WO2006014965A3 - Preparation pharmaceutique et processus - Google Patents
Preparation pharmaceutique et processus Download PDFInfo
- Publication number
- WO2006014965A3 WO2006014965A3 PCT/US2005/026506 US2005026506W WO2006014965A3 WO 2006014965 A3 WO2006014965 A3 WO 2006014965A3 US 2005026506 W US2005026506 W US 2005026506W WO 2006014965 A3 WO2006014965 A3 WO 2006014965A3
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- lyophilization
- protein
- bulking agent
- saccharide
- agent
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 238000004108 freeze drying Methods 0.000 abstract 6
- 239000004067 bulking agent Substances 0.000 abstract 4
- 102000004169 proteins and genes Human genes 0.000 abstract 4
- 108090000623 proteins and genes Proteins 0.000 abstract 4
- 150000001720 carbohydrates Chemical class 0.000 abstract 3
- 239000012669 liquid formulation Substances 0.000 abstract 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- 239000013543 active substance Substances 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 238000002425 crystallisation Methods 0.000 abstract 1
- 230000008025 crystallization Effects 0.000 abstract 1
- 150000002016 disaccharides Chemical class 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 1
- 229940127557 pharmaceutical product Drugs 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
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
- A61K9/14—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
- 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
- A61K47/06—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
Abstract
La présente invention concerne un processus de lyophilisation ou de déshydratation de produit congelé d'un produit pharmaceutique et une préparation liquide qui convient pour la lyophilisation. Cette invention concerne en particulier un processus de lyophilisation ou de déshydratation de produit congelé d'une préparation liquide qui comprend un agent actif protéine, un agent gonflant et un agent stabilisant saccharide. Le rapport saccharide sur agent gonflant et la concentration de protéines de cette préparation sont des facteurs importants qui ont un effet sur la cristallisation de l'agent gonflant pendant la lyophilisation et le stockage comme des conditions de traitement le sont. Dans un mode de réalisation, le saccharides est un disaccharide tels que du saccharose et l'agent gonflant cristallin est du mannitol. La protéine peut être une protéine anticorps ou non.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/626,264 US20070196364A1 (en) | 2004-07-27 | 2007-01-23 | Pharmaceutical Formulation and Process |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US59110204P | 2004-07-27 | 2004-07-27 | |
| US60/591,102 | 2004-07-27 | ||
| US67783805P | 2005-05-05 | 2005-05-05 | |
| US60/677,838 | 2005-05-05 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US11/626,264 Continuation-In-Part US20070196364A1 (en) | 2004-07-27 | 2007-01-23 | Pharmaceutical Formulation and Process |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| WO2006014965A2 WO2006014965A2 (fr) | 2006-02-09 |
| WO2006014965A9 WO2006014965A9 (fr) | 2006-03-30 |
| WO2006014965A3 true WO2006014965A3 (fr) | 2007-03-29 |
Family
ID=35787773
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2005/026506 WO2006014965A2 (fr) | 2004-07-27 | 2005-07-27 | Preparation pharmaceutique et processus |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2006014965A2 (fr) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2006272804B2 (en) * | 2005-07-22 | 2011-02-24 | Amgen Inc. | Concentrated protein lyophilates, methods, and uses |
| MX2009005984A (es) * | 2006-12-06 | 2009-06-16 | Wyeth Corp | Formulaciones con alta concentracion de proteina que contiene manitol. |
| EP2124890A2 (fr) * | 2007-02-16 | 2009-12-02 | Wyeth a Corporation of the State of Delaware | Utilisation de saccharose pour supprimer une agrégation de protéines provoquée par du mannitol |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| HUE068207T2 (hu) | 2013-11-21 | 2024-12-28 | Genmab As | Antitest-drog konjugátumkészítmény |
| CN108348579B (zh) | 2015-04-21 | 2021-04-27 | 舒泰神（北京）生物制药股份有限公司 | 神经生长因子组合物及注射粉剂 |
| EP3287140B1 (fr) | 2015-04-21 | 2021-06-02 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Composition de facteur de croissance nerveux et poudre injectable. |
| SG11201805534TA (en) | 2016-01-13 | 2018-07-30 | Genmab As | Formulation for antibody and drug conjugate thereof |
| TWI841554B (zh) | 2018-03-21 | 2024-05-11 | 丹麥商珍美寶股份有限公司 | 以鉑為主之劑與抗組織因子抗體－藥物共軛物的組合治療癌症之方法 |
| CN110606868A (zh) * | 2018-10-30 | 2019-12-24 | 中国科学院化学研究所 | 一种制备多肽或蛋白质单晶或无定型物的方法 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997004801A1 (fr) * | 1995-07-27 | 1997-02-13 | Genentech, Inc. | Formulation de proteine lyophilisee isotonique et stable |
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US20030113316A1 (en) * | 2001-07-25 | 2003-06-19 | Kaisheva Elizabet A. | Stable lyophilized pharmaceutical formulation of IgG antibodies |
-
2005
- 2005-07-27 WO PCT/US2005/026506 patent/WO2006014965A2/fr active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997004801A1 (fr) * | 1995-07-27 | 1997-02-13 | Genentech, Inc. | Formulation de proteine lyophilisee isotonique et stable |
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US20030113316A1 (en) * | 2001-07-25 | 2003-06-19 | Kaisheva Elizabet A. | Stable lyophilized pharmaceutical formulation of IgG antibodies |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2006014965A9 (fr) | 2006-03-30 |
| WO2006014965A2 (fr) | 2006-02-09 |
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