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Abstract

In 1981 Federation International Pharmaceutique (FIP) published “Guidelines for Dissolution Testing of Solid Oral Products” as a joint report of the Section for Official Laboratories and Medicines Control Services and the Section of Industrial Pharmacists. These guidelines were intended as suggestions primarily directed to compendial committees, working on the introduction of dissolution/release tests for the respective Pharmacopoeias.

During the past decade there have been many developments. Biopharmaceutics has attracted much scientific as well as political interest. Dissolution test methodology has been introduced to many Pharmacopoeias and a number of regulations and guidelines on bioavailability, bioquivalence, and in vitro dissolution testing have been issued at national and international levels.

The joint working group on dissolution of the two FIP sections, therefore, decided to establish a new dissolution guideline, taking all these developments into consideration but adding proposals for further harmonization and for definitions and procedures which are not yet covered by international recommendations.

The following guideline is the final draft version elaborated by the FIP working group with contributions from J. M. Mache, Clermont Ferrant; H. Blume, Eschborn; H. D. Friedet, Leverkusen; L. T. Grady, Rockville; V. Gray, Rockville; B. Hubert, Rockville; J. Krämer, Eschborn; I. McGilveray, Ottawa; F. Langenbucher, Basel; L. Leeson, Montville; L. Lesko, Rockville; H. Möller, Frankfurt; S. Qureshi, Ottawa; V. P. Shah, Rockville; M. Siewert, Frankfurt; R. Süverkrp, Bonn; J. O. Waltersson, Uppsala; and E. Wirbitzki, Frankfurt.

The FIP working group decided to publish this final draft version to give colleagues from universities, drug authorities, Pharmacopoeias, and the pharmaceutical industry the opportunity to contribute with their comments to further improvement of the guideline text prior to publication of the final official version. FIP will organize a symposium on all biopharmaceutical aspects of in vitro dissolution testing of solid oral products in November 1996, where the final guidelines for dissolution testing of solid oral products will be discussed and issued.

Keywords

Dissolution testing Solid oral products FIP

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FIP Guidelines for Dissolution Testing of Solid Oral Products (Final Draft,1995)

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