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

Recommendation

23-25 May 2023
Vienna, Austria

Analytical Instrument Qualification
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)