WO1998042379A3 - Chemically and thermally stable norastemizole formulations - Google Patents

Chemically and thermally stable norastemizole formulations Download PDF

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Publication number
WO1998042379A3
WO1998042379A3 PCT/US1998/005701 US9805701W WO9842379A3 WO 1998042379 A3 WO1998042379 A3 WO 1998042379A3 US 9805701 W US9805701 W US 9805701W WO 9842379 A3 WO9842379 A3 WO 9842379A3
Authority
WO
WIPO (PCT)
Prior art keywords
chemically
thermally stable
norastemizole
formulations
norastemizole formulations
Prior art date
Application number
PCT/US1998/005701
Other languages
French (fr)
Other versions
WO1998042379A2 (en
Inventor
Martin P Redmon
Hal T Butler
Stephen A Wald
Original Assignee
Sepracor Inc
Martin P Redmon
Hal T Butler
Stephen A Wald
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 Sepracor Inc, Martin P Redmon, Hal T Butler, Stephen A Wald filed Critical Sepracor Inc
Priority to KR1019997008817A priority Critical patent/KR20010005746A/en
Priority to AU68680/98A priority patent/AU735257C/en
Priority to HU0001823A priority patent/HUP0001823A3/en
Priority to CA002284705A priority patent/CA2284705A1/en
Priority to EP98914283A priority patent/EP1035869A1/en
Priority to JP54589398A priority patent/JP2002512614A/en
Priority to BR9808428-3A priority patent/BR9808428A/en
Publication of WO1998042379A2 publication Critical patent/WO1998042379A2/en
Priority to NO994655A priority patent/NO994655L/en
Publication of WO1998042379A3 publication Critical patent/WO1998042379A3/en

Links

Classifications

    • 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
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to chemically and thermally stable pharmaceutical formulations of the potent antihistamine, norastemizole. The compositions are lactose-free, non-hygroscopic, or anhydrous, or comprise large particles or inertly coated norastemizole, or a pharmaceutically acceptable salt thereof, and are stable and easily manufactured.
PCT/US1998/005701 1997-03-26 1998-03-25 Chemically and thermally stable norastemizole formulations WO1998042379A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
KR1019997008817A KR20010005746A (en) 1997-03-26 1998-03-25 Chemically and thermally stable norastemizole formulations
AU68680/98A AU735257C (en) 1997-03-26 1998-03-25 Chemically and thermally stable norastemizole formulations
HU0001823A HUP0001823A3 (en) 1997-03-26 1998-03-25 Chemically and thermally stable norastemizole formulations
CA002284705A CA2284705A1 (en) 1997-03-26 1998-03-25 Chemically and thermally stable norastemizole formulations
EP98914283A EP1035869A1 (en) 1997-03-26 1998-03-25 Chemically and thermally stable norastemizole formulations
JP54589398A JP2002512614A (en) 1997-03-26 1998-03-25 A chemically and thermally stable norastemizole formulation
BR9808428-3A BR9808428A (en) 1997-03-26 1998-03-25 Pharmaceutical composition, process for treating allergic disorders in a mammal and solid unit dosage form
NO994655A NO994655L (en) 1997-03-26 1999-09-24 Chemically and thermally stable norastemizole preparations

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US82447797A 1997-03-26 1997-03-26
US08/824,477 1997-03-26
US85178697A 1997-05-06 1997-05-06
US08/851,786 1997-05-06

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US85178697A Continuation-In-Part 1997-03-26 1997-05-06

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US09719843 A-371-Of-International 2000-11-21
US10/075,616 Continuation-In-Part US20020173522A1 (en) 1997-03-26 2002-02-15 Pharmaceutical compositions comprising norastemizole

Publications (2)

Publication Number Publication Date
WO1998042379A2 WO1998042379A2 (en) 1998-10-01
WO1998042379A3 true WO1998042379A3 (en) 2001-03-01

Family

ID=27124816

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/005701 WO1998042379A2 (en) 1997-03-26 1998-03-25 Chemically and thermally stable norastemizole formulations

Country Status (13)

