Dissolution Group

Objectives

  • Share and collate member company experience in the area of dissolution testing for inhaled products

  • Develop a sensitive, robust and easy-to-use R&D dose collection and dissolution methodology that can be placed into the public domain

  • Build EPAG expertise in the area with respect to evolving methodology and regulatory activity

The desire and need to understand the dissolution behavior of inhaled products has been increasing over the recent years. There have been discussions around the principles of a pulmonary biopharmaceutical classification system and the use of comparative dissolution data is now suggested in United States Food and Drug Administration (FDA) product-specific guidance as supportive evidence of in vitro bioequivalence.

This increased regulatory interest in dissolution characteristics of inhaled products has opened questions and debate about the best way to carry out these measurements. Thus far, there is no standardized method of aerosol capture and subsequent dissolution testing for inhaled products. The dissolution sub-team has begun collaborative work to assess ways in which dose collection and subsequent dissolution sampling could be improved to enable a discriminatory and relevant R&D test method.

Members

Andy Cooper

Kindeva

Eunice Costa

Hovione

Frank Chambers

Inhalytic

Gopi Kandasamy

Novartis

Joe Takher-Smith

Viatris (Leader)

Laura Matilainen

Orion

Marc Kelly

Teva

Per Backman

Emmace

Per Gerde

Inhalation Sciences

Sara Sefton

Vectura

Sim Bansal

Chiesi

Project Title

  • Objective:
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  • Status:
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Contact

European Pharmaceutical
Aerosol Group

EPAG
European Pharmaceutical Aerosol Group
PO Box 3486
BRISTOL, BS4 9HU
United Kingdom