BRPI0507733A - composition for the release of a hypnotic agent through the oral mucosa, and method for treating a sleep disorder in a patient in need thereof - Google Patents

composition for the release of a hypnotic agent through the oral mucosa, and method for treating a sleep disorder in a patient in need thereof

Info

Publication number
BRPI0507733A
BRPI0507733A BRPI0507733-8A BRPI0507733A BRPI0507733A BR PI0507733 A BRPI0507733 A BR PI0507733A BR PI0507733 A BRPI0507733 A BR PI0507733A BR PI0507733 A BRPI0507733 A BR PI0507733A
Authority
BR
Brazil
Prior art keywords
oral mucosa
release
hypnotic agent
patient
hypnotic
Prior art date
Application number
BRPI0507733-8A
Other languages
Portuguese (pt)
Inventor
Nikhilesh N Singh
Original Assignee
Transoral Pharmaceuticals Inc
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 Transoral Pharmaceuticals Inc filed Critical Transoral Pharmaceuticals Inc
Publication of BRPI0507733A publication Critical patent/BRPI0507733A/en

Links

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
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

"COMPOSIçãO PARA A LIBERAçãO DE UM AENTE HIPNóTICO ATRAVéS DA MUCOSA ORAL, E, MéTODO PARA TRATAR UM DISTúRBIO DO SONO EM UM PACIENTE EM NECESSIDADE DESTE" A presente invenção ornece novas composições para a liberação de um agente hipnótico através da mucosa oral. Em paticular, sistema de tampão nas composicções da presente invenção eleva o pH da saliva a um pH maior do que cerca de 7,8 facilitando desse modo a conversão substancialmente completa do agente hipnótico de sua forma ionizada à sua forma não ionizada. Como um resultado, a dose do agente hipnótico é rápida e eficientemente absorvida pela mucosa oral variabilidade inter-paciente supreendentemente baixa. Além disso, a liberação do agente hipnótico através da mucosa oral vantajosamente desvia a primeiro metabolismo de passagem hepática do medicamento e evita a degradação enzimática do medicamento dentro do trato gastrointestinal. Os métodos para usar as composições da presente invenção para tratar distúbios do sono tais como insónia também são fornecidos."COMPOSITION FOR THE RELEASE OF A HYPNOTIC HEALTH THROUGH ORAL MUCOSA AND METHOD FOR TREATING A SLEEP DISTURBANCE IN A PATIENT NEEDING THIS" The present invention provides novel compositions for the release of a hypnotic agent through the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the saliva pH to a pH greater than about 7.8 thereby facilitating substantially complete conversion of the hypnotic agent from its ionized form to its nonionized form. As a result, the hypnotic agent dose is rapidly and efficiently absorbed by the oral mucosa surprisingly low inter-patient variability. In addition, release of the hypnotic agent through the oral mucosa advantageously bypasses the first hepatic passage metabolism of the drug and prevents enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention to treat sleep disorders such as insomnia are also provided.

BRPI0507733-8A 2004-02-17 2005-02-16 composition for the release of a hypnotic agent through the oral mucosa, and method for treating a sleep disorder in a patient in need thereof BRPI0507733A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US78311804A 2004-02-17 2004-02-17
US59862904P 2004-08-03 2004-08-03
PCT/US2005/005021 WO2005079761A1 (en) 2004-02-17 2005-02-16 Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof

Publications (1)

Publication Number Publication Date
BRPI0507733A true BRPI0507733A (en) 2007-07-10

Family

ID=34890604

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0507733-8A BRPI0507733A (en) 2004-02-17 2005-02-16 composition for the release of a hypnotic agent through the oral mucosa, and method for treating a sleep disorder in a patient in need thereof

Country Status (7)

Country Link
AU (1) AU2005215782B2 (en)
BR (1) BRPI0507733A (en)
CA (1) CA2556450C (en)
IL (1) IL177227A (en)
MX (1) MXPA06009296A (en)
NZ (1) NZ548856A (en)
WO (1) WO2005079761A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0423800D0 (en) 2004-10-27 2004-12-01 Orexo Ab New pharmaceutical formulations
EP1883408A4 (en) * 2005-05-25 2009-11-11 Transcept Pharmaceuticals Inc Solid compositions and methods for treating middle-of-the night insomnia
EP2455076A1 (en) * 2007-04-09 2012-05-23 Sepracor Inc. Compositions comprising desvenlafaxine for use in treating sleep-related breathing disorders
FR2968992B1 (en) * 2010-12-16 2013-02-08 Sanofi Aventis ORODISPERSIBLE PHARMACEUTICAL TABLET BASED ON ZOLPIDEM
CN103919780B (en) * 2012-12-26 2016-12-28 上海中西制药有限公司 Calming soporific preparation, its compound preparation, preparation method and pharmaceutical composition
SG11202103255RA (en) * 2018-10-08 2021-04-29 Troikaa Pharmaceuticals Ltd Oromucosal solutions of zolpidem or pharmaceutically acceptable salts thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6005109A (en) * 1997-10-30 1999-12-21 Pflizer Inc. Pyrazoles and pyrazolopyrimidines having CRF antagonistic activity
TW370529B (en) * 1992-12-17 1999-09-21 Pfizer Pyrazolopyrimidines
US6624162B2 (en) * 2001-10-22 2003-09-23 Pfizer Inc. Imidazopyridine compounds as 5-HT4 receptor modulators

Also Published As

Publication number Publication date
MXPA06009296A (en) 2007-01-26
AU2005215782A1 (en) 2005-09-01
CA2556450C (en) 2013-08-06
IL177227A0 (en) 2006-12-10
IL177227A (en) 2013-05-30
AU2005215782B2 (en) 2011-04-21
CA2556450A1 (en) 2005-09-01
NZ548856A (en) 2009-10-30
WO2005079761A1 (en) 2005-09-01

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Legal Events

Date Code Title Description
B25D Requested change of name of applicant approved

Owner name: TRANSCEPT PHARMACEUTICALS, INC. (US)

Free format text: ALTERADO DE: TRANSORAL PHARMACEUTICALS, INC.

B25G Requested change of headquarter approved

Owner name: TRANSCEPT PHARMACEUTICALS, INC. (US)

Free format text: SEDE ALTERADA CONFORME SOLICITADO NA PETICAO NO 020080123757/RJ DE 24/09/2008.

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B11E Dismissal acc. art. 34 of ipl - requirements for examination incomplete
B11T Dismissal of application maintained [chapter 11.20 patent gazette]