Tablets & Capsules

TC0920

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28 September 2020 Tablets & Capsules W P. H. M. Janssen, R. J. Blezard, and B. H. J. Dickhoff DFE Pharma Water activity and moisture: The complexity and interrelationships explained analytical techniques Water activity and moisture content both represent a measure of water in a material. While the terms are often confused with each other, they are two very different parameters, and under- standing the difference can be important for the development of robust pharmaceutical formulations. This article evaluates the two parameters and discusses their relevance for the stability of solid dosage formulations. ater is a critical factor for the physical and chemical stability of solid oral dosage formulations. It is necessary for the growth of microorganisms and can impact a for- mulation's stickiness, caking, and structure. Water's role in stability is in its potential to contribute to and partici- pate in deteriorative reactions [1]. Degradation of a drug product's active pharmaceutical ingredient (API) through hydrolysis before the end of the product's shelf life can be detrimental to therapeutic efficacy or patient safety.

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