KR100366439B1 - 상피세포 성장인자를 유효성분으로 하는 안정한 약제학적조성물 - Google Patents
상피세포 성장인자를 유효성분으로 하는 안정한 약제학적조성물 Download PDFInfo
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- KR100366439B1 KR100366439B1 KR10-2000-0008116A KR20000008116A KR100366439B1 KR 100366439 B1 KR100366439 B1 KR 100366439B1 KR 20000008116 A KR20000008116 A KR 20000008116A KR 100366439 B1 KR100366439 B1 KR 100366439B1
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- Prior art keywords
- egf
- carbomer
- carboxy vinyl
- base
- active ingredient
- Prior art date
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- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 title claims abstract description 92
- 101800003838 Epidermal growth factor Proteins 0.000 title claims abstract description 88
- 229940116977 epidermal growth factor Drugs 0.000 title claims abstract description 88
- 239000004480 active ingredient Substances 0.000 title claims abstract description 13
- 102000009024 Epidermal Growth Factor Human genes 0.000 title claims abstract 8
- 239000008194 pharmaceutical composition Substances 0.000 title description 3
- 239000000203 mixture Substances 0.000 claims abstract description 54
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 45
- 238000002360 preparation method Methods 0.000 claims abstract description 32
- 238000009472 formulation Methods 0.000 claims description 38
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 26
- 229960001631 carbomer Drugs 0.000 claims description 25
- 239000003889 eye drop Substances 0.000 claims description 13
- 229940012356 eye drops Drugs 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 10
- JVTIXNMXDLQEJE-UHFFFAOYSA-N 2-decanoyloxypropyl decanoate 2-octanoyloxypropyl octanoate Chemical compound C(CCCCCCC)(=O)OCC(C)OC(CCCCCCC)=O.C(=O)(CCCCCCCCC)OCC(C)OC(=O)CCCCCCCCC JVTIXNMXDLQEJE-UHFFFAOYSA-N 0.000 claims description 3
- WLAMNBDJUVNPJU-UHFFFAOYSA-N 2-methylbutyric acid Chemical compound CCC(C)C(O)=O WLAMNBDJUVNPJU-UHFFFAOYSA-N 0.000 claims description 3
- 229940049638 carbomer homopolymer type c Drugs 0.000 claims description 3
- 229940082484 carbomer-934 Drugs 0.000 claims description 3
- 229940043234 carbomer-940 Drugs 0.000 claims description 3
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 claims 2
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 claims 2
- 229920000642 polymer Polymers 0.000 abstract description 10
- 239000007864 aqueous solution Substances 0.000 abstract description 6
- 230000007935 neutral effect Effects 0.000 abstract description 4
- 208000025865 Ulcer Diseases 0.000 abstract description 3
- 230000002378 acidificating effect Effects 0.000 abstract description 3
- 231100000397 ulcer Toxicity 0.000 abstract description 3
- 239000003732 agents acting on the eye Substances 0.000 abstract description 2
- 229920003174 cellulose-based polymer Polymers 0.000 abstract description 2
- 229940125702 ophthalmic agent Drugs 0.000 abstract description 2
- 102400001368 Epidermal growth factor Human genes 0.000 description 80
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 12
- 239000012153 distilled water Substances 0.000 description 12
- 239000007924 injection Substances 0.000 description 10
- 238000002347 injection Methods 0.000 description 10
- 239000008363 phosphate buffer Substances 0.000 description 10
- 206010052428 Wound Diseases 0.000 description 9
- 208000027418 Wounds and injury Diseases 0.000 description 9
- 239000000499 gel Substances 0.000 description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 8
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 8
