Method of formation of shape-retentive aggregates of gel particles and their uses
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/00
A61K-009/14
A61K-009/16
G02C-007/04
출원번호
UP-0960461
(2004-10-06)
등록번호
US-7811605
(2010-11-01)
발명자
/ 주소
Moro, Daniel G.
St. John, John V.
Shannon, Kevin F.
Ponder, Bill C.
출원인 / 주소
ULURU Inc.
대리인 / 주소
Konski, Antoinette F.
인용정보
피인용 횟수 :
5인용 특허 :
21
초록▼
The present invention relates to a method of forming shape-retentive aggregates of gel particles in which the aggregates are held together by non-covalent bond physical forces such as, without limitation, hydrophobic-hydrophilic interactions and hydrogen bonds. The method comprises introducing a sus
The present invention relates to a method of forming shape-retentive aggregates of gel particles in which the aggregates are held together by non-covalent bond physical forces such as, without limitation, hydrophobic-hydrophilic interactions and hydrogen bonds. The method comprises introducing a suspension of gel particles in a polar liquid at a selected concentration, wherein the gel particles have an absolute zeta potential, into a medium in which the absolute zeta potential of the gel particles is decreased, resulting in the gel particles coalescing into the claimed shape-retentive aggregate. This invention also relates to uses of the method of formation of the shape-retentive aggregates of gel particles.
대표청구항▼
What is claimed: 1. A method for forming a shape-retentive aggregate of gel particles, comprising: providing a suspension system comprising a plurality of gel particles, the particles having an average diameter of less than about 955 nanometers, wherein the gel particles have a first absolute zeta
What is claimed: 1. A method for forming a shape-retentive aggregate of gel particles, comprising: providing a suspension system comprising a plurality of gel particles, the particles having an average diameter of less than about 955 nanometers, wherein the gel particles have a first absolute zeta potential and are made in a polymerization system by adding from 0.1 to 10 mol percent of a surfactant to a monomer, or two or more different monomers, wherein the monomer(s) are selected from the group consisting of a 2-alkenoic acid, a hydroxy(2C-4C)alkyl 2-alkenoate, a hydroxy(2C-4C)alkoxy(2C-4C)alkyl 2-alkenoate, a (1C-4C)alkoxy(2C-4C)alkoxy(2C-4C)alkyl 2-alkenoate and a vicinyl epoxy(1C-4C)alkyl 2-alkenoate and a combination of two or more thereof, in a polar liquid or a mixture of polar liquids, wherein the polar liquid or at least one of the two or more polar liquids comprise(s) one or more hydroxyl groups; and, introducing the suspension system into a receiving medium, which after introduction, the gel particles acquire a second absolute zeta potential which is lower (closer to zero) than the first absolute zeta potential whereupon the gel particles coalesce into a shape-retentive aggregate that maintains indefinitely a shape and the particles of the aggregate are held together by non-covalent bond physical forces comprising hydrophobic-hydrophilic interactions and hydrogen bonds. 2. The method of claim 1, wherein the gel particles are at a concentration of from about 1 to about 500 mg wet weight/mL in the suspension system. 3. The method of claim 2, wherein the gel particles are at a concentration of from about 25 to about 250 mg wet weight/mL in the suspension system. 4. The method of claim 1 wherein the plurality of gel particles is of one size, one or more chemical compositions and a narrow polydispersivity. 5. The method of claim 1, wherein the plurality of gel particles is of two or more different sizes, the composition of each different size being the same as, or different than, the composition of each of the other different sizes, all sizes being of narrow polydispersivity. 6. The method of claim 1, wherein the plurality of gel particles comprises one or more chemical compositions and broad polydispersivity. 7. The method of claim 5, wherein the plurality of gel particles are at a concentration in the suspension system that results in cluster formation. 8. The method of claim 7, wherein the concentration of gel particles in the suspension system is from about 300 mg wet weight/mL to about 500 mg wet weight/mL. 9. The method of claim 1, wherein providing a suspension system comprises mixing together preformed dry gel particles, the liquid(s) and the surfactant. 10. The method of claim 1, wherein the suspension is introduced into the receiving medium through an orifice. 11. The method of claim 10, wherein the orifice comprises a hollow needle selected from the group consisting of 10 gauge to 30 gauge needles. 12. The method of claim 11, wherein the hollow needle is selected from the group consisting of 15 gauge to 27 gauge needles. 13. The method of claim 1, wherein the selected introduction rate is from about 0.05 ml/minute to about 15 ml/minute. 14. The method of claim 13, wherein the selected introduction rate is from about 0.25 ml/minute to about 10 ml/minute. 15. The method of claim 1, wherein the receiving, medium is an in vivo medium. 16. The method of claim 15, where the in vivo medium comprises a bodily tissue. 17. The method of claim 16, wherein the bodily tissue is selected from the group consisting of epithelium, connective, muscle and nerve. 18. The method of claim 17, wherein the connective tissue is selected from the group consisting of blood, bone and cartilage. 19. The method of claim 1, wherein the monomer(s) are selected from the group consisting of acrylic acid, methacrylic acid, 2-hydroxyethyl acrylate, 2-hydroxyethylmethacrylate, diethyleneglycol monoacrylate, diethyleneglycol monomethacrylate, 2-hydroxypropyl acrylate, 2-hydroxypropyl methyacrylate, 3-hydroxypropyl acrylate, 3-hydroxypropyl methacrylate, dipropylene glycol monoacrylate, dipropylene glycol monomethacrylate, gylcidyl methacrylate, 2,3-dihydroxypropyl methacrylate, glycidyl acrylate and glycidyl methacrylate and a combination of two or more thereof. 