This document discusses drug stability and factors that affect it. It defines stability as the extent to which a drug retains its properties within specifications throughout its shelf life under storage and usage conditions. Accelerated stability studies are conducted under exaggerated conditions to gather more data in less time and predict a product's shelf life. Various methods like Arrhenius plots and calculating t90 values are used to extrapolate accelerated data and determine shelf life. Factors like temperature, moisture, light and pH can impact stability and degradation kinetics. Stress testing involves even more severe conditions to understand a drug's intrinsic stability. Maintaining quality and safety throughout a product's shelf life is the goal of stability testing.
1. The document discusses the stability of pharmaceutical products and factors that affect stability such as temperature, moisture, light, and packaging.
2. It covers different types of stability including chemical, physical, and microbiological stability. Regulatory requirements for stability studies and guidelines from organizations like ICH are also reviewed.
3. The major pathways for drug degradation are described as physical degradation, chemical degradation through oxidation, hydrolysis, and other reactions. Methods to protect against these degradation pathways are summarized.
Drug stability refers to a drug substance or product remaining within established specifications over time. The stability of a product is expressed as its shelf life or expiry period. Stability testing involves multiple stages from early stress testing to ongoing long-term testing as required by regulatory bodies. Stability is affected by various factors related to the drug, formulation, and environment. Reduced stability study designs like bracketing and matrixing allow testing of representative samples and are acceptable with proper scientific justification.
stability tests for pharmaceutical productsalaaalfayez
These documents provide guidance on stability testing and evaluation for pharmaceutical products. The purpose of stability testing is to provide evidence on how a drug product's quality varies over time under various environmental conditions. Key aspects addressed include testing the drug substance and finished product under different timepoints and storage conditions to establish or extend a product's shelf life. The documents outline best practices for conducting long-term, accelerated, and intermediate stability studies to evaluate the impact of factors like temperature, humidity, and light on a product's physical, chemical, biological, and microbiological properties over time.
This document discusses preformulation stability studies. It outlines the key factors that affect drug stability like temperature, moisture, and light. The objectives of stability testing are to determine shelf life and provide better storage conditions. The main types of stability are chemical, physical, microbiological, therapeutic, and toxicological. Various methods for stability testing include real-time testing, accelerated testing, and retained sample testing. Guidelines for long-term stability testing from ICH are presented. Common dosage forms that undergo stability testing are discussed.
Stability Testing Of Pharmaceutical Dosage FormNirmalyaDutta3
Stability testing ensures that pharmaceutical products retain their quality attributes throughout their shelf life. It establishes a product's expiration date and appropriate storage conditions. The main types of stability testing are real-time, accelerated, and stress testing. Studies are conducted according to ICH guidelines and involve testing physical, chemical, and microbiological properties over time under different climatic zone storage conditions. Stability testing plays a key role in pharmaceutical development and registration.
Optimization techniques in pharmaceutical formulation and processingReshma Fathima .K
This document discusses various optimization techniques used in pharmaceutical formulation and processing. It defines optimization as making something as perfect or effective as possible. The advantages of optimization include reducing costs, saving time, and improving safety, reproducibility, and efficacy. Key optimization parameters discussed include problem type (constrained or unconstrained), variables (independent and dependent), and applied optimization methods like evolutionary operation, simplex method, search method, Lagrangian method, and canonical analysis.
This document discusses modern pharmaceutics and preformulation concepts. It begins with an introduction to preformulation, which involves investigating a drug's physical and chemical properties alone and with excipients. This information guides dosage form development. The document then discusses drug-excipient interactions and compatibility testing methods. It also covers topics like solid dispersions, emulsions, suspensions, and parenteral product formulation and testing requirements.
1. The document discusses the stability of pharmaceutical products and factors that affect stability such as temperature, moisture, light, and packaging.
2. It covers different types of stability including chemical, physical, and microbiological stability. Regulatory requirements for stability studies and guidelines from organizations like ICH are also reviewed.
3. The major pathways for drug degradation are described as physical degradation, chemical degradation through oxidation, hydrolysis, and other reactions. Methods to protect against these degradation pathways are summarized.
Drug stability refers to a drug substance or product remaining within established specifications over time. The stability of a product is expressed as its shelf life or expiry period. Stability testing involves multiple stages from early stress testing to ongoing long-term testing as required by regulatory bodies. Stability is affected by various factors related to the drug, formulation, and environment. Reduced stability study designs like bracketing and matrixing allow testing of representative samples and are acceptable with proper scientific justification.
stability tests for pharmaceutical productsalaaalfayez
These documents provide guidance on stability testing and evaluation for pharmaceutical products. The purpose of stability testing is to provide evidence on how a drug product's quality varies over time under various environmental conditions. Key aspects addressed include testing the drug substance and finished product under different timepoints and storage conditions to establish or extend a product's shelf life. The documents outline best practices for conducting long-term, accelerated, and intermediate stability studies to evaluate the impact of factors like temperature, humidity, and light on a product's physical, chemical, biological, and microbiological properties over time.
