Abstract: A pharmaceutical composition under the form of a sterile and injectable dosage form having a controlled release dosage form including colchicine for treating a joint disease such as osteoarthritis, Erosive Hand Osteoarthritis and any other type of chondropathy and/or treating a pain-associated joint disease and/or protecting joint, bone and/or cartilage, by intra-articular injection of the pharmaceutical composition into a joint. The time required to release 80% by weight of the colchicine is greater than one month and the colchicine is present in a concentration ranging from 1 to 27.5 mg per ml of the sterile and injectable dosage form. The composition of the controlled release dosage form including colchicine has an adapted in vitro dissolution profile. The composition has a formulation in the form of a powder and microparticles having a polymeric matrix and forms an associated kit or article of manufacture.
Type:
Application
Filed:
January 23, 2024
Publication date:
July 30, 2026
Applicant:
PK MED
Inventors:
Farah MARZOUKI, Charles SANSON, Daniel HAYOZ, Gauthier POULIQUEN
Abstract: The present invention relates to process for preparing a drug delivery composition comprising the steps of a) preparing a masterbatch comprising a drug and a first polymer by (i) extruding the first polymer, wherein said first polymer has a melting temperature below 140° C.; and (ii) introducing the drug during extrusion of the first polymer, with a drug content between 0.1% and 90%, based on the total weight of the masterbatch; and b) introducing the masterbatch in a polymer-based matrix during production of the drug delivery composition, wherein step a) is performed at a temperature at which the first polymer is in a partially or totally molten state, and step b) is performed at a temperature at which both the first polymer and at least a polymer of the polymer-based matrix are in a partially or totally molten state.
Type:
Grant
Filed:
July 25, 2018
Date of Patent:
February 27, 2024
Assignee:
PK MED
Inventors:
Philippe Pouletty, Frédérique Guillamot