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MA53050A1 - Solutions oromuqueuses de zolpidem ou sels pharmaceutiquement acceptables de celles-ci - Google Patents

Solutions oromuqueuses de zolpidem ou sels pharmaceutiquement acceptables de celles-ci

Info

Publication number
MA53050A1
MA53050A1 MA53050A MA53050A MA53050A1 MA 53050 A1 MA53050 A1 MA 53050A1 MA 53050 A MA53050 A MA 53050A MA 53050 A MA53050 A MA 53050A MA 53050 A1 MA53050 A1 MA 53050A1
Authority
MA
Morocco
Prior art keywords
zolpidem
pharmaceutically acceptable
formulations
acceptable salts
allow
Prior art date
Application number
MA53050A
Other languages
English (en)
Other versions
MA53050B1 (fr
Inventor
Ketan R Patel
Milan R Patel
Asheel K Patel
Nisheel K Patel
Kush M Patel
Original Assignee
Troikaa Pharmaceuticals Ltd
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 Troikaa Pharmaceuticals Ltd filed Critical Troikaa Pharmaceuticals Ltd
Publication of MA53050A1 publication Critical patent/MA53050A1/fr
Publication of MA53050B1 publication Critical patent/MA53050B1/fr

Links

Classifications

    • 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
    • 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
    • A61K9/08—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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Physiology (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)

Abstract

La présente invention concerne des formulations buccales ou sublinguales de zolpidem ou un sel pharmaceutiquement acceptable de celles-ci. Les formulations réduisent au minimum la quantité d'amplificateurs de pénétration tout en assurant une pénétration transmucosale rapide du médicament. Ces formulations permettent non seulement une concentration souhaitée (0,5 % à 10 % p/v) du médicament sous la forme d'une solution claire, mais permettent également d'obtenir des formulations stables pendant toute la durée de conservation qui est d'au moins environ 2 ans. Le ph des solutions non aqueuses stables de la présente invention est compris entre 5 et 9, de préférence entre 6 et 9, et de préférence encore entre 7 et 9.
MA53050A 2018-10-08 2019-10-04 Solutions oromuqueuses de zolpidem ou sels pharmaceutiquement acceptables de celles-ci MA53050B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821038060 2018-10-08
PCT/IN2019/050734 WO2020075183A1 (fr) 2018-10-08 2019-10-04 Solutions oromuqueuses de zolpidem ou sels pharmaceutiquement acceptables de celles-ci

Publications (2)

Publication Number Publication Date
MA53050A1 true MA53050A1 (fr) 2022-06-30
MA53050B1 MA53050B1 (fr) 2023-03-31

Family

ID=68296607

Family Applications (1)

Application Number Title Priority Date Filing Date
MA53050A MA53050B1 (fr) 2018-10-08 2019-10-04 Solutions oromuqueuses de zolpidem ou sels pharmaceutiquement acceptables de celles-ci

Country Status (29)

Country Link
US (1) US12133845B2 (fr)
EP (1) EP3863604B1 (fr)
JP (1) JP2022501407A (fr)
KR (1) KR102860999B1 (fr)
CN (1) CN112996488B (fr)
AR (1) AR116721A1 (fr)
AU (1) AU2019358394B2 (fr)
BR (1) BR112021006551A2 (fr)
CA (1) CA3115195A1 (fr)
CL (1) CL2021000856A1 (fr)
CO (1) CO2021005969A2 (fr)
DO (1) DOP2021000060A (fr)
EA (1) EA202190765A1 (fr)
EC (1) ECSP21024213A (fr)
ES (1) ES2998438T3 (fr)
GE (1) GEP20237492B (fr)
HU (1) HUE069302T2 (fr)
IL (1) IL282020B2 (fr)
JO (1) JOP20210068A1 (fr)
MA (1) MA53050B1 (fr)
MX (1) MX2021003975A (fr)
PE (1) PE20211007A1 (fr)
PH (1) PH12021550748A1 (fr)
PL (1) PL3863604T3 (fr)
SG (1) SG11202103255RA (fr)
TN (1) TN2021000051A1 (fr)
UY (1) UY38405A (fr)
WO (1) WO2020075183A1 (fr)
ZA (1) ZA202102322B (fr)