This document discusses preformulation stability studies. It outlines the key factors that affect drug stability like temperature, moisture, and light. The objectives of stability testing are to determine shelf life and provide better storage conditions. The main types of stability are chemical, physical, microbiological, therapeutic, and toxicological. Various methods for stability testing include real-time testing, accelerated testing, and retained sample testing. Guidelines for long-term stability testing from ICH are presented. Common dosage forms that undergo stability testing are discussed.
Stability Testing Of Pharmaceutical Dosage FormNirmalyaDutta3
Stability testing ensures that pharmaceutical products retain their quality attributes throughout their shelf life. It establishes a product's expiration date and appropriate storage conditions. The main types of stability testing are real-time, accelerated, and stress testing. Studies are conducted according to ICH guidelines and involve testing physical, chemical, and microbiological properties over time under different climatic zone storage conditions. Stability testing plays a key role in pharmaceutical development and registration.
Optimization techniques in pharmaceutical formulation and processingReshma Fathima .K
This document discusses various optimization techniques used in pharmaceutical formulation and processing. It defines optimization as making something as perfect or effective as possible. The advantages of optimization include reducing costs, saving time, and improving safety, reproducibility, and efficacy. Key optimization parameters discussed include problem type (constrained or unconstrained), variables (independent and dependent), and applied optimization methods like evolutionary operation, simplex method, search method, Lagrangian method, and canonical analysis.
This document discusses modern pharmaceutics and preformulation concepts. It begins with an introduction to preformulation, which involves investigating a drug's physical and chemical properties alone and with excipients. This information guides dosage form development. The document then discusses drug-excipient interactions and compatibility testing methods. It also covers topics like solid dispersions, emulsions, suspensions, and parenteral product formulation and testing requirements.
Accelerated stability testing is used to predict the shelf life of pharmaceutical formulations by subjecting them to elevated temperatures and humidity to accelerate any degradation. The key steps involve conducting studies at different temperatures, determining the reaction order, calculating rate constants (k) at each temperature, determining the energy of activation using the Arrhenius equation, and extrapolating to room temperature to estimate shelf life. Limitations include changes in degradation mechanism or order at higher temperatures that limit the accuracy of shelf life predictions.
This document compares different methods for comparing dissolution profiles of drug products. It defines dissolution profile comparison and its objectives such as developing bioequivalent products and in vitro-in vivo correlations. Graphical, statistical, model-dependent and model-independent methods are described. The most common model-independent method is the f2 similarity factor test recommended by the FDA, which provides a single value to determine if two dissolution profiles are similar based on the percent dissolved over time. Proper selection of time points and criteria for coefficient of variation are important for f2 testing.
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Stability studies are conducted to prove how the quality of a drug substance or product varies over time under different environmental conditions like temperature, humidity, and light. The purpose is to determine the shelf life and appropriate storage conditions. Key factors that can affect stability include active ingredient properties, interactions, manufacturing process, dosage form, container, and storage conditions during transport and handling. Studies are done under long term, accelerated, and intermediate conditions following protocols to collect data at various time points and interpret results to establish expiration dates.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
FORMULATION FACTORS EFFECTING BIOAVAILABILITY OF DRUGSN Anusha
Bioavailability means the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action.
When the drug is given orally, only part of the administered dose appears in the plasma.
By plotting plasma concentrations of the drug versus time, one can measure the area under the curve (AUC).
This curve reflects the extent of absorption of the drug.
This document presents theories of dispersion and mechanisms of emulsion formation. It discusses four traditional theories of dispersion: viscosity theory, film theory, wedge theory, and interfacial tension theory. It also describes limitations of these theories. The document then introduces a modern approach involving droplet formation and stabilization by emulsifying agents. Three mechanisms of emulsion stabilization are described: monomolecular adsorption, multimolecular adsorption, and solid particle adsorption.
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
This document provides an overview of large and small volume parenteral preparations. It begins with definitions of parenteral preparations and routes of administration. Advantages and disadvantages of the parenteral route are discussed. General requirements for parenteral dosage forms like containers, glass types, closures, and aseptic areas are covered. Parenteral preparations are classified based on volume as small volume parenterals (SVP) and large volume parenterals (LVP). Physiological considerations like pH, buffer, tonicity, and stabilizers are explained. Formulation considerations for various parenteral preparations are provided. The manufacturing process including cleaning, preparation, filtration, filling, sealing, and sterilization is outlined. Key evaluation tests like sterility testing,
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
This document discusses bracketing and matrixing designs for stability testing of new drug substances and products according to ICH Q1D guidelines. Bracketing design involves testing only the extremes of design factors like strength or container size, assuming stability of intermediates is represented by extremes. Matrixing design involves testing selected combinations of factors at each time point rather than all combinations at all time points. Both designs provide reduced testing compared to full design testing all samples at all time points, but require justification and carry potential risks of underestimating shelf life if variability is high.