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 7
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 description 7
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 description 7
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 6
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 6
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 238000013112 stability test Methods 0.000 description 6
- 230000001225 therapeutic effect Effects 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- 238000003860 storage Methods 0.000 description 5
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 description 4
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 4
- 229940105329 carboxymethylcellulose Drugs 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 4
- 230000008859 change Effects 0.000 description 4
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 4
- 229960000502 poloxamer Drugs 0.000 description 4
- 229920001983 poloxamer Polymers 0.000 description 4
- 239000011780 sodium chloride Substances 0.000 description 4
- 239000012086 standard solution Substances 0.000 description 4
- 238000002965 ELISA Methods 0.000 description 3
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 3
- 229910000397 disodium phosphate Inorganic materials 0.000 description 3
- 235000019800 disodium phosphate Nutrition 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 239000008055 phosphate buffer solution Substances 0.000 description 3
- 230000001737 promoting effect Effects 0.000 description 3
- 239000003381 stabilizer Substances 0.000 description 3
- 229940124597 therapeutic agent Drugs 0.000 description 3
- 230000029663 wound healing Effects 0.000 description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- 238000008157 ELISA kit Methods 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- 206010040943 Skin Ulcer Diseases 0.000 description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 210000004087 cornea Anatomy 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 150000003904 phospholipids Chemical class 0.000 description 2
- 229920001992 poloxamer 407 Polymers 0.000 description 2
- 229940044476 poloxamer 407 Drugs 0.000 description 2
- 229920001184 polypeptide Polymers 0.000 description 2
- 239000003755 preservative agent Substances 0.000 description 2
- 230000002335 preservative effect Effects 0.000 description 2
- 102000004196 processed proteins & peptides Human genes 0.000 description 2
- 108090000765 processed proteins & peptides Proteins 0.000 description 2
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 2
- 230000002829 reductive effect Effects 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 231100000019 skin ulcer Toxicity 0.000 description 2
- 239000000600 sorbitol Substances 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- 238000011146 sterile filtration Methods 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 238000013268 sustained release Methods 0.000 description 2
- 239000012730 sustained-release form Substances 0.000 description 2
- 229910052725 zinc Inorganic materials 0.000 description 2
- 239000011701 zinc Substances 0.000 description 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- 208000028006 Corneal injury Diseases 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 239000004909 Moisturizer Substances 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 235000002789 Panax ginseng Nutrition 0.000 description 1
- 240000004371 Panax ginseng Species 0.000 description 1
- 108091005804 Peptidases Proteins 0.000 description 1
- 239000004365 Protease Substances 0.000 description 1
