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Content archived on 2024-05-21

Clean supercritical technology as a production method for improved pharmaceutical products

Objective

Limiting factors in pharmaceutical industry are related to organic solvent use in the production of drug systems, which generate waste streams and form toxic traces in the drug systems that often promote drug degradation. The solvent problems have increased with the development of drug delivery systems. Besides this, the applicability of several drug systems is restricted due to crystal habit and particle size distribution. Supercritical Fluid technology using compressed carbon dioxide does not have the drawback of forming contamination traces in drugs. Because of the additional degree of freedom related to the density of carbon dioxide, when either used as solvent or as anti-solvent, the technology is able to produce better designed pharmaceutical products, either simple drugs or complex encapsuled particles. Supercritical fluid technology does not create waste streams and has the advantage that the drug system is directly dry after depressurization.
WP I- Description of six drug systems - Report concerning drugs, materials, conditions, fluids and class of SC process;
WP II- Evaluation of bench scale facilities: RESS, SAS and impregnation - Manuals on the bench scale facilities, including GMP compliance - Report on single solute precipitation by RESS and SAS;
WP III- Report on impregnation of biocompatible polymers with drugs using SCF - Report on the production of drugs using RESS and SAS, including protocols for the production of specific particles;
WP IV - Process flow sheets to manufacture solvent free drug systems using SCF techniques for three selected industrial drug systems - Final report on the production of the three selected products containing:
1) Process evaluation 2) Costs comparison 3) Product comparison

WP V- Final evaluation on product and marketing aspects of the three selected drug systems.
This includes information regarding:
- the drug release profile;
- the required amount of drug;
- therapy and administration;
- marketing prospects.

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Call for proposal

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Coordinator

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE
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Rue Paul Bert 27 Raoux-Cassin Délégué régional adj
94204 IVRY-SUR-SEINE
France

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Participants (6)