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WO2007044069A3 - Pth formulations and methods of use - Google Patents

Pth formulations and methods of use Download PDF

Info

Publication number
WO2007044069A3
WO2007044069A3 PCT/US2006/013377 US2006013377W WO2007044069A3 WO 2007044069 A3 WO2007044069 A3 WO 2007044069A3 US 2006013377 W US2006013377 W US 2006013377W WO 2007044069 A3 WO2007044069 A3 WO 2007044069A3
Authority
WO
WIPO (PCT)
Prior art keywords
pth
formulation
mammal
agent
surface active
Prior art date
Application number
PCT/US2006/013377
Other languages
French (fr)
Other versions
WO2007044069A2 (en
Inventor
Henry R. Costantino
Steven C. Quay
Michael V. Templin
Ching-Yuan Li
Anthony Sileno
Original Assignee
Nastech Pharmaceutical Company Inc.
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
Priority claimed from US11/246,450 external-priority patent/US20060052306A1/en
Priority claimed from US11/246,406 external-priority patent/US20060052305A1/en
Priority claimed from US11/347,551 external-priority patent/US20060127320A1/en
Priority claimed from US11/390,940 external-priority patent/US20060189533A1/en
Application filed by Nastech Pharmaceutical Company Inc. filed Critical Nastech Pharmaceutical Company Inc.
Priority to AU2006299887A priority Critical patent/AU2006299887A1/en
Priority to JP2008534515A priority patent/JP2009511472A/en
Priority to CA002625084A priority patent/CA2625084A1/en
Priority to EP06749687A priority patent/EP1931374A2/en
Publication of WO2007044069A2 publication Critical patent/WO2007044069A2/en
Priority to IL190583A priority patent/IL190583A0/en
Publication of WO2007044069A3 publication Critical patent/WO2007044069A3/en

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
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

What is described is an aqueous pharmaceutical formulation of PTH, comprising PTH(I -34) and a nonionic surface active agent, a dosage form comprising the formulation, a system of delivering PTH to a human, comprising exposing a layer of mucosal cells to the formulation, and a method of using such formulation for treating osteoporosis in a mammal, preferably wherein a time to maximum plasma concentration, Tmax, of PTH(I -34) following administration is less than 30 minutes. Also described is a method for treating osteoporosis in a mammal comprising administering intranasally a PTH formulation comprises a therapeutically effective amount of PTH(I -34) and one or more excipients selected from the group consisting of a solubilizing agent, a chelating agent, and one or more polyols. Comprising PTH(l-34) and a nonionic surface active agent. Also described is a use of PTH(l-34) in the manufacture of a medicament for treating osteoporosis in a mammal, wherein the medicament comprises a therapeutically effective amount of PTH(I -34) and one or more excipients selected from the group consisting of a nonionic surface active agent, a solubilizing agent, a chelating agent, and one or more polyols.
PCT/US2006/013377 2005-10-06 2006-04-10 Pth formulations and methods of use WO2007044069A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU2006299887A AU2006299887A1 (en) 2005-10-06 2006-04-10 PTH formulations and methods of use
JP2008534515A JP2009511472A (en) 2005-10-06 2006-04-10 PTH dosage form and method of use thereof
CA002625084A CA2625084A1 (en) 2005-10-06 2006-04-10 Pth formulations and methods of use
EP06749687A EP1931374A2 (en) 2005-10-06 2006-04-10 Pth formulations and methods of use
IL190583A IL190583A0 (en) 2005-10-06 2008-04-02 Pth formulations and methods of use

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US11/246,450 US20060052306A1 (en) 2004-05-10 2005-10-06 GRAS composition for enhanced mucosal delivery of parathyroid hormone
US11/246,406 US20060052305A1 (en) 2004-05-10 2005-10-06 Method of treating osteoporosis using intranasal parathyroid hormone
US11/246,406 2005-10-06
US11/246,450 2005-10-06
US11/347,551 US20060127320A1 (en) 2004-05-10 2006-02-03 Method of delivering parathyroid hormone to a human
US11/347,551 2006-02-03
US11/390,940 US20060189533A1 (en) 2004-05-10 2006-03-27 Stable pharmaceutical dosage forms of teriparatide
US11/390,940 2006-03-27

