Dissolution Testing of new and special Dosage Forms - Updated FIP/AAPS Document
Recommendation

5-7 May 2026
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
In 2003, the FIP Dissolution Working group published a position paper on dissolution/drug release testing for special and novel dosage forms that represented the scientific knowledge in the field at that time. This position paper from 2003 has given impetus in the scientific, technical, and regulatory community.
Due to the rapid evolution of new practices and techniques for dissolution/drug release testing, the FIP Special Interest Group on Dissolution/Drug Release decided to revise the previous paper.
In the recently presented Workshop Report the following dosage forms are discussed:
- Conventional solid drug products
- Oral suspensions
- Orally disintegrating tablets
- Chewable tablets
- Powders and granules
- Thin dissolvable films
- Chewing gums
- Dermal systems (patches)
- Topical systems (semisolid dosage forms)
- Suppositories
- Microparticulate formulations
- Implants
- Aerosols
Please find the extensive Report at "FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms".
Author:
Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
23.04.2026Revised Chapter 2.8.25 HPTLC of Herbal Products” Published in Ph. Eur. 13.1
22.04.2026USP plans new General Chapter on Supercritical Fluid Chromatography (SFC)
08.04.2026FDA Warning Letter: Batch Release Without Appropriate Laboratory Evidence
01.04.2026FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data
31.03.2026Questions and Answers on System Suitability Tests (SST) - Part 3
31.03.2026Statistical Process Control (SPC) - Survey Result Report now Available


