CN101528261B - 氯硝西泮药物组合物及其使用方法 - Google Patents

氯硝西泮药物组合物及其使用方法 Download PDF

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CN101528261B
CN101528261B CN2007800399467A CN200780039946A CN101528261B CN 101528261 B CN101528261 B CN 101528261B CN 2007800399467 A CN2007800399467 A CN 2007800399467A CN 200780039946 A CN200780039946 A CN 200780039946A CN 101528261 B CN101528261 B CN 101528261B
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clonazepam
solvent
compositions
drug
administration
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CN101528261A (zh
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G·贾米森
M·德贾丁
C·奥菲恩
S·奥拉夫斯多蒂
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Jazz Pharmaceuticals Inc
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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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • 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
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/28—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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions

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  • Organic Chemistry (AREA)
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  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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CN2007800399467A 2006-08-28 2007-08-27 氯硝西泮药物组合物及其使用方法 Expired - Fee Related CN101528261B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US84056806P 2006-08-28 2006-08-28
US60/840,568 2006-08-28
PCT/US2007/018877 WO2008027357A2 (en) 2006-08-28 2007-08-27 Pharmaceutical compositions of clonazepam and methods of use thereof

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CN101528261A CN101528261A (zh) 2009-09-09
CN101528261B true CN101528261B (zh) 2012-07-18

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US (2) US8716279B2 (enExample)
EP (2) EP2068933A2 (enExample)
JP (2) JP2010502614A (enExample)
KR (1) KR20090043603A (enExample)
CN (1) CN101528261B (enExample)
AR (1) AR062556A1 (enExample)
AU (1) AU2007290589B2 (enExample)
BR (1) BRPI0714907A2 (enExample)
CA (1) CA2662197A1 (enExample)
IL (1) IL197275A0 (enExample)
MX (1) MX2009002310A (enExample)
NO (1) NO20091211L (enExample)
NZ (2) NZ575744A (enExample)
PE (1) PE20081361A1 (enExample)
TW (1) TW200824693A (enExample)
UY (1) UY30561A1 (enExample)
WO (2) WO2008027395A2 (enExample)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

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US20080275030A1 (en) * 2007-01-19 2008-11-06 Sveinbjorn Gizurarson Methods and Compositions for the Delivery of a Therapeutic Agent
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US8946208B2 (en) 2007-08-31 2015-02-03 Archimedes Development Limited Non-aqueous pharmaceutical composition
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RU2018135967A (ru) * 2011-03-31 2018-11-14 Акорда Терапьютикс, Инк. Интраназальные фармацевтические композиции на основе бензодиазепина
EP3415139B8 (en) 2011-06-14 2022-05-18 Neurelis, Inc. Administration of benzodiazepine
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US9125805B2 (en) * 2012-06-27 2015-09-08 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of small molecule drugs
US8999393B1 (en) * 2013-01-09 2015-04-07 Edgemont Pharmaceuticals Llc Sustained release formulations of lorazepam
EP2958594A4 (en) * 2013-02-22 2017-03-01 Eastgate Pharmaceuticals Inc. Pharmaceutical composition for enhanced transmucosal administration of benzodiazepines
KR101635635B1 (ko) * 2014-12-04 2016-07-01 주식회사 엘지생활건강 디팔미토일 하이드록시프롤린과 갈릭산 에스터 유도체를 함유하는 화장료 조성물
WO2016191413A1 (en) 2015-05-25 2016-12-01 Iso Therapeutics Group, Llc Dotmp kit formulations for radioisotopes
HUE064864T2 (hu) * 2016-12-09 2024-04-28 Alexza Pharmaceuticals Inc Az alprazolam alkalmazása epilepszia kezelésében
MX2020005169A (es) * 2017-11-17 2020-12-03 Neurana Pharmaceuticals Inc Métodos de administración de tolperisona.
US11278492B2 (en) 2018-01-05 2022-03-22 Impel Neuropharma, Inc. Intranasal delivery of olanzapine by precision olfactory device
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US20200338090A1 (en) * 2019-04-29 2020-10-29 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
CN110420190B (zh) * 2019-08-29 2021-07-09 湖南洞庭药业股份有限公司 氯硝西泮片及其制备方法
EP4351586A4 (en) * 2021-06-10 2025-04-02 Neurelis, Inc. Methods and compositions for treating seizure disorders in pediatric patients
CN115707451A (zh) * 2021-08-19 2023-02-21 北京万全德众医药生物技术有限公司 氯硝西泮口服溶液
CN114656410A (zh) * 2022-03-02 2022-06-24 济南同路医药科技发展有限公司 一种氯硝西泮杂质及其制备方法

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实施例10、11
实施例11
实施例8、9
权利要求1
第10页
第16页至第18页
第4页第31-3439段
第6页第69-70段
第6页第73段至第7页第73段
第8页第81段.
说明书第11页第17-21行
说明书第12页第2-6行
说明书第28页第1-3行

Cited By (35)

* Cited by examiner, † Cited by third party
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US12115145B2 (en) 2016-07-22 2024-10-15 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12115142B2 (en) 2016-07-22 2024-10-15 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11766418B2 (en) 2016-07-22 2023-09-26 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12263150B2 (en) 2016-07-22 2025-04-01 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11826335B2 (en) 2016-07-22 2023-11-28 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11896572B2 (en) 2016-07-22 2024-02-13 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12097176B2 (en) 2016-07-22 2024-09-24 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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US20080076761A1 (en) 2008-03-27
EP2068933A2 (en) 2009-06-17
WO2008027395A2 (en) 2008-03-06
AR062556A1 (es) 2008-11-19
WO2008027357A3 (en) 2008-04-17
TW200824693A (en) 2008-06-16
IL197275A0 (en) 2009-12-24
AU2007290589B2 (en) 2012-04-05
WO2008027357A2 (en) 2008-03-06
BRPI0714907A2 (pt) 2014-08-19
US8716279B2 (en) 2014-05-06
JP2010502612A (ja) 2010-01-28
MX2009002310A (es) 2009-09-21
WO2008027357A9 (en) 2009-04-30
NZ575744A (en) 2011-10-28
KR20090043603A (ko) 2009-05-06
PE20081361A1 (es) 2008-11-06
CN101528261A (zh) 2009-09-09
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JP2010502614A (ja) 2010-01-28
AU2007290589A1 (en) 2008-03-06
US8609651B2 (en) 2013-12-17
WO2008027395A3 (en) 2008-04-17
NO20091211L (no) 2009-05-27
CA2662197A1 (en) 2008-03-06
UY30561A1 (es) 2008-03-31
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