Country Link
EP (1) EP1035869A1 (en)
JP (1) JP2002512614A (en)
KR (1) KR20010005746A (en)
CN (1) CN1257431A (en)
AR (1) AR012187A1 (en)
BR (1) BR9808428A (en)
CA (1) CA2284705A1 (en)
HU (1) HUP0001823A3 (en)
NO (1) NO994655L (en)
NZ (3) NZ517472A (en)
RU (1) RU2214245C2 (en)
WO (1) WO1998042379A2 (en)
ZA (1) ZA982562B (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ20002567A3 (en) * 2000-07-11 2001-12-12 Léčiva, A.S. Tablet that can be prepared by direct tabletting containing 4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid as active substance and process for preparing thereof
EP2201982A1 (en) * 2008-12-24 2010-06-30 INSERM (Institut National de la Santé et de la Recherche Médicale) Histamine H4 receptor antagonists for the treatment of vestibular disorders
EA201270309A1 (en) * 2009-08-24 2012-07-30 Абды Ибрахым Иладж Санайи Ве Тыджарет Аноным Сыркеты OTILONIA TABLETS RECEIVED BY DIRECT PRESSING

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0232937A2 (en) * 1986-02-03 1987-08-19 Janssen Pharmaceutica N.V. Anti-histaminic compositions containing N-heterocyclyl-4-piperidinamines
DE4037426A1 (en) * 1990-11-24 1992-05-27 Kali Chemie Pharma Gmbh PIPERIDINOALKYLBENZAZAZIN- AND -THIAZIN COMPOUNDS AND METHOD FOR THE PRODUCTION THEREOF AND THE COMPOSITIONS CONTAINING SUCH COMPOUNDS
WO1994007495A1 (en) * 1992-09-03 1994-04-14 Sepracor Inc. Use of norastemizole for the treatment of allergic disorders
WO1997019074A1 (en) * 1995-11-17 1997-05-29 Hoechst Marion Roussel, Inc. Substituted 4-(1h-benzimidazol-2-yl-amino)piperidines useful for the treatment of allergic diseases
WO1998006394A1 (en) * 1996-08-16 1998-02-19 Schering Corporation Treatment of upper airway allergic responses with a combination of histamine receptor antagonists

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0232937A2 (en) * 1986-02-03 1987-08-19 Janssen Pharmaceutica N.V. Anti-histaminic compositions containing N-heterocyclyl-4-piperidinamines
DE4037426A1 (en) * 1990-11-24 1992-05-27 Kali Chemie Pharma Gmbh PIPERIDINOALKYLBENZAZAZIN- AND -THIAZIN COMPOUNDS AND METHOD FOR THE PRODUCTION THEREOF AND THE COMPOSITIONS CONTAINING SUCH COMPOUNDS
WO1994007495A1 (en) * 1992-09-03 1994-04-14 Sepracor Inc. Use of norastemizole for the treatment of allergic disorders
WO1997019074A1 (en) * 1995-11-17 1997-05-29 Hoechst Marion Roussel, Inc. Substituted 4-(1h-benzimidazol-2-yl-amino)piperidines useful for the treatment of allergic diseases
WO1998006394A1 (en) * 1996-08-16 1998-02-19 Schering Corporation Treatment of upper airway allergic responses with a combination of histamine receptor antagonists

Also Published As

Publication number Publication date
ZA982562B (en) 1998-10-01
RU2214245C2 (en) 2003-10-20
NZ517472A (en) 2003-08-29
AU6868098A (en) 1998-10-20
AU735257B2 (en) 2001-07-05
HUP0001823A2 (en) 2001-04-28
WO1998042379A2 (en) 1998-10-01
NO994655D0 (en) 1999-09-24
CA2284705A1 (en) 1998-10-01
JP2002512614A (en) 2002-04-23
HUP0001823A3 (en) 2002-04-29
NZ527200A (en) 2004-12-24
NO994655L (en) 1999-11-15
NZ527201A (en) 2004-12-24
AR012187A1 (en) 2000-09-27
BR9808428A (en) 2000-05-23
KR20010005746A (en) 2001-01-15
EP1035869A1 (en) 2000-09-20
CN1257431A (en) 2000-06-21

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