WO2006055511A3 - Stable tablet formulation of tetrahydrobiopterin - Google Patents

Stable tablet formulation of tetrahydrobiopterin Download PDF

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Publication number
WO2006055511A3
WO2006055511A3 PCT/US2005/041252 US2005041252W WO2006055511A3 WO 2006055511 A3 WO2006055511 A3 WO 2006055511A3 US 2005041252 W US2005041252 W US 2005041252W WO 2006055511 A3 WO2006055511 A3 WO 2006055511A3
Authority
WO
WIPO (PCT)
Prior art keywords
tetrahydrobiopterin
tablet formulation
stable tablet
stable
formulations
Prior art date
Application number
PCT/US2005/041252
Other languages
French (fr)
Other versions
WO2006055511A2 (en
Inventor
Steven Jungles
Mark Henderson
Victoria Sluzky
Robert Baffi
Original Assignee
Biomarin Pharm Inc
Steven Jungles
Mark Henderson
Victoria Sluzky
Robert Baffi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35849290&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2006055511(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to BRPI0517088-5A priority Critical patent/BRPI0517088A/en
Priority to JP2007541419A priority patent/JP2008520574A/en
Priority to MX2007005039A priority patent/MX2007005039A/en
Priority to CA2581814A priority patent/CA2581814C/en
Priority to AU2005306686A priority patent/AU2005306686B2/en
Application filed by Biomarin Pharm Inc, Steven Jungles, Mark Henderson, Victoria Sluzky, Robert Baffi filed Critical Biomarin Pharm Inc
Priority to EP05822282A priority patent/EP1845952A2/en
Priority to US10/563,418 priority patent/US8003126B2/en
Publication of WO2006055511A2 publication Critical patent/WO2006055511A2/en
Publication of WO2006055511A3 publication Critical patent/WO2006055511A3/en
Priority to IL182161A priority patent/IL182161A/en
Priority to US12/106,621 priority patent/US7566462B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism

Abstract

The present invention is directed to a stable solid formulations of tetrahydrobiopterin, processes for producing them, and treatment methods using such formulations.
PCT/US2005/041252 2004-11-17 2005-11-16 Stable tablet formulation of tetrahydrobiopterin WO2006055511A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
US10/563,418 US8003126B2 (en) 2004-11-17 2005-11-16 Stable tablet formulation
JP2007541419A JP2008520574A (en) 2004-11-17 2005-11-16 Tetrahydrobiopterin stable tablet formulation
MX2007005039A MX2007005039A (en) 2004-11-17 2005-11-16 Stable tablet formulation of tetrahydrobiopterin.
CA2581814A CA2581814C (en) 2004-11-17 2005-11-16 Stable tablet formulation of tetrahydrobiopterin
AU2005306686A AU2005306686B2 (en) 2004-11-17 2005-11-16 Stable tablet formulation of tetrahydrobiopterin
BRPI0517088-5A BRPI0517088A (en) 2004-11-17 2005-11-16 stable tablet formulation
EP05822282A EP1845952A2 (en) 2004-11-17 2005-11-16 Stable tablet formulation of tetrahydrobiopterin
IL182161A IL182161A (en) 2004-11-17 2007-03-25 Stable formulation comprising a crystalline polymorph of (6r)-l-erythro-tetrahydrobiopterin dihydrochloride
US12/106,621 US7566462B2 (en) 2004-11-17 2008-04-21 Stable tablet formulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US62918904P 2004-11-17 2004-11-17
US60/629,189 2004-11-17

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US10/563,418 A-371-Of-International US8003126B2 (en) 2004-11-17 2005-11-16 Stable tablet formulation
US12/106,621 Continuation US7566462B2 (en) 2004-11-17 2008-04-21 Stable tablet formulation

Publications (2)

Publication Number Publication Date
WO2006055511A2 WO2006055511A2 (en) 2006-05-26
WO2006055511A3 true WO2006055511A3 (en) 2006-10-05

Family

ID=35849290

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/041252 WO2006055511A2 (en) 2004-11-17 2005-11-16 Stable tablet formulation of tetrahydrobiopterin

Country Status (15)

Country Link
US (2) US8003126B2 (en)
EP (2) EP1845952A2 (en)
JP (2) JP2008520574A (en)
KR (1) KR20070084270A (en)
CN (1) CN101132776A (en)
AR (1) AR052238A1 (en)
AU (1) AU2005306686B2 (en)
BR (1) BRPI0517088A (en)
CA (1) CA2581814C (en)
IL (1) IL182161A (en)
MX (1) MX2007005039A (en)
MY (1) MY142120A (en)
PE (1) PE20061294A1 (en)
TW (1) TW200624120A (en)
WO (1) WO2006055511A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9216178B2 (en) 2011-11-02 2015-12-22 Biomarin Pharmaceutical Inc. Dry blend formulation of tetrahydrobiopterin

