RU2011139984A - Лекарственные формы инсулина, обладающие быстрым усвоением - Google Patents
Лекарственные формы инсулина, обладающие быстрым усвоением Download PDFInfo
- Publication number
- RU2011139984A RU2011139984A RU2011139984/15A RU2011139984A RU2011139984A RU 2011139984 A RU2011139984 A RU 2011139984A RU 2011139984/15 A RU2011139984/15 A RU 2011139984/15A RU 2011139984 A RU2011139984 A RU 2011139984A RU 2011139984 A RU2011139984 A RU 2011139984A
- Authority
- RU
- Russia
- Prior art keywords
- dosage form
- insulin
- acid
- group
- dissolving agent
- Prior art date
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- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 title claims abstract 49
- 102000004877 Insulin Human genes 0.000 title claims abstract 23
- 108090001061 Insulin Proteins 0.000 title claims abstract 23
- 229940125396 insulin Drugs 0.000 title claims abstract 23
- 230000029087 digestion Effects 0.000 title 1
- 239000002552 dosage form Substances 0.000 claims abstract 44
- 239000003795 chemical substances by application Substances 0.000 claims abstract 16
- 239000002738 chelating agent Substances 0.000 claims abstract 15
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical group OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims abstract 14
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract 12
- 239000001509 sodium citrate Substances 0.000 claims abstract 9
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims abstract 8
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims abstract 8
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims abstract 6
- 101000976075 Homo sapiens Insulin Proteins 0.000 claims abstract 6
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims abstract 6
- 239000002253 acid Substances 0.000 claims abstract 6
- PBGKTOXHQIOBKM-FHFVDXKLSA-N insulin (human) Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(=O)N[C@@H](CC(N)=O)C(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 PBGKTOXHQIOBKM-FHFVDXKLSA-N 0.000 claims abstract 6
- AGBQKNBQESQNJD-UHFFFAOYSA-N lipoic acid Chemical compound OC(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-N 0.000 claims abstract 6
- ACTRVOBWPAIOHC-UHFFFAOYSA-N succimer Chemical compound OC(=O)C(S)C(S)C(O)=O ACTRVOBWPAIOHC-UHFFFAOYSA-N 0.000 claims abstract 6
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims abstract 6
- 229940038773 trisodium citrate Drugs 0.000 claims abstract 6
- 229910052725 zinc Inorganic materials 0.000 claims abstract 6
- 239000011701 zinc Substances 0.000 claims abstract 6
- 150000003839 salts Chemical class 0.000 claims abstract 5
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Natural products OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims abstract 4
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims abstract 4
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 claims abstract 4
- 239000007864 aqueous solution Substances 0.000 claims abstract 4
- 239000011668 ascorbic acid Substances 0.000 claims abstract 4
- 235000010323 ascorbic acid Nutrition 0.000 claims abstract 4
- DEFVIWRASFVYLL-UHFFFAOYSA-N ethylene glycol bis(2-aminoethyl)tetraacetic acid Chemical compound OC(=O)CN(CC(O)=O)CCOCCOCCN(CC(O)=O)CC(O)=O DEFVIWRASFVYLL-UHFFFAOYSA-N 0.000 claims abstract 4
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims abstract 4
- FCKYPQBAHLOOJQ-UHFFFAOYSA-N Cyclohexane-1,2-diaminetetraacetic acid Chemical compound OC(=O)CN(CC(O)=O)C1CCCCC1N(CC(O)=O)CC(O)=O FCKYPQBAHLOOJQ-UHFFFAOYSA-N 0.000 claims abstract 3
- 239000000783 alginic acid Substances 0.000 claims abstract 3
- 229960001126 alginic acid Drugs 0.000 claims abstract 3
- 235000010443 alginic acid Nutrition 0.000 claims abstract 3
- 229920000615 alginic acid Polymers 0.000 claims abstract 3
- 150000004781 alginic acids Chemical class 0.000 claims abstract 3
- 235000015165 citric acid Nutrition 0.000 claims abstract 3
- 235000019136 lipoic acid Nutrition 0.000 claims abstract 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract 3
- 229960002663 thioctic acid Drugs 0.000 claims abstract 3
- HFVMEOPYDLEHBR-UHFFFAOYSA-N (2-fluorophenyl)-phenylmethanol Chemical compound C=1C=CC=C(F)C=1C(O)C1=CC=CC=C1 HFVMEOPYDLEHBR-UHFFFAOYSA-N 0.000 claims abstract 2
- QISOBCMNUJQOJU-UHFFFAOYSA-N 4-bromo-1h-pyrazole-5-carboxylic acid Chemical compound OC(=O)C=1NN=CC=1Br QISOBCMNUJQOJU-UHFFFAOYSA-N 0.000 claims abstract 2
- CKLJMWTZIZZHCS-UHFFFAOYSA-N Aspartic acid Chemical compound OC(=O)C(N)CC(O)=O CKLJMWTZIZZHCS-UHFFFAOYSA-N 0.000 claims abstract 2
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims abstract 2