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999016417A1 (fr) 1997-10-01 1999-04-08 Flemington Pharmaceutical Corporation Pulverisation ou capsule buccale, polaire et non polaire
US7632517B2 (en) * 1997-10-01 2009-12-15 Novadel Pharma Inc. Buccal, polar and non-polar spray containing zolpidem
WO1999046417A1 (fr) 1998-03-12 1999-09-16 Nkk Corporation Tole d'acier au silicium et son procede de fabrication
EP1596824A4 (fr) * 2003-02-04 2011-11-23 Chrysalis Tech Inc Formulations d'aerosols et distribution par aerosols de buspirone, buprenorphine, triazolam, cyclobenzaprine et zolpidem
GB0329918D0 (en) * 2003-12-24 2004-01-28 West Pharm Serv Drug Res Ltd Intranasal compositions
KR20130116378A (ko) * 2004-02-17 2013-10-23 트랜스셉트 파마슈티칼스, 인코포레이티드 구강 점막을 가로지르는 수면제 전달용 조성물 및 이의 사용 방법
WO2005079761A1 (fr) 2004-02-17 2005-09-01 Transoral Pharmaceuticals, Inc. Compositions permettant d'administrer des agents hypnotiques dans la muqueuse orale et methodes d'utilisation
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
US20060281783A1 (en) 2005-05-25 2006-12-14 Transoral Pharmaceuticals, Inc. Compositions and methods of treating middle-of-the night insomnia
DE102005034549A1 (de) 2005-07-23 2007-02-01 Siemens Ag Übersetzen von MAC-Adressen
US20070248548A1 (en) * 2006-04-19 2007-10-25 Blondino Frank E Stable hydroalcoholic oral spray formulations and methods
WO2008141264A1 (fr) 2007-05-10 2008-11-20 Novadel Pharma Inc. Compositions et procédés anti-insomnie
US8946208B2 (en) * 2007-08-31 2015-02-03 Archimedes Development Limited Non-aqueous pharmaceutical composition
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
SMT201900135T1 (it) * 2010-10-12 2019-05-10 Ivax Pharmaceuticals Ireland Dispositivo di nebulizzazione nasale

Also Published As

Publication number Publication date
MX2021003975A (es) 2021-05-27
KR20210074311A (ko) 2021-06-21
MA53050B1 (fr) 2023-03-31
TN2021000051A1 (en) 2022-10-03
IL282020B2 (en) 2025-04-01
CA3115195A1 (fr) 2020-04-16
ZA202102322B (en) 2023-01-25
JP2022501407A (ja) 2022-01-06
EP3863604C0 (fr) 2024-09-11
EP3863604A1 (fr) 2021-08-18
PH12021550748A1 (en) 2022-02-14
US20220000845A1 (en) 2022-01-06
SG11202103255RA (en) 2021-04-29
UY38405A (es) 2020-03-31
KR102860999B1 (ko) 2025-09-16
CN112996488A (zh) 2021-06-18
CO2021005969A2 (es) 2021-05-20
IL282020B1 (en) 2024-12-01
JOP20210068A1 (ar) 2023-01-30
AU2019358394A1 (en) 2021-05-06
BR112021006551A2 (pt) 2021-07-06
HUE069302T2 (hu) 2025-02-28
AR116721A1 (es) 2021-06-09
ECSP21024213A (es) 2021-06-30
US12133845B2 (en) 2024-11-05
WO2020075183A1 (fr) 2020-04-16
EA202190765A1 (ru) 2021-07-01
PE20211007A1 (es) 2021-06-01
ES2998438T3 (en) 2025-02-20
AU2019358394B2 (en) 2025-02-20
IL282020A (en) 2021-05-31
PL3863604T3 (pl) 2025-02-24
CL2021000856A1 (es) 2021-09-24
EP3863604B1 (fr) 2024-09-11
GEP20237492B (en) 2023-04-10
CN112996488B (zh) 2025-03-14
DOP2021000060A (es) 2021-08-31

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