AU2002320134B2 - Lyophilized formulation comprising olanzapine - Google Patents

Lyophilized formulation comprising olanzapine Download PDF

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Publication number
AU2002320134B2
AU2002320134B2 AU2002320134A AU2002320134A AU2002320134B2 AU 2002320134 B2 AU2002320134 B2 AU 2002320134B2 AU 2002320134 A AU2002320134 A AU 2002320134A AU 2002320134 A AU2002320134 A AU 2002320134A AU 2002320134 B2 AU2002320134 B2 AU 2002320134B2
Authority
AU
Australia
Prior art keywords
formulation
olanzapine
lactose
stabilizer
formulation according
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.)
Expired
Application number
AU2002320134A
Other languages
English (en)
Other versions
AU2002320134A1 (en
Inventor
Kurt Douglas Dekemper
Alan Lee Fites
Steven L. Nail
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.)
Eli Lilly and Co
Original Assignee
Eli Lilly and Co
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 Eli Lilly and Co filed Critical Eli Lilly and Co
Publication of AU2002320134A1 publication Critical patent/AU2002320134A1/en
Application granted granted Critical
Publication of AU2002320134B2 publication Critical patent/AU2002320134B2/en
Anticipated expiration legal-status Critical
Expired legal-status Critical Current

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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K47/06—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Anesthesiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
AU2002320134A 2001-07-20 2002-07-05 Lyophilized formulation comprising olanzapine Expired AU2002320134B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US30682901P 2001-07-20 2001-07-20
US60/306,829 2001-07-20
US38647402P 2002-06-07 2002-06-07
US60/386,474 2002-06-07
PCT/US2002/019799 WO2003007912A2 (en) 2001-07-20 2002-07-05 Lyophilized formulation comprising olanzapine

Publications (2)

Publication Number Publication Date
AU2002320134A1 AU2002320134A1 (en) 2003-05-22
AU2002320134B2 true AU2002320134B2 (en) 2007-04-05

Family

ID=26975390

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2002320134A Expired AU2002320134B2 (en) 2001-07-20 2002-07-05 Lyophilized formulation comprising olanzapine

Country Status (32)

