HRP20210239T1 - Tetrahidrobiopterin za liječenje stanja povezanih s povišenim razinama fenilalanina - Google Patents
Tetrahidrobiopterin za liječenje stanja povezanih s povišenim razinama fenilalanina Download PDFInfo
- Publication number
- HRP20210239T1 HRP20210239T1 HRP20210239TT HRP20210239T HRP20210239T1 HR P20210239 T1 HRP20210239 T1 HR P20210239T1 HR P20210239T T HRP20210239T T HR P20210239TT HR P20210239 T HRP20210239 T HR P20210239T HR P20210239 T1 HRP20210239 T1 HR P20210239T1
- Authority
- HR
- Croatia
- Prior art keywords
- salt
- meal
- tetrahydrobiopterin
- conditions associated
- treating conditions
- 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 claims 16
- COLNVLDHVKWLRT-QMMMGPOBSA-N L-phenylalanine Chemical compound OC(=O)[C@@H](N)CC1=CC=CC=C1 COLNVLDHVKWLRT-QMMMGPOBSA-N 0.000 title claims 2
- COLNVLDHVKWLRT-UHFFFAOYSA-N phenylalanine Natural products OC(=O)C(N)CC1=CC=CC=C1 COLNVLDHVKWLRT-UHFFFAOYSA-N 0.000 title claims 2
- 229960004617 sapropterin Drugs 0.000 title claims 2
- 150000003839 salts Chemical class 0.000 claims 13
- 235000012054 meals Nutrition 0.000 claims 5
- 239000007909 solid dosage form Substances 0.000 claims 2
- 208000014249 Classic phenylketonuria Diseases 0.000 claims 1
- 208000014252 Mild phenylketonuria Diseases 0.000 claims 1
- 201000011252 Phenylketonuria Diseases 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
Classifications
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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
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
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- 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
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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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- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B63/00—Purification; Separation; Stabilisation; Use of additives
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- 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
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- 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
- G01N33/6848—Methods of protein analysis involving mass spectrometry
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- 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
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- 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
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- 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
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- 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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
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- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- 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)
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- General Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Food Science & Technology (AREA)
- Spectroscopy & Molecular Physics (AREA)
Claims (7)
1. Tetrahidrobiopterin (BH4) ili njegova farmaceutski prihvatljiva sol za uporabu u liječenju stanja povezanih s povišenim razinama fenilalanina, naznačen time što je BH4 ili njegova sol za oralnu primjenu jednom dnevno 5 do 60 minuta nakon obroka i pri čemu je stanje odabrano iz skupine koju čine blaga fenilketonurija (PKU), klasična PKU i hiperfenilalaninemija.
2. BH4 ili sol za uporabu u skladu s patentnim zahtjevom 1, naznačeni time što je BH4 ili njegova sol za primjenu 5 do 20 minuta nakon obroka.
3. BH4 ili sol za uporabu u skladu s patentnim zahtjevom 1 ili 2, naznačeni time što je BH4 ili njegova sol za primjenu ujutro.
4. BH4 ili sol za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačeni time što je obrok visoko-masni, visokokalorični obrok koji sadrži najmanje oko 700 kcal i najmanje oko 45% masti.
5. BH4 ili sol za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačeni time što je BH4 ili njegova sol za primjenu u ukupnoj dnevnoj dozi od 1 mg / kg do 20 mg / kg.
6. BH4 ili sol za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-5, naznačeni time što je BH4 ili njegova sol za primjenu otopljen u tekućini ili kao čvrsti oblik doziranja, poželjno pri čemu je čvrsti oblik doziranja tableta ili kapsula.
7. BH4 ili sol za uporabu u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačeni time što je BH4 ili njegova sol za primjenu s obrokom kako bi se povećala apsorpcija BH4.
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 |
---|---|
HRP20210239T1 true HRP20210239T1 (hr) | 2021-04-02 |
Family
ID=39620159
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20220188TT HRP20220188T3 (hr) | 2007-04-11 | 2008-04-11 | Načini primjene tetrahidrobiopterina, povezani pripravci i postupci mjerenja |
HRP20121072AT HRP20121072T1 (hr) | 2007-04-11 | 2012-12-27 | Postupci za davanje tetrahidrobiopterina, povezani pripravci i postupci mjerenja |
HRP20210239TT HRP20210239T1 (hr) | 2007-04-11 | 2021-02-11 | Tetrahidrobiopterin za liječenje stanja povezanih s povišenim razinama fenilalanina |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20220188TT HRP20220188T3 (hr) | 2007-04-11 | 2008-04-11 | Načini primjene tetrahidrobiopterina, povezani pripravci i postupci mjerenja |
HRP20121072AT HRP20121072T1 (hr) | 2007-04-11 | 2012-12-27 | Postupci za davanje tetrahidrobiopterina, povezani pripravci i postupci mjerenja |
Country Status (23)
Country | Link |
---|---|
US (6) | US7612073B2 (hr) |
EP (4) | EP4029519A1 (hr) |
JP (2) | JP2010523708A (hr) |
KR (5) | KR20150080026A (hr) |
CN (1) | CN101678025A (hr) |
AU (1) | AU2008240259C1 (hr) |
BR (1) | BRPI0809470A2 (hr) |
CA (1) | CA2682598C (hr) |
CY (3) | CY1113543T1 (hr) |
DE (1) | DE22154751T1 (hr) |
DK (3) | DK2545939T3 (hr) |
ES (3) | ES2397746T3 (hr) |
HK (1) | HK1139864A1 (hr) |
HR (3) | HRP20220188T3 (hr) |
HU (2) | HUE058030T2 (hr) |
IL (1) | IL201101A (hr) |
LT (2) | LT2545939T (hr) |
MX (1) | MX2009010977A (hr) |
PL (3) | PL2139485T3 (hr) |
PT (3) | PT2139485E (hr) |
RU (1) | RU2486899C2 (hr) |
SI (2) | SI2545939T1 (hr) |
WO (1) | WO2008128049A2 (hr) |
Families Citing this family (52)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
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