Patent ID: 11931466
Assignee: FERRING B.V.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  B | IPC A  B

Claim 0:
1. A process for the production of nano- and/or microparticles containing a therapeutically active agent embedded in a polymer matrix or encapsulated by a polymer shell, said process comprising the steps of:
a) providing a solution of a polymer selected from polylactide, polyglycolide, and polyester copolymers comprising copolymerized units of lactic acid and/or glycolic acid in an organic solvent S1 having a solubility in water of 10 to 600 g/L;
b) providing a solution or suspension of a therapeutically active agent in an organic solvent or mixture of organic solvents S2 comprising at least 50 vol. % benzyl alcohol,
c) combining the solutions or the solution and the suspension provided in step a) and step b) to provide an organic phase which comprises dissolved polymer and dissolved or dispersed therapeutically active agent in a mixture of the organic solvents S1 and S2;
d) agitating the organic phase provided in step c) in a vessel and adding an aqueous surfactant solution to the organic phase agitated in the vessel in a volume ratio of at least 2:1 in terms of the total volume of the aqueous surfactant solution to the total volume of the organic phase as provided in step c), thus causing the formation of a dispersion containing a continuous aqueous phase and a discontinuous organic phase; and
e) allowing the spontaneous formation of a suspension of the nano- and/or microparticles via transfer of organic solvent from the discontinuous organic phase into the continuous aqueous phase directly after the dispersion has been formed in step d),
wherein the nano- and/or microparticles have a mean particle diameter of from 5 μm to 125 μm.