Stability Studies of Solid Dosage Forms
Pharmaceutical preparation mechanism is a continuous phenomenon. Hundreds of new solid formulations are developed every year. Thus, it is necessary to test and evaluate each solid dosage form for the accurate dispensing and safety of consumers. For this p
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Ghulam Murtaza, Munazza Ijaz, Hafsa Anam, and Saba Shamim
Abstract
Pharmaceutical preparation mechanism is a continuous phenomenon. Hundreds of new solid formulations are developed every year. Thus, it is necessary to test and evaluate each solid dosage form for the accurate dispensing and safety of consumers. For this purpose, stability studies and chemical kinetic evaluation pattern must be observed to get the license for the delivery of new drug formulation. For the stability evaluation of solid dosage forms, ICH and WHO guidelines have to be followed, in which a series of tests is involved to prove the validity and rationality of solid dosage forms. Furthermore, the factors or issues related to stability are observed, and chemical kinetics of the solid dosage forms are monitored. The chemical kinetics involved in drug products from their preparation to storage cause chemical instability of drug formulation. This instability may be due to hydrolysis, photolysis, racemization, or other chemical reactions induced during preparation or storage. Thus, for this purpose, stability studies are applied to achieve the stable finished product. Degradation reactions constitute the reason of chemical instability. Thus, it is considered as the most important aspect during stability studies. Degradation processes affect the pre-formulation studies. If this process is not monitored, drugs stored in optimum conditions could be vigorously degraded. Thus, the stability testing is required to prevent any kind of unwanted effects and for the achievement of stable drug throughout its expected shelf life.
G. Murtaza (*) · H. Anam Department of Pharmacy, COMSATS University Islamabad, Lahore, Pakistan e-mail: [email protected] M. Ijaz · S. Shamim Institute of Molecular Biology and Biotechnology, The University of Lahore, Lahore, Pakistan # The Editor(s) (if applicable) and The Author(s), under exclusive licence to Springer Nature Singapore Pte Ltd. 2020 M. S. H. Akash, K. Rehman (eds.), Drug Stability and Chemical Kinetics, https://doi.org/10.1007/978-981-15-6426-0_16
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Keywords
Pharmaceutical preparations · Stability · Chemical kinetics · ICH and WHO guidelines · Chemical instability · Pre-formulation studies
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Introduction
Drug stability is considered as an important factor for preparing pharmaceutical products. It is the property of pharmaceutical dosage form, which is essential for its pharmacological, microbial, physical, and chemical integrity during its storage and use. There are various properties of drugs, which are studied to investigate its stability: these are ionic strength, pH, and reaction rate constant under different environmental conditions [1]. Chemical kinetics is the physiochemical science to study reactions involved in different mechanism of actions and their engineering at the molecular level [2].
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Types of Solid Dosage Form
Solid dosage forms are the most commonly used forms of drug that can be administered orally. The following are the types of solid dosag
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