PE20061294A1 - Formulacion de tableta estable que contiene polimorfo b de (6r)-l-eritro-tetra hidrobiopterina - Google Patents
Formulacion de tableta estable que contiene polimorfo b de (6r)-l-eritro-tetra hidrobiopterinaInfo
- Publication number
- PE20061294A1 PE20061294A1 PE2005001350A PE2005001350A PE20061294A1 PE 20061294 A1 PE20061294 A1 PE 20061294A1 PE 2005001350 A PE2005001350 A PE 2005001350A PE 2005001350 A PE2005001350 A PE 2005001350A PE 20061294 A1 PE20061294 A1 PE 20061294A1
- Authority
- PE
- Peru
- Prior art keywords
- formulation
- weight
- erythro
- amount
- polymorph
- Prior art date
Links
- FNKQXYHWGSIFBK-RPDRRWSUSA-N sapropterin Chemical compound N1=C(N)NC(=O)C2=C1NC[C@H]([C@@H](O)[C@@H](O)C)N2 FNKQXYHWGSIFBK-RPDRRWSUSA-N 0.000 title abstract 3
- 239000007916 tablet composition Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 7
- 238000009472 formulation Methods 0.000 abstract 6
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 abstract 2
- 239000004475 Arginine Substances 0.000 abstract 1
- 206010060378 Hyperinsulinaemia Diseases 0.000 abstract 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- MHQJUHSHQGQVTM-HNENSFHCSA-N Octadecyl fumarate Chemical compound CCCCCCCCCCCCCCCCCCOC(=O)\C=C/C(O)=O MHQJUHSHQGQVTM-HNENSFHCSA-N 0.000 abstract 1
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 abstract 1
- 239000002253 acid Substances 0.000 abstract 1
- 239000003963 antioxidant agent Substances 0.000 abstract 1
- 230000003078 antioxidant effect Effects 0.000 abstract 1
- 235000006708 antioxidants Nutrition 0.000 abstract 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- 235000010323 ascorbic acid Nutrition 0.000 abstract 1
- 229960005070 ascorbic acid Drugs 0.000 abstract 1
- 239000011668 ascorbic acid Substances 0.000 abstract 1
- 239000011230 binding agent Substances 0.000 abstract 1
- 229910000389 calcium phosphate Inorganic materials 0.000 abstract 1
- 239000001506 calcium phosphate Substances 0.000 abstract 1
- 235000011010 calcium phosphates Nutrition 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 229960000913 crospovidone Drugs 0.000 abstract 1
- 206010012601 diabetes mellitus Diseases 0.000 abstract 1
- 229940014144 folate Drugs 0.000 abstract 1
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 abstract 1
- 235000019152 folic acid Nutrition 0.000 abstract 1
- 239000011724 folic acid Substances 0.000 abstract 1
- 230000003451 hyperinsulinaemic effect Effects 0.000 abstract 1
- 201000008980 hyperinsulinism Diseases 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 208000030159 metabolic disease Diseases 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 abstract 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 abstract 1
- 229940071138 stearyl fumarate Drugs 0.000 abstract 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 abstract 1
Classifications
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- 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
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Psychology (AREA)
- Pain & Pain Management (AREA)
- Molecular Biology (AREA)
- Psychiatry (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Urology & Nephrology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
SE REFIERE A UNA COMPOSICION FARMACEUTICA QUE COMPRENDE: A) UN POLIMORFO CRISTALINO DE (6R)-L-ERITRO-TETRAHIDROBIOPTERINA (POLIMORFO B) QUE PRESENTA UN PATRON DE DIFRACCION EN POLVO DE RAYOS X CON LOS SIGUIENTES PICOS EXPRESADOS EN (Å): 8.7 (vs), 5.63 (m), 4.76 (m), 4.40 (m), 4.00(s), 3.23 (s), 3.11 (vs), ENTRE OTROS, EN UNA CANTIDAD COMPRENDIDA ENTRE 30% A 40% EN PESO DE LA FORMULACION; B) UN AGLUTINANTE TAL COMO FOSFATO CALCICO DIBASICO ANHIDRO EN UNA CANTIDAD COMPRENDIDA ENTRE 1% A 5% POR PESO DE LA FORMULACION; C) UN AGENTE DE DESINTEGRACION TAL COMO CROSPOVIDONA EN UNA CANTIDAD COMPRENDIDA ENTRE 3% A 10% POR PESO DE LA FORMULACION; D) UN ANTIOXIDANTE ACIDO TAL COMO ACIDO ASCORBICO EN UNA CANTIDAD COMPRENDIDA ENTRE 1% A 3% POR PESO DE LA FORMULACION; E) UN LUBRICANTE TAL COMO FUMARATO DE ESTEARILO EN UNA CANTIDAD COMPRENDIDA ENTRE 0.1% A 2% POR PESO DE LA FORMULACION; Y F) ADEMAS COMPRENDE VITAMINA B2, B12, UN FOLATO Y ARGININA. LA COMPOSICION SE PRESENTA EN FORMA DE TABLETA Y RETIENE AL MENOS 95% DE LA CANTIDAD INICIAL DE (6R)-L-ERITRO-TETRAHIDROBIOPTERINA DESPUES DE SEIS A NUEVE MESES A TEMPERATURA AMBIENTE Y 60% DE HUMEDAD. DICHA FORMULACION ES UTIL EN EL TRATAMIENTO DE TRANSTORNOS METABOLICOS TALES COMO DIABETES, HIPERINSULINEMIA
