Implication of Data Obtained from Real Time Stability Studies of Pharmaceutical Preparations

Abstract

The major reason for carrying out stability studies of a drug product is to establish the shelf life of a drug during the period of storage so as to guarantee its quality, effectiveness and safety. Real time stability studies data from 2018-2022 were obtained from selected pharmaceutical industries located within North Central, Nigeria. The analysis of variance (ANOVA) of the data obtained for the real time stability studies was carried out using IBM SPSS Statistics Version 23. The results obtained showed that both chemical and microbiological parameters checked were within the pre-set specifications despite the changes in the results as the storage increases due to environmental factors such as: temperature, humidity, light, exposure to oxygen and container –closure system used for the packaging of the drug product. Pathogenic bacteria such as: Escherichia coli, Staphylococcus aureus, Salmonella typhimurium and Pseudomonas aeruginosa recorded 0.00 cfu/ml and the values obtained for total viable aerobic mesophilic bacteria plate count and fungi were within the pre-set specifications while Staphylococcus aureus and Candida albicans were sensitive to Methylated Spirit. There was a significant difference in the data analysed (P<0.05). The implication of this study is that the drug product may not be stable if the shelf life increases beyond what was stated for them. Hence, these results provided clues to how the quality of the product changes with time under different environmental factors (temperature, relative humidity, exposure to oxygen and light) and the interaction between the drug product and container-closure system used. This study suggests the need for pharmaceutical industries to continuously carry out stability studies of drug products in order to know the changes that may likely occur during the storage and to establish the shelf life of the drug product.