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UY38405A - Soluciones oromucosas de zolpidem o sales farmacéuticamente aceptables de los mismos - Google Patents

Soluciones oromucosas de zolpidem o sales farmacéuticamente aceptables de los mismos

Info

Publication number
UY38405A
UY38405A UY0001038405A UY38405A UY38405A UY 38405 A UY38405 A UY 38405A UY 0001038405 A UY0001038405 A UY 0001038405A UY 38405 A UY38405 A UY 38405A UY 38405 A UY38405 A UY 38405A
Authority
UY
Uruguay
Prior art keywords
zolpidem
pharmaceutically acceptable
solutions
formulations
acceptable salts
Prior art date
Application number
UY0001038405A
Other languages
English (en)
Inventor
K Patel Nisheel
R Patel Ketan
r patel Milan
M Patel Kush
K Patel Asheel
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 UY38405A publication Critical patent/UY38405A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/4353Heterocyclic 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
    • A61K31/437Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; 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 presente invención trata de soluciones oromucosas de Zolpidem o sales farmacéuticamente aceptables del mismo. La presente invención se refiere a formulaciones bucales o sublinguales de Zolpidem o una sal farmacéuticamente aceptable del mismo. Las formulaciones minimizan la cantidad de potenciadores de la penetración y, sin embargo, proporcionan una rápida penetración transmucosal del fármaco. Estas formulaciones no solo proporcionan la concentración deseada (0.5% a 10% p/v ) del medicamento en forma de solución transparente (clara), sino que también logran formulaciones estables durante toda la vida útil de al menos aproximadamente 2 años. El pH de las soluciones estables no acuosas de la presente invención está en el intervalo de pH 5 a 9, preferiblemente de 6 a 9, más preferiblemente de 7 a 9.
UY0001038405A 2018-10-08 2019-10-07 Soluciones oromucosas de zolpidem o sales farmacéuticamente aceptables de los mismos UY38405A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN201821038060 2018-10-08

Publications (1)

Publication Number Publication Date
UY38405A true UY38405A (es) 2020-03-31

Family

ID=68296607

Family Applications (1)

Application Number Title Priority Date Filing Date
UY0001038405A UY38405A (es) 2018-10-08 2019-10-07 Soluciones oromucosas de zolpidem o sales farmacéuticamente aceptables de los mismos

Country Status (29)

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

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2306024C (en) 1997-10-01 2011-04-26 Flemington Pharmaceutical Corporation Buccal, polar and non-polar spray or capsule
US7632517B2 (en) * 1997-10-01 2009-12-15 Novadel Pharma Inc. Buccal, polar and non-polar spray containing zolpidem
KR100334860B1 (ko) 1998-03-12 2002-05-02 야마오카 요지로 규소강판 및 그 제조방법
US7501113B2 (en) * 2003-02-04 2009-03-10 Philip Morris Usa Inc. Aerosol formulations and aerosol delivery of buprenorphine
GB0329918D0 (en) * 2003-12-24 2004-01-28 West Pharm Serv Drug Res Ltd Intranasal compositions
WO2005079761A1 (en) 2004-02-17 2005-09-01 Transoral Pharmaceuticals, Inc. Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
EP1715853A4 (en) * 2004-02-17 2012-07-18 Transcept Pharmaceuticals Inc COMPOSITIONS FOR THE DISTRIBUTION OF HYPNOTICS IN THE FIELD OF MUNICHCHLEIMHÄUTE AND USE METHOD THEREOF
GB0423800D0 (en) 2004-10-27 2004-12-01 Orexo Ab New pharmaceutical formulations
WO2006089082A2 (en) * 2005-02-17 2006-08-24 Velcera Pharmaceuticals Transmucosal administration of drug compositions for treating and preventing disorders in animals
US20070123562A1 (en) * 2005-05-25 2007-05-31 Transoral Pharmaceuticals, Inc. Compositions and methods for treating middle-of-the-night insomnia
DE102005034549A1 (de) 2005-07-23 2007-02-01 Siemens Ag Übersetzen von MAC-Adressen
JP2009534387A (ja) * 2006-04-19 2009-09-24 ノヴァデル ファーマ インコーポレイテッド 安定な含水アルコール性経口噴霧調剤物および方法
EP2152247A4 (en) 2007-05-10 2012-12-26 Novadel Pharma Inc COMPOSITIONS AND METHODS ANTI-INSOMNIA
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
RS54037B1 (sr) * 2010-10-12 2015-10-30 Ivax Pharmaceuticals Ireland Uređaj za nazalni sprej

Also Published As

Publication number Publication date
GEP20237492B (en) 2023-04-10
EA202190765A1 (ru) 2021-07-01
IL282020B1 (en) 2024-12-01
US20220000845A1 (en) 2022-01-06
WO2020075183A1 (en) 2020-04-16
JP2022501407A (ja) 2022-01-06
CA3115195A1 (en) 2020-04-16
JOP20210068A1 (ar) 2023-01-30
MX2021003975A (es) 2021-05-27
CL2021000856A1 (es) 2021-09-24
PH12021550748A1 (en) 2022-02-14
TN2021000051A1 (en) 2022-10-03
PL3863604T3 (pl) 2025-02-24
SG11202103255RA (en) 2021-04-29
ZA202102322B (en) 2023-01-25
ECSP21024213A (es) 2021-06-30
EP3863604B1 (en) 2024-09-11
MA53050B1 (fr) 2023-03-31
EP3863604A1 (en) 2021-08-18
DOP2021000060A (es) 2021-08-31
AU2019358394B2 (en) 2025-02-20
EP3863604C0 (en) 2024-09-11
AR116721A1 (es) 2021-06-09
HUE069302T2 (hu) 2025-02-28
AU2019358394A1 (en) 2021-05-06
IL282020B2 (en) 2025-04-01
BR112021006551A2 (pt) 2021-07-06
IL282020A (en) 2021-05-31
ES2998438T3 (en) 2025-02-20
CN112996488A (zh) 2021-06-18
MA53050A1 (fr) 2022-06-30
PE20211007A1 (es) 2021-06-01
US12133845B2 (en) 2024-11-05
CN112996488B (zh) 2025-03-14
CO2021005969A2 (es) 2021-05-20
KR20210074311A (ko) 2021-06-21
KR102860999B1 (ko) 2025-09-16

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