CN111491635A - 包含墨蝶呤的药物组合物及其用途 - Google Patents

包含墨蝶呤的药物组合物及其用途 Download PDF

Info

Publication number
CN111491635A
CN111491635A CN201880070952.7A CN201880070952A CN111491635A CN 111491635 A CN111491635 A CN 111491635A CN 201880070952 A CN201880070952 A CN 201880070952A CN 111491635 A CN111491635 A CN 111491635A
Authority
CN
China
Prior art keywords
pharmaceutical composition
crystal
mopterin
pharmaceutically acceptable
salt
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN201880070952.7A
Other languages
English (en)
Chinese (zh)
Inventor
D.E.勒维
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PTC Therapeutics MP Inc
Original Assignee
Censa Pharmaceuticals Inc
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
Application filed by Censa Pharmaceuticals Inc filed Critical Censa Pharmaceuticals Inc
Publication of CN111491635A publication Critical patent/CN111491635A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/40—Transferrins, e.g. lactoferrins, ovotransferrins
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201880070952.7A 2017-09-01 2018-09-04 包含墨蝶呤的药物组合物及其用途 Pending CN111491635A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762553603P 2017-09-01 2017-09-01
US62/553603 2017-09-01
US201862678069P 2018-05-30 2018-05-30
US62/678069 2018-05-30
PCT/US2018/049359 WO2019046849A1 (en) 2017-09-01 2018-09-04 PHARMACEUTICAL COMPOSITION COMPRISING SEPAPTERINE AND USES THEREOF

Publications (1)

Publication Number Publication Date
CN111491635A true CN111491635A (zh) 2020-08-04

Family

ID=65526057

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201880070952.7A Pending CN111491635A (zh) 2017-09-01 2018-09-04 包含墨蝶呤的药物组合物及其用途

Country Status (7)

Country Link
US (3) US11752154B2 (https=)
EP (1) EP3675863A4 (https=)
JP (2) JP7811085B2 (https=)
CN (1) CN111491635A (https=)
CA (1) CA3073957A1 (https=)
MX (1) MX2020002271A (https=)
WO (1) WO2019046849A1 (https=)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2562176B1 (en) 2010-04-22 2018-08-15 Nihon University Medicinal agent and beverage/food for preventing cerebral dysfunction and improving same
MA46972A (fr) 2016-11-29 2019-10-09 Censa Pharmaceuticals Inc Forme polymorphe de sépiaptérine
MA46973A (fr) 2016-11-29 2019-10-09 Censa Pharmaceuticals Inc Polymorphes de sépiaptérine et leurs sels
JP7811085B2 (ja) 2017-09-01 2026-02-04 ピーティーシー セラピューティクス エムピー，インコーポレイテッド セピアプテリンを含む医薬組成物及びその使用
FI3801536T3 (fi) 2018-05-30 2024-08-29 Ptc Therapeutics Mp Inc Sepiapteriinin antaminen ilman ruokaa käytettäväksi menetelmässä sepiapteriinin plasma-altistuksen lisäämiseksi
EP3801534B1 (en) 2018-05-30 2026-02-18 PTC Therapeutics MP, Inc. Treatment of phenylketonuria with sepiapterin
AU2019277372B2 (en) 2018-05-30 2024-12-19 Ptc Therapeutics Mp, Inc. Pharmaceutically acceptable salts of sepiapterin
IL290321B1 (en) 2019-08-05 2026-04-01 Ptc Therapeutics Inc Use of spiapterin and its metabolites for radiation exposure treatment
IL291565B1 (en) * 2019-09-25 2026-04-01 Ptc Therapeutics Inc Method for treating phenylalanine irregularity
EP4093405A1 (en) 2020-01-24 2022-11-30 PTC Therapeutics MP, Inc. Methods for treating parkinson's disease with sepiapterin
WO2021168206A1 (en) * 2020-02-19 2021-08-26 Musc Foundation For Research Development L-sepiapterin and methods of use for treating diseases and disorders
WO2022173823A1 (en) 2021-02-09 2022-08-18 Ptc Therapeutics Mp, Inc. Methods for treating covid-19 with sepiapterin
IL305037A (en) 2021-02-09 2023-10-01 Ptc Therapeutics Mp Inc Methods of treating glioblastomas with spiafatrin
PE20241579A1 (es) 2021-09-29 2024-08-01 Ptc Therapeutics Inc Composicion farmaceutica de sepiapterina

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1905863A (zh) * 2003-11-17 2007-01-31 生物马林药物股份有限公司 用于治疗代谢紊乱的方法和组合物
CN101132776A (zh) * 2004-11-17 2008-02-27 生物马林药物股份有限公司 稳定的四氢生物喋呤片剂制剂
US20110144117A1 (en) * 2008-08-12 2011-06-16 Orpha Swiss Gmbh Pharmaceutical Dosage Form Containing Tetrahydrobiopterin
US20130197000A1 (en) * 2010-04-22 2013-08-01 Nihon University Drug and food/drink for preventing or improving cerebral dysfunction
CN104736539A (zh) * 2012-05-07 2015-06-24 白鸟制药株式会社 墨蝶呤和四氢乳酰蝶呤的制造法
CN106572976A (zh) * 2014-03-31 2017-04-19 瓦索珐姆有限公司 包含生物蝶呤衍生物的固体药物组合物及此类组合物的用途
CN110248948A (zh) * 2016-11-29 2019-09-17 显莎制药公司 墨蝶呤及其盐的多晶型物

