SYSTEM FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF POLYMERIC AGENTS AND METHODS OF USE THEREOF
원문보기
IPC분류정보
국가/구분
United States(US) Patent
공개
국제특허분류(IPC7판)
A61N-001/30
A61N-001/30
A61K-038/02
A61K-038/02
A61K-031/728
A61K-031/726
A61K-038/39
A61K-038/39
출원번호
US-0090675
(2006-10-19)
공개번호
US-0221985
(2009-09-03)
국제출원번호
PCT/IL06/001206
(2006-10-19)
발명자
/ 주소
Bukshpan, Shmuel
Zilberstein, Gleb
대리인 / 주소
WINSTON & STRAWN LLP
인용정보
피인용 횟수 :
0인용 특허 :
0
초록▼
A system for iontophoretic transdermal delivery of a non-peptidic polymeric cosmetic or therapeutic agent or of a polypeptide useful for delivery of high molecular weight cosmetic or therapeutic agents. Particularly, the present invention relates to a system that includes an iontophoresis device and
A system for iontophoretic transdermal delivery of a non-peptidic polymeric cosmetic or therapeutic agent or of a polypeptide useful for delivery of high molecular weight cosmetic or therapeutic agents. Particularly, the present invention relates to a system that includes an iontophoresis device and a pharmaceutical composition of a non-peptidic polymeric cosmetic or therapeutic agent together with a peptide, polypeptide or protein and a pharmaceutically acceptable carrier having a pH below or above the isoelectric pH of the peptide, polypeptide or protein.
대표청구항▼
1.-27. (canceled) 28. A system for iontophoretic transdermal delivery of a non-peptidic cosmetic or therapeutic agent comprising an iontophoresis device comprising at least one agent reservoir adapted for holding a cosmetic or pharmaceutical composition, wherein the cosmetic or pharmaceutical comp
1.-27. (canceled) 28. A system for iontophoretic transdermal delivery of a non-peptidic cosmetic or therapeutic agent comprising an iontophoresis device comprising at least one agent reservoir adapted for holding a cosmetic or pharmaceutical composition, wherein the cosmetic or pharmaceutical composition comprising as active ingredients a non-peptidic polymeric cosmetic or therapeutic agent and a peptide, polypeptide or protein, and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier has a pH of at least one pH unit below or above the isoelectric pH of the peptide, polypeptide or protein, thereby increasing the positive or negative charge of the peptide, polypeptide or protein. 29. The system according to claim 28, wherein the iontophoresis device comprises a first agent reservoir adapted for holding a first cosmetic or pharmaceutical composition comprising as active ingredients a non-peptidic polymeric cosmetic or therapeutic agent and a peptide, polypeptide or protein, and a first pharmaceutically acceptable carrier, wherein the first pharmaceutically acceptable carrier has a pH of at least one pH unit below the isoelectric pH of the peptide, polypeptide or protein, and a second agent reservoir adapted for holding a second cosmetic or pharmaceutical composition comprising as active ingredients the non-peptidic polymeric cosmetic or therapeutic agent and the peptide, polypeptide or protein, and a second pharmaceutically acceptable carrier, wherein the second pharmaceutically acceptable carrier has a pH of at least one pH unit above the isoelectric pH of the peptide, polypeptide or protein. 30. The system according to claim 28, wherein the non-peptidic polymeric cosmetic or therapeutic agent is selected from the group consisting of polysaccharides, polynucleotides, and synthetic polymers. 31. The system according to claim 30, wherein the polysaccharide is selected from the group consisting of hyaluronic acid, polylactic acid, heparin, heparan sulphate, dermatan sulphate and chondroitin sulphate. 32. The system according to claim 28, wherein the peptide, polypeptide or protein is selected from the group consisting of insulin, proinsulin, follicle stimulating hormone, insulin like growth factor-1, insulin like growth factor-2, platelet derived growth factor, epidermal growth factor, fibroblast growth factors, nerve growth factor, colony stimulating factors, transforming growth factors, tumor necrosis factor, calcitonin, parathyroid hormone, growth hormone, bone morphogenic protein, erythropoietin, hemopoietic growth factors, luteinizing hormone, calcitonin, glucagons, clotting factors such as factor VIIIC, factor IX, tissue factor, and von Willebrand factor, anti-clotting factors such as Protein C, atrial natriuretic factor, lung surfactant, plasminogen activator, such as urokinase or tissue-type plasminogen activator, including human tissue-type plasminogen activator (t-PA), bombesin, thrombin, enkephalinase, a collagen domain, mullerian-inhibiting agent, relaxin A-chain, relaxin B-chain, prorelaxin, Dnase, inhibin, activin, vascular endothelial growth factor, receptors for hormones or growth factors, integrin, protein A or D, a neurotrophic factor such as bone-derived neurotrophic factor (BDNF), neurotrophin-3,-4,-5, or-6 (NT-3, NT-4, NT-5, or NT-6), immunotoxins, interferon such as interferon-alpha,-beta, and-gamma; colony stimulating factors (CSFs), interleukins (ILs) such as IL-1 to IL-10; surface membrane proteins, viral antigen such as a portion of the AIDS envelope, transport proteins, homing receptors, regulatory proteins, collagen, gelatin, fibrin, keratin, elastin, laminin, bovine serum albumin (BSA), polylysine, antibodies, glycoproteins, phosphoproteins, avidin-biotin complexes and lectins. 