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims abstract 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims abstract 2
- 235000011054 acetic acid Nutrition 0.000 claims abstract 2
- 239000001361 adipic acid Substances 0.000 claims abstract 2
- 235000011037 adipic acid Nutrition 0.000 claims abstract 2
- 229960005070 ascorbic acid Drugs 0.000 claims abstract 2
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000001530 fumaric acid Substances 0.000 claims abstract 2
- 239000004220 glutamic acid Substances 0.000 claims abstract 2
- 235000013922 glutamic acid Nutrition 0.000 claims abstract 2
- -1 insulin Chemical compound 0.000 claims abstract 2
- 239000011976 maleic acid Substances 0.000 claims abstract 2
- 239000000243 solution Substances 0.000 claims abstract 2
- 206010012601 diabetes mellitus Diseases 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 2
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims 2
- 229940072107 ascorbate Drugs 0.000 claims 2
- 229940009098 aspartate Drugs 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 229930195712 glutamate Natural products 0.000 claims 2
- 229910052751 metal Inorganic materials 0.000 claims 2
- 239000002184 metal Substances 0.000 claims 2
- 239000000843 powder Substances 0.000 claims 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- 238000009825 accumulation Methods 0.000 claims 1
- WNLRTRBMVRJNCN-UHFFFAOYSA-L adipate(2-) Chemical compound [O-]C(=O)CCCCC([O-])=O WNLRTRBMVRJNCN-UHFFFAOYSA-L 0.000 claims 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 claims 1
- 210000002919 epithelial cell Anatomy 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- 239000011777 magnesium Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- GCHCGDFZHOEXMP-UHFFFAOYSA-L potassium adipate Chemical compound [K+].[K+].[O-]C(=O)CCCCC([O-])=O GCHCGDFZHOEXMP-UHFFFAOYSA-L 0.000 claims 1
- 239000001608 potassium adipate Substances 0.000 claims 1
- 235000011051 potassium adipate Nutrition 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000001601 sodium adipate Substances 0.000 claims 1
- 235000011049 sodium adipate Nutrition 0.000 claims 1
- 150000007513 acids Chemical class 0.000 abstract 1
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
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- C—CHEMISTRY; METALLURGY
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- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
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- 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
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- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Obesity (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
1. Лекарственная форма инсулина, включающая инсулин, растворяющий агент и хелатор цинка, где лекарственная форма имеет физиологическое значение рН и представляет собой прозрачный водный раствор.2. Лекарственная форма по п.1, где хелатор выбран из группы, состоящей из этилендиаминтетрауксусной кислоты (EDTA), EGTA, тринатриевого цитрата (TSC), альгиновой кислоты, альфа-липоевой кислоты, димеркаптоянтарной кислоты (DMSA), CDTA (1,2-диаминциклогексантетрауксусной кислоты).3. Лекарственная форма по п.2, где хелатором является этилендиаминтетрауксусная кислота (EDTA).4. Лекарственная форма по п.1, где растворяющий агент является кислотой, выбранной из группы, состоящей из уксусной кислоты, аскорбиновой кислоты, лимонной кислоты, глутаминовой кислоты, янтарной, аспарагиновой, малеиновой, фумаровой и адипиновой кислоты или их солей.5. Лекарственная форма по п.4, где растворяющий агент является лимонной кислотой или лимоннокислым натрием.6. Лекарственная форма по п.1, где значение рН находится в пределах между 7 и 7,5.7. Лекарственная форма по п.1, где лекарственную форму создают повышением значения рН раствора инсулина приблизительно от рН 4 до физиологического значения рН.8. Лекарственная форма по п.1, где инсулин выбран из группы, состоящей из человеческого инсулина, аналогов инсулина и их комбинаций.9. Лекарственная форма по п.8, где инсулин является рекомбинантным человеческим инсулином.10. Лекарственная форма инсулина, включающая инсулин, растворяющий агент и хелатор цинка, где растворяющий агент представляет собой соль.11. Лекарственная форма по п.10, где хелатор выбран из группы, состоящей из этилендиаминтетрауксусной кислоты (EDTA), EGTA, три�
Claims (27)
1. Лекарственная форма инсулина, включающая инсулин, растворяющий агент и хелатор цинка, где лекарственная форма имеет физиологическое значение рН и представляет собой прозрачный водный раствор.
