CO5261492A1 - Formas de dosificacion de liberacion controlada que comprenden zolpidem o sales del mismo - Google Patents

Formas de dosificacion de liberacion controlada que comprenden zolpidem o sales del mismo

Info

Publication number
CO5261492A1
CO5261492A1 CO99076139A CO99076139A CO5261492A1 CO 5261492 A1 CO5261492 A1 CO 5261492A1 CO 99076139 A CO99076139 A CO 99076139A CO 99076139 A CO99076139 A CO 99076139A CO 5261492 A1 CO5261492 A1 CO 5261492A1
Authority
CO
Colombia
Prior art keywords
phase
release
pharmaceutical composition
composition according
profile
Prior art date
Application number
CO99076139A
Other languages
English (en)
Inventor
Gerard Alaux
Gareth Lewis
Frederique Andre
Original Assignee
Sanofi Aventis
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8235578&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO5261492(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Aventis filed Critical Sanofi Aventis
Publication of CO5261492A1 publication Critical patent/CO5261492A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Una composición farmacéutica que comprende de 4 a 16 mg de zolpidem o una sal del mismo y excipientes farmacéuticamente aceptables, caracterizada porque está compuesta por una forma de dosificación de liberación controlada adaptada para liberar zolpidem o su sal durante un período predeterminado, de acuerdo con el perfil bifásico in vitro de disolución cuando se mide en un aparato de disolución tipo II de acuerdo con la farmacopea de los Estados Unidos en tampón acuoso a 37°C, en donde la primera fase es una fase de liberación inmediata y la segunda fase es una fase de liberación prolongada, Una composición farmacéutica de acuerdo con la reivindicación 1, caracterizada porque la primera fase tiene una duración máxima de 30 minutos. Una composición farmacéutica de acuerdo con la reivindicación 1 o 2, caracterizada porque la segunda fase tiene un perfil de liberación de orden cero.Una composición farmacéutica de acuerdo con la reivindicación 1 o 2, caracterizada porque la segunda fase tiene un perfil en donde la liberación es proporcional a la raíz cuadrada del tiempo. Una composición farmacéutica de acuerdo con la reivindicación 1 o 2, caracterizada porque la segunda fase tiene un perfil de liberación de primer orden.<EMI FILE="99076139_1" ID="1" IMF=JPEG >
CO99076139A 1998-12-04 1999-12-03 Formas de dosificacion de liberacion controlada que comprenden zolpidem o sales del mismo CO5261492A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP98403037A EP1005863A1 (en) 1998-12-04 1998-12-04 Controlled-release dosage forms comprising a short acting hypnotic or a salt thereof

Publications (1)

Publication Number Publication Date
CO5261492A1 true CO5261492A1 (es) 2003-03-31

Family

ID=8235578

Family Applications (1)

Application Number Title Priority Date Filing Date
CO99076139A CO5261492A1 (es) 1998-12-04 1999-12-03 Formas de dosificacion de liberacion controlada que comprenden zolpidem o sales del mismo

Country Status (28)

Country Link
US (1) US6514531B1 (es)
EP (2) EP1005863A1 (es)
JP (2) JP4574857B2 (es)
KR (2) KR101013272B1 (es)
CN (1) CN1212838C (es)
AR (1) AR021535A1 (es)
AT (1) ATE290861T1 (es)
AU (1) AU771902B2 (es)
BR (1) BR9915939A (es)
CA (1) CA2391983C (es)
CO (1) CO5261492A1 (es)
CZ (1) CZ20011969A3 (es)
DE (1) DE69924283T8 (es)
DK (1) DK1135125T3 (es)
ES (1) ES2239479T3 (es)
HK (1) HK1037319A1 (es)
HU (1) HUP0201915A3 (es)
IL (2) IL143146A0 (es)
NO (1) NO20012668L (es)
NZ (1) NZ511750A (es)
PL (1) PL198396B1 (es)
PT (1) PT1135125E (es)
SI (1) SI1135125T1 (es)
SK (1) SK7612001A3 (es)
TR (1) TR200101588T2 (es)
TW (1) TW565448B (es)
WO (1) WO2000033835A1 (es)
ZA (1) ZA200104169B (es)

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