RU2010142353A - Водные фармацевтические композиции, содержащие борат-полиольные комплексы - Google Patents
Водные фармацевтические композиции, содержащие борат-полиольные комплексы Download PDFInfo
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- RU2010142353A RU2010142353A RU2010142353/15A RU2010142353A RU2010142353A RU 2010142353 A RU2010142353 A RU 2010142353A RU 2010142353/15 A RU2010142353/15 A RU 2010142353/15A RU 2010142353 A RU2010142353 A RU 2010142353A RU 2010142353 A RU2010142353 A RU 2010142353A
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 title claims abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 229920005862 polyol Polymers 0.000 claims abstract 14
- 150000003077 polyols Chemical class 0.000 claims abstract 14
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract 9
- 239000003755 preservative agent Substances 0.000 claims abstract 8
- 230000002335 preservative effect Effects 0.000 claims abstract 8
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract 6
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 claims abstract 4
- 239000004094 surface-active agent Substances 0.000 claims abstract 4
- 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 claims abstract 3
- 229930195725 Mannitol Natural products 0.000 claims abstract 3
- 239000000594 mannitol Substances 0.000 claims abstract 3
- 235000010355 mannitol Nutrition 0.000 claims abstract 3
- 230000001225 therapeutic effect Effects 0.000 claims abstract 3
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims abstract 2
- 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 claims abstract 2
- 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 claims abstract 2
- 230000000845 anti-microbial effect Effects 0.000 claims abstract 2
- 239000004599 antimicrobial Substances 0.000 claims abstract 2
- 229960000686 benzalkonium chloride Drugs 0.000 claims abstract 2
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000000460 chlorine Substances 0.000 claims abstract 2
- 229910052801 chlorine Inorganic materials 0.000 claims abstract 2
- 150000003856 quaternary ammonium compounds Chemical class 0.000 claims abstract 2
- 239000000600 sorbitol Substances 0.000 claims abstract 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 208000010412 Glaucoma Diseases 0.000 claims 1
- 206010020751 Hypersensitivity Diseases 0.000 claims 1
- 206010061218 Inflammation Diseases 0.000 claims 1
- 230000007815 allergy Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- MKPLKVHSHYCHOC-AHTXBMBWSA-N travoprost Chemical group CC(C)OC(=O)CCC\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\C=C\[C@@H](O)COC1=CC=CC(C(F)(F)F)=C1 MKPLKVHSHYCHOC-AHTXBMBWSA-N 0.000 claims 1
- 229960002368 travoprost Drugs 0.000 claims 1
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
- A01N59/14—Boron; Compounds thereof
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
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- A01N31/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic oxygen or sulfur compounds
- A01N31/02—Acyclic compounds
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- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
- A01N33/02—Amines; Quaternary ammonium compounds
- A01N33/12—Quaternary ammonium compounds
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
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- A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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Abstract
1. Мультидозовая офтальмологическая композиция, включающая: ! первый полиол, где первый полиол выбран из маннита, сорбита или их комбинации, где первый полиол составляет по меньшей мере 0,01, но менее чем приблизительно 0,5 масс./об.% композиции; ! второй полиол, где второй полиол выбран из пропиленгликоля, глицерина или их комбинации, где второй полиол составляет по меньшей мере 0,1, но менее чем приблизительно 5 масс./об.% композиции; ! борат, где борат составляет по меньшей мере 0,05 масс./об.% композиции, но менее чем 0,5 масс./об.% композиции; ! противомикробный консервант, где консервант составляет по меньшей мере 0,0003, но менее чем приблизительно 0,003 масс./об.% композиции, и где консервант представляет собой полимерное четверичное соединение аммония, ! терапевтический компонент; и ! воду. ! 2. Композиция по п.1, где композиция соответствует Ph. Eur. A, Ph. Eur. B или обеим. ! 3. Композиция по п.1, где консервант включает поликватериум-1. ! 4. Композиция по п.1, где композиция по существу не содержит любых хлорсодержащих компонентов. ! 5. Композиция по п.1, где композиция по существу не содержит хлорида бензалкония. ! 6. Композиция по п.1, дополнительно включающая поверхностно-активное вещество. ! 7. Композиция по п.6, где поверхностно-активное вещество представляет собой HCO-40. ! 8. Композиция по п.7, где HCO-40 составляет по меньшей мере приблизительно 0,03, но меньше, чем приблизительно 0,5 масс./об.% композиции. ! 9. Композиция по п.1, где сопротивление композиции к нормализации pH слезы после инстилляции в глаз составляет меньше, чем 15 мкл на 1М NaOH/мл композиции. ! 10. Композиция по п.1, где сопротивление композиции к нормализации pH слезы после инстилляции в глаз с�
Claims (17)
1. Мультидозовая офтальмологическая композиция, включающая:
первый полиол, где первый полиол выбран из маннита, сорбита или их комбинации, где первый полиол составляет по меньшей мере 0,01, но менее чем приблизительно 0,5 масс./об.% композиции;
второй полиол, где второй полиол выбран из пропиленгликоля, глицерина или их комбинации, где второй полиол составляет по меньшей мере 0,1, но менее чем приблизительно 5 масс./об.% композиции;
борат, где борат составляет по меньшей мере 0,05 масс./об.% композиции, но менее чем 0,5 масс./об.% композиции;
противомикробный консервант, где консервант составляет по меньшей мере 0,0003, но менее чем приблизительно 0,003 масс./об.% композиции, и где консервант представляет собой полимерное четверичное соединение аммония,
терапевтический компонент; и
воду.
