Implant for subcutaneous or intradermal injection
The invention concerns an injection implant for filling up wrinkles, thin lines, skin cracks and scars, for reparative or plastic surgery, aesthetic dermatology, and for filling up gums in dental treatment. The invention concerns the use of biologically absorbable polymer microspheres or microparticles suspended in a gel. Said suspension is produced either ready-for-use or freeze-dried. The biological absorbability of the microspheres is controlled and enables the production of implants having well defined persistence and deliberately limited to 3 years.
1. A reconstitutable product, which upon the addition of water becomes a bioresorbable, injectable implant product, wherein said reconstitutable product comprises a freeze-dried composition of:
microparticles of at least one polymer of non-animal origin selected from the group consisting of lactic acid polymers, glycolic acid polymers, and lactic acid-glycolic acid co-polymers; and
a hydrogel precursor consisting essentially of materials of non-animal origin, wherein said precursor forms a hydrogel upon the addition of water.
2. The reconstitutable product according to claim 1 wherein said microparticles are bioresorbable within a period of about 1 year to about 3 years.
3. The reconstitutable product according to claim 1 wherein said microparticles consist of a polymer selected from the group consisting of poly-L-lactic acid, poly-D-lactic acid, and mixtures thereof.
4. The reconstitutable product according to claim 1 wherein the materials of said hydrogel precursor comprise:
a gelling agent, and
a cryoprotecting agent.
5. The reconstitutable product according to claim 4 wherein said gelling agent is a cellulose derivative.
6. The reconstitutable product according to claim 5 , wherein said cellulose derivative is at least one member selected from the group consisting of carboxymethylcellulose and hydroxypropylmethylcellulose.
7. The reconstitutable product according to claim 4 , wherein said gelling agent is synthetic hyaluronic acid.
8. The reconstitutable product according to claim 4 , wherein said cryoprotecting agent is apyrogenic mannitol.
9. The reconstitutable product according to claim 1 further comprising a surfactant.
10. The reconstitutable product according to claim 9 , wherein said surfactant is at least one member selected from the group consisting of polyoxyethylene sorbitan monooleate and polyoxypropylene block copolymer surfactant.
11. A reconstitutable bioresorbable injectable implant product made by freeze-drying a composition consisting essentially of:
bioresorbable microspheres or microparticles suspended in a gel, said gel consisting essentially of materials of non-animal origin,
said microspheres or microparticles consisting of at least one polymer of non-animal origin selected from the group consisting of lactic acid polymers, glycolic acid polymers, and lactic acid-glycolic acid co-polymers.
12. A kit comprising the reconstitutable product of claim 1 in a vial.
13. The kit of claim 12 further comprising a container of water for injection.
14. The kit of claim 12 further comprising a syringe.
15. A kit comprising a syringe prefilled with a bioresorbable injectable implant for human administration consisting essentially of:
bioresorbable microspheres or microparticles suspended in a gel, said gel consisting essentially of materials of non-animal origin,
said microspheres or microparticles consisting of at least one polymer of non-animal origin selected from the group consisting of lactic acid polymers, glycolic acid polymers, and lactic acid-glycolic acid co-polymers.