Estimation of Drug Shell-life Time Using Statistical Reliability Models

• DOI: 10.22533/at.ed.65123300812

• Palavras-chave: -

• Keywords: drug shelf-life, stability, natural testing, accelerated testing, statistical reliability models

• Abstract: Stability is the property of a drug to keep its physical, chemical, and microbiological characteristics between the specified limits, during the time of storage and use. Its study should include the evaluation of those attributes that are susceptible to change and that is known they influence its quality, safety and fitness for use. Studies could be accelerated or natural aging. Accelerated aging i designed to increase the rate of chemical degradation and physical change under extreme conditions to predict drug shelf life in a short-term. This research was aimed to make a comparison between the results obtained by both studies to determine whether the accelerated aging is a reliable tool to predict drug shell-life. The natural stability study was developed over a period of 60 months under controlled conditions, meanwhile, the accelerated stability study was carried out over a period of 3 months, during which 3 pilot batches were tested. Comparison of both types of trials yielded similar results, but in less time and less batches with the application of accelerated trials.