HRP20121072T1 - Postupci za davanje tetrahidrobiopterina, povezani pripravci i postupci mjerenja - Google Patents

Postupci za davanje tetrahidrobiopterina, povezani pripravci i postupci mjerenja Download PDF

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Publication number
HRP20121072T1
HRP20121072T1 HRP20121072AT HRP20121072T HRP20121072T1 HR P20121072 T1 HRP20121072 T1 HR P20121072T1 HR P20121072A T HRP20121072A T HR P20121072AT HR P20121072 T HRP20121072 T HR P20121072T HR P20121072 T1 HRP20121072 T1 HR P20121072T1
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Croatia
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salt
use according
meal
methods
pharmaceutically acceptable
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HRP20121072AT
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English (en)
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Daniel I. Oppenheimer
Alejandro Dorenbaum
Augustus Okhamafe
Erik Foehr
Sianna Castillo
Paul John Kostel
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Biomarin Pharmaceutical Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39620159&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20121072(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biomarin Pharmaceutical Inc. filed Critical Biomarin Pharmaceutical Inc.
Publication of HRP20121072T1 publication Critical patent/HRP20121072T1/hr

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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/08—Solutions
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P25/24—Antidepressants
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • 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
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • G01—MEASURING; TESTING
    • 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
    • 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
    • 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.]

Claims (13)

1. Tetrahidrobiopterin (BH4) ili njegova farmaceutski prihvatljiva sol za uporabu kod liječenja hiperfenilalaninemije naznačen time da se BH4 ili njegova sol daje oralno unutar 0-30 minuta nakon obroka.
2. BH4 ili sol za uporabu prema zahtjevu 1, naznačen time da BH4 ili njegova sol je za oralno davanje uz obrok.
3. BH4 ili sol za uporabu prema zahtjevu 1 ili zahtjevu 2, naznačen time da obrok sadrži obrok visoke masnoće i visoke kalorijske vrijednosti.
4. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-3, naznačen time da BH4 ili njegova sol je za davanje u ukupnoj dnevnoj dozi od 1 mg/kg do 20 mg/kg.
5. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-4, naznačen time da se BH4 ili njegova farmaceutski prihvatljiva sol primjenjuje otopljen u tekućini.
6. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-5 naznačen time da se BH4 ili njegova farmaceutski prihvatljiva sol uzima gutanjem kao kruti oblik doziranja.
7. BH4 ili sol za uporabu prema zahtjevu 6 naznačen time da kruti oblik doziranja je tableta.
8. BH4 ili sol za uporabu prema zahtjevu 6 naznačen time da kruti oblik doziranja je kapsula.
9. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-8, naznačen time da BH4 ili farmaceutski prihvatljiva sol je za uzimanje samo jednom dnevno.
10. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-9, naznačen time da pacijent pati od fenilketonurije (PKU), uključujući blažu ili klasičnu PKU.
11. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-10 naznačen time da se BH4 ili njegova sol uzima unutar 5-20 minuta nakon obroka.
12. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-11 naznačen time da se BH4 ili njegova sol uzima u isto vrijeme dana, jednom dnevno.
13. BH4 ili sol za uporabu prema bilo kojem od zahtjeva 1-12, naznačen time da se BH4 daje uz obrok da se poveća apsorpcija BH4.
HRP20121072AT 2007-04-11 2012-12-27 Postupci za davanje tetrahidrobiopterina, povezani pripravci i postupci mjerenja HRP20121072T1 (hr)

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
PCT/US2008/060041 WO2008128049A2 (en) 2007-04-11 2008-04-11 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring

Publications (1)

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HRP20121072T1 true HRP20121072T1 (hr) 2013-01-31

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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

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HRP20220188TT HRP20220188T3 (hr) 2007-04-11 2008-04-11 Načini primjene tetrahidrobiopterina, povezani pripravci i postupci mjerenja

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HRP20210239TT HRP20210239T1 (hr) 2007-04-11 2021-02-11 Tetrahidrobiopterin za liječenje stanja povezanih s povišenim razinama fenilalanina

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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) ES2851177T3 (hr)
HK (1) HK1139864A1 (hr)
HR (3) HRP20220188T3 (hr)
HU (2) HUE053107T2 (hr)
IL (1) IL201101A (hr)
LT (2) LT3461503T (hr)
MX (1) MX2009010977A (hr)
PL (3) PL2139485T3 (hr)
PT (3) PT2545939T (hr)
RU (1) RU2486899C2 (hr)
SI (2) SI3461503T1 (hr)
WO (1) WO2008128049A2 (hr)

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