DK3102184T3 - Stabile formuleringer af peptider og fremgangsmåder til fremstilling - Google Patents
Stabile formuleringer af peptider og fremgangsmåder til fremstilling Download PDFInfo
- Publication number
- DK3102184T3 DK3102184T3 DK15706976.6T DK15706976T DK3102184T3 DK 3102184 T3 DK3102184 T3 DK 3102184T3 DK 15706976 T DK15706976 T DK 15706976T DK 3102184 T3 DK3102184 T3 DK 3102184T3
- Authority
- DK
- Denmark
- Prior art keywords
- peptides
- procedures
- preparation
- stable formulations
- formulations
- Prior art date
Links
- 238000000034 method Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 102000004196 processed proteins & peptides Human genes 0.000 title 1
- 108090000765 processed proteins & peptides Proteins 0.000 title 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
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
-
- 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
-
- 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
- A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
-
- 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
- A61K38/26—Glucagons
-
- 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
- A61K38/28—Insulins
-
- 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
- A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
-
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
- A61K38/4893—Botulinum neurotoxin (3.4.24.69)
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- 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
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Biochemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461936675P | 2014-02-06 | 2014-02-06 | |
| PCT/US2015/014756 WO2015120231A2 (en) | 2014-02-06 | 2015-02-06 | Stable peptide formulations and methods for preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3102184T3 true DK3102184T3 (da) | 2019-05-06 |
Family
ID=52595433
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15706976.6T DK3102184T3 (da) | 2014-02-06 | 2015-02-06 | Stabile formuleringer af peptider og fremgangsmåder til fremstilling |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US20170007675A1 (enExample) |
| EP (1) | EP3102184B1 (enExample) |
| JP (1) | JP6763777B2 (enExample) |
| KR (1) | KR102327754B1 (enExample) |
| CN (1) | CN106132430A (enExample) |
| DK (1) | DK3102184T3 (enExample) |
| WO (1) | WO2015120231A2 (enExample) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012122535A2 (en) | 2011-03-10 | 2012-09-13 | Xeris Pharmaceuticals, Inc. | Stable formulations for parenteral injection of peptide drugs |
| US9125805B2 (en) | 2012-06-27 | 2015-09-08 | Xeris Pharmaceuticals, Inc. | Stable formulations for parenteral injection of small molecule drugs |
| KR102428675B1 (ko) | 2014-08-06 | 2022-08-02 | 엑스에리스 파머수티클스, 인크. | 페이스트의 피내 및／또는 피하 주사를 위한 주사기, 키트, 및 방법 |
| US9649364B2 (en) | 2015-09-25 | 2017-05-16 | Xeris Pharmaceuticals, Inc. | Methods for producing stable therapeutic formulations in aprotic polar solvents |
| US11590205B2 (en) | 2015-09-25 | 2023-02-28 | Xeris Pharmaceuticals, Inc. | Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents |
| JP7217700B2 (ja) | 2016-09-13 | 2023-02-03 | アラーガン、インコーポレイテッド | 安定化非タンパク質クロストリジウム毒素組成物 |
| CN117085022A (zh) | 2017-06-02 | 2023-11-21 | Xeris药物公司 | 抗沉淀的小分子药物制剂 |
| WO2019126753A1 (en) * | 2017-12-22 | 2019-06-27 | Xeris Pharmaceuticals, Inc. | Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes |
| CN111936159A (zh) * | 2018-01-23 | 2020-11-13 | Xeris药物公司 | 使用微剂量的稳定胰高血糖素治疗减肥术后低血糖症 |
| KR102146555B1 (ko) * | 2018-11-27 | 2020-08-20 | 국방과학연구소 | 탄저균 특이적 항균능을 갖는 약학적 조성물 및 이의 제조방법 |
| JPWO2022025093A1 (enExample) * | 2020-07-29 | 2022-02-03 | ||
| CN112353934B (zh) * | 2020-11-23 | 2023-05-19 | 中国人民解放军军事科学院军事医学研究院 | 一种芋螺毒素药物组合物及其冻干制剂 |
| JP2024149926A (ja) * | 2021-08-06 | 2024-10-23 | ブライトパス・バイオ株式会社 | がんペプチドワクチンカクテル製剤、及びその製造方法 |
| EP4398874A1 (en) | 2021-09-09 | 2024-07-17 | Xeris Pharmaceuticals, Inc. | Injectable high concentration pharmaceutical formulations and methods of manufacturing and use thereof |
| WO2025089467A1 (ko) * | 2023-10-27 | 2025-05-01 | 주식회사 엔솔바이오사이언스 | 염형태 변형 펩타이드의 제조방법 및 그를 이용하여 제조된 펩타이드 |
| WO2025089463A1 (ko) * | 2023-10-27 | 2025-05-01 | 주식회사 엔솔바이오사이언스 | 펩타이드 정제방법 및 그를 이용하여 정제된 펩타이드 |
| WO2025089465A1 (ko) * | 2023-10-27 | 2025-05-01 | 주식회사 엔솔바이오사이언스 | 펩타이드 제조방법 및 그를 이용하여 제조된 펩타이드 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5932547A (en) * | 1996-07-03 | 1999-08-03 | Alza Corporation | Non-aqueous polar aprotic peptide formulations |
| EP1589901A4 (en) * | 2002-12-20 | 2006-08-09 | Generipharm Inc | INTRAKUTANE INJECTION |
| CA2637569C (en) * | 2006-01-18 | 2013-01-08 | Yuhua Li | Pharmaceutical compositions with enhanced stability |
| US9084849B2 (en) * | 2011-01-26 | 2015-07-21 | Kaleo, Inc. | Medicament delivery devices for administration of a medicament within a prefilled syringe |
| WO2012122535A2 (en) * | 2011-03-10 | 2012-09-13 | Xeris Pharmaceuticals, Inc. | Stable formulations for parenteral injection of peptide drugs |
| JP6117811B2 (ja) * | 2011-10-31 | 2017-04-19 | ゼリス ファーマシューティカルズ インコーポレイテッド | 糖尿病を処置するための製剤 |
| US9522235B2 (en) * | 2012-05-22 | 2016-12-20 | Kaleo, Inc. | Devices and methods for delivering medicaments from a multi-chamber container |
-
2015
- 2015-02-06 WO PCT/US2015/014756 patent/WO2015120231A2/en not_active Ceased
- 2015-02-06 EP EP15706976.6A patent/EP3102184B1/en active Active
- 2015-02-06 JP JP2016550716A patent/JP6763777B2/ja active Active
- 2015-02-06 KR KR1020167023950A patent/KR102327754B1/ko active Active
- 2015-02-06 US US15/117,016 patent/US20170007675A1/en not_active Abandoned
- 2015-02-06 CN CN201580018099.0A patent/CN106132430A/zh active Pending
- 2015-02-06 DK DK15706976.6T patent/DK3102184T3/da active
Also Published As
| Publication number | Publication date |
|---|---|
| JP6763777B2 (ja) | 2020-09-30 |
| WO2015120231A8 (en) | 2015-10-29 |
| WO2015120231A3 (en) | 2015-12-23 |
| JP2017505331A (ja) | 2017-02-16 |
| US20170007675A1 (en) | 2017-01-12 |
| KR102327754B1 (ko) | 2021-11-17 |
| KR20160118292A (ko) | 2016-10-11 |
| EP3102184A2 (en) | 2016-12-14 |
| EP3102184B1 (en) | 2019-01-30 |
| WO2015120231A2 (en) | 2015-08-13 |
| CN106132430A (zh) | 2016-11-16 |
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