 2022
Physical instability
20. Parenteral solutions
instability problems
• Discoloration due to photo chemical
reaction or oxidation
• Presence of precipitate due to
interaction with container or stopper
• Clouds due to:
(i) Chemical changes
(ii) The original preparation of a
supersaturated form.
Effects :Change in appearance and in
bio-availability
20
GSPC REFRESHER COURSE- AUGUST 2022
Physical instability
21. Oral Suspensions
Instability problems
• 1. Settling
• 2. Caking
• 3. Crystal growth
Effects
• Loss of drug content uniformity and loss of elegance.
21
GSPC REFRESHER COURSE- AUGUST 2022
Physical instability
22. Emulsions
Instability problems
• Creaming: The rise of dispersed particles to the
surface of an emulsion is referred to as creaming,
which occurs due to density differences between the
dispersed particles and the continuous phase.
• Cracking: the separation of two layers of disperse
and continuous phase, Due to the coalescence of
disperse phase globules which are difficult to
redisperse.
22
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Physical instability
23. Semisolids (Ointments and suppositories)
Instability problems
1. Changes in:
a. Particle size
b. Polymorphic state, or hydration or solvation state
c. Consistency
d. Drug release rate
2. Caking or coalescence. Irreversible phase separation.
3. Bleeding loss of structure and viscosity
Effects
• Loss of drug content uniformity, loss of elegance and change
in drug release rate.
23
GSPC REFRESHER COURSE- AUGUST 2022
Physical instability
24. Suppositories
Instability problems
Effects
• Hardness or shrinkage
• Loss of drug content uniformity,
• loss of elegance and
• change in drug release rate.
24
GSPC REFRESHER COURSE- AUGUST 2022
Physical instability
25. Instability problems
Uncoated Tablet
• Changes in disintegrarion/ dissolution time/Change in
hardness/change in appearance/ Change in drug release
• Appearance of crystals
• Excessive powder visible
• Discoloration
Coated tablet
• Swell with moisture
Effervecent tablet
• Swell with moisture
25
GSPC REFRESHER COURSE- AUGUST 2022
Physical instability
26. Gelatin Capsules (Hard and Soft)
Instability problems
Change in
a. Appearance
Harding or softening
b. Capsules sticking together
c. Poor Strength
Effects
• Change in drug release
26
GSPC REFRESHER COURSE- AUGUST 2022
Physical instability
28. The storage environment should possess
the following:
• Adequate temperature,
• Sufficient lighting,
• Clean conditions,
• Humidity control,
• Cold storage facilities,
• Adequate racks and cupboards to
ensure quality and integrity of the
stored drugs.
28
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
Drug Storage Environment
29. GSPC REFRESHER COURSE- AUGUST 2022 29
Factors Affecting Product Stability
Environmental factors
Microbial contamination
Containers and Closures
31. Temperature
•Increase in temperature usually causes a
very pronounced increase in the hydrolysis
rate of drugs in solution
• The rate of chemical reactions
doubles for every 10°C rise in temperature.
31
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
35. Effect of Moisture (%Relative Humidity)
a. Water catalyses chemical reactions as
oxidation, hydrolysis and reduction
b. Water promotes microbial growth.
Packing materials such as Glass and Plastic are usually
chosen to prevent exposure of drug product to high
humid conditions
35
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
The typical storage conditions for pharmaceuticals at room
temperature should be kept between 15 °C and 25 °C (59 °-77
°F) with relative humidity levels somewhere between 30% and
50%.
36. Effect of Light:
• Light affects drug stability through its energy or
thermal effect which lead to oxidation.
• As a result there will be a loss of potency of the
drug, often accompanied by changes in the
appearance of the product, such as
discoloration or formation of a precipitate.
36
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
37. Light sensitive drugs:
• Antibiotics (ciprofloxacin, doxycycline,
levofloxacin, ofloxacin, tetracycline,
trimethoprim)
• Antifungals (flucytosine, griseofulvin,
voricanozole)
• Many pharmaceutical compounds, including the
phenothiazine tranquillizers, hydrocortisone,
prednisolone, riboflavin, ascorbic acid and folic
acid, degrade when exposed to light.
37
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
38. • Relationship between wavelength and
associated energy of various forms of light.
Type of
radiation
board outers
Wavelength (nm) Energy
Kcal/mol
U.V.
Short wavelength
50 – 400 Degrade the drug
below 450 nm.