This document summarizes the presentation of ICH stability testing guidelines for new drug substances and products. It discusses the objectives, scope, general principles and guidelines for conducting stability testing of drug substances and products. The key aspects covered include selection of batches, container closure systems, specifications, testing frequency and storage conditions for long term, intermediate and accelerated stability studies. The goals of stability testing are to provide evidence of quality changes over time and establish re-test or shelf life periods under various environmental conditions.
This document discusses stability testing of pharmaceutical products. It states that stability testing involves complex procedures to ensure quality, efficacy and safety of drug formulations. The most important developmental steps are pharmaceutical analysis and stability studies to determine identity, potency and safety. Stability testing provides evidence of how drug quality changes over time and is used to establish shelf life and storage conditions. It discusses various types of stability studies including real-time, accelerated and cyclic temperature stress testing. The document also outlines the guidelines for stability testing protocols.
Accelerated stability testing is used to predict the shelf life of pharmaceutical formulations by subjecting them to elevated temperatures and humidity to accelerate any degradation. The key steps involve conducting studies at different temperatures, determining the reaction order, calculating rate constants (k) at each temperature, determining the energy of activation using the Arrhenius equation, and extrapolating to room temperature to estimate shelf life. Limitations include changes in degradation mechanism or order at higher temperatures that limit the accuracy of shelf life predictions.
This document compares different methods for comparing dissolution profiles of drug products. It defines dissolution profile comparison and its objectives such as developing bioequivalent products and in vitro-in vivo correlations. Graphical, statistical, model-dependent and model-independent methods are described. The most common model-independent method is the f2 similarity factor test recommended by the FDA, which provides a single value to determine if two dissolution profiles are similar based on the percent dissolved over time. Proper selection of time points and criteria for coefficient of variation are important for f2 testing.
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Stability studies are conducted to prove how the quality of a drug substance or product varies over time under different environmental conditions like temperature, humidity, and light. The purpose is to determine the shelf life and appropriate storage conditions. Key factors that can affect stability include active ingredient properties, interactions, manufacturing process, dosage form, container, and storage conditions during transport and handling. Studies are done under long term, accelerated, and intermediate conditions following protocols to collect data at various time points and interpret results to establish expiration dates.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
FORMULATION FACTORS EFFECTING BIOAVAILABILITY OF DRUGSN Anusha
Bioavailability means the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action.
When the drug is given orally, only part of the administered dose appears in the plasma.
By plotting plasma concentrations of the drug versus time, one can measure the area under the curve (AUC).
This curve reflects the extent of absorption of the drug.
This document presents theories of dispersion and mechanisms of emulsion formation. It discusses four traditional theories of dispersion: viscosity theory, film theory, wedge theory, and interfacial tension theory. It also describes limitations of these theories. The document then introduces a modern approach involving droplet formation and stabilization by emulsifying agents. Three mechanisms of emulsion stabilization are described: monomolecular adsorption, multimolecular adsorption, and solid particle adsorption.
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
This document provides an overview of large and small volume parenteral preparations. It begins with definitions of parenteral preparations and routes of administration. Advantages and disadvantages of the parenteral route are discussed. General requirements for parenteral dosage forms like containers, glass types, closures, and aseptic areas are covered. Parenteral preparations are classified based on volume as small volume parenterals (SVP) and large volume parenterals (LVP). Physiological considerations like pH, buffer, tonicity, and stabilizers are explained. Formulation considerations for various parenteral preparations are provided. The manufacturing process including cleaning, preparation, filtration, filling, sealing, and sterilization is outlined. Key evaluation tests like sterility testing,
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
This document discusses bracketing and matrixing designs for stability testing of new drug substances and products according to ICH Q1D guidelines. Bracketing design involves testing only the extremes of design factors like strength or container size, assuming stability of intermediates is represented by extremes. Matrixing design involves testing selected combinations of factors at each time point rather than all combinations at all time points. Both designs provide reduced testing compared to full design testing all samples at all time points, but require justification and carry potential risks of underestimating shelf life if variability is high.
This document summarizes the presentation of ICH stability testing guidelines for new drug substances and products. It discusses the objectives, scope, general principles and guidelines for conducting stability testing of drug substances and products. The key aspects covered include selection of batches, container closure systems, specifications, testing frequency and storage conditions for long term, intermediate and accelerated stability studies. The goals of stability testing are to provide evidence of quality changes over time and establish re-test or shelf life periods under various environmental conditions.
This document discusses stability testing of pharmaceutical products. It states that stability testing involves complex procedures to ensure quality, efficacy and safety of drug formulations. The most important developmental steps are pharmaceutical analysis and stability studies to determine identity, potency and safety. Stability testing provides evidence of how drug quality changes over time and is used to establish shelf life and storage conditions. It discusses various types of stability studies including real-time, accelerated and cyclic temperature stress testing. The document also outlines the guidelines for stability testing protocols.
