RU2017134002A - Стабильные композиции тетрагидробиоптерина - Google Patents
Стабильные композиции тетрагидробиоптерина Download PDFInfo
- Publication number
- RU2017134002A RU2017134002A RU2017134002A RU2017134002A RU2017134002A RU 2017134002 A RU2017134002 A RU 2017134002A RU 2017134002 A RU2017134002 A RU 2017134002A RU 2017134002 A RU2017134002 A RU 2017134002A RU 2017134002 A RU2017134002 A RU 2017134002A
- Authority
- RU
- Russia
- Prior art keywords
- tetrahydrobiopterin
- composition
- ascorbic acid
- composition according
- ascorbate
- Prior art date
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Classifications
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (5)
1. Фармацевтическая композиция, содержащая тетрагидробиоптерин и по меньшей мере один антиоксидант, выбранный из группы, состоящей из аскорбиновой кислоты, сложного эфира жирной кислоты аскорбиновой кислоты, выбранного из аскорбилпальмитата или аскорбилстеарата, и соли аскорбиновой кислоты, выбранной из аскорбата натрия, аскорбата кальция или аскорбата калия, где соотношение антиоксиданта к тетрагидробиоптерину составляет от 0,005:1 до 0,03:1.
2. Композиция по п. 1, отличающаяся тем, что тетрагидробиоптерин представляет собой сапроптерина дигидрохлорид.
3. Композиция по п. 1, дополнительно содержащая по меньшей мере одно фармацевтически приемлемое вспомогательное вещество, причем указанное вспомогательное вещество представляет собой разбавитель, связующее вещество, средство, обеспечивающее распадаемость, смазывающее средство, краситель, ароматизатор, регулятор pH, буфер, гомогенизатор, консервант, антиадгезив, средство, способствующее скольжению, подкислитель, подсластитель или любую их комбинацию.
4. Композиция по п. 1, отличающаяся тем, что композиция присутствует в форме твердой лекарственной формы, причем указанная твердая лекарственная форма представляет собой растворимую таблетку, диспергируемую таблетку, сухую суспензию для восстановления, или порошок или гранулы для растворения или суспендирования.
5. Применение композиции по п. 1 для лечения BH4-восприимчивой гиперфенилаланинемии.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN573MU2011 | 2011-03-01 | ||
| IN573/MUM/2011 | 2011-03-01 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014131786A Division RU2661033C9 (ru) | 2011-03-01 | 2012-03-01 | Стабильные композиции тетрагидробиоптерина |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2017134002A true RU2017134002A (ru) | 2019-02-07 |
Family
ID=46757402
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017134002A RU2017134002A (ru) | 2011-03-01 | 2012-03-01 | Стабильные композиции тетрагидробиоптерина |
| RU2014131786A RU2661033C9 (ru) | 2011-03-01 | 2012-03-01 | Стабильные композиции тетрагидробиоптерина |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014131786A RU2661033C9 (ru) | 2011-03-01 | 2012-03-01 | Стабильные композиции тетрагидробиоптерина |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US9492451B2 (ru) |
| EP (1) | EP2680848A4 (ru) |
| KR (1) | KR20140021585A (ru) |
| CN (1) | CN103458900A (ru) |
| CA (1) | CA2828685C (ru) |
| RU (2) | RU2017134002A (ru) |
| WO (1) | WO2012117362A1 (ru) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007052289A2 (en) * | 2005-07-22 | 2007-05-10 | Rubicon Research Pvt Ltd. | Novel dispersible tablet composition |
| PT2926805T (pt) * | 2014-03-31 | 2016-07-15 | Vasopharm Gmbh | Composições farmacêuticas sólidas que contêm derivados de biopterina e utilizações dessas composições |
| CN104257623A (zh) * | 2014-09-09 | 2015-01-07 | 广东中盛药物研究院有限公司 | 一种含盐酸沙丙蝶呤的泡腾片 |
| TWI686197B (zh) * | 2015-06-25 | 2020-03-01 | 德商瓦索珐姆生物技術有限公司 | 包含生物蝶呤衍生物之固體醫藥組合物及該等組合物之用途 |
| CN106692097B (zh) * | 2015-07-16 | 2019-10-25 | 北京福元医药股份有限公司 | 还原型谷胱甘肽药物制剂 |
| BR112018075689A2 (pt) | 2016-06-13 | 2019-04-02 | Meharry Medical College | modulação da via da óxido nítrico sintase para saúde bucal |