20. The method of claim 19, wherein the monomer(s) are selected from the group comprising 2-hydroxyathyl methacrylate, 2-hydroxypropyl methacrylate, 3-hydroxypropyl methacrylate, and a combination of two or more thereof. 21. The method of claim 1, wherein the liquid(s) are selected from the group consisting of water, a (1C-10C) alcohol, a (2C-8C)polyol, a (1C-4C)alkyl ether of a (2C-8C)polyol, a (1C-4C)acid ester of a (2C-8C)polyol; a hydroxy-terminated polyethylene oxide, a polyalkylene glycol and a hydroxy(2C-4C)alkyl ester of a mono, di- or tricarboxylic acid. 22. The method of claim 21, wherein the liquid(s) are selected from the group consisting of water, methanol, ethanol, isopropyl alcohol, ethylene glycol, diethylene glycol, triethylene glycol, polyethylene glycol 200-600, propylene glycol, dipropylene glycol, 1,4-butanediol, 2,3-butanediol, 1,6-hexanediol, 2,5-hexanediol, ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, methylcellosolve ether, ethylene glycol monoacetate, propylene glycol monomethyl ether, glycerine, glycerol monoacetate, tri(2-hydroxyethyl)citrate, di(hydroxypropyl)oxalate, glycerine, glyceryl monoacetate, glyceryl diacetate, and glyceryl monobutyrate. 23. The method of claim 22, wherein the liquid is water. 24. The method of claim 1, comprising adding from about 0.1 to about 15% mol percent of a cross-linking agent to the polymerization system which results in cross-linking of the polymer strands. 25. The method of claim 24, wherein the cross-linking agent is selected from the group consisting of ethylene glycol diacrylate, ethylene glycol dimethacrylate, 1,4-dihydroxybutane dimethacrylate, diethylene glycol dimethacrylate, propylene glycol dimethacrylate, diethylene glycol dimethacrylate, dipropylene glycol dimethacrylate, diethyleneglycol diacrylate, dipropylene glycol diacrylate, divinyl benzene, divinyltoluene, diallyl tartrate, diallyl malate, divinyl tartrate, triallyl melamine, N,N′-methylene bisacrylamide, diallyl maleate, divinyl ether, 1,3-diallyl 2-(2-hydroxyethyl) citrate, vinyl ally) citrate, allyl vinyl maleate, diallyl itaconate, di(2-hydroxyethyl) itaconate, divinyl sulfone, hexahydro-1,3,5-triallyltriazine, triallyl phosphite, diallyl benzenephosphonate, triallyl aconitate, divinyl citraconate, trimethyloipropane trimethacrylate and diallyl fumarate. 26. The method of claim 24, wherein the cross-linking agent is selected from the group consisting of alpha-hydroxy acid esters. 27. The method of claim 24, wherein the cross-linked polymer strands have an average molecular weight of from about 3,000 to about 2,000,000. 28. The method of claim 1, further comprising adding one or more working substance(s) to the polar liquid(s) of the polymerization system prior to polymerization wherein, after polymerization, a portion of the working substance(s)-containing liquid is occluded by the gel particles to give working substance-containing gel particles and wherein the working substance is one or more of a biomedical agent, a pharmaceutical agent, or a pharmaceutical excipient. 29. The method of claim 28, wherein the working substance-containing gel particles occlude from about 0.1 to about 90 weight percent working substance-containing liquid. 30. The method of claim 1, further comprising adding one or more working substance(s) to the suspension system, wherein the working substance is one or more of a biomedical agent, a pharmaceutical agent, or a pharmaceutical excipient. 31. The method of claim 30, wherein, upon formation of the shape-retentive aggregate, from about 0.1 to about 90 weight percent of the working substance(s)-containing-liquid is entrapped with in the shape-retentive aggregate. 32. The method of any one of claims 28-31, wherein the working substance(s) comprise one or more biomedical agent(s), which may be the same or different. 33. The method of claim 32, wherein one or more of the biomedical agent(s) comprise(s) one or more pharmaceutical agent(s). 34. The method of claim 33, wherein the pharmaceutical agent(s) further comprises/comprise one or more pharmaceutically acceptable excipient(s). 35. The method of claim 33, wherein the pharmaceutical agent(s) comprises/comprise a peptide or a protein. 36. The method of claim 33, wherein the pharmaceutical agent(s) is/are useful for the treatment of cancer. 37. The method of claim 33, wherein the pharmaceutical agent(s) is/are useful for the treatment of coronary artery disease. 38. The method of claim 33, wherein the pharmaceutical agent(s) is/are useful for the treatment of respiratory diseases. 39. The method of claim 33, wherein the pharmaceutical agent(s) is/are useful for the treatment of infectious diseases. 40. The method of claim 33, wherein the pharmaceutical agent(s) is/are useful for the treatment of ocular disease. 41. The method of claim 33, wherein the pharmaceutical agent(s) is/are growth factors. 42. The method of claim 33, wherein the biomedical agent(s) comprises/comprise one or more tissue-growth scaffold materials. 43. The method of claim 33, wherein the biomedical agent(s) comprises/comprise cosmetic tissue enhancement substances. 44. The method of claim 1, wherein the size of the gel particles is from about 10 to about 800 nanometers in diameter. 45. The method of claim 1, wherein the shape-retentive aggregate is elastic. 46. The method of claim 1, wherein from 1.27 to about 2.77 mole percent of surfactant is added to the liquid(s).
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