DK0735896T3 - Parathyroideahormonformulering - Google Patents

Parathyroideahormonformulering

Info

Publication number
DK0735896T3
DK0735896T3 DK95903732T DK95903732T DK0735896T3 DK 0735896 T3 DK0735896 T3 DK 0735896T3 DK 95903732 T DK95903732 T DK 95903732T DK 95903732 T DK95903732 T DK 95903732T DK 0735896 T3 DK0735896 T3 DK 0735896T3
Authority
DK
Denmark
Prior art keywords
parathyroid hormone
hormone formulation
excipient
buffering agent
formulation
Prior art date
Application number
DK95903732T
Other languages
Danish (da)
English (en)
Inventor
Josephus Johannes Mar Holthuis
Albert Mekking
Alwinus Antonius Voetman
Original Assignee
Nps Allelix Corp
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 Nps Allelix Corp filed Critical Nps Allelix Corp
Application granted granted Critical
Publication of DK0735896T3 publication Critical patent/DK0735896T3/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/29Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Obesity (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Nutrition Science (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
DK95903732T 1993-12-23 1994-12-16 Parathyroideahormonformulering DK0735896T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/172,206 US5496801A (en) 1993-12-23 1993-12-23 Parathyroid hormone formulation
PCT/CA1994/000693 WO1995017207A1 (en) 1993-12-23 1994-12-16 Parathyroid hormone formulation

Publications (1)

Publication Number Publication Date
DK0735896T3 true DK0735896T3 (da) 2008-02-04

Family

ID=22626763

Family Applications (1)

Application Number Title Priority Date Filing Date
DK95903732T DK0735896T3 (da) 1993-12-23 1994-12-16 Parathyroideahormonformulering

Country Status (23)

Country Link
US (1) US5496801A (ja)
EP (2) EP0735896B1 (ja)
JP (1) JP3065662B2 (ja)
KR (1) KR100398461B1 (ja)
CN (1) CN1116897C (ja)
AT (1) ATE374621T1 (ja)
AU (1) AU681737B2 (ja)
BR (1) BR9408398A (ja)
CA (1) CA2179207C (ja)
CZ (1) CZ184296A3 (ja)
DE (1) DE69435033T2 (ja)
DK (1) DK0735896T3 (ja)
ES (1) ES2293637T3 (ja)
FI (1) FI120291B (ja)
HK (1) HK1010336A1 (ja)
HU (1) HUT74381A (ja)
LV (1) LV11731B (ja)
NO (1) NO324905B1 (ja)
NZ (1) NZ277463A (ja)
PL (1) PL315158A1 (ja)
PT (1) PT735896E (ja)
SK (1) SK82896A3 (ja)
WO (1) WO1995017207A1 (ja)