Family Cites Families (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5925323A (ja) 1982-03-03 1984-02-09 鐘淵化学工業株式会社 プテリン誘導体からなる脳内神経伝達物質の関わる疾病の治療剤
EP0722731B1 (en) 1994-08-05 2002-06-05 Suntory Limited Remedy for spinocerebellar degeneration
JP2002515965A (ja) 1995-08-18 2002-05-28 ダブリュー． ランドリ，ドナルド 抗体触媒反応の調節による有機化合物の検出
US8188043B2 (en) * 1999-07-28 2012-05-29 The Board Of Trustees Of The Leland Stanford Jr. University Nicotine in therapeutic angiogenesis and vasculogenesis
GB0116620D0 (en) 2001-07-07 2001-08-29 Astrazeneca Ab Formulation
ITMI20011732A1 (it) 2001-08-07 2003-02-07 Indena Spa Composizioni farmaceutiche e/o cosmetiche orali per il trattamento e la prevenzione di disturbi del cuoio capelluto
FR2859996B1 (fr) 2003-09-19 2006-02-03 Aventis Pharma Sa Solvat acetonique du dimethoxy docetaxel et son procede de preparation
JP2007509909A (ja) 2003-10-31 2007-04-19 アルタナ　ファルマ　アクチエンゲゼルシャフト 呼吸器疾患の治療のためのｂｈ４の使用
JP5184783B2 (ja) 2003-11-17 2013-04-17 バイオマリン ファーマシューティカル インコーポレイテッド テトラヒドロビオプテリン、及びテトラヒドロビオプテリン類似体の製造方法
EP1687308B1 (en) 2003-11-17 2019-06-12 Merck & Cie Process for preparating (6R)-L-erythrotetrahydrobiopterin hydrochloride crystalline form B from other crystalline forms
JP2008523090A (ja) 2004-12-08 2008-07-03 バイオマリン ファーマシューティカル インコーポレイテッド 新生児肺高血圧症の治療のための方法および組成物
BRPI0609421B1 (pt) 2005-04-28 2021-06-01 Shiratori Pharmaceutical Co., Ltd. Processos para produção de um composto 1,1-bis-alquil sulfonila, para produção de um composto aldeído, e para produção de um derivado de hidrazona
US20080075666A1 (en) * 2006-08-25 2008-03-27 Dudley Samuel C Jr Methods and compositions for treating diastolic dysfunction
LT2545939T (lt) 2007-04-11 2021-03-10 Biomarin Pharmaceutical Inc. Tetrahidrobiopterinas, skirtas gydyti ligas, susijusias supadidėjusiu fenilalanino kiekiu
EA017064B1 (ru) 2008-03-10 2012-09-28 Такеда Фармасьютикал Компани Лимитед Кристаллическое производное бензимидазола
CN102256976A (zh) 2008-12-23 2011-11-23 贝林格尔.英格海姆国际有限公司 有机化合物的盐形式
JP2012533633A (ja) 2009-07-20 2012-12-27 ベテゲン・エルエルシー 経口投与のための安定な薬学的オメプラゾール製剤
CA2771432A1 (en) 2009-08-20 2011-02-24 Novartis Ag Heterocyclic oxime compounds
US9884909B2 (en) 2010-12-01 2018-02-06 Alderbio Holdings Llc Anti-NGF compositions and use thereof
CN103458900A (zh) 2011-03-01 2013-12-18 鲁必康研究私人有限公司 四氢生物蝶呤的稳定组合物
US9216178B2 (en) 2011-11-02 2015-12-22 Biomarin Pharmaceutical Inc. Dry blend formulation of tetrahydrobiopterin
DK3546464T3 (da) 2014-05-12 2020-07-27 Alfasigma Spa Fremstilling og anvendelse af den krystallinske form tau af rifaximin solvateret med degme
PL3227273T3 (pl) 2014-12-02 2022-05-30 Minerva Neurosciences, Inc. Kompozycje zawierające 2-((1-(2-(4-fluorofenylo)-2-oksoetylo)piperydyn-4-ylo)metylo)izoindolin-1-on do leczenia schizofrenii
JP2018531964A (ja) 2015-10-27 2018-11-01 インシス・ディベロップメント・カンパニー・インコーポレイテッド 液体ブプレノルフィン製剤
JP6967334B2 (ja) 2015-12-21 2021-11-17 備前化成株式会社 高度不飽和脂肪酸のエステルを含む組成物
EP3468534A4 (en) 2016-06-13 2020-02-05 Meharry Medical College MODULATION OF THE NITROGEN OXIDE SYNTHASE SIGNAL PATH FOR ORAL HEALTH
WO2018019931A1 (en) * 2016-07-29 2018-02-01 Dipharma S.A. Pharmaceutical composition kit comprising sapropterin dihydrochloride
MA46972A (fr) 2016-11-29 2019-10-09 Censa Pharmaceuticals Inc Forme polymorphe de sépiaptérine
BR102018007822A2 (pt) 2017-04-20 2018-11-06 Gilead Sciences, Inc. composto, métodos para inibir pd-1, pd-l1 e/ou interação de pd-1/pd-l1 e para tratamento de câncer, composição farmacêutica, e, kit para tratamento de ou prevenção de câncer ou uma doença ou condição
JP7811085B2 (ja) 2017-09-01 2026-02-04 ピーティーシー セラピューティクス エムピー，インコーポレイテッド セピアプテリンを含む医薬組成物及びその使用
AU2019277372B2 (en) 2018-05-30 2024-12-19 Ptc Therapeutics Mp, Inc. Pharmaceutically acceptable salts of sepiapterin
FI3801536T3 (fi) 2018-05-30 2024-08-29 Ptc Therapeutics Mp Inc Sepiapteriinin antaminen ilman ruokaa käytettäväksi menetelmässä sepiapteriinin plasma-altistuksen lisäämiseksi
EP3801534B1 (en) 2018-05-30 2026-02-18 PTC Therapeutics MP, Inc. Treatment of phenylketonuria with sepiapterin
IL290321B1 (en) 2019-08-05 2026-04-01 Ptc Therapeutics Inc Use of spiapterin and its metabolites for radiation exposure treatment
IL291565B1 (en) 2019-09-25 2026-04-01 Ptc Therapeutics Inc Method for treating phenylalanine irregularity