1. This document summarizes guidelines for conducting stability studies on drug products and substances according to ICH recommendations. It discusses factors that affect drug stability like temperature, humidity and light. 2. The guidelines describe long term, accelerated and intermediate testing conditions specified by ICH for different climate zones. They also provide examples of accelerated stability testing methods for formulations like emulsions, suspensions and tablets. 3. The document stresses the importance of summarizing stability study results and proposing a shelf life and storage conditions based on the data collected over time.
ICH is an international organization that brings together regulatory authorities and pharmaceutical companies from Europe, Japan and the US to discuss guidelines for drug approval. The purpose is to harmonize technical requirements to reduce redundant testing and delays in approval processes while maintaining standards of quality, safety and efficacy. Stability testing provides evidence of how a drug's quality changes over time under different environmental conditions like temperature and humidity to establish appropriate storage conditions and shelf life. [/SUMMARY]
Stability testing protocol for herbal products in a detailed review.It’s the ability of formulation to retain its physical, chemical, microbiological and toxicological parameter same as that time of manufacture .
Drug product remains within specifications established to ensure its identity, strength, quality and purity.
Stability – Chemical and Physical integrity of herbal medicinal products.
Over a given time period and under the influence of environmental factors including temperature, humidity and light.
To provide evidence on how the quality of active substance varies with time and environmental factors
To establish re- test period for active substance
To establish shelf life of finished products.
To recommend storage conditions.
To evaluate the efficacy of drug.
To develop suitable packing information for drug product
To submit stability information for regulatory agencies.
1.Physical stability study:-
The original physical properties namely appearance, uniformity, palatability, dissolution, and suspend ability are maintained.
Chemical stability study:-
Each and every active ingredient retains its chemical integrity as well as potency specified on label, within the specified limits.
It involves drug assay and determination of drug degradation.
Comparison of stability testing requirements of ich with otherJun Brown
Stability plays an important role in the drug development process. Present work aims to compare the stability
testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory
agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and
European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability
testing requirements for new drug substance and drug product. WHO guidelines describe stability testing
requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information
to be submitted in original and subsequent applications for marketing authorization of their related Finished
pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters
like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term
storage condition (general case) and accelerated storage conditions (substance/product intended to be stored
in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along
with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and
real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on
stability testing requirements for new active substance and related products. It sets out the stability testing
requirements for existing active substance and related finished product. The minimum time period to be covered
by data at the time of submission during long term storage conditions differs from ICH guidelines.
This document summarizes key ICH guidelines related to quality and stability testing. It defines key terms like drug substance, dosage form, drug product, and finished pharmaceutical product. It describes the types of studies conducted for drug substances and products under various storage conditions to establish shelf life and re-test periods. These include long term, intermediate, and accelerated studies. It also summarizes ICH guidelines on specific topics like stability testing (Q1A-Q1F), validation of analytical procedures (Q2), impurities (Q3A-Q3C), and others.
This document provides an overview of stability studies, including the basic concepts, objectives, factors affecting stability, types of stability studies, ICH guidelines, climatic zones, steps for stability testing, and a reference. It defines stability as a drug substance or product retaining its properties and characteristics within specifications for a given time period. The objectives of stability testing are to determine shelf life and storage conditions, ensure formulation and packaging adequacy, understand quality variations over time, and prevent recalls. ICH guidelines cover testing requirements. Studies include long-term, accelerated, and intermediate testing under various climatic zone storage conditions.
The document summarizes ICH guidelines for stability studies of new drug substances and products. It discusses the objectives and scope of stability testing, including providing evidence of a drug's quality over time under various environmental conditions to establish storage requirements and shelf life. The types of stability testing include chemical, physical, microbiological, therapeutic, and toxicological. Testing is conducted over various time periods and storage conditions as outlined in the ICH Q1A-Q1F guidelines. Evaluation of stability data includes assessing parameter results and using statistical analyses to determine a product's retest period or shelf life.
Stability testing of herbal products involves subjecting samples to various conditions like heat, light, and humidity to determine shelf life and ensure quality over time. Key aspects of stability testing include establishing acceptance criteria and storage conditions, conducting both accelerated and long-term real-time tests, and developing a protocol that specifies test attributes, analytical methods, sampling plans, and evaluation procedures. Challenges with testing herbal products relate to their complex compositions, but can be addressed through marker analyses and fingerprinting techniques. Proper stability testing is important for determining appropriate packaging, storage, and expiry dates.
