News|Articles|April 1, 2002

Pharmaceutical Technology

  • Pharmaceutical Technology-04-02-2002
  • Volume 26
  • Issue 4

Alteration in Dissolution Characteristics of Gelatin-Containing Formulations: A Review of the Problem, Test Methods, and Solutions

Eventual change in the dissolution characteristics of some dosage forms, which is ascribed to cross-linking of gelatin, continues to present challenges to drug manufacturers. The authors discuss the causes, mechanisms, and solutions to the problem.


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Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.