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WO2005107759A1 (en) * 2004-05-11 2005-11-17 Daiichi Asubo Pharma Co., Ltd. Bh4-responsive hyperphenylalaninemia remedies
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WO2008089148A1 (en) * 2007-01-12 2008-07-24 Biomarin Pharmaceutical Inc. Method of treating a metabolic or neuropsychiatry disorder with a bh4 derivative prodrug
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DE22154751T1 (en) 2007-04-11 2022-09-08 Biomarin Pharmaceutical Inc. TETRAHYDROBIOPTERIN FOR THE TREATMENT OF CONDITIONS ASSOCIATED WITH ELEVATED LEVELS OF PHENYLALANIN
ECSP077628A (en) * 2007-05-03 2008-12-30 Smithkline Beechman Corp NEW PHARMACEUTICAL COMPOSITION
AU2008347005B2 (en) * 2008-01-03 2013-10-03 Biomarin Pharmaceutical Inc. Pterin analog for treating BH4 responsive condition
ES2736730T3 (en) * 2008-08-12 2020-01-07 Orpha Swiss Gmbh Pharmaceutical administration form containing tetrahydrobiopterin
CN103458900A (en) * 2011-03-01 2013-12-18 鲁必康研究私人有限公司 Stable compositions of tetrahydrobiopterin
WO2012127431A1 (en) * 2011-03-24 2012-09-27 Rubicon Research Private Limited Stabilized compositions of tetrahydrobiopterin
CN104530051B (en) * 2012-01-20 2016-08-24 连云港金康和信药业有限公司 Stable (6R, S)-5-methyltetrahydrofolate crystal formation and preparation method thereof
CN102775408B (en) * 2012-01-20 2015-09-02 连云港金康医药科技有限公司 Stable 5-methyltetrahydrofolate crystal formation and preparation method thereof
PT2926805T (en) 2014-03-31 2016-07-15 Vasopharm Gmbh Solid pharmaceutical compositions comprising biopterin derivatives and uses of such compositions
WO2017106130A1 (en) * 2015-12-16 2017-06-22 Merck Sharp & Dohme Corp. Process for preparing pharmaceutical compositions
CN108366921A (en) * 2015-12-18 2018-08-03 高露洁-棕榄公司 Instant capacity permonosulphuric acid salt composite
KR20230161535A (en) 2016-07-26 2023-11-27 바이오마린 파머수티컬 인크. Novel adeno-associated virus capsid proteins
EP3490536A1 (en) 2016-07-29 2019-06-05 Dipharma S.A. Pharmaceutical composition kit comprising sapropterin dihydrochloride
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
BR122021026889A8 (en) * 2016-11-29 2022-11-22 Censa Pharmaceuticals Inc FREE BASE CRYSTALLINE FORMS OF SEPIAPTERIN AND SALTS THEREOF, THEIR METHOD OF PREPARATION, COMPOSITIONS THAT COMPRISE THEM, USE OF THEM AND METHOD OF PREPARATION OF A LIQUID FORMULATION
CA3043499A1 (en) 2016-11-29 2018-06-07 Censa Pharmaceuticals Inc. Polymorphic form of sepiapterin
MX2020002271A (en) * 2017-09-01 2020-10-05 Ptc Therapeutics Mp Inc Pharmaceutical compositions comprising sepiapterin and uses thereof.
KR20210008501A (en) 2018-05-09 2021-01-22 바이오마린 파머수티컬 인크. How to treat phenylketonuria
TW202005978A (en) 2018-05-14 2020-02-01 美商拜奧馬林製藥公司 Novel liver targeting adeno-associated viral vectors
MX2020012979A (en) 2018-05-30 2021-04-29 Ptc Therapeutics Mp Inc Methods for increasing sepiapterin plasma exposure.
TR201914420A2 (en) * 2019-09-23 2021-04-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi PHARMACEUTICAL FORMULATIONS CONTAINING SAPROPTERIN DIHYDROCHLORIDE AND AT LEAST ONE ANTIOXIDANT
TR201914406A2 (en) * 2019-09-23 2021-04-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi SOLID ORAL PHARMACEUTICAL FORMULATIONS CONTAINING SAPROPTERIN DIHYDROCHLORIDE AND AT LEAST ONE PHARMACEUTICAL EXCIPIENT
TW202144575A (en) 2020-04-03 2021-12-01 美商拜奧馬林製藥公司 Treatment of phenylketonuria with aav and therapeutic formulations

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