JP6063377B2 - Ｃｎｓ化合物の安定化製剤 - Google Patents

Ｃｎｓ化合物の安定化製剤 Download PDF

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JP6063377B2
JP6063377B2 JP2013502785A JP2013502785A JP6063377B2 JP 6063377 B2 JP6063377 B2 JP 6063377B2 JP 2013502785 A JP2013502785 A JP 2013502785A JP 2013502785 A JP2013502785 A JP 2013502785A JP 6063377 B2 JP6063377 B2 JP 6063377B2
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formulation
acid
release
component
enantiomer
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JP2013523758A5 (OSRAM
JP2013523758A (ja
Inventor
ロン−クン チャン
ロン−クン チャン
マイケル エル． ヴィエイラ
マイケル エル． ヴィエイラ
リカン リャン
リカン リャン
パドマナブフ ピー． バット
パドマナブフ ピー． バット
オースチン ビー． ホアン
オースチン ビー． ホアン
サチン ブイ． パテル
サチン ブイ． パテル
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スパーナス ファーマシューティカルズ インコーポレイテッド
スパーナス ファーマシューティカルズ インコーポレイテッド
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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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • 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
    • 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
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/48—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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Anesthesiology (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2013502785A 2010-03-31 2011-03-30 Ｃｎｓ化合物の安定化製剤 Active JP6063377B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US28278710P 2010-03-31 2010-03-31
US61/282,787 2010-03-31
PCT/US2011/030444 WO2011123497A1 (en) 2010-03-31 2011-03-30 Stabilized formulations of cns compounds

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015204851A Division JP6529416B2 (ja) 2010-03-31 2015-10-16 Ｃｎｓ化合物の安定化製剤

Publications (3)

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JP2013523758A JP2013523758A (ja) 2013-06-17
JP2013523758A5 JP2013523758A5 (OSRAM) 2014-05-22
JP6063377B2 true JP6063377B2 (ja) 2017-01-18

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JP2013502785A Active JP6063377B2 (ja) 2010-03-31 2011-03-30 Ｃｎｓ化合物の安定化製剤
JP2015204851A Active JP6529416B2 (ja) 2010-03-31 2015-10-16 Ｃｎｓ化合物の安定化製剤
JP2017161044A Active JP6588948B2 (ja) 2010-03-31 2017-08-24 Ｃｎｓ化合物の安定化製剤
JP2019125672A Active JP6759426B2 (ja) 2010-03-31 2019-07-05 Ｃｎｓ化合物の安定化製剤

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JP2017161044A Active JP6588948B2 (ja) 2010-03-31 2017-08-24 Ｃｎｓ化合物の安定化製剤
JP2019125672A Active JP6759426B2 (ja) 2010-03-31 2019-07-05 Ｃｎｓ化合物の安定化製剤

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Country Link
US (4) US8748472B2 (OSRAM)
EP (3) EP3269363B1 (OSRAM)
JP (4) JP6063377B2 (OSRAM)
AU (1) AU2011235222B2 (OSRAM)
CA (1) CA2793222C (OSRAM)
ES (3) ES2852899T3 (OSRAM)
MX (1) MX2012010829A (OSRAM)
WO (1) WO2011123497A1 (OSRAM)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2009335709A1 (en) 2008-12-19 2011-07-14 Supernus Pharmaceuticals, Inc. Method of treatment of aggression
AU2011235222B2 (en) * 2010-03-31 2014-09-25 Supernus Pharmaceuticals Inc. Stabilized formulations of CNS compounds
MX2015005937A (es) * 2012-11-13 2015-09-08 Supernus Pharmaceuticals Inc Metodo de tratamiento de la agresion.
CA3022339A1 (en) 2016-04-29 2017-11-02 Supernus Pharmaceuticals, Inc. Methods, system, and kit for monitoring, diagnosing, and treating impulsive aggression
US20180078516A1 (en) * 2016-09-19 2018-03-22 Innovazone Labs LLC Pharmaceutical Composition of Ibuprofen Sodium for Oral Administration
WO2019014201A1 (en) * 2017-07-10 2019-01-17 Apicore Us Llc MOLINDONE COMPOSITIONS WITH EXTENDED RELEASE
EP4212149A1 (en) 2022-01-18 2023-07-19 Rijksuniversiteit Groningen Oral dosage forms of acid-labile salt and methods and uses related thereto

