Keep Timing the Tablets: Statistical Analysis of Pill Dissolution Rates

Martin J. Crowder

Journal of the Royal Statistical Society Series C, 1996, vol. 45, issue 3, 323-334

Abstract: The way in which medicinal tablets, pills and capsules dissolve in liquid is important in the pharmaceutical industry, which collects and analyses data to assess the effects of different formulations of a medicine, different storage conditions, etc. The data usually comprise repeated measures, the record for an individual tablet consisting of either the fractions dissolved at a given sequence of time points or the times taken for given fractions to dissolve. Commonly, mixed model analysis of variance is used for data processing. However, this does not use well‐established physical models for the process of dissolution in a liquid. This paper proposes a repeated measures regression analysis based on established non‐linear dissolution curves, together with a model for the covariance structure of the set of observations made on a dissolving tablet, pill or capsule.

Date: 1996
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