AU2003291715A1 - Modified release composition comprising a short-acting hypnotic for treatment of sleep disorders - Google Patents

Modified release composition comprising a short-acting hypnotic for treatment of sleep disorders Download PDF

Info

Publication number
AU2003291715A1
AU2003291715A1 AU2003291715A AU2003291715A AU2003291715A1 AU 2003291715 A1 AU2003291715 A1 AU 2003291715A1 AU 2003291715 A AU2003291715 A AU 2003291715A AU 2003291715 A AU2003291715 A AU 2003291715A AU 2003291715 A1 AU2003291715 A1 AU 2003291715A1
Authority
AU
Australia
Prior art keywords
core
pharmaceutically acceptable
zaleplon
coating
component
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
AU2003291715A
Other languages
English (en)
Inventor
Maurice Clancy
Janet Codd
Melanie O'hanlon
Alison Wilson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Elan Pharmaceuticals LLC
Original Assignee
Elan Pharmaceuticals LLC
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 Elan Pharmaceuticals LLC filed Critical Elan Pharmaceuticals LLC
Publication of AU2003291715A1 publication Critical patent/AU2003291715A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations 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
    • A61K31/495Heterocyclic 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
AU2003291715A 2002-11-15 2003-11-14 Modified release composition comprising a short-acting hypnotic for treatment of sleep disorders Abandoned AU2003291715A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US42636902P 2002-11-15 2002-11-15
US60/426,369 2002-11-15
US10/704,633 2003-11-12
US10/704,633 US20050038042A1 (en) 2002-11-15 2003-11-12 Modified release composition comprising a short-acting hypnotic for treatment of sleep disorders
PCT/US2003/035046 WO2004045589A1 (en) 2002-11-15 2003-11-14 Modified release composition comprising a short-acting hypnotic for treatment of sleep disorders

Publications (1)

Publication Number Publication Date
AU2003291715A1 true AU2003291715A1 (en) 2004-06-15

Family

ID=32329106

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2003291715A Abandoned AU2003291715A1 (en) 2002-11-15 2003-11-14 Modified release composition comprising a short-acting hypnotic for treatment of sleep disorders

Country Status (6)

