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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

Hovione
Vectura
Inhalytic
Novartis
Kindeva
Viatris (Leader)
Orion
Teva
Emmace
Inhalation Sciences
Chiesi
Chiesi

Project Title

  • Objective:
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  • Status:
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