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000013011 aqueous formulation Substances 0.000 description 1
- -1 aryl sucrose Chemical compound 0.000 description 1
- 125000002843 carboxylic acid group Chemical group 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000009786 epithelial differentiation Effects 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 230000027119 gastric acid secretion Effects 0.000 description 1
- 235000008434 ginseng Nutrition 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 239000007951 isotonicity adjuster Substances 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000002502 liposome Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000006210 lotion Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000000394 mitotic effect Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000001333 moisturizer Effects 0.000 description 1
- 229940096984 ophthalmic cream Drugs 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000037314 wound repair Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/27—Growth hormone [GH], i.e. somatotropin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1808—Epidermal growth factor [EGF] urogastrone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Dermatology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Endocrinology (AREA)
- Ophthalmology & Optometry (AREA)
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
EGF | 0.5 mg |
카보머 934P | 0.1 g |
만니톨 | 5 g |
파라옥시안식향산메틸 | 0.04g |
파라옥시안식향산프로필 | 0.01g |
수산화나트륨 | 적당량 |
주사용증류수 | 적당량 |
총량 | 100 g |
EGF | 0.5 mg |
인산일수소나트륨 | 0.14 g |
염화나트륨 | 0.88 g |
20% 인산용액 | 적당량 |
총량 | 100 g |
EGF | 0.5 mg |
카르복시메틸셀룰로오즈 나트륨(CMC) | 0.5 g |
소르비톨 | 5.47 g |
파라옥시안식향산메틸 | 0.05 g |
수산화나트륨 | 적당량 |
주사용증류수 | 적당량 |
총량 | 100 g |
EGF | 5 mg |
카보머 934P | 1 g |
파라옥시안식향산메틸 | 0.2 g |
프로필렌글리콜 | 20 g |
수산화나트륨 | 적당량 |
주사용증류수 | 적당량 |
총량 | 100 g |
EGF | 5 mg |
폴록사머 407 | 15 g |
파라옥시안식향산메틸 | 0.2g |
인산일수소나트륨 | 272.18 mg |
염화나트륨 | 666.22 mg |
인산 | 적당량 |
프로필렌글리콜 | 20 g |
주사용증류수 | 적당량 |
총량 | 100 g |
시 료 | 초 기 | 4℃ | |||
2 주 | 4 주 | 8 주 | 18 주 | ||
실시예 10.1% 카보머 제제 | 100±2.5 | 99.2±3.2 | 102.0±4.3 | 103.7±1.2 | 101.6±3.5 |
실시예 210mM 인산완충액 제제 | 100±1.9 | 98.4±5.4 | 96.8±14.0 | 91.6±10.3 | 92.5±5.9 |
실시예 30.5% 카르복시메틸 셀룰로오즈 나트륨 제제 | 100±2.1 | 104.9±3.4 | 99.7±6.0 | 102.7±2.3 | 87.3±3.1 |
시 료 | 초 기 | 25℃ | |||
2 주 | 4 주 | 8 주 | 18 주 | ||
실시예 10.1% 카보머 제제 | 100±2.5 | 98.2±2.5 | 101.8±2.4 | 101.8±2.4 | 87.6±5.2 |
실시예 210mM 인산완충액 제제 | 100±1.9 | 81.6±3.6 | 88.4±6.9 | 81.3±1.7 | 72.5±3.3 |
실시예 30.5% 카르복시메틸 셀룰로오즈 나트륨 제제 | 100±2.1 | 93.5±6.5 | 88.4±0.2 | 78.5±2.7 | 48.7±9.3 |
시 료 | 초 기 | 4℃ | |||
2 주 | 4 주 | 8 주 | 18 주 | ||
실시예 210mM 인산완충액제제 | 100±1.9 | 98.4±5.4 | 96.8±14.0 | 91.6±10.3 | 92.5±5.9 |
실시예 41% 카보머 제제 | 100±1.8 | 104.5±14.2 | 102.3±2.6 | 101.2±0.8 | 100.3±2.3 |
실시예 515% 플록사머 제제 | 100±2.8 | 103.5±9.3 | 95.7±0.8 | 94.2±4.2 | 90.5±4.5 |
시 료 | 초 기 | 25℃ | |||
2 주 | 4 주 | 8 주 | 18 주 | ||
실시예 210mM 인산완충액 제제 | 100±1.9 | 81.6±3.6 | 88.4±6.9 | 81.3±1.7 | 72.5±3.3 |
실시예 41% 카보머 제제 | 100±1.8 | 107.3±2.0 | 92.5±0.5 | 101.8±2.4 | 99.5±4.5 |
실시예 515% 플록사머 제제 | 100±2.8 | 90.3±41.4 | 79.5±5.0 | 78.5±2.7 | 66.4±2.6 |
Claims (8)
- 천연형 또는 재조합 단백질 형태로 제조된 생물학적 활성이 있는 상피세포 성장인자(EGF)를 유효성분으로 하고, 카르복시 비닐 폴리머를 기제로 포함하는 안정한 외용제.
- 제 1항에 있어서,카르복시 비닐 폴리머는 카보머 934, 카보머 934P, 카보머 940,카보머 941 또는 카보머 947P인 것을 특징으로 하는안정한 외용제.
- 제 1항에 있어서,생물학적 활성이 있는 EGF는 전체 제제에 대하여 농도가 0.01 내지1000㎍/g이고, 카르복시 비닐 폴리머는 전체 제제에 대하여 농도가0.001 내지 50(w/w)%인 것을 특징으로 하는안정한 외용제.
- 제 1항에 있어서,pH가 4 내지 8인 것을 특징으로 하는안정한 외용제.
- 천연형 또는 재조합 단백질 형태로 제조된 생물학적 활성이 있는 상피세포 성장인자(EGF)를 유효성분으로 하고, 카르복시 비닐 폴리머를 기제로 포함하는 안정한 점안제.