Quality Safety Efficacy Multidisciplinary (Q S E M)
ICH Q1 Stability
Case toxicity of ethylene glycol and diethylene glycol in cough syrup.
accelerated stability studies
constant interval method
The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
ICH Guideline Stability Testing of New Drug Substances and Product Q1A(R2).pptxTrishala Bhatt
This presentation outlines the ICH Guideline for Stability Testing of New Drug Substances and Products, Q1A(R2). It serves as a comprehensive framework for ensuring the stability of new pharmaceuticals, with a focus on the requirements for registration applications within the EC, Japan, and the United States. The guideline emphasizes a balance between a standardized approach and the flexibility to adapt to specific scientific considerations and characteristics of the materials under evaluation.
This document summarizes guidelines from the International Conference on Harmonisation (ICH) regarding stability testing of new drug substances and products. It discusses ICH guidelines Q1A(R2) through Q1F, which provide recommendations on conducting stability studies under various storage conditions to determine appropriate re-test periods and shelf lives. The guidelines specify the types of studies, including stress testing, selection of batches, container closure systems, specifications, testing frequency, and evaluation criteria. The document outlines recommended storage conditions and minimum time periods for long-term, intermediate, and accelerated stability studies to support product registrations.
1. Drug stability testing involves conducting studies under various temperature, humidity and light conditions to determine a drug's shelf life and optimal storage requirements.
2. The ICH Q1A guideline provides the standard process for stability testing new drug substances and products to obtain registration. It defines testing stages, storage conditions and frequencies to evaluate how quality varies over time.
3. Stability testing helps establish expiration dates and provides evidence for appropriate packaging and labeling to ensure drug quality through a product's shelf life.
Seminor on accelerated stability testing of dosage forms sahilsahilhusen
This document discusses stability testing and shelf life prediction of pharmaceutical products. It defines stability as a product remaining within specifications over its shelf life under recommended storage conditions. Stability testing determines a product's shelf life and recommended storage. Types of stability studies discussed are long term, intermediate, and accelerated. The Arrhenius equation is used to predict shelf life from accelerated studies by determining reaction kinetics at different temperatures. Packaging selection, addition of overages, and limitations of shelf life prediction are also summarized.
Seminor on accelerated stability testing of dosage forms sahilsahilhusen
This document discusses stability testing and shelf life prediction of pharmaceutical products. It defines stability as a product remaining within specifications over its shelf life. Stability testing establishes a shelf life and optimal storage conditions. Types of stability studies discussed are long term, intermediate, and accelerated testing under various temperature and humidity conditions. The Arrhenius equation is used to predict shelf life from accelerated data by relating reaction rate to temperature. Packaging selection considers permeability. Accelerated tests for emulsions and suspensions are also summarized.
Shivam Dubey Pharmaceutics Assignment 03: ICH Guidelines On Drug StudiesMrHotmaster1
The document summarizes ICH guidelines for stability studies of new drug substances and products. It discusses the purpose of stability testing to ensure drug quality over shelf life. Key guidelines covered include Q1A for stability testing of new drug substances and products, Q1B for photostability testing, Q1C for new dosage forms, and Q1D for bracketing and matrixing designs. The summary also discusses long term, intermediate, and accelerated storage conditions for drug substances and products, and criteria for evaluation of stability data and establishing retest periods or shelf lives.
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2. 21 April 2020 2
DRUG STABILITY
By
Mr. Hemant Bansode
Assistant Prof.
Department of Pharmaceutics,
Dattakala College of Pharmacy
3. 21 April 2020 3
Contents:
Introduction
Chemical kinetic
Collision Theory
Stability
Expiry Date
Accelerated Stability study
Shelf Life
4. Stability :-
USP defines “ extent of which a product retains within specified limits and
throughout its period of storage & use i.e. its shelf life , the same property & the
characteristics that is possesed at the time of its manufacture.
Objective :-
1. To know the quality of a drug substance or drug product.
2. Shelf life for the drug product.
3. Recommended storage condition.
4. To determine container-closure system suitability.
Need:-
For patient safety.
For drug activity.
21 April 2020 4
5. Expiry date:
• Means that drug can not be used after this date because the concentration of drug is
decreased and become lower than therapeutic concentration.
In addition, some products of drug degradation are toxic and harmful to patients.
• Note!
After the opening of the drug container, the expiry date will be shorter as a result of
the decreased concentration of drug during usage and the effects of external factors.
21 April 2020 5
6. Example:
1. Eye drops: can be used for one month after opening the droppers
2. Syrups and suspension of antibiotics: can be used for one week by storage in
room temperature and for two weeks by storage in 4°c.
3. Tablets and capsules remain stable in the package but after removal the expiry
date will change.
4. Ampoules: must be used immediately but the vials (multidose) are stable for 24
h for the presence of preservatives.
21 April 2020 6
7. Factors affecting drug stability:
1. Temperature,
2. pH.
3. Moisture
4. Light
5. Pharmaceutical dosage forms
6. Concentration
21 April 2020 7
8. 1. Temperature:
High temperature accelerate oxidation, reduction and hydrolysis
reaction which lead to drug degradation.
2. pH:
• Acidic and alkaline pH influence the rate of decomposition of most drugs.
