DK3461503T3 - Fremgangsmåder til indgivelse af tetrahydrobiopterin, associerede sammensætninger og målingsfremgangsmåder - Google Patents

Fremgangsmåder til indgivelse af tetrahydrobiopterin, associerede sammensætninger og målingsfremgangsmåder Download PDF

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Publication number
DK3461503T3
DK3461503T3 DK18205446.0T DK18205446T DK3461503T3 DK 3461503 T3 DK3461503 T3 DK 3461503T3 DK 18205446 T DK18205446 T DK 18205446T DK 3461503 T3 DK3461503 T3 DK 3461503T3
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Prior art keywords
tetrahydrobiopterin
administration
methods
measurement procedures
associated compositions
Prior art date
Application number
DK18205446.0T
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English (en)
Inventor
Daniel I Oppenheimer
Alejandro Dorenbaum
Augustus Okhamafe
Erik Foehr
Sianna Castillo
Paul John Kostel
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Biomarin Pharm Inc
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Application filed by Biomarin Pharm Inc filed Critical Biomarin Pharm Inc
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Publication of DK3461503T3 publication Critical patent/DK3461503T3/da

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    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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    • A—HUMAN NECESSITIES
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    • C—CHEMISTRY; METALLURGY
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    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B63/00—Purification; Separation; Stabilisation; Use of additives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04—Ortho-condensed systems
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
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    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • G—PHYSICS
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    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01J—ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS
    • H01J49/00—Particle spectrometers or separator tubes
    • H01J49/004—Combinations of spectrometers, tandem spectrometers, e.g. MS/MS, MSn
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/145555—Hetero-N
    • Y10T436/147777—Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]

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  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nutrition Science (AREA)
  • Hematology (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Psychiatry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
DK18205446.0T 2007-04-11 2008-04-11 Fremgangsmåder til indgivelse af tetrahydrobiopterin, associerede sammensætninger og målingsfremgangsmåder DK3461503T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US92282107P 2007-04-11 2007-04-11
US1975308P 2008-01-08 2008-01-08
EP12005352.5A EP2545939B1 (en) 2007-04-11 2008-04-11 Tetrahydrobiopterin for treating conditions associated with elevated phenylalanine levels

Publications (1)

Publication Number Publication Date
DK3461503T3 true DK3461503T3 (da) 2022-02-14

Family

ID=39620159

Family Applications (3)

Application Number Title Priority Date Filing Date
DK12005352.5T DK2545939T3 (da) 2007-04-11 2008-04-11 Tetrahydrobiopterin til behandling af tilstande associeret med forhøjede phenylalaninniveauer
DK18205446.0T DK3461503T3 (da) 2007-04-11 2008-04-11 Fremgangsmåder til indgivelse af tetrahydrobiopterin, associerede sammensætninger og målingsfremgangsmåder
DK08745614.1T DK2139485T3 (da) 2007-04-11 2008-04-11 Fremgangsmåder til admistration af tetrahydrobiopterin, associerede sammensætninger, og fremgangsmåder til måling

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK12005352.5T DK2545939T3 (da) 2007-04-11 2008-04-11 Tetrahydrobiopterin til behandling af tilstande associeret med forhøjede phenylalaninniveauer

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK08745614.1T DK2139485T3 (da) 2007-04-11 2008-04-11 Fremgangsmåder til admistration af tetrahydrobiopterin, associerede sammensætninger, og fremgangsmåder til måling

Country Status (23)

Country Link
US (6) US7612073B2 (da)
EP (4) EP4029519A1 (da)
JP (2) JP2010523708A (da)
KR (5) KR20150080026A (da)
CN (1) CN101678025A (da)
AU (1) AU2008240259C1 (da)
BR (1) BRPI0809470A2 (da)
CA (1) CA2682598C (da)
CY (3) CY1113543T1 (da)
DE (1) DE22154751T1 (da)
DK (3) DK2545939T3 (da)
ES (3) ES2397746T3 (da)
HK (1) HK1139864A1 (da)
HR (3) HRP20220188T3 (da)
HU (2) HUE058030T2 (da)
IL (1) IL201101A (da)
LT (2) LT2545939T (da)
MX (1) MX2009010977A (da)
PL (3) PL2139485T3 (da)
PT (3) PT2139485E (da)
RU (1) RU2486899C2 (da)
SI (2) SI2545939T1 (da)
WO (1) WO2008128049A2 (da)