- 제 5항에 있어서,카르복시 비닐 폴리머는 카보머 934, 카보머 934P, 카보머 940,카보머 941 또는 카보머 947P인 것을 특징으로 하는안정한 점안제.
- 제 5항에 있어서,생물학적 활성이 있는 EGF는 전체 제제에 대하여 농도가 0.01 내지1000㎍/g이고, 카르복시 비닐 폴리머는 전체 제제에 대하여 농도가0.001 내지 50(w/w)%인 것을 특징으로 하는안정한 점안제.
- 제 5항에 있어서,pH가 4 내지 8인 것을 특징으로 하는안정한 점안제.
Priority Applications (14)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR10-2000-0008116A KR100366439B1 (ko) | 2000-02-21 | 2000-02-21 | 상피세포 성장인자를 유효성분으로 하는 안정한 약제학적조성물 |
CA002368364A CA2368364A1 (en) | 2000-02-21 | 2001-02-06 | A stable composition comprising epidermal growth factor as an active ingredient |
CN01800267A CN1362883A (zh) | 2000-02-21 | 2001-02-06 | 包含表皮生长因子作为活性成分的稳定组合物 |
IDW00200102257A ID30336A (id) | 2000-02-21 | 2001-02-06 | Komposisi stabil yang mengandung faktor pertumbuhan epidermal sebagai bahan aktif |
AU32403/01A AU3240301A (en) | 2000-02-21 | 2001-02-06 | A stable composition comprising epidermal growth factor as an active ingredient |
US09/958,116 US20030050238A1 (en) | 2000-02-21 | 2001-02-06 | Stable composition comprising epidermal growth factor as an active ingredient |
RU2001131354/15A RU2222344C2 (ru) | 2000-02-21 | 2001-02-06 | Стабильная композиция, включающая фактор роста эпидермиса в качестве активного ингредиента |
MXPA01010566A MXPA01010566A (es) | 2000-02-21 | 2001-02-06 | Una composicion estable que comprende factor de crecimiento epidermico como un ingrediente activo. |
JP2001561341A JP3761816B2 (ja) | 2000-02-21 | 2001-02-06 | 上皮細胞成長因子を有効成分とする安定した組成物 |
BR0104587-3A BR0104587A (pt) | 2000-02-21 | 2001-02-06 | Composição estável |
EP01904630A EP1178818A4 (en) | 2000-02-21 | 2001-02-06 | A STABLE COMPOSITION CONTAINING EPIDERMAL GROWTH FACTOR AS AN ACTIVE COMPONENT |
PCT/KR2001/000170 WO2001062276A1 (en) | 2000-02-21 | 2001-02-06 | A stable composition comprising epidermal growth factor as an active ingredient |
HK03100035.4A HK1047712A1 (zh) | 2000-02-21 | 2003-01-03 | 包含表皮生長因子作為活性成分的穩定組合物 |
US11/113,075 US20050186280A1 (en) | 2000-02-21 | 2005-04-25 | Method for stabilizing a composition having a biologically active epidermal growth factor as an active ingredient |
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KR10-2000-0008116A KR100366439B1 (ko) | 2000-02-21 | 2000-02-21 | 상피세포 성장인자를 유효성분으로 하는 안정한 약제학적조성물 |
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KR20010081888A KR20010081888A (ko) | 2001-08-29 |
KR100366439B1 true KR100366439B1 (ko) | 2003-01-09 |
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KR10-2000-0008116A KR100366439B1 (ko) | 2000-02-21 | 2000-02-21 | 상피세포 성장인자를 유효성분으로 하는 안정한 약제학적조성물 |
Country Status (13)
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US (2) | US20030050238A1 (ko) |
EP (1) | EP1178818A4 (ko) |
JP (1) | JP3761816B2 (ko) |
KR (1) | KR100366439B1 (ko) |
CN (1) | CN1362883A (ko) |