• Many drugs are stable between pH 4 and 8.
• Weekly acidic and basic drugs show good solubility when they are ionized and they
also decompose faster when they are ionized.
• So if the pH of a drug solution has to be adjusted to improve solubility and the
resultant pH leads to instability then a way out of this tricky problem is to introduce a
water miscible solvent into the product. `.
21 April 2020 8
9. 3. Moisture:
a. Water catalyses chemical reactions as oxidation, hydrolysis and reduction reaction
b. Water promotes microbial growth
4. Light: affects drug stability through its energy or thermal effect which lead to
oxidation
5. Pharmaceutical dosage forms: solid dosage forms are more stable than
liquid dosage forms for presence of water.
6. Concentration:
Rate of drug degradation is constant for the solutions of the same drug with different
concentration.
Stock solutions: are concentrated solutions which diluted by using (i.e. syrup 85%)
at high concentration the stability is high
21 April 2020 9
10. 7. Drug incompatibility:
Reactions between components of pharmaceutical dosage forms it self or
between these components and cover of the container .
8. Oxygen:
Exposure of drug formulations to oxygen affects their stability.
21 April 2020 10
11. Types of stability study:-
1. Accelerated stability testing.
2. Long term testing.
3. Stress testing.
4. Photo stability study.
21 April 2020 11
12. Objectives of stability testing:
What is the purpose?
" to provide evidence on how the quality of a drug substance
or drug product varies with time under the influence of a
variety of environmental factors such as temperature,
humidity & light, & enables recommended storage
conditions, re-test periods & shelf lives to be established.”
21 April 2020 12
13. Accelerated Stability Studies
Definition :-
Stability study to predict the shelf life of a product by accelerating
the rate of decomposition, preferably by increasing the temperature of reaction
condition.
Salient features of the experimental design:-
1. Gross picture on stability study is evaluated.
2. Property of degradation should be decided.
3. Mechanism of the chemical reaction need not be explored.
4. A stability indicating assay method is essential.
5. Linear relationship with respect to time should be established as per kinetic
principle.
6. Temperature dependency on the chemical degradation must be established.
7. Appropriate statistical methods should be employed to predict the shelf life.
8. Conclusions obtained by accelerated stability studies should be corroborated by
results obtained at normal storage (Temperature) condition .
21 April 2020 13
14. Accelerated stability testing :-
• All medicinal products decompose with time. Paradoxically, when this
decomposition is being assessed the skilled formulator becomes a victim of his own
expertise, as a good formulation will take a long time to decompose.
• Instability in modern formulations is often detectable only after considerable
storage periods under normal conditions.
• To assess the stability of a formulated product it is usual to expose it to “high stress”,
i.e. condition of temperature, humidity and light intensity that cause break down
• High stress conditions enhance the deterioration of the product and so reduce the time
required for testing.
Importance Of Accelerated Stability Study
21 April 2020 14
15. • Thus these are the studies designed to increase the rate of chemical degradation
and physical change of a drug by using exaggerated storage conditions as part of
the formal stability testing programme.
• This enables more data to be gathered in shorter time, which in turn will allow
unsatisfactory formulation to be eliminated early in a study and will also reduce the
time for a successful product to reach a market.
• It must be emphasized that extrapolation to normal storage condition must be
made with care, the formulator must be sure that such extrapolation are valid.
• The results of accelerated testing studies are not always predictive of physical
changes.
21 April 2020 15
16. Significant change occurs due to accelerated testing :-
• Significant change at the accelerated conditions is defined as:
• A 5% potency loss from the initial assay value of a batch.
• Any specified degradants exceeding its specified limit.
• The product exceeding its pH limits.
• Dissolution exceeding the specified limits for 12 capsules or tablets.
21 April 2020 16
17. • Physical Changes under Accelerated conditions of Temperature &
Humidity :
1. Under Light, both Primary and Secondary packaging affected, and fading of
container
2. color, and the print is fading.
3. Effervescent Tablet : Gain of moisture, loss of integrity
4. Capsule: Color fading in Blister and Sticking in a Glass bottle.
5. Powder : Spread within strip pockets
6. Suppositories : Softening
7. Change in Viscosity of a Gel, Jelly, Cream & Ointment
8. Lozenges : melting
9. Emulsions : Phase separation
21 April 2020 17
18. Objective :-
1. To predict the stability profile of a drug product that prediction of self life of the
product before launching into market.
2. The rapid detection of deterioration different initial formulations of the same
product.
3. Prediction of shelf life.
4. The provision of rapid mean of quality control,
5. Good formulation will invariably break down more slowly than poor ones.
6. Fixing an expiry date depends on the particular drug.
21 April 2020 18
19. Stability Profiles: Accelerated stability study:-
SR.NO. Storage Condition Testing Condition
01 Controlled room temperature
20-25 C
40 C and 75% RH for 6 months
02 Refrigerated condition 2-8 C 25 C and 60% RH for 6 months
03 Freezer condition -2 to -10 C 5 C for 6 months
21 April 2020 19
20. Prediction of shelf life from accelerated stability data :-
Based on the principle of chemical kinetics demonstrated by :-
01. Garret and Carper method
02. Free and Blythe method
Shelf Life Determination Based on Arrhenius Plot (Garret and Carper
method):-
•Based on the application of the Arrhenious equation.