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SI3138566T1 (sl) 2003-11-17 2022-04-29 Biomarin Pharmaceutical Inc. Postopki in sestavki za zdravljenje presnovnih motenj
ES2397746T3 (es) 2007-04-11 2013-03-11 Biomarin Pharmaceutical Inc. Métodos de administración de tetrahidrobiopterina, composiciones asociadas y métodos de medición
RU2011109210A (ru) * 2008-08-12 2012-09-20 Орфа Свисс Гмбх (Ch) Лекарственная форма, содержащая тетрагидробиоптерин
US9089573B2 (en) 2009-07-22 2015-07-28 University Of Massachusetts Methods and compositions to reduce oxidative stress
WO2011132435A1 (ja) 2010-04-22 2011-10-27 学校法人日本大学 脳機能障害予防・改善用の薬剤及び飲食物
KR102105857B1 (ko) * 2010-12-03 2020-05-04 오렉시젠 세러퓨틱스 인크. 날트렉손 요법에서 약물 생체이용률의 증가
US9492451B2 (en) * 2011-03-01 2016-11-15 Dipharma S.A. Stable compositions of tetrahydrobiopterin
US9549563B2 (en) 2011-10-24 2017-01-24 Kickass Candy Llc Sweet tart energy tablet
US9216178B2 (en) * 2011-11-02 2015-12-22 Biomarin Pharmaceutical Inc. Dry blend formulation of tetrahydrobiopterin
SI2806877T1 (sl) 2012-01-23 2020-01-31 Sage Therapeutics, Inc. Nevroaktivne steroidne formulacije, ki obsegajo kompleks alopregnanolona in sulfobutil etra beta-ciklodekstrina
ES2646197T3 (es) 2012-01-26 2017-12-12 Vanda Pharmaceuticals Inc. Tratamiento de trastornos del ritmo circadiano
US11918557B2 (en) 2012-01-26 2024-03-05 Vanda Pharmaceuticals Inc. Treatment of circadian rhythm disorders
CN102650621B (zh) * 2012-05-02 2014-06-25 安徽农业大学 一种从蚕体提取的墨蝶呤的鉴定方法
WO2014124392A1 (en) * 2013-02-08 2014-08-14 University Of Iowa Research Foundation Diagnostic tools to predict onset of preeclampsia
US11090285B2 (en) 2013-11-12 2021-08-17 Vanda Pharmaceuticals Inc Treatment of circadian rhythm disorders
US10376487B2 (en) 2013-11-12 2019-08-13 Vanda Pharmaceuticals Inc. Method of treatment
US20150204834A1 (en) * 2014-01-22 2015-07-23 Sarfaraz K. Niazi Thermodynamic equivalence surrogate test (test) for bioequivalence
EP2926805B1 (en) 2014-03-31 2016-05-18 Vasopharm GmbH Solid pharmaceutical compositions comprising biopterin derivatives and uses of such compositions
MA41124A (fr) * 2014-12-05 2017-10-10 Sun Pharmaceutical Ind Ltd Compositions en suspension à libération prolongée à rétention gastrique
US10744088B2 (en) 2015-10-06 2020-08-18 G-Treebnt Co., Ltd. Method for preparing ophthalmic preparation containing thymosin beta-4
JOP20170059B1 (ar) 2016-03-08 2021-08-17 Sage Therapeutics Inc ستيرويدات وتركيبات نشطة عصبيًا واستخداماتها
WO2018102314A1 (en) * 2016-11-29 2018-06-07 Censa Pharmaceuticals Inc. Polymorphic form of sepiapterin
IL266955B2 (en) 2016-11-29 2023-09-01 Ptc Therapeutics Mp Inc Polymorphs of spiafatrin and its salts
CN108627576A (zh) * 2017-03-17 2018-10-09 武汉宏韧生物医药科技有限公司 一种人血浆中他达拉非的定量分析方法
CN110944689B (zh) 2017-06-07 2022-12-09 施菲姆德控股有限责任公司 血管内流体运动设备、系统和使用方法
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