RU2014133818A - Стабилизированный состав pth - Google Patents

Стабилизированный состав pth Download PDF

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Publication number
RU2014133818A
RU2014133818A RU2014133818A RU2014133818A RU2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A
Authority
RU
Russia
Prior art keywords
pharmaceutical composition
mannitol
stabilizer
lactate
parenteral administration
Prior art date
Application number
RU2014133818A
Other languages
English (en)
Russian (ru)
Inventor
Ваибхав Дньянешвар ДЕОКАР
Анджали Деепак Апте-Дешпанде
Шеетал Арвинд РАУТ
Баладжи ДАМОДАРАН
Сайрус КАРКАРИА
Original Assignee
Люпин Лимитед
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 Люпин Лимитед filed Critical Люпин Лимитед
Publication of RU2014133818A publication Critical patent/RU2014133818A/ru

Links

Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
RU2014133818A 2012-01-20 2013-01-19 Стабилизированный состав pth RU2014133818A (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN53/KOL/2012 2012-01-20
IN53KO2012 2012-01-20
PCT/IB2013/050503 WO2013108235A1 (en) 2012-01-20 2013-01-19 Stabilized pth formulation

Publications (1)

Publication Number Publication Date
RU2014133818A true RU2014133818A (ru) 2016-03-20

Family

ID=47714479

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2014133818A RU2014133818A (ru) 2012-01-20 2013-01-19 Стабилизированный состав pth

Country Status (12)

Country Link
US (1) US20150011473A1 (enExample)
EP (1) EP2804622A1 (enExample)
JP (1) JP2015504087A (enExample)
AU (1) AU2013210689A1 (enExample)
BR (1) BR112014017424A8 (enExample)
CA (1) CA2862776A1 (enExample)
IN (1) IN2014MN01470A (enExample)
MX (1) MX2014008668A (enExample)
PH (1) PH12014501658A1 (enExample)
RU (1) RU2014133818A (enExample)
WO (1) WO2013108235A1 (enExample)
ZA (1) ZA201404918B (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI3423103T1 (sl) 2016-03-01 2024-12-31 Ascendis Pharma Bone Diseases A/S Predzdravila PTH
JP7039574B2 (ja) 2016-09-29 2022-03-22 アセンディス ファーマ ボーン ディジージズ エー/エス 放出制御pth化合物の漸増用量設定
HUE063235T2 (hu) 2016-09-29 2024-01-28 Ascendis Pharma Bone Diseases As Adagolási rendszer szabályozott leadású PTH vegyülethez
GB201706781D0 (en) 2017-04-28 2017-06-14 Univ Sheffield Parathyroid hormone fusion polypeptide
WO2019059303A1 (ja) 2017-09-22 2019-03-28 旭化成ファーマ株式会社 薬物動態及び/又は安全性に優れるテリパラチド含有液状医薬組成物
JP2019060866A (ja) * 2017-09-22 2019-04-18 旭化成ファーマ株式会社 液状医薬組成物の体内動態を予測する方法
US20200289621A1 (en) * 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent stability
JP2019156805A (ja) * 2018-03-16 2019-09-19 ナガセ医薬品株式会社 容器充填ヒトpth(1−34)液体医薬組成物及びその製造方法
KR20210038618A (ko) * 2018-07-30 2021-04-07 샤이어-엔피에스 파마슈티칼즈, 인크. 재조합 인간 부갑상선 호르몬의 개선된 안정성을 위한 제형
AU2020221491B2 (en) * 2019-02-11 2025-02-27 Ascendis Pharma Bone Diseases A/S Liquid pharmaceutical formulations of PTH conjugates
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
WO2021195877A1 (en) * 2020-03-30 2021-10-07 Sichuan Luzhou Buchang Bio-Pharmaceutical Co., Ltd. Formulations of human parathyroid hormone (pth) and methods for producing same
JP6947946B1 (ja) * 2020-05-11 2021-10-13 旭化成ファーマ株式会社 テリパラチド又はその塩を含有する安定な液状医薬製剤
TWI888383B (zh) * 2020-06-19 2025-07-01 丹麥商阿森迪斯藥物骨疾病股份有限公司 Pth綴合物的液體藥物製劑
TWI919913B (zh) 2020-06-19 2026-03-21 丹麥商阿森迪斯藥物骨疾病股份有限公司 Pth綴合物的液體藥物製劑

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6770623B1 (en) 1997-12-09 2004-08-03 Eli Lilly And Company Stabilized teriparatide solutions
US20030059376A1 (en) * 1999-06-04 2003-03-27 Libbey Miles A. Formulations comprising dehydrated particles of pharmaceutical agents and process for preparing the same
BRPI0514408B8 (pt) * 2004-08-24 2021-05-25 Asubio Pharma Co Ltd preparação liquida de peptídeo fisiologicamente ativo
KR100700869B1 (ko) 2005-06-03 2007-03-29 재단법인 목암생명공학연구소 Pth, 완충제 및 안정제를 포함하는 안정한 pth조성물
GB0700523D0 (en) * 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins

Also Published As

Publication number Publication date
CA2862776A1 (en) 2013-07-25
BR112014017424A2 (pt) 2017-06-13
BR112014017424A8 (pt) 2017-07-04
WO2013108235A1 (en) 2013-07-25
EP2804622A1 (en) 2014-11-26
US20150011473A1 (en) 2015-01-08
JP2015504087A (ja) 2015-02-05
PH12014501658A1 (en) 2014-10-13
AU2013210689A1 (en) 2014-07-31
ZA201404918B (en) 2016-01-27
IN2014MN01470A (enExample) 2015-04-17
MX2014008668A (es) 2014-10-06

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