• which indicates the effect of temperature on the rate constant, k, of a chemical
reaction of thermodynamic temperature, 1/T, is a straight line.
• If the slope of this line is determined from the results of temperature by extrapolation,
the k value obtained. And this k value is substituted in appropriate order of reaction
allows the amount of decomposition after a given time. Preliminary experiments are
there for necessary to determine this order.
21 April 2020 20
21. Arrhenious Equation:-
K=Ae-Ea/RT ………………………………………1
Log K=Log A - Ea/2.303*RT ………………2
Where,
K= rate constant ,
R= gas constant =1.987 cal/mole,
T = absolute temperature,
A = frequency factor ,
Ea = energy of activation,
T10% = (2.303/K)*(log100/90),
T90% = (2.303/K)*(log100/10),f
21 April 2020 21
22. Garret and Carper method:-
1. Keep several samples of the drug product at at least three temperatures, such as
40oC, 500 C and 600C.
2. Determine the drug content at all three storage points by taking a number of
samples and take the mean drug content. We do this for a few weeks.
3. At each temperature we plot a graph between time and log percent drug
remaining.
4. If the decomposition is first order this gives a straight line.
5. If it is zero order, percent drug remaining versus time will give a straight line.
6. Next we take the log K or log of reaction constant on Y axis and 1/T x 10-3 on X
axis and draw a best fit line.
7. This line is the Arrhenius Plot, extrapolate this line to get k at 25 oC and from
this we calculate the shelf-life.
21 April 2020 22
23. Arrhenius plot for predicting drug stability at room temp.
21 April 2020 23
24. Arrhenius plot for predicting drug stability at room temp
21 April 2020 24
25. • If the reaction is following zero-order :-
Expiration date at 25 oC = Initial potency – minimum potency / reaction rate at 25 °C
tx =Yo - Yx/ Ko
• If the reaction is following first order
Expiration date at 25 oC (tx) = Log initial potency – log minimum potency/reaction
rate at 25
tx =log Yo – log Yx / K1
Where ,
Yo = initial potency,
Yx = final potency ,
Ko = zero order constant,
K1 = first order constant
21 April 2020 25
26. Limitation of Arrhenious relationship for stability prediction:
• There are varieties of situation in which arrhenious equation can be erroneous or
invalid.
• Higher temperature may evaporate solvents thus producing unequal moisture
concentration at different temperature.
• At higher temperature stability for drugs sensitive to the presence of moisture and
oxygen.
• For dispersive systems viscosity decrease as a temperature increases and physical
characteristic may alter and resulting in potentially large errors in predicting of
stability.
• In spite of these difficulties the application of accelerated testing to pharmaceutical
product is often useful, and predicted shelf lives are sufficiently accurate.
21 April 2020 26
27. SHELF LIFE DETERMINATION Based on t90 values (Free and Blythe /method):-
•Fraction life period is plotted against a reciprocal temp. and the time in days required for
drug to decompose to some fraction of its original potency at room temp.
• This approach clearly illustrate in below fig.
The log% of drug remaining is plotted against time and days and the time for the loss line at
several temp. to reach 90% of the theoretical potency is noted by the doted line. Shelf life and
expiration date are estimated in this way.
21 April 2020 27
28. The log time to 90% is then plotted against 1/T and the time for 10% loss of potency at
room temp. can be obtain from the resulting straight line by extrapolation to 25 C .
0
21 April 2020 28
29. Limitation of accelerated stability studies :-
•Valid only when the breakdown depends on temperature.
•Valid only the energy of activation is about 10 to 30 kcal / mol.
• Reaction at such high temperature may not have any relevance, because they do not reflect
ambient storage condition.
• The result obtained for one set of condition for a preparation cannot be applied to other
preparation of same drug.
• Stability prediction at elevated temperature is of little use when degradation is due to
diffusion, microbial contamination, and photo-chemical reaction.
• Stability studies are meaningless when the product looses its physical integrity at higher
temperature like coagulation of suspending agent, denaturation of proteins.
• Prediction will become erroneous when the order changes at elevated temperatures, as in
case of suspension (zero order) which at higher temperature get converted to solution which
follow 1st order.
21 April 2020 29
30. SHELF LIFE DETERMINATION BASED ON REAL TIME TESTING :-
• Another method which involves real time testing and statistical analysis, followed for
determining shelf life.
1. Keep three batches for stability study at least for 1 year at one fixed temperature.
2. Test them at 0, 1, 3, 6, 9, and 12 months for drug content. At each testing time test a
number of samples, so that you have a mean and a standard deviation value of the result.