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US5202128A (en) * 1989-01-06 1993-04-13 F. H. Faulding & Co. Limited Sustained release pharmaceutical composition
US6489319B2 (en) 1999-08-16 2002-12-03 Revaax Pharmaceuticals, Llc Neurotherapeutic use of carboxypeptidase inhibitors
NZ511900A (en) * 1999-09-30 2003-06-30 Penwest Pharmaceuticals Co Sustained release matrix systems for highly soluble drugs
FR2814463B1 (fr) 2000-09-22 2002-11-15 Sanofi Synthelabo Nouveaux polysaccharides a activite antithrombotique comprenant au moins une liaison covalente avec la biotine ou un derive de la biotine
US6344215B1 (en) 2000-10-27 2002-02-05 Eurand America, Inc. Methylphenidate modified release formulations
US6613763B2 (en) * 2001-04-20 2003-09-02 Mgi Applied Genomics Use of molindone to treat oppositional defiant disorder and conduct disorder
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DE10149108A1 (de) 2001-10-05 2003-04-30 Degussa Bioactives Deutschland Verwendung von Phosphatidylserin zur Behandlung des Aufmerksamkeits-Defizit-Syndroms (ADHS)
WO2004050068A1 (en) 2002-11-29 2004-06-17 Janssen Pharmaceutica N.V. Pharmaceutical compositions comprising a basic respectively acidic drug compound, a surfactant and a physiologically tolerable water-soluble acid respectively base
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CL2007002214A1 (es) * 2006-08-14 2008-03-07 Boehringer Ingelheim Int Composicion farmaceutica en la forma de comprimido, donde al menos la longitud del comprimido en el estado anterior de la aplicacion es al menos 7/12 del diametro pilorico del paciente y despues de ingerirlo en estado alimentado, la longitud del comp
BRPI0716196A2 (pt) 2006-08-31 2013-11-12 Eurand Inc Sistemas de distribuição de fármacos que compreendem soluções sólidas de fármacos fracamente básicos.
JP2008189616A (ja) 2007-02-07 2008-08-21 Mitsubishi Tanabe Pharma Corp 注意欠陥多動性障害の治療薬
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AU2009335709A1 (en) 2008-12-19 2011-07-14 Supernus Pharmaceuticals, Inc. Method of treatment of aggression
AU2011235222B2 (en) * 2010-03-31 2014-09-25 Supernus Pharmaceuticals Inc. Stabilized formulations of CNS compounds
SE536078C2 (sv) 2010-10-09 2013-04-30 Core Link Ab Anordning för bearbetning av hylsor

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Publication number Publication date
CA2793222A1 (en) 2011-10-06
US20150086629A1 (en) 2015-03-26
MX2012010829A (es) 2012-11-12
EP2552423A4 (en) 2015-05-27
EP3572074B1 (en) 2021-01-06
ES2643497T3 (es) 2017-11-23
EP3269363B1 (en) 2019-08-28
US11077114B2 (en) 2021-08-03
US20210322429A1 (en) 2021-10-21
EP2552423A1 (en) 2013-02-06
ES2852899T3 (es) 2021-09-14
EP3269363A1 (en) 2018-01-17
JP6529416B2 (ja) 2019-06-12
ES2756711T3 (es) 2020-04-27
US20190060323A1 (en) 2019-02-28
US8748472B2 (en) 2014-06-10
JP6588948B2 (ja) 2019-10-09
WO2011123497A1 (en) 2011-10-06
AU2011235222B2 (en) 2014-09-25
JP6759426B2 (ja) 2020-09-23
JP2018024680A (ja) 2018-02-15
US10149853B2 (en) 2018-12-11
CA2793222C (en) 2018-01-23
JP2013523758A (ja) 2013-06-17
JP2019189645A (ja) 2019-10-31
EP3572074A1 (en) 2019-11-27
JP2016041722A (ja) 2016-03-31
AU2011235222A1 (en) 2012-10-04
EP2552423B1 (en) 2017-07-12
US20110244042A1 (en) 2011-10-06

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