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US62918904P | 2004-11-17 | 2004-11-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20061294A1 true PE20061294A1 (es) | 2006-12-18 |
Family
ID=35849290
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2005001350A PE20061294A1 (es) | 2004-11-17 | 2005-11-17 | Formulacion de tableta estable que contiene polimorfo b de (6r)-l-eritro-tetra hidrobiopterina |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US8003126B2 (es) |
| EP (2) | EP2436379A1 (es) |
| JP (2) | JP2008520574A (es) |
| KR (1) | KR20070084270A (es) |
| CN (1) | CN101132776A (es) |
| AR (1) | AR052238A1 (es) |
| AU (1) | AU2005306686B2 (es) |
| BR (1) | BRPI0517088A (es) |
| CA (1) | CA2581814C (es) |
| IL (1) | IL182161A (es) |
| MX (1) | MX2007005039A (es) |
| MY (1) | MY142120A (es) |
| PE (1) | PE20061294A1 (es) |
| TW (1) | TW200624120A (es) |
| WO (1) | WO2006055511A2 (es) |
Families Citing this family (38)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7442372B2 (en) | 2003-08-29 | 2008-10-28 | Biomarin Pharmaceutical Inc. | Delivery of therapeutic compounds to the brain and other tissues |
| AU2004291149C1 (en) | 2003-11-17 | 2021-01-21 | Biomarin Pharmaceutical Inc. | Methods and Compositions for the Treatment of Metabolic Disorders |
| DK1757293T3 (da) * | 2004-05-11 | 2012-10-22 | Daiichi Sankyo Co Ltd | Bh4-responsiv hyperphenylalaninæmi-medikamenter |
| AU2005306686B2 (en) | 2004-11-17 | 2011-06-02 | Biomarin Pharmaceutical Inc. | Stable tablet formulation of tetrahydrobiopterin |
| WO2008089008A2 (en) * | 2007-01-12 | 2008-07-24 | Biomarin Pharmaceutical Inc. | Tetrahydrobiopterin prodrugs |
| WO2008089148A1 (en) * | 2007-01-12 | 2008-07-24 | Biomarin Pharmaceutical Inc. | Method of treating a metabolic or neuropsychiatry disorder with a bh4 derivative prodrug |
| ES2397746T3 (es) | 2007-04-11 | 2013-03-11 | Biomarin Pharmaceutical Inc. | Métodos de administración de tetrahidrobiopterina, composiciones asociadas y métodos de medición |
| ECSP077628A (es) * | 2007-05-03 | 2008-12-30 | Smithkline Beechman Corp | Nueva composición farmacéutica |
| CN101969953B (zh) * | 2008-01-03 | 2013-01-09 | 生物马林药物股份有限公司 | 用于治疗bh4反应性疾病的喋呤类似物 |
| WO2010017570A2 (de) * | 2008-08-12 | 2010-02-18 | Orpha Swiss Gmbh | Pharmazeutische darreichungsform enthaltend tetrahydrobiopterin |
| EP2680848A4 (en) | 2011-03-01 | 2014-11-05 | Rubicon Res Private Ltd | STABLE TETRAHYDROBIOPTERINE COMPOSITIONS |
| WO2012127431A1 (en) * | 2011-03-24 | 2012-09-27 | Rubicon Research Private Limited | Stabilized compositions of tetrahydrobiopterin |
| US9216178B2 (en) | 2011-11-02 | 2015-12-22 | Biomarin Pharmaceutical Inc. | Dry blend formulation of tetrahydrobiopterin |
| CN102775408B (zh) * | 2012-01-20 | 2015-09-02 | 连云港金康医药科技有限公司 | 稳定的5-甲基四氢叶酸晶型及其制备方法 |
| CN104530051B (zh) * | 2012-01-20 | 2016-08-24 | 连云港金康和信药业有限公司 | 稳定的(6r,s)-5-甲基四氢叶酸晶型及其制备方法 |
| PT2926805T (pt) | 2014-03-31 | 2016-07-15 | Vasopharm Gmbh | Composições farmacêuticas sólidas que contêm derivados de biopterina e utilizações dessas composições |
| WO2017106130A1 (en) | 2015-12-16 | 2017-06-22 | Merck Sharp & Dohme Corp. | Process for preparing pharmaceutical compositions |
| MX383942B (es) * | 2015-12-18 | 2025-03-14 | Colgate Palmolive Co | Composicion de peroximonosulfato de disolucion rapida. |
