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    Drug Stability for Pharmaceutical Scientists
    Drug Stability for Pharmaceutical Scientists
    Drug Stability for Pharmaceutical Scientists
    Ebook286 pages5 hours

    Drug Stability for Pharmaceutical Scientists

    By Thorsteinn Loftsson

    3.5/5

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    About this ebook

    Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries.

    • Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material
    • Provides answers and explanations to test your knowledge
    • Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more
    • Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability
    LanguageEnglish
    PublisherAcademic Press
    Release dateJan 25, 2014
    ISBN9780124115620
    Drug Stability for Pharmaceutical Scientists
    Author

    Thorsteinn Loftsson

    Dr. Thorsteinn Loftsson is a Professor of Physical Pharmacy at the University of Iceland in Reykjavik. He received his MS Pharm degree from University of Copenhagen and his MS and PhD degrees from the Department of Pharmaceutical Chemistry at the University of Kansas. Dr. Loftsson has authored or co-authors over 200 papers in peer-reviewed journals, numerous book chapters and 20 patents and patent applications. His main research areas include the pharmaceutical applications of cyclodextrins, marine lipids, prodrugs and soft drugs. He has conducted over 100 lectures and is a Fellow of the American Association of Pharmaceutical Scientists (AAPS). Dr. Loftsson is also a member for the editorial board of Journal of Pharmaceutical Sciences, International Journal of Pharmaceutics, Journal of Pharmacy and Pharmacology, die Pharmazie and Journal of Drug Delivery Science and Technology (formerly STP Pharma Sciences).

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    Book preview

    Drug Stability for Pharmaceutical Scientists - Thorsteinn Loftsson

    1

    Introduction

    In Chapter 1, some common terms used in stability evaluation of drugs and drug products are explained. Drug stability is categorized into three categories, that is, chemical stability, physical stability, and microbial stability, and drug degradation is classified according to the environment created by the drug product.

    Keywords

    Stability; API; shelf-life; expiration date; ideal solution; physical degradation; chemical degradation

    Stability of pharmaceutical products refers to the capacity of the product or a given drug substance to remain within established specifications of identity, potency, and purity during a specified time period. Drug stability can be divided into three categories: chemical stability, physical stability, and microbial stability (Table 1.1). Drug degradation can also be classified according to the environment created by the drug product (Table 1.2). The drug formulation can strongly influence the rate and mechanism of drug degradation. In general, drugs degrade at much faster rates in solution than in their solid states, and much faster in aqueous solutions than in no aqueous solutions. Besides monitoring the loss of the active pharmaceutical ingredient (API), (i.e., the drug), stability testing of a finished drug product may involve monitoring: formation of degradation products, changes in drug disintegration and dissolution, loss of package integrity, and microbial contamination. During stability testing of the finished drug product, the appearance of the product and its package will also be monitored. Stability testing provides evidence of how the quality of a finished drug product, API, or pharmaceutical excipient varies with time under the influence of a variety of environmental factors such as temperature, humidity, pH, and light. It can also provide evidence of how transportation, package materials, pharmaceutical excipients, and microbes affect the product. Stability testing of a finished drug product is performed under the guidelines of the European Medicines Agency (EMA), Food and Drug Administration (FDA), or some other authoritative organization. Shelf-life is the length of time the finished drug product will last without deteriorating. Frequently, shelf-life is defined as the time for the original potency (i.e., 100%) of the active drug to be reduced to 95% (t95) or, more frequently, 90% (t90), although more stringent time limits may apply if the degradation products are toxic. Besides chemical degradation of the active ingredient, the shelf-life can be limited by the physical stability of the drug products, such as changes in the drug crystal form or changes in the appearance of the drug product. Stability testing will provide information on the recommended storage conditions, degradation products, and shelf-life of the drug product. The term expiration date (or expiry date) is sometimes defined as the date up until which the manufacturer guarantees the full safety and potency of the drug product. The expiration date may be set as a fixed time after product manufacturing, after dispensing of the product (e.g., oral antibiotic mixtures), or after opening the drug container (e.g., eye drops). Thus, the expiration date of a given drug product may differ from its shelf-life.

    Table 1.1

    The Three Main Categories of Drug Stability and Some Examples of Degradation Mechanisms

    Table 1.2

    Classification of Drug Degradation According to the Drug Product Form

    In chemistry, an ideal solution is defined as a solution whose activity coefficients are equal to unity. In such solutions, the interaction between molecules does not differ from the interactions between molecules of each component. In other words, an ideal solution is a solution that conforms exactly to Raoult’s law. It shows no internal energy change on mixing and no attractive force between components. Pharmaceutical products are never ideal solutions and, thus, their physicochemical behavior can deviate from common theoretical equations and display unexpected behavior. Although various preformulation studies can be performed in dilute aqueous drug solutions, the final stability evaluations and shelf-life predictions have to be based on studies of the final pharmaceutical product.

    Although drug degradation in the solid state is, in general, treated as a special case, it frequently follows the same degradation mechanisms as drug degradation in concentrated aqueous solutions. In such cases, the drug degradation rate may be proportional to the amount of water absorbed into the product.

    Chapter 2

    Principles of Drug Degradation

    In this chapter, the kinetics of drug degradation is reviewed, and it is shown how various excipients, such as buffer salts and complexing agents, the phase distribution of the drug such as in suspensions and emulsions, and external factors such as temperature, oxygen, and light, can influence reaction rates. It is shown how the shelf-life of drug products can be enhanced through proper formulation. The chapter contains numerous practical examples of how various equations and theories are used to solve problems encountered during drug stability

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