Country Link
US (1) US20040176357A1 (enExample)
EP (1) EP1423124B1 (enExample)
JP (1) JP2004537546A (enExample)
KR (1) KR20040017330A (enExample)
CN (1) CN1537007A (enExample)
AR (1) AR036180A1 (enExample)
AT (1) ATE369137T1 (enExample)
AU (1) AU2002320134B2 (enExample)
BR (1) BR0211250A (enExample)
CA (1) CA2448724A1 (enExample)
CO (1) CO5540279A2 (enExample)
CY (1) CY1107759T1 (enExample)
CZ (1) CZ200484A3 (enExample)
DE (1) DE60221674T2 (enExample)
DK (1) DK1423124T3 (enExample)
EA (1) EA006506B1 (enExample)
ES (1) ES2289126T3 (enExample)
HR (1) HRP20040037A2 (enExample)
HU (1) HUP0401157A3 (enExample)
IL (1) IL159098A0 (enExample)
MX (1) MXPA04000541A (enExample)
MY (1) MY135452A (enExample)
NZ (1) NZ529667A (enExample)
PE (1) PE20030281A1 (enExample)
PL (1) PL366614A1 (enExample)
PT (1) PT1423124E (enExample)
SI (1) SI1423124T1 (enExample)
SK (1) SK182004A3 (enExample)
SV (1) SV2003001179A (enExample)
UA (1) UA80095C2 (enExample)
WO (1) WO2003007912A2 (enExample)
ZA (1) ZA200400798B (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7323459B2 (en) * 2002-12-24 2008-01-29 Teva Pharmaceutical Industries Ltd. Crystal forms, methods for their preparation and method for preparation of olanzapine
HU226410B1 (en) * 2003-04-22 2008-11-28 Egis Gyogyszergyar Nyilvanosan Novel polymorphous forms of olanzapine hydrochlorides, process for producing them, use thereof and pharmaceutical compositions containing them
GB0314149D0 (en) * 2003-06-18 2003-07-23 Generics Uk Ltd Novel amorphous forms
ATE504588T1 (de) 2004-01-27 2011-04-15 Synthon Bv Stabile salze von olanzapin
WO2006076124A2 (en) * 2004-12-16 2006-07-20 Nektar Therapeutics Stable, non-crystalline formulation comprising olanzapine
US8158152B2 (en) * 2005-11-18 2012-04-17 Scidose Llc Lyophilization process and products obtained thereby
US20070293479A1 (en) * 2006-05-18 2007-12-20 Osinga Niels J Olanzapine pharmaceutical composition
EP3735223A4 (en) * 2018-01-05 2021-10-13 Impel Neuropharma Inc. INTRANASAL ADMINISTRATION OF OLANZAPINE BY A PRECISION OLFACTORY DEVICE
PE20212195A1 (es) * 2019-03-01 2021-11-15 Eurofarma Laboratorios S A Composicion farmaceutica liofilizada de antiinflamatorio no esteroideo
HUP2100259A1 (hu) 2021-07-07 2023-01-28 Richter Gedeon Nyrt Cariprazine tartalmú szabályozott hatóanyag-leadású injekciós készítmények
CN115006406A (zh) * 2021-12-28 2022-09-06 南京清普生物科技有限公司 一种稳定的奥氮平制剂
WO2025056094A1 (zh) * 2023-09-15 2025-03-20 广州帝奇医药技术有限公司 一种冻干制剂和注射液及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0421297A2 (en) * 1989-09-30 1991-04-10 Eisai Co., Ltd. Injectable preparations containing cephalosporin medicament and the use thereof
US5457101A (en) * 1994-06-03 1995-10-10 Eli Lilly And Company Thieno[1,5]benzoidiazepine use

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0421297A2 (en) * 1989-09-30 1991-04-10 Eisai Co., Ltd. Injectable preparations containing cephalosporin medicament and the use thereof
US5457101A (en) * 1994-06-03 1995-10-10 Eli Lilly And Company Thieno[1,5]benzoidiazepine use

Also Published As

Publication number Publication date
UA80095C2 (en) 2007-08-27
WO2003007912A3 (en) 2003-05-01
CA2448724A1 (en) 2003-01-30
PE20030281A1 (es) 2003-03-27
CY1107759T1 (el) 2013-06-19
PL366614A1 (en) 2005-02-07
CZ200484A3 (cs) 2005-01-12
CN1537007A (zh) 2004-10-13
ATE369137T1 (de) 2007-08-15
EP1423124B1 (en) 2007-08-08
EA200400211A1 (ru) 2004-06-24
DE60221674T2 (de) 2008-04-30
WO2003007912A2 (en) 2003-01-30
JP2004537546A (ja) 2004-12-16
DE60221674D1 (de) 2007-09-20
ES2289126T3 (es) 2008-02-01
HRP20040037A2 (en) 2004-06-30
AR036180A1 (es) 2004-08-18
EA006506B1 (ru) 2005-12-29
NZ529667A (en) 2006-02-24
IL159098A0 (en) 2004-05-12
HUP0401157A3 (en) 2008-01-28
CO5540279A2 (es) 2005-07-29
US20040176357A1 (en) 2004-09-09
SI1423124T1 (sl) 2008-02-29
MY135452A (en) 2008-04-30
SV2003001179A (es) 2003-07-29
KR20040017330A (ko) 2004-02-26
BR0211250A (pt) 2004-07-27
EP1423124A2 (en) 2004-06-02
HUP0401157A2 (hu) 2004-10-28
PT1423124E (pt) 2007-10-29
DK1423124T3 (da) 2007-12-03
MXPA04000541A (es) 2004-05-04
SK182004A3 (en) 2004-09-08
ZA200400798B (en) 2005-07-27
HK1066484A1 (en) 2005-03-24

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Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired