Tablets & Capsules


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Tablets & Capsules October 2019 33 I B. H. J. Dickhoff, T. Schigt, H. L. Blaauw, and A. W. van Gessel DFE Pharma Using multivariate analysis of batch-to-batch excipient variation to reduce risk quality by design This article describes the batch-to-batch variation of a multi- year excipient production data set and the subsequent impact of the variation observed on the excipient's processability and/ or functionality. This type of consistency data can help drug product manufacturers assess the risks associated with using specific grades of excipients and/or vendors for their products. n the pharmaceutical industry, a detailed understand- ing of the impact of raw material variation on a drug product's performance and manufacturing is key [1]. Drug products consist of an active pharmaceutical ingredient (API) as well as many functional excipients. The func- tional excipients enable the API to be processed into a final dosage form and may also enhance stability, bio- availability, or patient acceptance [2]. While the impact of API variability (such as particle size, morphology, or

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