Procedure for the purification of biodegradable thermoplastic polymeric particles for medical and/or pharmaceutical use
AssigneeLaboratorios Farmaceuticos Rovi, S.A.
InventorsIBON GUTIERRO ADURIZ, Maria GARCIA AMO, ELENA Cebadera Miranda
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Abstract
Procedure for the purification of biodegradable thermoplastic polymer particles for medical and/or pharmaceutical use without the use of organic solvents, as well as the particles obtained themselves, and the use of polymeric particles obtained by this procedure to manufacture parenteral administered medicinal products and/or implantable medical devices.
Claims19
A solvent-free process for removing extrinsic particles from preformed powdered biodegradable thermoplastic polymer, the process comprising the steps of a) providing powdered biodegradable thermoplastic polymer comprising said extrinsic particles;
- b) heating said powdered polymer to a temperature that is not more than about 5.5° C. above its melting temperature (Tm) to form molten polymer;
- c) filtering the molten polymer through at least one filter having a pore size of about 5-300 μm to form an extruded polymer;
- d) cooling the extruded polymer by means of a sterile gas stream to a temperature at least 4.5-5.5° C. below the glass transition temperature (Tg) of the biodegradable thermoplastic polymer;
- and e) comminuting the cooled polymer to form purified powdered biodegradable thermoplastic polymer free from visible extrinsic particles of a size greater than greater than 150 μm.
The process of claim 11, wherein the biodegradable thermoplastic polymer is selected from the group consisting of poly (L-lactic), poly (D-lactic), poly (DL-lactic), polyglycolic, poly (ε-caprolactone), copolymer of L-lactic/S-lactic acids, copolymer of L-lactic/DL-lactic, copolymer of L-lactic/glycolic, copolymer of DL-lactic/glycolic, copolymer of L-lactic/ε-caprolactone, PLGA, PLA, PC, PE, PEEK, PEI, PES, POM, PP, PPS, PPSU, PS, PSU, PTFE and UHMWPE.
Dependencies are inferred from the claim text.