Lewis J. Leeson

The development of USP dissolution and drug release standards

Dissolution tests have been in use in the pharmaceutical industry for over 20 years, and they are official in The United States Pharmacopeia since the early 1960s. The dissolution test, reviewed primarily as a quality control tool, replaced the use of disintegration tests which had been official in The United States Pharmacopeia since 1950. Refinements in the dissolution test equipment and methodology have occurred over the years in order to enhance its relevance. The Subcommittees of the USP Committee of Revision dealing with these issues have developed and refined compendial dissolution standards and policies for conventional solid-oral dosage forms and modified-release dosage forms.

Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests

As part of its evaluation of the performance verification tests used periodically to affirm the integrity of the USP Performance test when General Chapter Dissolution is relied upon, the Biopharmaceutics Expert Committee of the Council of Experts, working with staff, decided to change the form of the accept/reject decision from one based on the result for each tablet to one based on the mean and coefficient of variation of results from a set of tablets. This paper describes the new approach. The paper also describes an implementation period for the approach, coupled with a period during which USP will discontinue use of the Salicylic Acid tablet in a performance verification test.