Patent ID: 8084045

Claim:
A liquid pharmaceutical formulation for the prolonged release of active principle(s) (AP), wherein: said formulation is liquid under injection conditions; said formulation is liquid at physiological temperature and at physiological pH and in the presence of: a physiological electrolyte in a physiological concentration, or at least one surfactant, said formulation comprises an aqueous colloidal suspension of low viscosity based on submicronic particles of water-soluble biodegradable polymer [PO] non-covalently associated with at least one active principle (AP); wherein said [PO] is a polyamino acid formed of aspartic residues, glutamic residues, or both aspartic and glutamic residues, at least one of said residues carrying at least one tocopherol group attached laterally to the chain, and wherein the concentration of [PO] is greater than or equal to 0.9×C1, where C1 is the “induced gelling” concentration of the particles of [PO], as measured in an induced gelling (IG) test, said test comprising the following steps: dissolving increasing amounts of amphiphilic polymer [PO] in a dry powdered form in deionized water, and keeping the obtained solutions at 25° C. for 16 hours, with magnetic stirring, mixing said solutions with a concentrated solution of active principle(s) to get the desired active principle(s) concentration(s) mixing said solutions with a concentrated aqueous solution of bovine serum albumin (BSA) to obtain a solution containing 30 mg/ml of BSA, and centrifuging for 15 minutes at 3000 rpm, stirring gently for 24 h, measuring the relaxation time Tr of the polymer [PO] solutions to define the concentration C1 at which this time Tr exceeds 1 second; and said formulation prolongs and controls the in vivo release time of the AP beyond 24 h after administration.