BR112014017424A8 - formulação farmacêutica aquosa estabilizada e método para tratar osteoporose - Google Patents
formulação farmacêutica aquosa estabilizada e método para tratar osteoporoseInfo
- Publication number
- BR112014017424A8 BR112014017424A8 BR112014017424A BR112014017424A BR112014017424A8 BR 112014017424 A8 BR112014017424 A8 BR 112014017424A8 BR 112014017424 A BR112014017424 A BR 112014017424A BR 112014017424 A BR112014017424 A BR 112014017424A BR 112014017424 A8 BR112014017424 A8 BR 112014017424A8
- Authority
- BR
- Brazil
- Prior art keywords
- pharmaceutical formulation
- aqueous pharmaceutical
- stabilized aqueous
- treating osteoporosis
- parathyroid hormone
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 5
- 208000001132 Osteoporosis Diseases 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 101001135770 Homo sapiens Parathyroid hormone Proteins 0.000 abstract 3
- 101001135995 Homo sapiens Probable peptidyl-tRNA hydrolase Proteins 0.000 abstract 3
- 102000058004 human PTH Human genes 0.000 abstract 3
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 abstract 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 abstract 2
- 229930195712 glutamate Natural products 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 238000007911 parenteral administration Methods 0.000 abstract 1
- 239000003755 preservative agent Substances 0.000 abstract 1
- 230000002335 preservative effect Effects 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
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)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Dermatology (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)
Abstract
resumo formulação farmacêutica aquosa estabilizada e método para tratar osteoporose trata-se de formulações farmacêuticas estáveis que compreendem hormônio paratireoide humano. a formulação farmacêutica aquosa estabilizada compreende hormônio paratireoide humano e um tampão selecionado a partir de lactato ou glutamato. em outra modalidade, é fornecida uma formulação farmacêutica aquosa estabilizada compreende hormônio paratireoide humano selecionado a partir do grupo de (1-34), (1-37), (1-38), (1-41), um tampão selecionado a partir de lactato ou glutamato, um agente estabilizante e um conservante parenteralmente aceitável, em que a dita formulação é estéril e está pronta para administração parenteral e que tem ph na faixa de 3 a 7. 1/1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN53KO2012 | 2012-01-20 | ||
| PCT/IB2013/050503 WO2013108235A1 (en) | 2012-01-20 | 2013-01-19 | Stabilized pth formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112014017424A2 BR112014017424A2 (pt) | 2017-06-13 |
| BR112014017424A8 true BR112014017424A8 (pt) | 2017-07-04 |
Family
ID=47714479
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112014017424A BR112014017424A8 (pt) | 2012-01-20 | 2013-01-19 | formulação farmacêutica aquosa estabilizada e método para tratar osteoporose |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20150011473A1 (pt) |
| EP (1) | EP2804622A1 (pt) |
| JP (1) | JP2015504087A (pt) |
| AU (1) | AU2013210689A1 (pt) |
| BR (1) | BR112014017424A8 (pt) |
| CA (1) | CA2862776A1 (pt) |
| IN (1) | IN2014MN01470A (pt) |
| MX (1) | MX2014008668A (pt) |
| PH (1) | PH12014501658A1 (pt) |
| RU (1) | RU2014133818A (pt) |
| WO (1) | WO2013108235A1 (pt) |
| ZA (1) | ZA201404918B (pt) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201706781D0 (en) | 2017-04-28 | 2017-06-14 | Univ Sheffield | Parathyroid hormone fusion polypeptide |
| EP3685850A4 (en) | 2017-09-22 | 2021-06-16 | Asahi Kasei Pharma Corporation | LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TRIPARATIDE WITH EXCELLENT PHARMACODYNAMIC PROPERTIES AND / OR STABILITY |
| 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 |
| CA3075977A1 (en) * | 2017-09-22 | 2019-03-28 | 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 |
| 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 |
| CN113423383A (zh) * | 2019-02-11 | 2021-09-21 | 阿森迪斯药物骨疾病股份有限公司 | Pth缀合物的液体药物制剂 |
| 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 |
| CN115279396A (zh) * | 2020-03-30 | 2022-11-01 | 四川泸州步长生物制药有限公司 | 人类甲状旁腺激素(pth)的制剂及用于生产其的方法 |
| WO2021229835A1 (ja) * | 2020-05-11 | 2021-11-18 | 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 |
| 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 |
Family Cites Families (5)
| 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 |
| JP4951344B2 (ja) * | 2004-08-24 | 2012-06-13 | 第一三共株式会社 | 生理活性ペプチド液状製剤 |
| 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 |
-
2013
- 2013-01-19 RU RU2014133818A patent/RU2014133818A/ru unknown
- 2013-01-19 US US14/373,288 patent/US20150011473A1/en not_active Abandoned
- 2013-01-19 IN IN1470MUN2014 patent/IN2014MN01470A/en unknown
- 2013-01-19 JP JP2014552739A patent/JP2015504087A/ja active Pending
- 2013-01-19 MX MX2014008668A patent/MX2014008668A/es unknown
- 2013-01-19 CA CA2862776A patent/CA2862776A1/en not_active Abandoned
- 2013-01-19 WO PCT/IB2013/050503 patent/WO2013108235A1/en active Application Filing
- 2013-01-19 BR BR112014017424A patent/BR112014017424A8/pt not_active Application Discontinuation
- 2013-01-19 EP EP13704232.1A patent/EP2804622A1/en not_active Withdrawn
- 2013-01-19 AU AU2013210689A patent/AU2013210689A1/en not_active Abandoned
-
2014
- 2014-07-04 ZA ZA2014/04918A patent/ZA201404918B/en unknown
- 2014-07-18 PH PH12014501658A patent/PH12014501658A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PH12014501658A1 (en) | 2014-10-13 |
| EP2804622A1 (en) | 2014-11-26 |
| IN2014MN01470A (pt) | 2015-04-17 |
| BR112014017424A2 (pt) | 2017-06-13 |
| US20150011473A1 (en) | 2015-01-08 |
| ZA201404918B (en) | 2016-01-27 |
| CA2862776A1 (en) | 2013-07-25 |
| RU2014133818A (ru) | 2016-03-20 |
| WO2013108235A1 (en) | 2013-07-25 |
| MX2014008668A (es) | 2014-10-06 |
| JP2015504087A (ja) | 2015-02-05 |
| AU2013210689A1 (en) | 2014-07-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B11A | Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing | ||
| B11Y | Definitive dismissal acc. article 33 of ipl - extension of time limit for request of examination expired | ||
| B350 | Update of information on the portal [chapter 15.35 patent gazette] |