Visible 400 – 750 287 – 72
IR 750 – 10,000 36 - 1
38
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
39. GSPC REFRESHER COURSE- AUGUST 2022 39
Photolysis is prevented by:
Suitable packing in amber colored bottles
Card board outers
Aluminum foil wrappers
Environmental factors
40. Influence of pH
• Most of the drugs degrade at
extreme pHs. ie. At high H+ and
OH- because they are the catalytic
species and accelerate the rate of
hydrolytic decomposition.
• Ionic species degrade at a faster
rate than the neutral/ unionized
species because the ionic species
are more water soluble & prone to
chemical reaction.
• The optimum pH for maximum
stability is 3.5 to 5.0
GSPC REFRESHER COURSE- AUGUST 2022 40
Environmental factors
41. • Some buffers such as acetate, citrate,
lactate, phosphate and ascorbate
buffers are utilized to prevent drastic
changes in pH.
• Sometimes pH can have a very serious
effect on decomposition. As little as 1
pH unit change in pH can cause a
change of ten fold in rate constant. So
when we are formulating a drug into a
solution, we should carefully prepare a
pH – decomposition profile and then
formulate the solution at a pH, which
is acceptable physiologically and
stability wise also.
41
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
42. Effect of Oxygen
• Molecular oxygen is involved in
many oxidation schemes
• Particular drug is likely to be
affected by oxidative breakdown
Prevention by
• Replacing the oxygen in the
storage containers with nitrogen
or carbon oxide
• Avoiding contact with heavy
metal ions
• Adding antioxidants
42
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
43. Hydrolysis
• Drug degradation that involves reaction with water
is called hydrolysis
• Hydrolysis is frequently catalysed by hydrogen ions
(specific acid-catalysis) or hydroxyl ions (specific base-
catalysis) and also by other acidic or basic species that
are commonly encountered as components of buffers.
43
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
44. Some functional groups subject to Hydrolysis
Drug type Examples
Esters Aspirin, alkaloids, Dexmethasone, Nitroglycerin
Lactones Pilocarpine Spironolactone
Amides Chloramphenicol
Imides Glutethimide
Malonic ureas Barbiturates
44
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
45. Isomerization
Isomerization is the conversion of one isomer into another.
This is also known as rearrangement reaction.
Conversion of an active drug into an inactive or a less active
drug is known as isomerization.
Different isomers of a drug often have differing
pharmacological activity or toxicity. so, any change in the
proportion of isomers on storage of a pharmaceutical
product is of importance.
Eg. betamethasone-17-valerate, Amphotericin B.
Cephalosporin 45
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
46. Racemization
• The conversion of an optically active
molecule with one chiral center into
its mirror-image is known as racemization.
• Racemization is a major consideration in pharmaceutical stability.
• Optical activity of a compound may be monitored by polarimetry
and reported in terms of specific rotation.
• The racemization of pharmacologically active agents is of
interest because enantiomers often have significantly different
absorption, distribution, metabolism, and excretion, in addition
to differing pharmacological actions.
46
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
47. Epimerization
• In drug molecules with
more than one chiral
Centre, racemization at one
of the chiral centers is
known as Epimerization.
• The epimer of tetracycline,
epitetracycline, has little or
no antibacterial activity
47
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
48. Polymerization
• Reaction of a drug molecule with another
molecule of the same drug may result in the
formation of a dimer or polymer.
• drugs that undergo polymerization during storage
in solution, for example concentrated aqueous
solutions of Amino-penicillins, Ampicillin sodium.
• Such polymeric substances have been shown to
be highly antigenic in animals.
48
GSPC REFRESHER COURSE- AUGUST 2022
Environmental factors
50. GSPC REFRESHER COURSE- AUGUST 2022 50
Microbial factors
Microbiological stability
•Microbiological deterioration is a critical
factor in the stability of sterile products
once the container is opened.
•Deterioration due to microorganism can either render the
product harmful to the patient or have an adverse effect
on the product’s properties.
•Injection products generally need to be used immediately
the container is opened and products for use in the eye
have a short in-use life once opened
51. 1. Contamination from microorganisms is a big problem
for all formulations containing moisture .
2. it can be a bother in solid dosage forms also if some
natural polymers are used because many natural
polymers are fertile sources of microorganisms.
3. In the type of hygienic manufacture carried out today
where “Quality Assurance” is a prerequisite as per the
GMP procedures, there are definite procedures to
prevent microbial contamination in all formulations.
