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WO2008030524A3 - Liquid pharmaceutical formulations for oral administration of a cgrp antagonist - Google Patents

Liquid pharmaceutical formulations for oral administration of a cgrp antagonist Download PDF

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Publication number
WO2008030524A3
WO2008030524A3 PCT/US2007/019461 US2007019461W WO2008030524A3 WO 2008030524 A3 WO2008030524 A3 WO 2008030524A3 US 2007019461 W US2007019461 W US 2007019461W WO 2008030524 A3 WO2008030524 A3 WO 2008030524A3
Authority
WO
WIPO (PCT)
Prior art keywords
oral administration
pharmaceutical formulations
liquid pharmaceutical
cgrp antagonist
oxo
Prior art date
Application number
PCT/US2007/019461
Other languages
French (fr)
Other versions
WO2008030524A2 (en
Inventor
David Breslin
Joyce Stellabott
Hossain Jahansouz
Laman L Alani
Karen Thompson
Original Assignee
Merck & Co Inc
David Breslin
Joyce Stellabott
Hossain Jahansouz
Laman L Alani
Karen Thompson
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 Merck & Co Inc, David Breslin, Joyce Stellabott, Hossain Jahansouz, Laman L Alani, Karen Thompson filed Critical Merck & Co Inc
Priority to AU2007293032A priority Critical patent/AU2007293032A1/en
Priority to CA002662748A priority patent/CA2662748A1/en
Priority to EP07837821A priority patent/EP2063708A2/en
Priority to JP2009527409A priority patent/JP2010502710A/en
Publication of WO2008030524A2 publication Critical patent/WO2008030524A2/en
Publication of WO2008030524A3 publication Critical patent/WO2008030524A3/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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Addiction (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Communicable Diseases (AREA)
  • Endocrinology (AREA)
  • Psychiatry (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Liquid formulations comprising the compound 1-[1-({[(3R,6S)-6-(2,3-difluorophenyl)-2-oxo-1-(2,2,2-trifluoroethyl)azepan-3-yl]amino}carbonyl)piperidin-4-yl]-2-oxo-1,2-dihydroimidazo[4,5-b]pyridin-3-ide have surprisingly improved bioavailability and stability in comprising polyethylene glycol, Tween (polysorbate 80), Cremophor® EL (polyoxyl 35 castor oil), propylene glycol, and optionally water, and may be filled into soft or hard gelatin capsules useful for treating conditions including migraine headache and cluster headache.
PCT/US2007/019461 2006-09-08 2007-09-06 Liquid pharmaceutical formulations for oral administration of a cgrp antagonist WO2008030524A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2007293032A AU2007293032A1 (en) 2006-09-08 2007-09-06 Liquid pharmaceutical formulations for oral administration of a CGRP antagonist
CA002662748A CA2662748A1 (en) 2006-09-08 2007-09-06 Liquid pharmaceutical formulations for oral administration of a cgrp antagonist
EP07837821A EP2063708A2 (en) 2006-09-08 2007-09-06 Liquid pharmaceutical formulations for oral administration of a cgrp antagonist
JP2009527409A JP2010502710A (en) 2006-09-08 2007-09-06 Liquid pharmaceutical formulation for oral administration of CGRP antagonist

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US84305206P 2006-09-08 2006-09-08
US60/843,052 2006-09-08

Publications (2)

Publication Number Publication Date
WO2008030524A2 WO2008030524A2 (en) 2008-03-13
WO2008030524A3 true WO2008030524A3 (en) 2008-10-02

Family

ID=39157840

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/019461 WO2008030524A2 (en) 2006-09-08 2007-09-06 Liquid pharmaceutical formulations for oral administration of a cgrp antagonist

Country Status (6)

Country Link
EP (1) EP2063708A2 (en)
JP (1) JP2010502710A (en)
CN (1) CN101511184A (en)
AU (1) AU2007293032A1 (en)
CA (1) CA2662748A1 (en)
WO (1) WO2008030524A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2011103170A (en) * 2008-06-30 2012-08-10 Мерк Шарп Энд Домэ Корп. (Us) SOLID DOSED FORMULATIONS OF POT
CN101756900B (en) * 2010-02-25 2012-05-30 谢恬 Elemene microemulsion
KR20210153745A (en) * 2013-09-16 2021-12-17 머크 샤프 앤드 돔 코포레이션 Formulations for cgrp receptor antagonists
WO2015164657A1 (en) * 2014-04-23 2015-10-29 Bcs Business Consulting Services Pte Ltd Incorporation of water soluble component(s) into anhydrous formulations
SG11202111251SA (en) * 2019-04-11 2021-11-29 R P Scherer Technologies Llc Formulation for oral delivery of proteins, peptides and small molecules with poor permeability
WO2023220109A1 (en) * 2022-05-11 2023-11-16 Eli Lilly And Company Glp1 pharmaceutical compositions

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6191105B1 (en) * 1993-05-10 2001-02-20 Protein Delivery, Inc. Hydrophilic and lipophilic balanced microemulsion formulations of free-form and/or conjugation-stabilized therapeutic agents such as insulin
WO2004092166A2 (en) * 2003-04-15 2004-10-28 Merck & Co., Inc. Cgrp receptor antagonists

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6191105B1 (en) * 1993-05-10 2001-02-20 Protein Delivery, Inc. Hydrophilic and lipophilic balanced microemulsion formulations of free-form and/or conjugation-stabilized therapeutic agents such as insulin
WO2004092166A2 (en) * 2003-04-15 2004-10-28 Merck & Co., Inc. Cgrp receptor antagonists

Also Published As

Publication number Publication date
EP2063708A2 (en) 2009-06-03
CN101511184A (en) 2009-08-19
AU2007293032A1 (en) 2008-03-13
JP2010502710A (en) 2010-01-28
CA2662748A1 (en) 2008-03-13
WO2008030524A2 (en) 2008-03-13

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