Publications (2)

Publication Number Publication Date
WO2007044069A2 WO2007044069A2 (en) 2007-04-19
WO2007044069A3 true WO2007044069A3 (en) 2009-08-27

Family

ID=36663931

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/013377 WO2007044069A2 (en) 2005-10-06 2006-04-10 Pth formulations and methods of use

Country Status (3)

Country Link
EP (1) EP1931374A2 (en)
AU (1) AU2006299887A1 (en)
WO (1) WO2007044069A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20100059858A (en) * 2007-09-11 2010-06-04 몬도바이오테크 래보래토리즈 아게 Use of rfrp, alone or in combination with neurokinin-b, as a therapeutic agent
US20100197585A1 (en) * 2007-09-11 2010-08-05 Dorian Bevec Use of a rgd-peptide and/or parathyroid hormone (1-34) as anti-hiv agent
EP2052736A1 (en) * 2007-10-26 2009-04-29 Nycomed Danmark ApS Parathyroid hormone formulations und uses thereof
KR101796604B1 (en) * 2016-08-30 2017-11-10 목포대학교 산학협력단 Oral dosage form of parathyroid hormone comprising the gastrointestinal absorption enhancer
CN110755380B (en) * 2019-11-04 2021-09-24 中国人民解放军军事科学院军事医学研究院 A kind of parathyroid hormone 1-34 nasal spray, its preparation method and use

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5578567A (en) * 1990-09-20 1996-11-26 Sandoz Ltd. Nasal pharmaceutical composition
EP0747054A2 (en) * 1995-06-06 1996-12-11 Eli Lilly And Company Methods for minimizing bone loss
EP0878201A1 (en) * 1996-02-01 1998-11-18 Chugai Seiyaku Kabushiki Kaisha Preventives and remedies for thrombocytopenia
US6416503B1 (en) * 1993-09-22 2002-07-09 Hisamitsu Pharmaceutical Co., Inc. Matrix for iontophoreses
WO2005051456A2 (en) * 2003-11-13 2005-06-09 Alza Corporation Composition and apparatus for transdermal delivery
WO2005115441A2 (en) * 2004-05-10 2005-12-08 Nastech Pharmaceutical Company Inc. Compositions and methods for enhanced mucosal delivery of parathyroid hormone
US20060052306A1 (en) * 2004-05-10 2006-03-09 Nastech Pharmaceutical Company Inc. GRAS composition for enhanced mucosal delivery of parathyroid hormone

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5578567A (en) * 1990-09-20 1996-11-26 Sandoz Ltd. Nasal pharmaceutical composition
US6416503B1 (en) * 1993-09-22 2002-07-09 Hisamitsu Pharmaceutical Co., Inc. Matrix for iontophoreses
EP0747054A2 (en) * 1995-06-06 1996-12-11 Eli Lilly And Company Methods for minimizing bone loss
EP0878201A1 (en) * 1996-02-01 1998-11-18 Chugai Seiyaku Kabushiki Kaisha Preventives and remedies for thrombocytopenia
WO2005051456A2 (en) * 2003-11-13 2005-06-09 Alza Corporation Composition and apparatus for transdermal delivery
WO2005115441A2 (en) * 2004-05-10 2005-12-08 Nastech Pharmaceutical Company Inc. Compositions and methods for enhanced mucosal delivery of parathyroid hormone
US20060052306A1 (en) * 2004-05-10 2006-03-09 Nastech Pharmaceutical Company Inc. GRAS composition for enhanced mucosal delivery of parathyroid hormone

Also Published As

Publication number Publication date
AU2006299887A1 (en) 2007-04-19
WO2007044069A2 (en) 2007-04-19
EP1931374A2 (en) 2008-06-18

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