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US5563122A (en) * 1991-12-09 1996-10-08 Asahi Kasei Kogyo Kabushiki Kaisha Stabilized parathyroid hormone composition
US6509316B2 (en) * 1995-03-07 2003-01-21 George Washington University Pharmaceutical compositions, methods, and kits for treatment and diagnosis of lung cancer
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AU8356198A (en) * 1997-07-22 1999-02-16 Chugai Seiyaku Kabushiki Kaisha Dental remedies containing pth
US6770623B1 (en) * 1997-12-09 2004-08-03 Eli Lilly And Company Stabilized teriparatide solutions
ZA9811127B (en) * 1997-12-09 2000-07-11 Lilly Co Eli Stabilized teriparatide solutions.
US6590081B1 (en) * 1997-12-18 2003-07-08 Eli Lilly And Company Crystalline teriparatide
SE9801495D0 (sv) * 1998-04-28 1998-04-28 Astra Ab Protein formulationa
JP4486256B2 (ja) * 1998-10-22 2010-06-23 ザ・ジェネラル・ホスピタル・コーポレイション 副甲状腺ホルモン(PTH)および副甲状腺ホルモン関連ペプチド(PTHrP)の生物活性ペプチドおよびペプチド誘導体
WO2000032771A1 (en) * 1998-11-30 2000-06-08 The General Hospital Corporation Pth1r and pth3r receptors, methods and uses thereof
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US6689566B1 (en) 1999-01-14 2004-02-10 Scantibodies Laboratory, Inc. Methods, kits, and antibodies for detecting parathyroid hormone
US20080108086A1 (en) * 1999-06-02 2008-05-08 Cantor Thomas L Parathyroid hormone antagonists and uses thereof
US7893021B2 (en) * 1999-06-02 2011-02-22 Scantibodies Laboratory, Inc. Parathyroid hormone antagonists and uses thereof
MXPA02000404A (es) * 1999-07-12 2004-05-21 Grandis Biotech Gmbh Formulaciones de hormona de crecimiento.
WO2001023521A2 (en) * 1999-09-29 2001-04-05 The General Hospital Corporation Polypeptide derivatives of parathyroid hormone (pth)
AU783952B2 (en) 2000-02-04 2006-01-05 Unigene Laboratories, Inc. Nasal calcitonin formulations
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US6387711B1 (en) * 2000-08-11 2002-05-14 Quest Diagnostics Investments Incorporated Liquid intact parathyroid hormone (PTH) standards
US6905886B2 (en) * 2000-08-11 2005-06-14 Quest Diagnostics Investments Incorporated Preservative solutions
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WO2003009804A2 (en) 2001-07-23 2003-02-06 The General Hospital Corporation Conformationally constrained parathyroid hormone (pth) analogs
WO2004022033A1 (en) * 2002-09-04 2004-03-18 Microchips, Inc. Method and device for the controlled delivery of parathyroid hormone
US20040067526A1 (en) * 2002-10-03 2004-04-08 Cantor Thomas L. Methods for diagnosing and guiding treatment of bone turnover disease
WO2004093902A1 (en) * 2003-03-19 2004-11-04 The General Hospital Corporation CONFORMATIONALLY CONSTRAINED PARATHYROID HORMONES WITH α-HELIX STABILIZERS
EP1638523B8 (en) * 2003-06-30 2013-12-25 ALZA Corporation Formulations for coated microprojections containing non-volatile counterions
KR100540659B1 (ko) * 2003-07-02 2006-01-10 삼성전자주식회사 이미지 확대 인쇄 방법과 장치 및 컴퓨터 프로그램을저장하는 컴퓨터로 읽을 수 있는 기록 매체
WO2005014034A1 (en) * 2003-07-14 2005-02-17 Nps Allelix Corp. Stabilized formulation of parathyroid hormone
WO2005009358A2 (en) 2003-07-17 2005-02-03 The General Hospital Corporation Conformationally constrained parathyroid hormone (pth) analogs
US7459276B2 (en) * 2003-09-29 2008-12-02 Scantibodies Laboratory, Inc. Methods and controls for monitoring assay quality and accuracy in parathyroid hormone measurement
US20050119183A1 (en) * 2003-11-12 2005-06-02 Nps Allelix Corp. Method for treating bone loss using parathyroid hormone
AU2004292954A1 (en) * 2003-11-13 2005-06-09 Alza Corporation Composition and apparatus for transdermal delivery
CN100406059C (zh) * 2004-04-30 2008-07-30 陈新梅 甲状旁腺激素的新用途
AU2005244734A1 (en) * 2004-05-13 2005-12-01 Alza Corporation Apparatus and method for transdermal delivery of parathyroid hormone agents
US7541140B2 (en) * 2004-06-03 2009-06-02 Scantibodies Laboratory, Inc. Assessing risk for kidney stones using parathyroid hormone agonist and antagonist
US20080076975A1 (en) * 2005-01-25 2008-03-27 Microchips, Inc. Method and implantable device with reservoir array for pre-clinical in vivo testing
US7488316B2 (en) * 2005-01-25 2009-02-10 Microchips, Inc. Control of drug release by transient modification of local microenvironments
KR100700869B1 (ko) 2005-06-03 2007-03-29 재단법인 목암생명공학연구소 Pth, 완충제 및 안정제를 포함하는 안정한 pth조성물
WO2007059470A2 (en) * 2005-11-10 2007-05-24 Board Of Control Of Michigan Technological University Black bear parathyroid hormone and methods of using black bear parathyroid hormone
WO2008019062A2 (en) * 2006-08-04 2008-02-14 The General Hospital Corporation Polypeptide derivatives of parathyroid hormone (pth)
EP1961765A1 (en) * 2006-12-08 2008-08-27 Zealand Pharma A/S Truncated PTH peptides with a cyclic conformation
US8568737B2 (en) 2007-08-01 2013-10-29 The General Hospital Corporation Screening methods using G-protein coupled receptors and related compositions
EP2173768B1 (en) * 2007-08-09 2014-03-05 USV Limited Novel orthogonal process for purification of recombinant human parathyroid hormone (rhpth) (1-34)
JP2009091363A (ja) * 2008-11-21 2009-04-30 Asahi Kasei Pharma Kk Pthの安定化水溶液注射剤
JP2013512688A (ja) 2009-12-07 2013-04-18 ミシガン テクノロジカル ユニバーシティ クロクマの副甲状腺ホルモン及びクロクマの副甲状腺ホルモンを使用する方法
JP5941040B2 (ja) 2010-05-13 2016-06-29 ザ ジェネラル ホスピタル コーポレイション 副甲状腺ホルモン類似体およびその使用
CN103442695B (zh) * 2011-03-10 2016-05-04 Xeris药物公司 肠胃外注射用肽药物的稳定制剂
KR101792473B1 (ko) * 2011-06-07 2017-10-31 아사히 가세이 파마 가부시키가이샤 고순도 pth 함유 동결 건조 제제 및 그의 제조 방법
JP2016512839A (ja) 2013-03-15 2016-05-09 シヴィダ・ユーエス・インコーポレイテッドPsivida Us, Inc. 治療物質の送達のための生体内分解性ケイ素系組成物
CN103301058A (zh) * 2013-06-17 2013-09-18 深圳翰宇药业股份有限公司 一种特立帕肽注射用组合物及其制备方法和制剂
JP7399382B2 (ja) * 2018-07-30 2023-12-18 武田薬品工業株式会社 組換えヒト副甲状腺ホルモンの安定性を向上させるための製剤
CN110917150A (zh) * 2019-12-31 2020-03-27 北京博康健基因科技有限公司 一种pth冻干制剂及其制备方法
EP4110370A4 (en) * 2020-03-30 2023-06-07 Sichuan Luzhou Buchang Bio-Pharmaceutical Co., Ltd. FORMULATIONS OF HUMAN PARATHYROID HORMONE (PTH) AND METHODS OF MANUFACTURE THEREOF