33. The system according to claim 28, wherein the pharmaceutically acceptable carrier has a pH of at least two pH units below or above the isoelectric pH of the peptide, polypeptide or protein. 34. The system according to claim 28, wherein the pharmaceutically acceptable carrier has a pH of at least three pH units below or above the isoelectric pH of the peptide, polypeptide or protein. 35. The system according to claim 28, wherein the pharmaceutical or cosmetic composition further comprises an additional therapeutic or cosmetic agent. 36. The system according to claim 35, wherein the therapeutic agent is selected from the group consisting of anti-infectives, analgesics, anesthetics, antiarthritic agents, antiasthmatic agents, anticonvulsants, anti-depressants, anti-diabetic agents, anti-diarrhea agents, anti-histamines, anti-inflammatory agents, anti-migraine agents, anti-motion sickness preparations, anti-neoplastics, anti-parkinsonism drugs, anti-pruritics, anti-psychotics, antipyretics, anti-spasmodics, anticholinergics, sympathomimetics, xanthine derivatives, calcium channel blockers, beta-blockers, anti-arrhythmics, anti-hypertensives, diuretics, vasodilators, central nervous system stimulants, cough suppressants, cold preparations, decongestants, diagnostics, hormones, hypnotics, immunosuppressives, muscle relaxants, parasympathomimetics, psychostimulants, sedatives tranquilizers, food supplements, derivatives and salts thereof. 37. The system according to claim 35, wherein the cosmetic agent is selected from the group consisting of polysaccharides, xanthines, retinoids, α-hydroxy acids, β-hydroxy acids, α-2 adrenergic inhibitors, β-adrenergic agonists, aromatase inhibitors, anti-estrogens, hydroquinone, vitamins, kojic acid, corticosteroids, estrogens, isoflavonoids, cinnamic acid, benzoyl peroxide, tropolone, catechol, mercaptoamine, niacinamide, ferulic acid, azelaic acid, botulinum, colors, dermal fillers, derivatives and salts thereof. 38. The system according to claim 28, wherein the cosmetic composition comprises hyaluronic acid and BSA. 39. The system according to claim 28, wherein the cosmetic composition comprises hyaluronic acid and collagen. 40. A system for iontophoretic transdermal delivery of a polypeptide comprising at least one hundred amino acid residues, the system comprises an iontophoresis device comprising at least one agent reservoir adapted for holding a cosmetic or pharmaceutical composition, wherein the cosmetic or pharmaceutical composition comprises as an active ingredient a polypeptide comprising at least one hundred amino acid residues, and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier has a pH of at least one pH unit below or above the isoelectric pH of the polypeptide, thereby increasing the positive or negative charge of said polypeptide. 41. The system according to claim 40, wherein the iontophoresis device comprises a first agent reservoir adapted for holding a first cosmetic or pharmaceutical composition, wherein the first cosmetic or pharmaceutical composition comprises as an active ingredient a polypeptide comprising at least one hundred amino acid residues, and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier has a pH of at least one pH unit below the isoelectric pH of the polypeptide, and a second agent reservoir adapted for holding a second cosmetic or pharmaceutical composition, wherein the second cosmetic or pharmaceutical composition comprises as an active ingredient the polypeptide, and a second pharmaceutically acceptable carrier, wherein the second pharmaceutically acceptable carrier has a pH of at least one pH unit above the isoelectric pH of the polypeptide. 42. A method for iontophoretic transdermal delivery of a non-peptidic polymeric cosmetic or therapeutic agent, which comprises: removing the stratum corneum from a predetermined site on the skin of a subject; providing a system for iontophoretic transdermal delivery comprising an iontophoresis device comprising at least one agent reservoir adapted for holding a pharmaceutical or cosmetic composition, wherein the pharmaceutical or cosmetic composition comprises as active ingredients a non-peptidic polymeric cosmetic or therapeutic agent and a peptide, polypeptide or protein, and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier has a pH of at least one pH unit below or above the isoelectric pH of the peptide, polypeptide or protein, thereby increasing the positive or negative charge of said peptide, polypeptide or protein; placing the at least one agent reservoir in contact with the site on the skin of the subject; and delivering the non-peptidic polymeric cosmetic or therapeutic agent and the peptide, polypeptide or protein to the subject by iontophoresis. 