RU2019104004A - Лекарственные формы нейроактивных стероидов и способы лечения нарушений цнс - Google Patents
Лекарственные формы нейроактивных стероидов и способы лечения нарушений цнс Download PDFInfo
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- RU2019104004A RU2019104004A RU2019104004A RU2019104004A RU2019104004A RU 2019104004 A RU2019104004 A RU 2019104004A RU 2019104004 A RU2019104004 A RU 2019104004A RU 2019104004 A RU2019104004 A RU 2019104004A RU 2019104004 A RU2019104004 A RU 2019104004A
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- Prior art keywords
- cyclodextrin
- allopregnanolone
- administered
- dose
- tetrahydroprogesterone
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- 238000000034 method Methods 0.000 title claims 40
- 150000003431 steroids Chemical class 0.000 title 1
- AURFZBICLPNKBZ-UHFFFAOYSA-N Pregnanolone Natural products C1CC2CC(O)CCC2(C)C2C1C1CCC(C(=O)C)C1(C)CC2 AURFZBICLPNKBZ-UHFFFAOYSA-N 0.000 claims 58
- AURFZBICLPNKBZ-SYBPFIFISA-N brexanolone Chemical compound C([C@@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)C)[C@@]2(C)CC1 AURFZBICLPNKBZ-SYBPFIFISA-N 0.000 claims 58
- 229920000858 Cyclodextrin Polymers 0.000 claims 46
- 239000001116 FEMA 4028 Substances 0.000 claims 25
- 229960004853 betadex Drugs 0.000 claims 25
- 239000002552 dosage form Substances 0.000 claims 14
- 229940080345 gamma-cyclodextrin Drugs 0.000 claims 13
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 claims 12
- 229940043377 alpha-cyclodextrin Drugs 0.000 claims 12
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 12
- 208000005809 status epilepticus Diseases 0.000 claims 11
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 10
- -1 cyclic oligosaccharides Chemical class 0.000 claims 9
- 238000001802 infusion Methods 0.000 claims 9
- PVPBHKCSQBLDEW-ZQOBQRRWSA-N (1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31S,33R,35R,36R,37R,38R,39R,40R,41R,42R,43R,44R,45R,46R,47R,48R,49R)-5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol 4-hydroxybutane-1-sulfonic acid Chemical compound OCCCCS(O)(=O)=O.OC[C@H]1O[C@@H]2O[C@@H]3[C@@H](CO)O[C@H](O[C@@H]4[C@@H](CO)O[C@H](O[C@@H]5[C@@H](CO)O[C@H](O[C@@H]6[C@@H](CO)O[C@H](O[C@@H]7[C@@H](CO)O[C@H](O[C@@H]8[C@@H](CO)O[C@H](O[C@H]1[C@H](O)[C@H]2O)[C@H](O)[C@H]8O)[C@H](O)[C@H]7O)[C@H](O)[C@H]6O)[C@H](O)[C@H]5O)[C@H](O)[C@H]4O)[C@H](O)[C@H]3O PVPBHKCSQBLDEW-ZQOBQRRWSA-N 0.000 claims 7
- NZAQRZWBQUIBSF-UHFFFAOYSA-N 4-(4-sulfobutoxy)butane-1-sulfonic acid Chemical compound OS(=O)(=O)CCCCOCCCCS(O)(=O)=O NZAQRZWBQUIBSF-UHFFFAOYSA-N 0.000 claims 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- 208000015114 central nervous system disease Diseases 0.000 claims 6
- 206010010904 Convulsion Diseases 0.000 claims 5
- 206010015037 epilepsy Diseases 0.000 claims 5
- 208000028329 epileptic seizure Diseases 0.000 claims 5
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 5
- HFHDHCJBZVLPGP-RWMJIURBSA-N alpha-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO HFHDHCJBZVLPGP-RWMJIURBSA-N 0.000 claims 3
- 150000002148 esters Chemical class 0.000 claims 3
- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 claims 3
- 238000012423 maintenance Methods 0.000 claims 3
- 238000009738 saturating Methods 0.000 claims 3
- 210000002966 serum Anatomy 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 229910019142 PO4 Inorganic materials 0.000 claims 2
- 208000030886 Traumatic Brain injury Diseases 0.000 claims 2
- 229940097362 cyclodextrins Drugs 0.000 claims 2
- 239000010452 phosphate Substances 0.000 claims 2
- 230000009529 traumatic brain injury Effects 0.000 claims 2
