Claims for Patent: 5,447,725

Summary for Patent: 5,447,725

Title:	Methods for aiding periodontal tissue regeneration
Abstract:	Methods for aiding periodontal tissue regeneration with compositions containing bioresorbable polymers, leachable solvents, and bioavailable drug actives. The compositions useful for these methods are characterized by becoming harder upon contact with the periodontal tissue such that the composition is effective for aiding tissue regeneration and by releasing a therapeutically-effective amount of drug active agent.
Inventor(s):	Damani; Nalinkant C. (Cincinnati, OH), Mohl; Douglas C. (Fairfield, OH), Singer, Jr.; Robert E. (Fairfield, OH)
Assignee:	The Procter & Gamble Company (Cincinnati, OH)
Application Number:	08/076,304
Patent Claims:	1. A method for aiding periodontal tissue regeneration in a human or lower animal, said method comprises placing at the site in need of periodontal tissue regeneration in a human or lower animal a composition comprising a bioresorbable polymer, leachable solvent, and bioavailable drug active agents, wherein said composition is further characterized by becoming harder upon contact with the periodontal tissue such that the composition is effective for aiding tissue regeneration, and by releasing a therapeutically-effective amount of drug active agent. 2. The method for aiding periodontal tissue regeneration according to claim 1 wherein the bioresorbable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, poly lactyl-co-glycolic acid, polyaminoacids, chitosan, collagen, polyalbumin, gelatin, hydrolyzed animal protein, water soluble gums, polyanhydride, and poly orthoesters. 3. The method for aiding periodontal tissue regeneration according to claim 1 wherein the leachable solvent is selected from the group consisting of propylene carbonate, glyceryl triacetate, triethyl citrate, and mixtures thereof. 4. The method for aiding periodontal tissue regeneration according to claim 1 wherein the bioavailable drug active is selected from the group consisting of antibacterial agents, antibiotics, anti-inflammatory agents, stimulatory agents, dentinal desensitizing agents, odor masking agents, immune reagents, local anesthetic agents, nutritional agents, antioxidants, lipopolysaccharide complexing agents, peroxides, growth factors, clot stabilizing factors, and mixtures thereof. 5. The method for aiding periodontal tissue regeneration according to claim 4 wherein the bioavailable drug active is selected from the group consisting of iodine, sulfonamides, mercurials, bisbiguanides, phenolics, tetracycline, neomycin, kanamycin, metronidazole, clindamycin, aspirin, naproxen, ibuprofen, flurbiprofen, indomethacin, eugenol, hydrocortisone, methotrexate, levamasole, strontium chloride, sodium fluoride, peppermint oil, chlorphyll, immunoglobulin, antigens, lidocaine, benzocaine, amino acids, essential fats, vitamin C, alphatocopherol, butylated hydroxy toluene, polymyxin, urea peroxide, insulin, platelet derived growth factors, bone morphogenic proteins, periodontal ligament chemotactic factor, tissue growth factor beta, IGF-1, fibrin, factor IX complex, and mixtures thereof. 6. The method for aiding periodontal tissue regeneration according to claim 4 wherein the bioresorbable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, and poly lactyl-co-glycolic acid. 7. A method for aiding periodontal tissue regeneration in a human or lower animal, said method comprises placing at the site in need of periodontal tissue regeneration in a human or lower animal a composition comprising: (a) a bioresorbable polymer selected from the group consisting of polylactic acid, polyglycolic acid, and poly lactyl-co-glycolic acid; (b) leachable solvent selected from the group consisting of propylene carbonate, glyceryl triacetate, triethyl citrate, and mixtures thereof, and (c) bioavailable drug active agents, and wherein said composition is further characterized by becoming harder upon contact with the periodontal tissue such that the composition is effective for aiding tissue regeneration, and by releasing a therapeutically-effective amount of drug active agent. 