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1905863A (zh) * 2003-11-17 2007-01-31 生物马林药物股份有限公司 用于治疗代谢紊乱的方法和组合物
CN101132776A (zh) * 2004-11-17 2008-02-27 生物马林药物股份有限公司 稳定的四氢生物喋呤片剂制剂
US20110144117A1 (en) * 2008-08-12 2011-06-16 Orpha Swiss Gmbh Pharmaceutical Dosage Form Containing Tetrahydrobiopterin
US20130197000A1 (en) * 2010-04-22 2013-08-01 Nihon University Drug and food/drink for preventing or improving cerebral dysfunction
CN104736539A (zh) * 2012-05-07 2015-06-24 白鸟制药株式会社 墨蝶呤和四氢乳酰蝶呤的制造法
CN106572976A (zh) * 2014-03-31 2017-04-19 瓦索珐姆有限公司 包含生物蝶呤衍生物的固体药物组合物及此类组合物的用途
CN110248948A (zh) * 2016-11-29 2019-09-17 显莎制药公司 墨蝶呤及其盐的多晶型物

Also Published As

Publication number Publication date
CA3073957A1 (en) 2019-03-07
JP7811085B2 (ja) 2026-02-04
JP2020532535A (ja) 2020-11-12
US11752154B2 (en) 2023-09-12
BR112020003865A2 (pt) 2020-09-08
US20250195526A1 (en) 2025-06-19
US20240100054A1 (en) 2024-03-28
MX2020002271A (es) 2020-10-05
JP2023116556A (ja) 2023-08-22
EP3675863A4 (en) 2021-01-27
EP3675863A1 (en) 2020-07-08
US12213982B2 (en) 2025-02-04
BR112020003865A8 (pt) 2022-08-16
US20200061070A1 (en) 2020-02-27
WO2019046849A1 (en) 2019-03-07

Similar Documents

Publication Publication Date Title
US12213982B2 (en) Pharmaceutical compositions comprising sepiapterin and uses thereof
JP7841008B2 (ja) セピアプテリンの薬学的に許容される塩
EP3801536B1 (en) Administration of sepiapterin without food for use in a method for increasing sepiapterin plasma exposure
EP3801534B1 (en) Treatment of phenylketonuria with sepiapterin
HK40087700A (zh) 墨蝶呤的药学上可接受的盐
JP7855033B2 (ja) テトラヒドロビオプテリン血漿曝露を増加させるための組成物及び方法
EA049074B1 (ru) Фармацевтически приемлемые соли сепиаптерина
EA042976B1 (ru) Фармацевтически приемлемые соли сепиаптерина
BR112020003865B1 (pt) Composições farmacêuticas compreendendo sepiapterina e usos das mesmas
HK40051961B (en) Administration of sepiapterin without food for use in a method for increasing sepiapterin plasma exposure
HK40051961A (en) Administration of sepiapterin without food for use in a method for increasing sepiapterin plasma exposure
BR122024013534A2 (pt) Sais e cocristais farmaceuticamente aceitáveis de sepiapterina, composição farmacêutica compreendendo os mesmos, e seus usos

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
CB02 Change of applicant information
CB02 Change of applicant information

Address after: new jersey

Applicant after: PTC THERAPEUTICS, Inc.

Address before: Massachusetts, USA

Applicant before: CENSA PHARMACEUTICALS Inc.

SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
CB02 Change of applicant information
CB02 Change of applicant information

Address after: new jersey

Applicant after: PTC medical MP company

Address before: new jersey

Applicant before: PTC THERAPEUTICS, Inc.