Process for the preparation of microspheres made of a biodegradable polymeric material
AssigneeDebio Recherche Pharmaceutique S.A.
InventorsPiero Orsolini, Frederic Heimgartner
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Abstract
The process is aimed at providing a composition designed for the sustained and controlled release of medicamentous peptide substances, obtained in the form of microspheres of a biodegradable polymeric material incorporating said medicamentous substance. It consists in converting first a water-soluble peptide or peptide salt into a water-insoluble peptide, respectively peptide salt. The following steps include preparing an organic-aqueous emulsion and then extracting the organic solvent in an excess of aqueous medium.
Claims7
A process for preparing a composition for the sustained and controlled release of a medicamentous peptide substance, said medicamentous peptide substance being a natural or synthetic poly peptide comprising from about 3 to about 45 amino acids, said composition being obtained in the form of microspheres of a biodegradable polymeric organic material incorporating said medicamentous substance, comprising the steps of:
- (a) converting a water soluble peptide or peptide salt into a corresponding water-insoluble peptide salt selected from the group consisting of the pamoate, stearate, and palmitate of said peptide;
- (b) suspending said water-insoluble peptide salt in an organic solvent containing a dissolved biodegradable polymeric organic material to form a suspension;
- (c) dispersing said organic suspension in an aqueous medium to form an aqueous emulsion, where the aqueous medium forms the continuous phase of the emulsion;
- (d) transferring said emulsion into an excess of an aqueous medium, and separating microspheres from the liquid phase.
Dependencies are inferred from the claim text.