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. 2011 Jun;12(2):782-94.
doi: 10.1208/s12249-011-9634-x. Epub 2011 Jun 18.

FIP/AAPS joint workshop report: dissolution/in vitro release testing of novel/special dosage forms

Cynthia K Brown  1 , Horst Dieter Friedel, Amy R Barker, Lucinda F Buhse, Susanne Keitel, Todd L Cecil, Johannes Kraemer, J Michael Morris, Christos Reppas, Mary P Stickelmeyer, Chikako Yomota, Vinod P Shah
Affiliations

FIP/AAPS joint workshop report: dissolution/in vitro release testing of novel/special dosage forms

Cynthia K Brown et al. AAPS PharmSciTech. 2011 Jun.

Abstract

In 2003, the FIP Dissolution Working group published a position paper on dissolution/drug release testing for special/novel dosage forms that represented the scientific opinions of many experts in the field at that time (1). The position paper has supported activities, programs, and decisions in the scientific, technical, and regulatory community. Due to the rapid evolution of new practices and techniques for in vitro testing, the FIP Special Interest Group (SIG) on Dissolution/Drug Release decided to revise the previous paper and added proposals for further harmonization of in vitro release testing practices for different pharmaceutical dosage forms. This article represents the current updates to the previously published paper. This revision has been aligned to coincide with the USP taxonomy including route of administration, intended site of drug release, and dosage form. The revised paper includes information from current literature, expert discussions, and presentations from recent workshops (2,3). The authors acknowledge and expect further updates to be made as additional progress is made in the relevant areas. Thus, comments and additional contributions are welcome and may be considered for the next revision of the position paper.

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References

    1. Siewert M, Dressman J, Brown C, Shah VP. 2003. FIP/AAPS guidelines for dissolution/in vitro release testing of novel/special dosage forms. Dissolution Technologies. 2003;10(1):6–15.
    1. International Pharmaceutical Federation (FIP) Workshop, special dosage forms—what’s new with in vitro drug release? Cosponsored with the Royal Pharmaceutical Society of Great Britain (RPSGB), London, UK 20–21 October, 2008.
    1. AAPS workshop: special dosage forms—what’s new with in vitro drug release? Cosponsored with FDA and FIP Los Angeles, CA, USA, 7–8 November 2009.
    1. FIP guidelines for dissolution testing of solid oral products, Die Pharmazeutische Industrie 59: 760–766 (1997) and Dissolution Technologies 4:5–14 November (1997).
    1. FDA guidance for industry: dissolution testing of immediate release solid oral dosage forms, August 1997, extended release solid oral dosage forms: development, evaluation and application of in vitro/in vivo correlations, September 1997; and Dissolution Technologies 4: 15–22 and 23–32, November 1997.

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