Country Link
US (1) US20050038042A1 (enExample)
EP (1) EP1562560A1 (enExample)
JP (1) JP2006512324A (enExample)
AU (1) AU2003291715A1 (enExample)
RU (1) RU2005119303A (enExample)
WO (1) WO2004045589A1 (enExample)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL163548A0 (en) * 2002-02-15 2005-12-18 Biogal Pharmaceutical Co Ltd Powder composition comprising zaleplon of defined particle size distribution and pharmaceutical products made therefrom
EP2343073A3 (en) * 2003-12-11 2011-10-12 Sepracor Inc. Combination of a sedative and a neurotransmitter modulator, and methods for improving sleep quality and treating depression
US20050215521A1 (en) * 2003-12-22 2005-09-29 Karim Lalji Modafinil combination therapy for improving sleep quality
EP1696959A2 (en) * 2003-12-24 2006-09-06 Sepracor, Inc. Melatonin combination therapy for improving sleep quality
US7658945B2 (en) 2004-02-17 2010-02-09 Transcept Pharmaceuticals, Inc. Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
EP1742624B1 (en) * 2004-02-18 2010-01-06 Sepracor, Inc. Dopamine-agonist combination therapy with sedatives for improving sleep quality
GB0423800D0 (en) 2004-10-27 2004-12-01 Orexo Ab New pharmaceutical formulations
GB0423964D0 (en) * 2004-10-28 2004-12-01 Jagotec Ag Dosage form
US20070287740A1 (en) * 2005-05-25 2007-12-13 Transcept Pharmaceuticals, Inc. Compositions and methods of treating middle-of-the night insomnia
US20070225322A1 (en) * 2005-05-25 2007-09-27 Transoral Pharmaceuticals, Inc. Compositions and methods for treating middle-of-the night insomnia
US20060276501A1 (en) * 2005-05-25 2006-12-07 Transoral Pharmaceuticals, Inc. Solid compositions for treating middle-of-the-night insomnia
US20070020333A1 (en) * 2005-07-20 2007-01-25 Chin-Chih Chiang Controlled release of hypnotic agents
TWI274889B (en) * 2005-10-06 2007-03-01 Elan Microelectronics Corp Resistive touch screen measurement system
AR056633A1 (es) * 2005-12-07 2007-10-17 Gador Sa Composiciones farmaceuticas de agentes hipnoticos de accion corta en forma de liberacion modificada y los procedimientos para preparar dichas formulaciones
US8309104B2 (en) * 2006-03-02 2012-11-13 Watson Pharmaceuticals, Inc. Oral controlled release formulation for sedative and hypnotic agents
KR20070091960A (ko) * 2006-03-08 2007-09-12 주식회사종근당 졸피뎀 또는 그의 염을 포함하는 안전한 제어방출형 제제조성물
WO2007107878A2 (en) * 2006-03-17 2007-09-27 Aurobindo Pharma Limited Solid dosage forms of hypnotic agent
US20070243252A1 (en) * 2006-04-17 2007-10-18 Actavis Group Ptc Hf Oral Dosage Formulations and Methods of Preparing the Same
US20070243245A1 (en) * 2006-04-17 2007-10-18 Actavis Group Ptc Hf Oral Dosage Formulations, Methods of Preparing the Same, and Methods of Reducing Food Effects on Drug Release
HUE029173T2 (hu) * 2006-04-26 2017-02-28 Alphapharm Pty Ltd Szabályozott hatóanyag-leadású készítmények, amelyek tartalmaznak nem bevont diszkrét egység(ek)et és egy késleltetett hatóanyag-leadású mátrixot
EP1970056A1 (en) * 2007-03-15 2008-09-17 Polichem S.A. Time-specific delayed/pulsatile release dosage forms
WO2009006299A2 (en) * 2007-06-29 2009-01-08 Dr. Reddy's Laboratories Ltd. Multi-particulate systems
WO2010064139A2 (en) * 2008-12-04 2010-06-10 Intec Pharma Ltd. Zaleplon gastroretentive drug delivery system
RU2384336C1 (ru) * 2009-04-22 2010-03-20 Маргарита Алексеевна Морозова Фармацевтический состав для коррекции психосоматических проявлений
CA2934595C (en) * 2014-02-06 2022-06-21 Sequential Medicine Limited Composition and method for aiding sleep
WO2019071270A1 (en) * 2017-10-06 2019-04-11 Adare Pharmaceuticals, Inc. PHARMACEUTICAL COMPOSITIONS

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4728512A (en) * 1985-05-06 1988-03-01 American Home Products Corporation Formulations providing three distinct releases
BR9802915A (pt) * 1997-09-12 2000-01-11 Oscar Gold Procedimento para formar composições farmaceuticas em pilulas ou granulos substancialmente esfericos, de ação controlada e continuada, contendo como agente ativo o (7-bromo-1,3-diidro-5-(2-piridninilo)-2h-1,4-benzodiazep ina-2(1h)-um)
CA2348871C (en) * 1998-11-02 2009-04-14 John G. Devane Multiparticulate modified release composition
EP1005863A1 (en) * 1998-12-04 2000-06-07 Synthelabo Controlled-release dosage forms comprising a short acting hypnotic or a salt thereof
WO2000059479A1 (en) * 1999-04-06 2000-10-12 Pharmaquest Ltd. Pharmaceutical dosage form for pulsatile delivery of methylphenidate
US6485746B1 (en) * 2000-08-25 2002-11-26 Neurocrine Biosciences, Inc. Controlled-release sedative-hypnotic compositions and methods related thereto
ATE241968T1 (de) * 1999-08-26 2003-06-15 Neurocrine Biosciences Inc Sedativ hypnotische zusammensetzungen mit gesteuerter freisetzung und diesbezügliche verfahren

Also Published As

Publication number Publication date
JP2006512324A (ja) 2006-04-13
RU2005119303A (ru) 2006-01-27
US20050038042A1 (en) 2005-02-17
EP1562560A1 (en) 2005-08-17
WO2004045589A1 (en) 2004-06-03

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Legal Events

Date Code Title Description
MK4 Application lapsed section 142(2)(d) - no continuation fee paid for the application