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Also Published As

Publication number Publication date
NO324905B1 (no) 2007-12-27
DE69435033T2 (de) 2008-05-29
CZ184296A3 (en) 1997-01-15
CA2179207C (en) 2000-11-14
EP1880732A1 (en) 2008-01-23
PT735896E (pt) 2007-12-07
CN1142772A (zh) 1997-02-12
NO962634D0 (no) 1996-06-20
HUT74381A (en) 1996-12-30
ATE374621T1 (de) 2007-10-15
AU1269895A (en) 1995-07-10
EP0735896B1 (en) 2007-10-03
NZ277463A (en) 1997-03-24
LV11731A (lv) 1997-04-20
FI962593A0 (fi) 1996-06-20
FI962593A (fi) 1996-08-19
AU681737B2 (en) 1997-09-04
ES2293637T3 (es) 2008-03-16
WO1995017207A1 (en) 1995-06-29
CA2179207A1 (en) 1995-06-29
FI120291B (fi) 2009-09-15
HU9601721D0 (en) 1996-08-28
SK82896A3 (en) 1997-01-08
KR100398461B1 (ko) 2004-03-20
EP0735896A1 (en) 1996-10-09
BR9408398A (pt) 1997-08-12
US5496801A (en) 1996-03-05
DE69435033D1 (de) 2007-11-15
JPH09506869A (ja) 1997-07-08
PL315158A1 (en) 1996-10-14
HK1010336A1 (en) 1999-06-17
NO962634L (no) 1996-06-20
JP3065662B2 (ja) 2000-07-17
CN1116897C (zh) 2003-08-06
LV11731B (en) 1997-08-20

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