2. Композиция по п.1, где композиция соответствует Ph. Eur. A, Ph. Eur. B или обеим.
3. Композиция по п.1, где консервант включает поликватериум-1.
4. Композиция по п.1, где композиция по существу не содержит любых хлорсодержащих компонентов.
5. Композиция по п.1, где композиция по существу не содержит хлорида бензалкония.
6. Композиция по п.1, дополнительно включающая поверхностно-активное вещество.
7. Композиция по п.6, где поверхностно-активное вещество представляет собой HCO-40.
8. Композиция по п.7, где HCO-40 составляет по меньшей мере приблизительно 0,03, но меньше, чем приблизительно 0,5 масс./об.% композиции.
9. Композиция по п.1, где сопротивление композиции к нормализации pH слезы после инстилляции в глаз составляет меньше, чем 15 мкл на 1М NaOH/мл композиции.
10. Композиция по п.1, где сопротивление композиции к нормализации pH слезы после инстилляции в глаз составляет меньше, чем 10 на 1М NaOH/мл композиции.
11. Композиция по п.1, где первый полиол представляет собой маннит.
12. Композиция по п.1, где второй полиол представляет собой пропиленгликоль.
13. Композиция по п.8, дополнительно включающая хлорид натрия.
14. Композиция по п.1, где pH композиции составляет от приблизительно 6,4 до приблизительно 7,2.
15. Композиция по п.1, где терапевтический компонент представляет собой травопрост.
16. Применение композиции по любому из пп.1-15 для получения лекарственного средства для лечения глаукомы, инфекций, аллергий или воспаления глаза.
17. Применение по п.16, где композицию получают в форме капель, непосредственно применяемых для глаз.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US3713708P | 2008-03-17 | 2008-03-17 | |
| US61/037,137 | 2008-03-17 | ||
| PCT/US2009/035830 WO2009117242A2 (en) | 2008-03-17 | 2009-03-03 | Aqueous pharmaceutical compositions containing borate-polyol complexes |
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| Publication Number | Publication Date |
|---|---|
| RU2010142353A true RU2010142353A (ru) | 2012-04-27 |
| RU2477631C2 RU2477631C2 (ru) | 2013-03-20 |
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| RU2010142353/15A RU2477631C2 (ru) | 2008-03-17 | 2009-03-03 | Водные фармацевтические композиции, содержащие борат-полиольные комплексы |
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| Country | Link |
|---|---|
| US (2) | US20090232763A1 (ru) |
| EP (3) | EP2420223B1 (ru) |
| JP (1) | JP5583111B2 (ru) |
| KR (1) | KR101541303B1 (ru) |
| CN (2) | CN105126109A (ru) |
| AR (1) | AR070887A1 (ru) |
| AU (1) | AU2009225931B9 (ru) |
| BR (1) | BRPI0909738A2 (ru) |
| CA (1) | CA2717679C (ru) |
| CL (1) | CL2009000625A1 (ru) |
| CY (1) | CY1114712T1 (ru) |
| DE (1) | DE202009019116U1 (ru) |
| DK (3) | DK2254549T4 (ru) |
| ES (3) | ES2443548T5 (ru) |
| HR (1) | HRP20131173T4 (ru) |
| MX (1) | MX2010009336A (ru) |
| PL (1) | PL2254549T5 (ru) |
| PT (1) | PT2254549E (ru) |
| RU (1) | RU2477631C2 (ru) |
| SI (1) | SI2254549T2 (ru) |
| TW (1) | TWI498122B (ru) |
| UY (1) | UY31718A1 (ru) |
| WO (1) | WO2009117242A2 (ru) |
| ZA (1) | ZA201005994B (ru) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2254549T5 (pl) † | 2008-03-17 | 2019-12-31 | Alcon Research, Ltd. | Wodne kompozycje farmaceutyczne zawierające kompleksy boran-poliole |
| US20100087540A1 (en) * | 2008-10-07 | 2010-04-08 | R-Tech Ueno, Ltd. | Pharmaceutical composition |
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