AU (1) | AU3240301A (ko) |
BR (1) | BR0104587A (ko) |
CA (1) | CA2368364A1 (ko) |
HK (1) | HK1047712A1 (ko) |
ID (1) | ID30336A (ko) |
MX (1) | MXPA01010566A (ko) |
RU (1) | RU2222344C2 (ko) |
WO (1) | WO2001062276A1 (ko) |
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Publication number | Priority date | Publication date | Assignee | Title |
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KR100366439B1 (ko) * | 2000-02-21 | 2003-01-09 | 주식회사 대웅 | 상피세포 성장인자를 유효성분으로 하는 안정한 약제학적조성물 |
WO2003075949A1 (en) * | 2002-03-12 | 2003-09-18 | Bio-Click Technologies Ltd. | Method and composition for treating skin wounds with epidermal growth factor |
CN101172091B (zh) * | 2007-09-25 | 2011-04-27 | 北京美福源生物医药科技有限公司 | 含人血清白蛋白与皮肤细胞生长因子的融合蛋白护肤产品制备工艺和用途 |
TW200505394A (en) * | 2003-06-06 | 2005-02-16 | Asahi Medical Co | Material promoting wound healing |
CN101217938A (zh) | 2005-05-27 | 2008-07-09 | 博哈拉特生物技术国际有限公司 | 表皮生长因子组合物,其方法及其应用 |
KR100748390B1 (ko) * | 2005-11-14 | 2007-08-10 | 주식회사 대웅 | 상피세포성장인자를 포함하는 상처치료용 서방성 필름 제형 |
KR100752990B1 (ko) * | 2006-08-02 | 2007-08-30 | 주식회사 대웅 | 나노리포좀 및 천연 추출물을 포함하는 피부 질환의 예방또는 치료용 조성물 |
KR100784134B1 (ko) * | 2006-10-09 | 2007-12-12 | 주식회사 대웅 | 상피세포성장인자를 함유하는 안정한 구내염 치료용 액상조성물 |
JP5303322B2 (ja) * | 2009-03-13 | 2013-10-02 | ピアス株式会社 | 皮膚外用組成物 |
GB0916124D0 (en) | 2009-09-15 | 2009-10-28 | Univ Cardiff | Method and kit for the classification and prognosis of wounds |
GB201021182D0 (en) | 2010-12-14 | 2011-01-26 | Univ Cardiff | Methdo and kit for the classification and prognosis of chronic wounds |
GB201103898D0 (en) * | 2011-03-08 | 2011-04-20 | Univ Cardiff | Molecular targets for healing or treating wounds |
ES2502691B1 (es) * | 2013-09-25 | 2015-07-07 | Sani-Red, S.L. | Método de conservación y estabilización de proteínas, aplicable para desarrollos industriales de formulaciones de productos sanitarios, farmacéuticos y cosméticos |
CN105078784B (zh) * | 2014-04-25 | 2018-07-20 | 张文炜 | 肽类护肤品及其制备方法 |
CN104644464A (zh) * | 2015-02-06 | 2015-05-27 | 深圳唯美度生物科技有限公司 | 一种提高细胞活力的防干燥油及其制备方法 |
KR101777910B1 (ko) | 2015-04-30 | 2017-09-13 | 주식회사 제네웰 | 만성창상 치료용 조성물, 이의 제조방법 및 이를 이용한 만성창상 치료용 드레싱재 |
KR20180060701A (ko) | 2016-11-29 | 2018-06-07 | 주식회사 엔씨엘바이오 | 표피 생장 인자를 함유하는 피부 상태 개선용 조성물 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR880005935A (ko) * | 1986-11-05 | 1988-07-21 | 로버트 엘.미니어 | 폴리펩타이드 성장 인자를 함유하는 안정화된 조성물 |
JPH05132426A (ja) * | 1991-02-15 | 1993-05-28 | Takeda Chem Ind Ltd | 骨組織の形成促進剤 |
KR20010057661A (ko) * | 1999-12-23 | 2001-07-05 | 유상옥,송운한 | 레티놀 및 표피성장인자를 함유하는 피부보호 화장료 조성물 |
WO2001062276A1 (en) * | 2000-02-21 | 2001-08-30 | Daewoong Pharm. Co., Ltd. | A stable composition comprising epidermal growth factor as an active ingredient |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4717717A (en) * | 1986-11-05 | 1988-01-05 | Ethicon, Inc. | Stabilized compositions containing epidermal growth factor |
