Abstract
AbstractDegradation kinetic study ascertains the shelf life of drugs under different environmental conditions. It can facilitate the prediction of specific critical factors that can affect the quality of pharmaceuticals during storage. To date, general systematic strategies for performing degradation kinetics of drugs have not been discussed in any literature. Moreover, no regulatory guideline is available on the degradation kinetic study of pharmaceuticals. Owing to this, the kinetic behavior of drugs is not being analyzed uniformly. This article provides a detailed insight into degradation kinetic approaches including criticality in selecting different variables for the study. Factors that can affect the quality of degradation kinetic study data have been critically discussed. In addition, a systematic strategy to perform degradation kinetic study with advanced degradation models has been discussed. This article will be helpful for the researcher working in the field of stability analysis and guide to select a logical path for determining the kinetic behavior of drugs. High-quality degradation kinetic data through the properly designed study will help to establish accurate storage conditions of pharmaceuticals. This article is unique and novel of its kind and would have a significant contribution to the field of stability analysis.
Publisher
Springer Science and Business Media LLC
Subject
General Physics and Astronomy,General Environmental Science,General Biochemistry, Genetics and Molecular Biology,General Materials Science,General Chemistry
Reference53 articles.
1. Agrahari V, Putty S, Mathes C, Murowchick JB, Youan BBC. Evaluation of degradation kinetics and physicochemical stability of tenofovir. Drug Test Anal. 2015;7:207–13.
2. Ahmad I, Vaid FH. Thermal degradation of 7, 8-dimethyl-10-formylmethylisoalloxazine in acid solution: a kinetic study. J Chem Soc Pak. 2011;30:688.
3. Ahmad I, Fasihullah Q, Vaid FH. Photolysis of formylmethylflavin in aqueous and organic solvents. Photochem Photobiol Sci. 2006;5:680–5.
4. Ahmad I, Anwar Z, Ahmed S, Sheraz MA, Bano R, Hafeez A. Solvent effect on the photolysis of riboflavin. AAPS PharmSciTech. 2015;16:1122–8.
5. Alibrandi G, Micali N, Trusso S, Villari A. Hydrolysis of aspirin studied by spectrophotometric and fluorometric variable-temperature kinetics. J Pharm Sci. 1996;85:1105–8.
Cited by
22 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献