- YZOUYRAONFXZSI-SBHWVFSVSA-N (1S,3R,5R,6R,8R,10R,11R,13R,15R,16R,18R,20R,21R,23R,25R,26R,28R,30R,31S,33R,35R,36R,37S,38R,39S,40R,41S,42R,43S,44R,45S,46R,47S,48R,49S)-5,10,15,20,25,30,35-heptakis(hydroxymethyl)-37,39,40,41,42,43,44,45,46,47,48,49-dodecamethoxy-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,38-diol Chemical compound O([C@@H]([C@H]([C@@H]1OC)OC)O[C@H]2[C@@H](O)[C@@H]([C@@H](O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3O)OC)O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3OC)OC)O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3OC)OC)O[C@@H]3[C@@H](CO)O[C@@H]([C@H]([C@@H]3OC)OC)O3)O[C@@H]2CO)OC)[C@H](CO)[C@H]1O[C@@H]1[C@@H](OC)[C@H](OC)[C@H]3[C@@H](CO)O1 YZOUYRAONFXZSI-SBHWVFSVSA-N 0.000 claims 1
- PCWPQSDFNIFUPO-VDQKLNDWSA-N (1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31S,33R,35R,36R,37S,38R,39S,40R,41S,42R,43S,44R,45S,46R,47S,48R,49S)-37,39,41,43,45,47,49-heptakis(2-hydroxyethoxy)-5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,38,40,42,44,46,48-heptol Chemical compound OCCO[C@H]1[C@H](O)[C@@H]2O[C@H]3O[C@H](CO)[C@@H](O[C@H]4O[C@H](CO)[C@@H](O[C@H]5O[C@H](CO)[C@@H](O[C@H]6O[C@H](CO)[C@@H](O[C@H]7O[C@H](CO)[C@@H](O[C@H]8O[C@H](CO)[C@@H](O[C@H]1O[C@@H]2CO)[C@@H](O)[C@@H]8OCCO)[C@@H](O)[C@@H]7OCCO)[C@@H](O)[C@@H]6OCCO)[C@@H](O)[C@@H]5OCCO)[C@@H](O)[C@@H]4OCCO)[C@@H](O)[C@@H]3OCCO PCWPQSDFNIFUPO-VDQKLNDWSA-N 0.000 claims 1
- CUJVBAPGYBSBHJ-YWBSARSQSA-N 2-[[(1R,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21R,23R,25R,26R,28R,30R,31R,33R,35R,36R,37R,38R,39R,40R,41R,42R,43R,44R,45R,46R,47R,48R,49R)-36,38,40,42-tetrakis(carboxymethoxy)-10,15-bis(carboxymethoxymethyl)-37,39,41,43,44,45,46,47,48,49-decahydroxy-20,25,30,35-tetrakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontan-5-yl]methoxy]acetic acid Chemical compound OC[C@H]1O[C@@H]2O[C@H]3[C@H](O)[C@@H](O)[C@H](O[C@@H]3COCC(O)=O)O[C@H]3[C@H](O)[C@@H](O)[C@H](O[C@@H]3COCC(O)=O)O[C@H]3[C@H](O)[C@@H](O)[C@H](O[C@@H]3COCC(O)=O)O[C@@H]3[C@@H](CO)O[C@H](O[C@@H]4[C@@H](CO)O[C@H](O[C@@H]5[C@@H](CO)O[C@H](O[C@H]1[C@H](OCC(O)=O)[C@H]2O)[C@H](O)[C@H]5OCC(O)=O)[C@H](O)[C@H]4OCC(O)=O)[C@H](O)[C@H]3OCC(O)=O CUJVBAPGYBSBHJ-YWBSARSQSA-N 0.000 claims 1
- 206010051290 Central nervous system lesion Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 claims 1
- 229920001542 oligosaccharide Polymers 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- DIRLEDPEXJLCIL-JCWBWLHSSA-N succinyl-β-cyclodextrin Chemical compound OC(=O)CCC(=O)OC[C@H]([C@H]([C@H]([C@@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COC(=O)CCC(O)=O)[C@H]([C@H]([C@@H]3O)O)O[C@H]3O[C@H](COC(=O)CCC(O)=O)[C@H]([C@H]([C@@H]3O)O)O[C@H]3O[C@H](COC(=O)CCC(O)=O)[C@H]([C@H]([C@@H]3O)O)O[C@H]3O[C@H](COC(=O)CCC(O)=O)[C@H]([C@H]([C@@H]3O)O)O3)[C@@H](O)[C@@H]2O)COC(=O)CCC(=O)C)O[C@@H]1O[C@H]1[C@@H](O)[C@H](O)[C@@H]3O[C@@H]1COC(=O)CCC(O)=O DIRLEDPEXJLCIL-JCWBWLHSSA-N 0.000 claims 1
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
- A61K47/549—Sugars, nucleosides, nucleotides or nucleic acids
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- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/61—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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- A—HUMAN NECESSITIES
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- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P25/08—Antiepileptics; Anticonvulsants
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
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- A—HUMAN NECESSITIES
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- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
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- 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
Claims (47)
1. Способ лечения черепно-мозговой травмы, включающий введение эффективного количества дозированной лекарственной формы аллопрегнанолона в циклодекстриновом носителе индивидууму, нуждающемуся в этом, для лечения поражения центральной нервной системы.