NZ226171A (en) * | 1987-09-18 | 1990-06-26 | Ethicon Inc | Gel formulation containing polypeptide growth factor |
IN172390B (ko) * | 1989-07-18 | 1993-07-10 | Ethicon Inc | |
CU22405A1 (es) * | 1993-07-05 | 1996-01-31 | Cigb | Composicion cosmetica para el cuidado de la piel |
US6541447B1 (en) * | 1999-09-01 | 2003-04-01 | B & M Healthcare Technologies, Inc. | Wound healing composition and method for use thereof |
-
2000
- 2000-02-21 KR KR10-2000-0008116A patent/KR100366439B1/ko active IP Right Grant
-
2001
- 2001-02-06 MX MXPA01010566A patent/MXPA01010566A/es active IP Right Grant
- 2001-02-06 JP JP2001561341A patent/JP3761816B2/ja not_active Expired - Lifetime
- 2001-02-06 US US09/958,116 patent/US20030050238A1/en not_active Abandoned
- 2001-02-06 ID IDW00200102257A patent/ID30336A/id unknown
- 2001-02-06 BR BR0104587-3A patent/BR0104587A/pt not_active Application Discontinuation
- 2001-02-06 AU AU32403/01A patent/AU3240301A/en not_active Abandoned
- 2001-02-06 RU RU2001131354/15A patent/RU2222344C2/ru active
- 2001-02-06 EP EP01904630A patent/EP1178818A4/en not_active Withdrawn
- 2001-02-06 CA CA002368364A patent/CA2368364A1/en not_active Abandoned
- 2001-02-06 WO PCT/KR2001/000170 patent/WO2001062276A1/en active Application Filing
- 2001-02-06 CN CN01800267A patent/CN1362883A/zh active Pending
-
2003
- 2003-01-03 HK HK03100035.4A patent/HK1047712A1/zh unknown
-
2005
- 2005-04-25 US US11/113,075 patent/US20050186280A1/en not_active Abandoned
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR880005935A (ko) * | 1986-11-05 | 1988-07-21 | 로버트 엘.미니어 | 폴리펩타이드 성장 인자를 함유하는 안정화된 조성물 |
JPH05132426A (ja) * | 1991-02-15 | 1993-05-28 | Takeda Chem Ind Ltd | 骨組織の形成促進剤 |
KR20010057661A (ko) * | 1999-12-23 | 2001-07-05 | 유상옥,송운한 | 레티놀 및 표피성장인자를 함유하는 피부보호 화장료 조성물 |
WO2001062276A1 (en) * | 2000-02-21 | 2001-08-30 | Daewoong Pharm. Co., Ltd. | A stable composition comprising epidermal growth factor as an active ingredient |
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Publication number | Publication date |
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ID30336A (id) | 2001-11-22 |
AU3240301A (en) | 2001-09-03 |
CA2368364A1 (en) | 2001-08-30 |
JP2003523399A (ja) | 2003-08-05 |
EP1178818A1 (en) | 2002-02-13 |
KR20010081888A (ko) | 2001-08-29 |
WO2001062276A1 (en) | 2001-08-30 |
MXPA01010566A (es) | 2002-11-04 |
EP1178818A4 (en) | 2009-05-13 |
CN1362883A (zh) | 2002-08-07 |
US20030050238A1 (en) | 2003-03-13 |
US20050186280A1 (en) | 2005-08-25 |
BR0104587A (pt) | 2002-01-08 |
HK1047712A1 (zh) | 2003-03-07 |
JP3761816B2 (ja) | 2006-03-29 |
RU2222344C2 (ru) | 2004-01-27 |
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