43. The method according to claim 42, wherein the iontophoresis device comprises a first agent reservoir adapted for holding a first cosmetic or pharmaceutical composition comprising as an active ingredient said peptide, polypeptide, or protein and a first pharmaceutically acceptable carrier, wherein the first pharmaceutically acceptable carrier has a pH of at least one pH unit below the isoelectric pH of the peptide, polypeptide, or protein and a second agent reservoir adapted for holding a second cosmetic or pharmaceutical composition comprising as an active ingredient the peptide, polypeptide, or protein and a second pharmaceutically acceptable carrier, wherein the second pharmaceutically acceptable carrier has a pH of at least one pH unit above the isoelectric pH of the peptide, polypeptide or protein. 44. The method according to claim 42, wherein the non-peptidic polymeric cosmetic or therapeutic agent is selected from the group consisting of polysaccharides, polynucleotides, and synthetic polymers. 45. The method according to claim 44, wherein the polysaccharide is selected from the group consisting of hyaluronic acid, polylactic acid, heparin, heparan sulphate, dermatan sulphate and chondroitin sulphate. 46. The method according to claim 42, wherein the peptide, polypeptide or protein is selected from the group consisting of insulin, proinsulin, follicle stimulating hormone, insulin like growth factor-1, insulin like growth factor-2, platelet derived growth factor, epidermal growth factor, fibroblast growth factors, nerve growth factor, colony stimulating factors, transforming growth factors, tumor necrosis factor, calcitonin, parathyroid hormone, growth hormone, bone morphogenic protein, erythropoietin, hemopoietic growth factors, luteinizing hormone, calcitonin, glucagons, clotting factors such as factor VIIIC, factor IX, tissue factor, and von Willebrand factor, anti-clotting factors such as Protein C, atrial natriuretic factor, lung surfactant, plasminogen activator, such as urokinase or tissue-type plasminogen activator, including human tissue-type plasminogen activator (t-PA), bombesin, thrombin, enkephalinase, a collagen domain, mullerian-inhibiting agent, relaxin A-chain, relaxin B-chain, prorelaxin, Dnase, inhibin, activin, vascular endothelial growth factor, receptors for hormones or growth factors, integrin, protein A or D, a neurotrophic factor such as bone-derived neurotrophic factor (BDNF), neurotrophin-3,-4,-5, or-6 (NT-3, NT-4, NT-5, or NT-6), immunotoxins, interferon such as interferon-alpha,-beta, and-gamma; colony stimulating factors (CSFs), interleukins (ILs) such as IL-1 to IL-10; surface membrane proteins, viral antigen such as a portion of the AIDS envelope, transport proteins, homing receptors, regulatory proteins, collagen, gelatin, fibrin, keratin, elastin, laminin, bovine serum albumin (BSA), polylysine, antibodies, glycoproteins, phosphoproteins, avidin-biotin complexes and lectins. 47. The method according to claim 42, wherein the cosmetic or pharmaceutical composition further comprises an additional therapeutic or cosmetic agent. 48. The method according to claim 42, wherein the cosmetic composition comprises hyaluronic acid and BSA. 49. The method according to claim 42, wherein the cosmetic composition comprises hyaluronic acid and collagen. 50. A method for iontophoretic transdermal delivery of a polypeptide comprising at least one hundred amino acid residues, which comprises: removing the stratum corneum from a predetermined site on the skin of a subject; providing a system for iontophoretic transdermal delivery comprising an iontophoresis device comprising at least one agent reservoir adapted for holding a cosmetic or pharmaceutical composition, wherein the cosmetic or pharmaceutical composition comprises as an active ingredient a polypeptide comprising at least one hundred amino acid residues, and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier has a pH of at least one pH unit below or above the isoelectric pH of the polypeptide, thereby increasing the positive or negative charge of said polypeptide; placing the agent reservoir in contact with the site on the skin of the subject; and a) delivering said polypeptide to the subject by iontophoresis.
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