51
GSPC REFRESHER COURSE- AUGUST 2022
Microbial factors
52. Source of microbial contamination
Gums Actinomyces
Animal products Salmonella, Coliforms
Personnel Coliforms, Staphylococci,
Sterptococci
Water gram-negative groups: Pseudomonas,
Xanthamonas, Flavobacterium
Air Mould spores: Penicillium, Aspergillus
Bacterial spores: Bacillus spp. Yeasts
Raw materials Micrococci
Starches Coliforms
Pigments Salmonella
52
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Microbial factors
53. Product stability can be maintained by addition of following
excipients in formulation.
• Antioxidants: a substance that inhibits oxidation, especially one
used to counteract the deterioration of products. Eg. Ascorbic acid
and sodium thiosulfate
• Antimicrobial preservatives: an additive used to protect against
decay, discoloration, or spoilage. Eg. Benzoic Acid, Benzalkonium
Chloride, Benzyl Alcohol, Methylparaben
• Buffering agent: Buffering agents are widely used to stabilize the
pH of solutions. Eg. Acetates , Citrates, Phosphates
• Chelating agents: A chelating agents are chemical compounds that
reacts with metal ions to form stable, water-soluble metal
complexes. • The chelating agent's molecules form several bonds
to a metal ion and prevent the metal from reacting to other
components of formulation eg. Disodium Edetate (EDTA)
GSPC REFRESHER COURSE- AUGUST 2022 53
Product Stability
54. TYPES OF PACKAGING
1. Primary packaging
2. Secondary packaging
3. Tertiary packaging
GSPC REFRESHER COURSE- AUGUST 2022 54
Containers and Closures
55. Types of Glass
1. TYPE I or Highly resistance borosilicate glass
2. TYPE II or Treated soda lime glass
3. TYPE III or Soda lime glass
4. TYPE IV or General purpose soda lime glass
TYPE OF GLASS PROPERTIES SUITABILITY
Type I Alkalinity is removed Parenteral preparation
Type II Treating the surface of type III glass by sulphur dioxide
Acidic buffered solution
Type III It is alkaline glass Dry powder and oleaginous solution
Type IV Similar in composition to that of type III glass Non
parenteral application
55
GSPC REFRESHER COURSE- AUGUST 2022
Containers and Closures
56. Glass containers :
Glass is resistant to chemical and physical
change and is the most commonly material
used for packaging of products.
Limitations Overcome
1. Its alkaline surface use of Borosilicate glass
2. Ions may precipitate
insoluble crystals from the glass
the use of buffers
3- Permits the transmission of
light which may accelerate
decomposition.
Amber colored glass
56
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Containers and Closures
57. PLASTIC CONTAINERS
• There are several different types of
plastics used in pharmaceutical
packaging, including:
PET: polyethylene terephthalate
HDPE: high-density polyethylene
PP: polypropylene
Polystyrene
Polyvinyl chloride (PVC)
57
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Containers and Closures
58. Drawback of Plastic containers:
• Permeation: The transmission of gases,
vapors or liquids in either direction
through plastic container is known as
“Permeation”.
• Leaching: Leaching of constituents from
plastic into the product
• Sorption: Sorption/Absorption of drug
molecules/ions on the plastic materials
• Alteration on the properties of plastics or product
• Poor printing
58
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Containers and Closures
59. Metal Containers
Various alloys and aluminum tubes
may be utilized as containers for
emulsions, ointments, creams and
pastes.
Limitation: They may cause corrosion
and precipitation in the drug
product.
Overcome: Coating the tubes with
polymers may reduce these
tendencies.
59
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Containers and Closures
60. RUBBER CLOSURES:
• Rubber is used mainly for the
construction of closure meant for vials,
transfusion fluid bottles, dropping bottles and as
washers in many other types of product.
Drawbacks of rubber closures:
• Rubber also has the problems of sorption of drug
ingredients and leaching of closure ingredients.
• The pre-treatment of rubber vial stoppers and
closures with water and steam reduces potential
leaching.
60
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Containers and Closures
61. GSPC REFRESHER COURSE- AUGUST 2022 61
BUTYL RUBBER:
Advantages:
•impermeability to water vapor .
•Water absorption is very low.
•They are relatively cheaper compared to
•Other synthetic rubbers.
Disadvantages:
•Slow decomposition takes place above 130 ▫ C.
•Oil and solvent resistance is not very good.
NITRILE RUBBER:
Advantages : Oil resistant due to polar nitrile group.
Heat resistant.
Disadvantages: Absorption of bactericide and leaching of
extractives are considerable.
Containers and Closures