WO2007044375A3 - Pth formulations and methods of use - Google Patents

Pth formulations and methods of use Download PDF

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Publication number
WO2007044375A3
WO2007044375A3 PCT/US2006/038735 US2006038735W WO2007044375A3 WO 2007044375 A3 WO2007044375 A3 WO 2007044375A3 US 2006038735 W US2006038735 W US 2006038735W WO 2007044375 A3 WO2007044375 A3 WO 2007044375A3
Authority
WO
WIPO (PCT)
Prior art keywords
pth
methods
formulation
mammal
treating osteoporosis
Prior art date
Application number
PCT/US2006/038735
Other languages
French (fr)
Other versions
WO2007044375A2 (en
Inventor
Henry R Costantino
Steven C Quay
Michael V Templin
Ching-Yuan Li
Anthony P Sileno
Kristin B Prinn
Original Assignee
Nastech Pharm Co
Henry R Costantino
Steven C Quay
Michael V Templin
Ching-Yuan Li
Anthony P Sileno
Kristin B Prinn
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 US11/246,406 external-priority patent/US20060052305A1/en
Priority claimed from US11/246,450 external-priority patent/US20060052306A1/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 Pharm Co, Henry R Costantino, Steven C Quay, Michael V Templin, Ching-Yuan Li, Anthony P Sileno, Kristin B Prinn filed Critical Nastech Pharm Co
Publication of WO2007044375A2 publication Critical patent/WO2007044375A2/en
Publication of WO2007044375A3 publication Critical patent/WO2007044375A3/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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Otolaryngology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

What is described is an aqueous pharmaceutical formulation of PTH, comprising a therapeutically effective amount of PTH(l-34) and one or more excipients selected from the group consisting of a solubilizing agent, a chelating agent, one or more polyols, and a nonionic surface active agent, a method of using such formulation for treating osteoporosis in a mammal by intranasal administration, and use of PTH(I -34) in the manufacture of such formulation for treating osteoporosis in a mammal.
PCT/US2006/038735 2005-10-06 2006-10-03 Pth formulations and methods of use WO2007044375A2 (en)

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US11/246,406 2005-10-06
US11/246,406 US20060052305A1 (en) 2004-05-10 2005-10-06 Method of treating osteoporosis using intranasal parathyroid hormone
US11/246,450 2005-10-06
US11/246,450 US20060052306A1 (en) 2004-05-10 2005-10-06 GRAS composition for enhanced mucosal delivery of parathyroid hormone
US73826405P 2005-11-17 2005-11-17
US60/738,264 2005-11-17
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
US80676006P 2006-07-07 2006-07-07
US60/806,760 2006-07-07

Publications (2)

Publication Number Publication Date
WO2007044375A2 WO2007044375A2 (en) 2007-04-19
WO2007044375A3 true WO2007044375A3 (en) 2007-12-06

Family

ID=37758552

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/038735 WO2007044375A2 (en) 2005-10-06 2006-10-03 Pth formulations and methods of use

Country Status (1)

Country Link
WO (1) WO2007044375A2 (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8506934B2 (en) 2005-04-29 2013-08-13 Robert I. Henkin Methods for detection of biological substances
WO2008095136A2 (en) 2007-01-31 2008-08-07 Henkin Robert I Methods for detection of biological substances
EP2052736A1 (en) * 2007-10-26 2009-04-29 Nycomed Danmark ApS Parathyroid hormone formulations und uses thereof
US8580801B2 (en) 2008-07-23 2013-11-12 Robert I. Henkin Phosphodiesterase inhibitor treatment
PL2328601T3 (en) 2008-08-15 2020-07-13 Ironwood Pharmaceuticals, Inc. Linaclotide-containing formulations for oral administration
WO2011017502A2 (en) 2009-08-06 2011-02-10 Ironwood Pharmaceuticals, Inc. Linaclotide-containing formulations for oral administration
UA108636C2 (en) 2010-02-17 2015-05-25 PEPTIDE
SI2603232T1 (en) 2010-08-11 2020-03-31 Ironwood Pharmaceuticals, Inc. Stable formulations of linaclotide
JP6312592B2 (en) 2011-08-17 2018-04-18 アイアンウッド ファーマシューティカルズ インコーポレイテッド Treatment of digestive disorders
WO2014055801A1 (en) * 2012-10-05 2014-04-10 Henkin Robert I Phosphodiesterase inhibitors for treating taste and smell disorders
WO2014143453A1 (en) * 2013-03-15 2014-09-18 Henkin Robert I Phosphodiesterase inhibitor treatment
EP3108245B1 (en) 2014-02-18 2020-07-22 Robert I. Henkin Methods and compositions for diagnosing and treating loss and/or distortion of taste or smell
WO2019059302A1 (en) * 2017-09-22 2019-03-28 旭化成ファーマ株式会社 Teriparatide-containing liquid pharmaceutical composition having excellent stability

Citations (8)

* 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
US20060189533A1 (en) * 2004-05-10 2006-08-24 Nastech Pharmaceutical Company Inc. Stable pharmaceutical dosage forms of teriparatide

Patent Citations (8)

* 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
US20060189533A1 (en) * 2004-05-10 2006-08-24 Nastech Pharmaceutical Company Inc. Stable pharmaceutical dosage forms of teriparatide

Also Published As

Publication number Publication date
WO2007044375A2 (en) 2007-04-19

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