Methods and Protocols for Drug Stability Studies
Stability is a significant quality attribute for drug molecules and pharmaceutical preparations. Investigation of drug stability is essential to improve quality, safety and efficacy. The drug toxicity and adverse effects prevented by proper evaluation of
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Methods and Protocols for Drug Stability Studies Hammad Ahmed, Waseem Hassan, Ghulam Murtaza, Sahar Bakht, and Furqan Muhammad Iqbal
Abstract
Stability is a significant quality attribute for drug molecules and pharmaceutical preparations. Investigation of drug stability is essential to improve quality, safety and efficacy. The drug toxicity and adverse effects prevented by proper evaluation of parameters are related to stability. The toxic effects could be due to degraded impurities, drug metabolites or functional groups of drug molecules. Therefore, stability studies are planned to identify and maintain the product quality, throughout the shelf life. The major role of such studies is to predict shelf life, determine the suitable storage condition and suggest the label instructions. Stability studies are deemed as prerequisite for the recognition and endorsement of pharmaceuticals. Stability studies should comply the guidelines of the ICH, the WHO or other agencies deemed fit. These guidelines postulate the outline for the execution of stability studies on both drug and dosage form. The aim of these guidelines is not to constrain the experimentation but to execute the proper and meaningful experiments. The scope of these guidelines is limited to pharmaceutical dosage forms and any feed impregnated with medicinal product. Stability studies are necessary for the development and registration of newer drug. H. Ahmed Department of Pharmacology, Sialkot Medical College, Sialkot, Pakistan Imran Idrees College of Pharmacy, Sialkot, Pakistan W. Hassan (*) · G. Murtaza Department of Pharmacy, COMSATS University Islamabad, Lahore, Pakistan e-mail: [email protected] S. Bakht Department of Pharmacy, The Islamia University of Bahawalpur, Bahawalpur, Pakistan F. M. Iqbal Department of Pharmaceutics, Bahauddin Zakariya University, Multan, 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_4
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Keywords
Stability studies · ICH guidelines · WHO guidelines
4.1
Introduction
Stability studies of drugs are carried out to identify the time in which the pharmaceuticals maintain their physical, chemical, microbiological and pharmacokinetic properties and characteristics. Bright light, sunlight, radiations, temperature, humidity and certain other environmental factors cause the drug to degrade. Despite the product is not expired. While developing pharmaceuticals, principal stages include analysis and stability studies. These studies are mandatory for the identification and maintenance of transparency and potency until its expiry date. To maintain the product integrity and suitability, it should be prevented from the exposure of any environmental factor up to a maximum extent. Drug stability studies are also carried out for the newly developed drugs and dosage forms to identify the expiry of the certain dosage forms. Sim
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