| MX2019006207A (es) | 2016-11-29 | 2019-11-18 | Censa Pharmaceuticals Inc | Forma polimorfica de sepiapterina. |
| IL266955B2 (en) | 2016-11-29 | 2023-09-01 | Ptc Therapeutics Mp Inc | Polymorphs of spiafatrin and its salts |
| EP3351118A1 (en) * | 2017-01-20 | 2018-07-25 | Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory | Fat-soluble active ingredient composition, microcapsule and uses thereof and process of preparation |
| BR112020003865A8 (pt) | 2017-09-01 | 2022-08-16 | Censa Pharmaceuticals Inc | Composições farmacêuticas compreendendo sepiapterina e seus usos |
| ES2914305T3 (es) | 2017-12-26 | 2022-06-09 | Ind Tech Res Inst | Composición para mejorar la solubilidad de sustancias poco solubles, uso de la misma y formulación compleja que contiene la misma |
| AU2019277382A1 (en) | 2018-05-30 | 2021-01-21 | Ptc Therapeutics Mp, Inc. | Methods for increasing sepiapterin plasma exposure |
| TR201914406A2 (tr) * | 2019-09-23 | 2021-04-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Sapropteri̇n di̇hi̇droklorür ve en az bi̇r farmasöti̇k eksi̇pi̇yan i̇çeren kati oral farmasöti̇k formülasyonlar |
| TR201914420A2 (tr) * | 2019-09-23 | 2021-04-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Sapropteri̇n di̇hi̇droklorür ve en az bi̇r anti̇oksi̇dan i̇çeren farmasöti̇k formülasyonlar |
| TR201914416A1 (tr) | 2019-09-23 | 2021-04-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Sapropteri̇n di̇hi̇droklorürün efervesan formülasyonlari |
| EP4132937A1 (en) * | 2020-04-06 | 2023-02-15 | Adama Agan Ltd. | Co-crystals of antioxidants and active ingredients and use of antioxidants as stabilizer |
| WO2023055923A1 (en) * | 2021-09-29 | 2023-04-06 | Ptc Therapeutics, Inc. | Pharmaceutical composition of sepiapterin |
| GB202201356D0 (en) * | 2022-02-02 | 2022-03-16 | Meta Healthcare Ltd | Sapropterin formulation |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61277618A (ja) | 1985-06-04 | 1986-12-08 | Suntory Ltd | 自閉症治療剤 |
| ES2393785T3 (es) | 2004-05-11 | 2012-12-28 | Daiichi Sankyo Company, Limited | Remedios para hiperfenilalaninemia sensible a BH4 |
| US8003126B2 (en) * | 2004-11-17 | 2011-08-23 | Biomarin Pharmaceutical Inc. | Stable tablet formulation |
| US20100234385A1 (en) * | 2006-03-20 | 2010-09-16 | Kaneka Corporation | Compsition Containing Biopterin and Method for Using The Same |
| PT2545939T (pt) * | 2007-04-11 | 2021-02-17 | Biomarin Pharm Inc | Métodos de administração de tetra-hidrobiopterina, composições associadas, e métodos de medição |
-
2012
- 2012-03-01 CA CA2828685A patent/CA2828685C/en active Active
- 2012-03-01 KR KR1020137025762A patent/KR20140021585A/ko not_active Application Discontinuation
- 2012-03-01 WO PCT/IB2012/050959 patent/WO2012117362A1/en active Application Filing
- 2012-03-01 EP EP12752803.2A patent/EP2680848A4/en not_active Ceased
- 2012-03-01 RU RU2017134002A patent/RU2017134002A/ru not_active Application Discontinuation
- 2012-03-01 CN CN2012800142552A patent/CN103458900A/zh active Pending
- 2012-03-01 US US14/002,313 patent/US9492451B2/en not_active Expired - Fee Related
- 2012-03-01 RU RU2014131786A patent/RU2661033C9/ru active
-
2013
- 2013-03-01 US US14/002,313 patent/US20130336945A1/en active Granted
Also Published As
| Publication number | Publication date |
|---|---|
| CA2828685C (en) | 2018-05-29 |
| CA2828685A1 (en) | 2012-09-07 |
| US9492451B2 (en) | 2016-11-15 |
| WO2012117362A1 (en) | 2012-09-07 |
| RU2661033C2 (ru) | 2018-07-11 |
| RU2014131786A (ru) | 2016-02-20 |
| CN103458900A (zh) | 2013-12-18 |
| KR20140021585A (ko) | 2014-02-20 |
| EP2680848A1 (en) | 2014-01-08 |
| US20130336945A1 (en) | 2013-12-19 |
| EP2680848A4 (en) | 2014-11-05 |
| RU2661033C9 (ru) | 2018-10-23 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA93 | Acknowledgement of application withdrawn (no request for examination) |
Effective date: 20200930 |