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[Packaging issues during the development of a medicinal product]
1Sanofi-Synthélabo Recherche, Direction des Affaires réglementaires Groupe, 1, avenue Pierre Brossolette, F 91385 Chilly Mazarin Cedex.
Annales Pharmaceutiques Francaises
|September 18, 2003
Summary
Medicinal product packaging is crucial for drug quality, identification, and proper use. Early development of packaging specifications ensures drug integrity and market compatibility.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- The "special packaging" of medicinal products is legally defined and integral to drug quality and integrity.
- Packaging plays a vital role in drug identification, administration, and patient adherence (therapeutic observance).
Framework:
- Packaging development evolves throughout drug development phases, culminating in the marketing authorization application.
- A detailed packaging specification ("cahier des charges") is essential early in development to ensure drug quality and device functionality during storage.
Implementation:
- Key considerations for packaging include material selection (glass, plastics, aluminum, elastomers) and compatibility with market distribution.
- Industrial, security, prescription, and administration aspects must be addressed during product development.
Implications:
- Proper packaging is critical for obtaining marketing authorization.
- Ensuring packaging permanence maintains drug qualities throughout the product's lifecycle and market presence.