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

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

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.

Publication types

  • Congress

MeSH terms

  • Animals
  • Chemistry, Pharmaceutical / legislation & jurisprudence
  • Chemistry, Pharmaceutical / methods*
  • Chemistry, Pharmaceutical / standards
  • Delayed-Action Preparations / chemistry
  • Delayed-Action Preparations / pharmacokinetics
  • Delayed-Action Preparations / standards
  • Dosage Forms* / standards
  • Drug Therapy / methods*
  • Drug Therapy / standards
  • Humans
  • Pharmaceutical Preparations / chemistry*
  • Pharmaceutical Preparations / metabolism
  • Pharmaceutical Preparations / standards
  • Societies, Pharmaceutical* / legislation & jurisprudence
  • Societies, Pharmaceutical* / standards
  • Solubility
  • United States

Substances

  • Delayed-Action Preparations
  • Dosage Forms
  • Pharmaceutical Preparations