Pharmaceutical Product Stability

Abstract

Pharmaceutical product stability may be defined as the capability of a particular formulation to remain within its physical, chemical, microbiological, therapeutic, and toxicological specifications while in a specific container closure system. There are many factors that can affect the stability of a pharmaceutical product. These include the stability of the active drug(s), interactions between active and inactive ingredients, the dosage form, manufacturing process, the container system, and environment for shipping, handling, and storage. This article focuses on the different types of pharmaceutical product stability, such as chemical degradation, physical degradation, and microbial degradation.

Preliminary studies on antimicrobial activities of ethanolic extracts of Ficus sycomorus Linn. and Ficus platyphylla Del. (Moraceae)

“…The capability of an active substance in a specific container/closure system to remain within its physical, chemical, microbiological and toxicological specification is referred to as stability of the substance (Webster, 2008). The antimicrobial activities of some plant metabolites have been reported to be unstable due to some factors.…”

“…The rate of hydrolysis depends on the quantity of water present, temperature and pH (Dumitinu, 2005). Increase in temperature increases the rate of chemical reactions in all active products (Webster, 2008). Deterioration of some thermolabile products usually occurs as a result of rapid rate of chemical reaction when normal range of temperature is exceeded (Aulton, 2000).…”

“…Deterioration of some thermolabile products usually occurs as a result of rapid rate of chemical reaction when normal range of temperature is exceeded (Aulton, 2000). Webster (2008) postulated that for every ten degree rise in temperature, the rate of chemical reactions doubles or triples.…”