8. The method for aiding periodontal tissue regeneration according to claim 7 wherein the bioavailable drug active is selected from the group consisting of antibacterial agents, antibiotics, anti-inflammatory agents, stimulatory agents, dentinal desensitizing agents, odor masking agents, immune reagents, local anesthetic agents, nutritional agents, antioxidants, lipopolysaccharide complexing agents, peroxides, growth factors, clot stabilizing factors, and mixtures thereof. 9. The method for aiding periodontal tissue regeneration according to claim 8 wherein the bioavailable drug active is selected from the group consisting of iodine, sulfonamides, mercurials, bisbiguanides, phenolics, tetracycline, neomycin, kanamycin, metronidazole, clindamycin, aspirin, naproxen, ibuprofen, flurbiprofen, indomethacin, eugenol, hydrocortisone, methotrexate, levamasole, strontium chloride, sodium fluoride, peppermint oil, chlorphyll, immunoglobulin, antigens, lidocaine, benzocaine, amino acids, essential fats, vitamin C, alphatocopherol, butylated hydroxy toluene, polymyxin, urea peroxide, insulin, platelet derived growth factors, bone morphogenic proteins, periodontal ligament chemotactic factor, tissue growth factor beta, IGF-1, fibrin, factor IX complex, and mixtures thereof. 10. The method for aiding periodontal tissue regeneration according to claim 7 wherein the method comprises placing by syringing at the site in need of periodontal tissue regeneration a composition in a form of a fluid or viscous gel capable of being syringed adjacent to a tooth surface. 11. A method for aiding periodontal tissue regeneration in a human or lower animal, said method comprises placing at the site in need of periodontal tissue regeneration in a human or lower animal a composition comprising: (a) from about 1% to about 90% bioresorbable polymer selected from poly lactyl-co-glycolic acid; (b) from about 0.1% to about 90% leachable solvent selected from the group consisting of propylene carbonate, glyceryl triacetate, triethyl citrate, and mixtures thereof, and (c) from about 0.1% to about 90% bioavailable drug active agents selected from the group consisting of antibacterial agents, antibiotics, anti-inflammatory agents, immune-suppressive agents, stimulatory agents, dentinal desensitizing agents, odor masking agents, immune reagents, local anesthetic agents, nutritional agents, antioxidants, lipopolysaccharide complexing agents, peroxides, growth factors, clot stabilizing factors, and mixtures thereof; and wherein said composition is further characterized by becoming harder upon contact with the periodontal tissue such that the composition is effective for aiding tissue regeneration, and by releasing a therapeutically-effective amount of drug active agent. 12. The method for aiding periodontal tissue regeneration according to claim 11 wherein the poly lactyl-co-glycolic acid bioresorbable polymers comprise from about 15% to about 85% lactide monomeric species and from about 15% to about 85% glycolide monomeric species, on a molar basis; and wherein further the number average molecular weight of the copolymer lies in the range of from about 1000 to about 120,000. 13. The method for aiding periodontal tissue regeneration according to claim 12 wherein the bioavailable drug active is selected from the group consisting of iodine, sulfonamides, mercurials, bisbiguanides, phenolics, tetracycline, neomycin, kanamycin, metronidazole, clindamycin, aspirin, naproxen, ibuprofen, flurbiprofen, indomethacin, eugenol, hydrocortisone, methotrexate, levamasole, strontium chloride, sodium fluoride, peppermint oil, chlorphyll, immunoglobulin, antigens, lidocaine, benzocaine, amino acids, essential fats, vitamin C, alphatocopherol, butylated hydroxy toluene, polymyxin, urea peroxide, insulin, platelet derived growth factors, bone morphogenic proteins, periodontal ligament chemotactic factor, tissue growth factor beta, IGF-1, fibrin, factor IX complex, and mixtures thereof. 14. The method for aiding periodontal tissue regeneration according to claim 11 wherein the method comprises placing by syringing at the site in need of periodontal tissue regeneration a composition in a form of a fluid or viscous gel capable of being syringed adjacent to a tooth surface.

Details for Patent 5,447,725

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	07/20/1981		2040-01-28