EA202190765A1 - Растворы золпидема или его фармацевтически приемлемых солей для оромукозного введения - Google Patents

Растворы золпидема или его фармацевтически приемлемых солей для оромукозного введения

Info

Publication number
EA202190765A1
EA202190765A1 EA202190765A EA202190765A EA202190765A1 EA 202190765 A1 EA202190765 A1 EA 202190765A1 EA 202190765 A EA202190765 A EA 202190765A EA 202190765 A EA202190765 A EA 202190765A EA 202190765 A1 EA202190765 A1 EA 202190765A1
Authority
EA
Eurasian Patent Office
Prior art keywords
zolpidem
pharmaceutically acceptable
formulations
administration
oromucose
Prior art date
Application number
EA202190765A
Other languages
English (en)
Inventor
Нишил К. Пател
Кетан Р. Пател
Милан Р. Пател
Куш М. Пател
Ашил К. Пател
Original Assignee
Троикаа Фармасьютикалз Лимитед
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Троикаа Фармасьютикалз Лимитед filed Critical Троикаа Фармасьютикалз Лимитед
Publication of EA202190765A1 publication Critical patent/EA202190765A1/ru

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Classifications

    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)

Abstract

Настоящее изобретение относится к составам на основе золпидема или его фармацевтически приемлемой соли для трансбуккального или подъязычного введения. Составы минимизируют количество способствующих проникновению средств и также обеспечивают быстрое трансмукозное проникновение лекарственного средства. Эти составы не только обеспечивают требуемую концентрацию (0,5-10% вес./об.) лекарственного средства в форме прозрачного раствора, но также обеспечивают стабильные составы в течение всего срока годности, составляющего по меньшей мере приблизительно 2 года. рН стабильных неводных растворов по настоящему изобретению находится в диапазоне 5-9, предпочтительно 6-9, более предпочтительно 7-9.
EA202190765A 2018-10-08 2019-10-04 Растворы золпидема или его фармацевтически приемлемых солей для оромукозного введения EA202190765A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821038060 2018-10-08
PCT/IN2019/050734 WO2020075183A1 (en) 2018-10-08 2019-10-04 Oromucosal solutions of zolpidem or pharmaceutically acceptable salts thereof

Publications (1)

Publication Number Publication Date
EA202190765A1 true EA202190765A1 (ru) 2021-07-01

Family

ID=68296607

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202190765A EA202190765A1 (ru) 2018-10-08 2019-10-04 Растворы золпидема или его фармацевтически приемлемых солей для оромукозного введения

Country Status (26)

Country Link
US (1) US20220000845A1 (ru)
EP (1) EP3863604B1 (ru)
JP (1) JP2022501407A (ru)
KR (1) KR20210074311A (ru)
CN (1) CN112996488A (ru)
AR (1) AR116721A1 (ru)
AU (1) AU2019358394A1 (ru)
BR (1) BR112021006551A2 (ru)
CA (1) CA3115195A1 (ru)
CL (1) CL2021000856A1 (ru)
CO (1) CO2021005969A2 (ru)
DO (1) DOP2021000060A (ru)
EA (1) EA202190765A1 (ru)
EC (1) ECSP21024213A (ru)
GE (1) GEP20237492B (ru)
IL (1) IL282020A (ru)
JO (1) JOP20210068A1 (ru)
MA (1) MA53050B1 (ru)
MX (1) MX2021003975A (ru)
PE (1) PE20211007A1 (ru)
PH (1) PH12021550748A1 (ru)
SG (1) SG11202103255RA (ru)
TN (1) TN2021000051A1 (ru)
UY (1) UY38405A (ru)
WO (1) WO2020075183A1 (ru)
ZA (1) ZA202102322B (ru)

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2293875T3 (es) 1997-10-01 2008-04-01 Novadel Pharma Inc. Aerosol bucal no polar.
US7632517B2 (en) * 1997-10-01 2009-12-15 Novadel Pharma Inc. Buccal, polar and non-polar spray containing zolpidem
JP2006516963A (ja) * 2003-02-04 2006-07-13 クリサリス テクノロジーズ インコーポレイテッド エアロゾル製剤及びブスピロン、ブプレノルフィン、トリアゾラム、シクロベンザプリン及びゾルピデムのエアロゾル送出
GB0329918D0 (en) * 2003-12-24 2004-01-28 West Pharm Serv Drug Res Ltd Intranasal compositions
CA2556450C (en) * 2004-02-17 2013-08-06 Transoral Pharmaceuticals, Inc. Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
KR20130116378A (ko) * 2004-02-17 2013-10-23 트랜스셉트 파마슈티칼스, 인코포레이티드 구강 점막을 가로지르는 수면제 전달용 조성물 및 이의 사용 방법
GB0423800D0 (en) 2004-10-27 2004-12-01 Orexo Ab New pharmaceutical formulations
AU2006214166B2 (en) * 2005-02-17 2011-09-29 Zoetis Belgium S.A. Transmucosal administration of drug compositions for treating and preventing disorders in animals
WO2006128022A2 (en) 2005-05-25 2006-11-30 Transcept Pharmaceuticals, Inc. Solid compositions and methods for treating middle-of-the night insomnia
CA2649895C (en) 2006-04-19 2013-03-26 Novadel Pharma Inc. Stable hydroalcoholic oral spray formulations and methods
BRPI0811430A2 (pt) * 2007-05-10 2015-06-23 Novadel Pharma Inc Composições anti-insônia e processos
BRPI0815782A2 (pt) * 2007-08-31 2015-02-24 Archimedes Dev Ltd Composição para a dispensação intranasal de uma droga, uso de uma composição não aquosa, dispositivo para a dispensação nasal de drogas ou um cartucho de dose, usos de um veículo, não aquoso, e de uma droga de benzodiazepina e um veículo não aquoso
US20090246256A1 (en) * 2008-03-27 2009-10-01 Al-Ghananeem Abeer M Compositions and Methods for Transmucosal Delivery of Lofexidine
CN101780038A (zh) * 2010-03-30 2010-07-21 上海现代药物制剂工程研究中心有限公司 酒石酸唑吡坦口腔喷雾剂及其制备方法
CA2814212C (en) * 2010-10-12 2015-06-02 Ivax Pharmaceuticals Ireland Nasal spray device

Also Published As

Publication number Publication date
KR20210074311A (ko) 2021-06-21
CA3115195A1 (en) 2020-04-16
JP2022501407A (ja) 2022-01-06
TN2021000051A1 (en) 2022-10-03
ECSP21024213A (es) 2021-06-30
MX2021003975A (es) 2021-05-27
MA53050A1 (fr) 2022-06-30
PE20211007A1 (es) 2021-06-01
CL2021000856A1 (es) 2021-09-24
BR112021006551A2 (pt) 2021-07-06
AU2019358394A1 (en) 2021-05-06
SG11202103255RA (en) 2021-04-29
US20220000845A1 (en) 2022-01-06
DOP2021000060A (es) 2021-08-31
CN112996488A (zh) 2021-06-18
EP3863604B1 (en) 2024-09-11
UY38405A (es) 2020-03-31
PH12021550748A1 (en) 2022-02-14
IL282020A (en) 2021-05-31
CO2021005969A2 (es) 2021-05-20
MA53050B1 (fr) 2023-03-31
ZA202102322B (en) 2023-01-25
GEP20237492B (en) 2023-04-10
EP3863604A1 (en) 2021-08-18
WO2020075183A1 (en) 2020-04-16
JOP20210068A1 (ar) 2023-01-30
AR116721A1 (es) 2021-06-09

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