A Statistical Evaluation on the Probability of USP Dissolution Test
Date Issued
2010
Date
2010
Author(s)
Huang, Meng-Yang
Abstract
Dissolution is the rate that drug dissolves in human body from a solid dosage form(tablet, capsule) after oral administration. It directly influences the quantity of chemical compound releasing from drug. So dissolution is important to the strength of drugs. The dissolution rate of each drug product is then needed to be examined before it release to consumers. For testing whether a drug product has an enough dissolution rate, the United States Pharmacopeia and National Formulary (USP/NF) provides a three-stage dissolution testing procedure. The sponsors usually wants to establish in-house passing probability. The USP/NF dissolution testing procedure is a three- stages test and these stages are dependent. In addition, the criteria at each stage consists of the characteristic of individual units (individual requirements) and the distribution of the sample means (average requirements). It follows that the average requirement and individual requirement are not only dependent within the stage but also correlated between stages. As a result, approximated methods may provide over-estimation or under-estimation of the true passing probability. In this thesis, we use Monte Carlo simulation to provide accurate estimations. Tables of the passing probabilities are pro- vided for practical use. An example is given to illustrate the application of the proposed methods.
Subjects
USP/NF dissolution test
passing probability
dependent three- stage procedure
Monte Carlo simulation
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