2. Способ по п. 1, где аллопрегнанолон вводят в схеме введения терапевтически эффективной двухуровневой дозы аллопрегнанолона, включающей первый период, где субъекту вводят первую почасовую дозу аллопрегнанолона, с последующим вторым периодом, где вводят более низкую почасовую инфузионную дозу аллопрегнанолона.
3. Способ по п. 2, где аллопрегнанолон вводят насыщающей дозой в течение 1 часа, с последующей поддерживающей инфузией в течение следующих 95 часов, после чего дозу постепенно снижают.
4. Способ по п. 1, где аллопрегнанолон вводят в течение пяти дней.
5. Способ по п. 1, где концентрация аллопрегнанолона составляет от приблизительно 0,25 мг/мл до приблизительно 15 мг/мл.
6. Способ по п. 1, где концентрация аллопрегнанолона составляет приблизительно 1,5 мг/мл.
7. Способ по п. 1, где дозировка аллопрегнанолона, вводимого инфузией, создает равновесную концентрацию аллопрегнанолона в сыворотке приблизительно от 150 нМ до 2500 нМ.
8. Способ по п. 1, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 6% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
9. Способ по п. 1, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 15% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
10. Способ по п. 1, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 30% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
11. Стандартная лекарственная форма, включающая комплекс аллопрегнанолона и циклодекстрина.
12. Стандартная лекарственная форма по п. 11, где аллопрегнанолон выбран из группы, состоящей из аллопрегнанолона и его солей и энантиомерных форм.
13. Стандартная лекарственная форма по п. 11, где циклодекстрин выбран из группы, состоящей из циклических олигосахаридов, содержащих или включающих шесть (α-циклодекстрин), семь (β-циклодекстрин), восемь (γ-циклодекстрин) или более α-(1,4)-связанных остатков глюкозы, и химически модифицированных циклодекстринов.
14. Стандартная лекарственная форма по п. 11, где циклодекстрин выбран из группы, состоящей из α-циклодекстрина; β-циклодекстрина; γ-циклодекстрина; метил-α-циклодекстрина; метил-β-циклодекстрина; метил-γ-циклодекстрина; этил-β-циклодекстрина; бутил-α-циклодекстрина; бутил-β-циклодекстрина; бутил-γ-циклодекстрина; пентил-γ-циклодекстрина; гидроксиэтил-β-циклодекстрина; гидроксиэтил γ-циклодекстрина; 2-гидроксипропил α-циклодекстрина; 2-гидроксипропил-β-циклодекстрина; 2-гидроксипропил-γ-циклодекстрина; 2-гидроксибутил-β-циклодекстрина; ацетил-α-циклодекстрина; ацетил-β-циклодекстрина; ацетил-γ-циклодекстрина; пропионил-β-циклодекстрина; бутирил-β-циклодекстрина; сукцинил-α-циклодекстрина; сукцинил-β-циклодекстрина; сукцинил-γ-циклодекстрина; бензоил-β-циклодекстрина; пальмитил-β-циклодекстрина; толуолсульфонил-β-циклодекстрина; ацетилметил-β-циклодекстрина; ацетилбутил-β-циклодекстрина; глюкозил-α-циклодекстрина; глюкозил-β-циклодекстрина; глюкозил-γ-циклодекстрина; мальтозил-α-циклодекстрина; мальтозил-β-циклодекстрина; мальтозил-γ-циклодекстрина; карбоксиметилового эфира α-циклодекстрина; карбоксиметилового эфира β-циклодекстрина; карбоксиметилового эфира γ-циклодекстрина; карбоксиметилэтил-β-циклодекстрина; фосфатного эфира α-циклодекстрина; фосфатного эфира β-циклодекстрина; фосфорного эфира γ-циклодекстрина; 3-триметиламмоний-2-гидроксипропил-β-циклодекстрина; сульфобутилового эфира β-циклодекстрина; карбоксиметил-α-циклодекстрина; карбоксиметил-β-циклодекстрина; карбоксиметил-γ-циклодекстрина, алкилциклодекстринов, гидроксиалкилциклодекстринов, карбокисалкилциклодекстринов и сульфоалкиловых эфиров циклодекстринов, а также их комбинаций.