2. Лекарственная форма по п.1, где хелатор выбран из группы, состоящей из этилендиаминтетрауксусной кислоты (EDTA), EGTA, тринатриевого цитрата (TSC), альгиновой кислоты, альфа-липоевой кислоты, димеркаптоянтарной кислоты (DMSA), CDTA (1,2-диаминциклогексантетрауксусной кислоты).
3. Лекарственная форма по п.2, где хелатором является этилендиаминтетрауксусная кислота (EDTA).
4. Лекарственная форма по п.1, где растворяющий агент является кислотой, выбранной из группы, состоящей из уксусной кислоты, аскорбиновой кислоты, лимонной кислоты, глутаминовой кислоты, янтарной, аспарагиновой, малеиновой, фумаровой и адипиновой кислоты или их солей.
5. Лекарственная форма по п.4, где растворяющий агент является лимонной кислотой или лимоннокислым натрием.
6. Лекарственная форма по п.1, где значение рН находится в пределах между 7 и 7,5.
7. Лекарственная форма по п.1, где лекарственную форму создают повышением значения рН раствора инсулина приблизительно от рН 4 до физиологического значения рН.
8. Лекарственная форма по п.1, где инсулин выбран из группы, состоящей из человеческого инсулина, аналогов инсулина и их комбинаций.
9. Лекарственная форма по п.8, где инсулин является рекомбинантным человеческим инсулином.
10. Лекарственная форма инсулина, включающая инсулин, растворяющий агент и хелатор цинка, где растворяющий агент представляет собой соль.
11. Лекарственная форма по п.10, где хелатор выбран из группы, состоящей из этилендиаминтетрауксусной кислоты (EDTA), EGTA, тринатриевого цитрата (TSC), альгиновой кислоты, альфа-липоевой кислоты, димеркаптоянтарной кислоты (DMSA), CDTA (1,2-диаминциклогексантетрауксусной кислоты).
12. Лекарственная форма по п.10, где хелатор является этилендиаминтетрауксусной кислотой (EDTA).
13. Лекарственная форма по п.10, где растворяющий агент является солью, выбранной из группы, состоящей из ацетата, аскорбата, цитрата, глутамата, аспартата, сукцината, фумарата, малеата и адипината и металла Группы I или металлов Группы II.
14. Лекарственная форма по п.13, где металлом Группы 2 является магний.
15. Лекарственная форма по п.13, где растворяющий агент выбран из группы, состоящей из аскорбата, цитрата, глутамата, аспартата, сукцината, фумарата, малеата и адипината натрия или калия.
16. Лекарственная форма по п.13, где растворяющий агент является лимоннокислым натрием.
17. Лекарственная форма по п.10, где значение рН находится в пределах между 7 и 7,5.
18. Лекарственная форма по п.10, где значение рН приблизительно равно 4.
19. Лекарственная форма по п.10, где инсулин выбран из группы, состоящей из человеческого инсулина, аналогов инсулина и их комбинаций.
20. Лекарственная форма по п.10, где инсулин является рекомбинантным человеческим инсулином.
21. Лекарственная форма по п.1, где инсулин представлен в виде сухого порошка в первом контейнере и, как минимум, один из хелаторов и растворяющих агентов представлен во втором контейнере, содержащем разбавитель.
22. Лекарственная форма по п.10, где инсулин представлен в виде сухого порошка в первом контейнере и, как минимум, один из хелаторов и растворяющих агентов представлен во втором контейнере, содержащем разбавитель.
23. Лекарственная форма по п.1, представленная в виде замороженной фармацевтически приемлемой лекарственной формы для лечения больного сахарным диабетом.
24. Лекарственная форма по п.10, представленная в виде замороженной фармацевтически приемлемой лекарственной формы для лечения больного сахарным диабетом.
25. Лекарственная форма по п.1, представленная в виде прозрачного водного раствора при 4°С.
26. Лекарственная форма по п.10, представленная в виде прозрачного водного раствора при 4°С.
27. Способ лечения больного сахарным диабетом, включающий инъецирование эффективного количества инъекционной лекарственной формы инсулина, включающей инсулин и эффективное количество растворяющего агента и хелатора цинка для повышения накопления и транспорта инсулина через эпителиальные клетки по сравнению с инсулином в комбинации с хелатором цинка и HCl, как определено в п.1.
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