| EP3491008A2 (en) | 2016-07-26 | 2019-06-05 | BioMarin Pharmaceutical Inc. | Novel adeno-associated virus capsid proteins |
| JP2019527242A (ja) | 2016-07-29 | 2019-09-26 | ディファーマ エッセ．ア． | サプロプテリンジヒドロクロリドを含む医薬組成物キット |
| US20180110781A1 (en) * | 2016-10-24 | 2018-04-26 | Research Foundation For Mental Hygiene, Inc. | System and method for diagnosis and treatment of neuropsychiatric disorders |
| US10758462B2 (en) * | 2016-11-16 | 2020-09-01 | Colgate-Palmolive Company | Oral care composition |
| IL266955B2 (en) * | 2016-11-29 | 2023-09-01 | Ptc Therapeutics Mp Inc | Polymorphs of spiafatrin and its salts |
| CA3043499A1 (en) | 2016-11-29 | 2018-06-07 | Censa Pharmaceuticals Inc. | Polymorphic form of sepiapterin |
| CA3073957A1 (en) | 2017-09-01 | 2019-03-07 | Censa Pharmaceuticals Inc. | Pharmaceutical compositions comprising sepiapterin and uses thereof |
| AU2019265560A1 (en) | 2018-05-09 | 2020-11-26 | Biomarin Pharmaceutical Inc. | Methods of treating phenylketonuria |
| TW202005978A (zh) | 2018-05-14 | 2020-02-01 | 美商拜奧馬林製藥公司 | 新穎肝靶向腺相關病毒載體 |
| MX2020012980A (es) | 2018-05-30 | 2021-04-29 | Ptc Therapeutics Mp Inc | Composiciones y métodos para incrementar la exposición plasmática de tetrahidrobiopterina. |
| ES2986920T3 (es) | 2018-05-30 | 2024-11-13 | Ptc Therapeutics Mp Inc | Administración de sepiapterina sin alimentos para su uso en un método para aumentar la exposición plasmática a sepiapterina |
| IL280880B2 (en) | 2018-08-27 | 2025-04-01 | Regeneron Pharma | Using Raman Spectroscopy in Downstream Purification |
| FI4009978T3 (fi) * | 2019-08-05 | 2024-11-01 | Ptc Therapeutics Mp Inc | Sepiapteriiinin ja sen metaboliittien käyttö säteilyaltistuksen hoitoon |
| 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 |
| 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 |
| AR122409A1 (es) | 2020-04-03 | 2022-09-07 | Biomarin Pharm Inc | Tratamiento de la fenilcetonuria con aav y formulaciones terapéuticas |
| GB202307239D0 (en) | 2023-05-15 | 2023-06-28 | Evox Therapeutics Ltd | Gene therapies for Phenylketonuria |
| WO2025053806A1 (en) * | 2023-09-08 | 2025-03-13 | Ilko Ilac Sanayi Ve Ticaret A.S. | Sapropterin soluble tablet composition |
| CN117205164B (zh) * | 2023-09-30 | 2024-07-26 | 山东新时代药业有限公司 | 一种盐酸沙丙蝶呤片剂及其制备方法 |
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- 2005-11-16 CN CNA2005800389108A patent/CN101132776A/zh active Pending
- 2005-11-16 WO PCT/US2005/041252 patent/WO2006055511A2/en not_active Ceased
- 2005-11-16 JP JP2007541419A patent/JP2008520574A/ja active Pending
- 2005-11-16 EP EP11171309A patent/EP2436379A1/en not_active Withdrawn
- 2005-11-16 US US10/563,418 patent/US8003126B2/en active Active
- 2005-11-16 EP EP05822282A patent/EP1845952A2/en not_active Withdrawn
- 2005-11-16 KR KR1020077011104A patent/KR20070084270A/ko not_active Ceased
- 2005-11-16 BR BRPI0517088-5A patent/BRPI0517088A/pt not_active IP Right Cessation
- 2005-11-16 MX MX2007005039A patent/MX2007005039A/es active IP Right Grant
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Also Published As
| Publication number | Publication date |
|---|---|
| WO2006055511A3 (en) | 2006-10-05 |
| JP2008520574A (ja) | 2008-06-19 |
| AU2005306686A1 (en) | 2006-05-26 |
| CA2581814A1 (en) | 2006-05-26 |
| WO2006055511A2 (en) | 2006-05-26 |
| MX2007005039A (es) | 2007-06-19 |
| EP1845952A2 (en) | 2007-10-24 |
| AR052238A1 (es) | 2007-03-07 |
| BRPI0517088A (pt) | 2008-09-30 |
| AU2005306686B2 (en) | 2011-06-02 |
| US7566462B2 (en) | 2009-07-28 |
| US20070270581A1 (en) | 2007-11-22 |
| IL182161A0 (en) | 2007-07-24 |
| CN101132776A (zh) | 2008-02-27 |
| EP2436379A1 (en) | 2012-04-04 |
| IL182161A (en) | 2011-08-31 |
| KR20070084270A (ko) | 2007-08-24 |
| US20080207626A1 (en) | 2008-08-28 |
| US8003126B2 (en) | 2011-08-23 |
| JP2014012740A (ja) | 2014-01-23 |
| CA2581814C (en) | 2015-10-13 |
| TW200624120A (en) | 2006-07-16 |
| MY142120A (en) | 2010-09-15 |
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