15. Фармацевтическая стандартная лекарственная форма по п. 11, включающая комплекс 3α,5α-тетрагидропрогестерона с сульфобутилэфиром β-циклодекстрина (SBEβCD).
16. Фармацевтическая стандартная лекарственная форма по п. 15, включающая 3α,5α-тетрагидропрогестерон в стерильном 0,9% растворе хлорида натрия, содержащая или включающая 6% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
17. Фармацевтическая стандартная лекарственная форма по п. 15, включающая 3α,5α-тетрагидропрогестерон в стерильном 0,9% растворе хлорида натрия, включающая 15% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
18. Фармацевтическая стандартная лекарственная форма по п. 15, включающая 3α,5α-тетрагидропрогестерон в стерильном 0,9% растворе хлорида натрия, включающая 30% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
19. Способ лечения нарушения ЦНС, включающий введение субъекту эффективного количества дозированной лекарственной формы аллопрегнанолона в циклодекстриновом носителе.
20. Способ по п. 19, где аллопрегнанолон вводят в схеме введения терапевтически эффективной двухуровневой дозы аллопрегнанолона, включающей первый период, где субъекту вводят первую почасовую дозу аллопрегнанолона, с последующим вторым периодом, где вводят более низкую почасовую инфузионную дозу аллопрегнанолона.
21. Способ по п. 20, где аллопрегнанолон вводят насыщающей дозой в течение 1 часа, с последующей поддерживающей инфузией в течение следующих 95 часов, после чего дозу постепенно снижают.
22. Способ по п. 19, где аллопрегнанолон вводят в течение пяти дней.
23. Способ по п. 19, где концентрация аллопрегнанолона составляет от приблизительно 0,25 мг/мл до приблизительно 15 мг/мл.
24. Способ по п. 19, где концентрация аллопрегнанолона составляет приблизительно 1,5 мг/мл.
25. Способ по п. 19, где дозировка аллопрегнанолона, который вводят инфузией, создает равновесную концентрацию аллопрегнанолона в сыворотке от приблизительно 150 нМ до 2500 нМ.
26. Способ по п. 19, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 6% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
27. Способ по п. 19, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 15% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
28. Способ по п. 19, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 30% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
29. Способ по п. 19, где нарушение ЦНС является эпилептическим статусом.
30. Способ по п. 29, где эпилептический статус является рефрактерным эпилептическим статусом.
31. Способ по п. 19, где эпилептический статус является бессудорожным эпилептическим статусом.
32. Способ по п. 19, где нарушение ЦНС является черепно-мозговой травмой.
33. Способ по п. 19, где нарушение ЦНС является эпилептическим припадком.
34. Способ по п. 19, где эпилептический припадок является острым повторным эпилептическим припадком или кластерным эпилептическим припадком.
35. Способ лечения нарушения ЦНС, включающий введение субъекту эффективного количества дозированной лекарственной формы аллопрегнанолона, где нарушение ЦНС является эпилептическим припадком или эпилептическим статусом.
36. Способ по п. 35, где нарушение является эпилептическим статусом.
37. Способ по п. 35, где эпилептический статус является рефрактерным эпилептическим статусом.
38. Способ по п. 35, где эпилептический статус является бессудорожным эпилептическим статусом.
39. Способ по п. 35, где аллопрегнанолон вводят в схеме введения терапевтически эффективной двухуровневой дозы аллопрегнанолона, включающей первый период, где субъекту вводят первую почасовую дозу аллопрегнанолона, с последующим вторым периодом, где вводят более низкую почасовую инфузионную дозу аллопрегнанолона.
40. Способ по п. 39, где аллопрегнанолон вводят насыщающей дозой в течение 1 часа, с последующей поддерживающей инфузией в течение следующих 95 часов, после чего дозу постепенно снижают.
41. Способ по п. 35, где аллопрегнанолон вводят в течение пяти дней.
42. Способ по п. 35, где концентрация аллопрегнанолона составляет от приблизительно 0,25 мг/мл до приблизительно 15 мг/мл.
43. Способ по п. 35, где концентрация аллопрегнанолона составляет приблизительно 1,5 мг/мл.
44. Способ по п. 35, где дозировка аллопрегнанолона, который вводят инфузией, создает равновесную концентрацию аллопрегнанолона в сыворотке от приблизительно 150 нМ до 2500 нМ.
45. Способ по п. 35, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 6% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
46. Способ по п. 35, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 15% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
47. Способ по п. 35, где аллопрегнанолон (3α,5α-тетрагидропрогестерон) включен в лекарственную форму с 30% сульфобутилэфира β-циклодекстрина фармацевтической чистоты (SBEβCD).
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