INJECTABLE FILLERS FOR AESTHETIC MEDICAL ENHANCEMENT AND FOR THERAPEUTIC APPLICATIONS
First Claim
1. An injectable tissue filler composition comprising(a) about 10% to about 75% calcium phosphate particles, based on the weight of the filler composition, wherein the calcium phosphate particles have a porosity of about 10% to about 90%, a surface area of about 1 m2/g to about 100 m2/g, and a mean particle size of about 1 micron to about 30 microns,(b) about 0.5% to about 50% thermoreversible gelling agent, based on the weight of the filler composition, wherein the gelling agent is a hydrogel that is in the form of a liquid a 25°
- C. and in the form of a gel having a viscosity of about 2000 cP or more at 35°
C., and(c) aqueous carrier,wherein the filler composition has a pH of about 6.5 to about 7.5.
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Abstract
The present invention relates to a biocompatible injectable filler composition comprising calcium phosphate particles having a porosity of about 10% to about 90%, a BET surface area of about 1 m2/g to about 100 m2/g, and a mean particle size of about 1 micron to about 30 microns, a thermoreversible hydrophilic gelling agent, a carrier comprising water and an optional persistence enhancer and/or volumizing agent, and methods of its use to restore tissue volume and/or to smooth out tissue defects as in soft tissue or deep tissue augmentation.
40 Citations
22 Claims
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1. An injectable tissue filler composition comprising
(a) about 10% to about 75% calcium phosphate particles, based on the weight of the filler composition, wherein the calcium phosphate particles have a porosity of about 10% to about 90%, a surface area of about 1 m2/g to about 100 m2/g, and a mean particle size of about 1 micron to about 30 microns, (b) about 0.5% to about 50% thermoreversible gelling agent, based on the weight of the filler composition, wherein the gelling agent is a hydrogel that is in the form of a liquid a 25° - C. and in the form of a gel having a viscosity of about 2000 cP or more at 35°
C., and(c) aqueous carrier, wherein the filler composition has a pH of about 6.5 to about 7.5. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
- C. and in the form of a gel having a viscosity of about 2000 cP or more at 35°
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16. A method of tissue augmentation comprising:
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(i) obtaining an injectable filler composition comprising; (a) about 10% to about 75% calcium phosphate particles, based on the weight of the filler composition, wherein the calcium phosphate particles have a porosity of about 10% to about 90%, a surface area of about 1 m2/g to about 100 m2/g, and a mean particle size of about 1 micron to about 30 microns, (b) about 0.5% to about 50% thermoreversible gelling agent, based on the weight of the filler composition, wherein the gelling agent is a hydrogel that is in the form of a liquid a 25°
C. and in the form of a gel having a viscosity of about 2000 cP or more at 35°
C., and(c) aqueous carrier, wherein the filler composition has a pH of about 6.5 to about 7.5; (ii) injecting or implanting the filler composition into or underneath tissue to form a bleb, wherein the formation of the bleb increases tissue volume in the region surrounding the site of injection or implantation. - View Dependent Claims (17, 18)
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19. A method of producing a calcium phosphate particles having a rounded morphology comprising:
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(i) providing calcium phosphate particles having a particle size of 30 micron or less and a surface area of 20 m2/g or less, and (ii) contacting the calcium phosphate particles with an acid selected from the group consisting of nitric acid, hydrochloric acid, sulfuric acid, and phosphoric acid, in water. - View Dependent Claims (20)
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21. A method of producing an injectable tissue filler composition comprising:
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(i) partially sintering calcium phosphate particles having a particle size of 30 micron or less and a surface area of 20 m2/g or less, and (ii) contacting the partially sintered calcium phosphate particles with an acid selected from the group consisting of nitric acid, hydrochloric acid, sulfuric acid, and phosphoric acid, in water to form calcium phosphate particles have a rounded morphology, a porosity of about 10% to about 90%, a surface area of about 1 m2/g to about 100 m2/g, and a mean particle size of about 1 micron to about 30 microns, and (iii) compounding the calcium phosphate particles with a thermoreversible gelling agent that is a hydrogel that is in the form of a liquid a 25°
C. and in the form of a gel having a viscosity of about 2000 cP or more at 35°
C., and an aqueous carrier. - View Dependent Claims (22)
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Specification