3. Now plot the graph of % drug content on Y axis and time on X axis along with confidence
intervals.
Where the lower 95% confidence curve intersects minimum potency, there you fix the
shelf life.
As an example we can see the data and figure given in Tablets, Volume 3, by Hebet A
Lieberman and Leon Lachmann. Vitamin Tablets Stability Confidence Intervals at 40 C
21 April 2020 30
31. Fig: Plot of In potency against time showing 95% confidence limit line
21 April 2020 31
33. Overages:-
• The excess quantity of drug that must be added to the preparation to maintain at least
100% of labeled amount during the expected self life of drug can be easily calculated and added
to the preparation at the time of manufacture.
• The international pharmaceutical federation has recommended that overage be limited to a
maximum of 30% over the labeled potency of an ingredient.
• While adding over-age safety and toxicity should also be considered.
• By convention overage to the of 10 % of excess dose of drug is added to the product at the time
of manufacture.
• This is to ensure that the product contain 100 % labeled amount during the shelf life period.
• In other word at the end of one shelf period the concentration of drug of about 100 %.
• The same product will now take one more shelf life period in order to decrease the drug content
to 90 % of labeled amount.
•Thus product will now take twice the shelf life as an expiry date.
21 April 2020 33
34. Stress testing :-
• Stress testing to elucidate the intrinsic stability of the drug substance is part of the
development strategy and is normally carried out under more severe conditions than
those used for accelerated testing.
• The testing typically includes the effects of temperature (in 10oC increments
(e.g. 50oC to 60oC) above that accelerated testing), humidity (e.g. 75%relative
humidity or greater) where appropriate oxidation and photolysis on the drug
substance.
• Stress testing of the drug product is undertaken to assess the effect of severe
condition of the products.
• Such studies include photo stability testing and specific testing of the certain
products.
21 April 2020 34
35. Common high stresses or challenges:-
• Temperature challenge
• An increase in temperature causes an increase in the rate of chemical reactions.
• The products are therefore stored at temperature higher than room temperature. Sample is
removed at various time intervals and the extent of decomposition is determined by analysis.
• Sensitive analytical methods are used in all stability tests of this nature, as small change can be
detected after very short storage periods.
• The effects caused by high temperature should not confuse with those that arise from the effect
of low humidity.
• Such confusion is possible because the relative humidity inside the high temperature in storage
cabinet is lower than that of room temperature.
• This low humidity causes loss of moisture, which leads to apparent increase in the concentration
of ingredients.
• If these concentration changes are not allowed for in subsequent analyses decomposition may
be unsuspected.
21 April 2020 35
36. LIMITATION:-
• T he arrhenious equation involve only one rate constant and therefore applies to a
simple(single step) decomposition mechanism.
• It cannot be used for complex reactions (consecutive, parallel etc.) or
heterogeneous process involving the phase boundaries.
• Ø The higher temperature may reduce the moisture content of the product, thus
slowing the hydrolysis, gelatin may soften or melt, and tablet coating may split.
• Ø The effects of temperature on photochemical and microbiological destruction are
not predictable
21 April 2020 36
37. • Humidity challenge :-
• Storage of the product in atmosphere in high humidity will accelerate
decomposition that result from hydrolysis.
• Marked acceleration will be obtained if the ‘naked product’ (i.e. not enclosed in a
container) is subjected to these tests, which usually indicate the minimum humidity
tolerated by the product without undue decomposition, and therefore useful in
determining the degree of protection that should be afforded by a container.
21 April 2020 37
38. • Light challenge :-
• The source of artificial light used to accelerate the effect of sunlight or
skylight.
• Day light fluorescent lamp provides a satisfactory source, and banks of
such lamps may be used to accelerate the effect of light.
• To reduce the heating effect of this lamp, glass plates used.
• Otherwise it is difficult to separate the accelerated decomposition
cause by light from that caused by increase temperature.
21 April 2020 38
39. Sr.
No.
Objective Use
01 To select adequate (from the view of
stability) formulation and container closure
system.
Development of product
02 To determine shelf life and storage condition. Development of the product and of
the registration dossier.
03 To verify no changes have been introduce in
the formulation or manufacturing that can
adversely affect the stability of the product.
Quality assurance in general,
including quality control.
21 April 2020 39
40. References :-
1. Aulton M. E, “Pharmaceutics the science of dosage form design”, “Kinetics and
stability testing”.
2. Carstensen, J.T., “Stability and Dating of Solid Dosage Forms” Pharmaceutics
of Solids and Solid Dosage Forms, Wiley-Interscience, 182-185, 1977 .
3. ICH Q1E Evaluation of stability data .
4. Haynes, J.D., “Worldwide Virtual Temperatures for Product Stability Testing,” J.
Pharm. Sci., Vol. 60, No. 6, 927 (June 1971).
.
21 April 2020 40