WO2006014965A3 - Pharmaceutical formulation and process - Google Patents
Pharmaceutical formulation and process 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
A process for lyophilization or freeze-drying of a pharmaceutical product is provided and a liquid formulation suitable for lyophilization. In particular, a process for lyophilization or freeze-drying a liquid formulation that includes a protein active agent, a bulking agent and a saccharide stablilizing agent is provided. The saccharide to bulking agent ratio and the protein concentration of the formulation are important factors that affect crystallization of the bulking agent during lyophilization and storage as are some processing conditions. In one embodiment, the saccharide is a disaccharide, such as sucrose and the crystalline bulking agent is mannitol. The protein can be an antibody or a non-antibody protein.
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 (en) | 2006-02-09 |
| WO2006014965A9 WO2006014965A9 (en) | 2006-03-30 |
| WO2006014965A3 true WO2006014965A3 (en) | 2007-03-29 |
Family
ID=35787773
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2005/026506 WO2006014965A2 (en) | 2004-07-27 | 2005-07-27 | Pharmaceutical formulation and process |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2006014965A2 (en) |
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 |
| WO2008070721A2 (en) * | 2006-12-06 | 2008-06-12 | Wyeth | High protein concentration formulations containing mannitol |
| JP2010519220A (en) * | 2007-02-16 | 2010-06-03 | ワイス エルエルシー | Use of sucrose to inhibit mannitol-induced protein aggregation |
| 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 |
| EP4420729A3 (en) | 2013-11-21 | 2024-10-30 | Genmab A/S | Antibody-drug conjugate formulation |
| DK3287139T3 (en) | 2015-04-21 | 2021-09-13 | Beijing Staidson Medical Tech Co Ltd | Nerve growth factor composition and injection powder |
| ES2882106T3 (en) | 2015-04-21 | 2021-12-01 | Staidson Beijing Biopharmaceuticals Co Ltd | Composition of nerve growth factor and powder for injection |
| BR112018014277A2 (en) | 2016-01-13 | 2018-12-18 | Genmab As | formulation, and method of preparing an injectable solution of an axl-adc |
| TWI841554B (en) | 2018-03-21 | 2024-05-11 | 丹麥商珍美寶股份有限公司 | Methods of treating cancer with a combination of a platinum-based agent and an anti-tissue factor antibody-drug conjugate |
| CN110606868A (en) * | 2018-10-30 | 2019-12-24 | 中国科学院化学研究所 | A method for preparing polypeptide or protein single crystal or amorphous substance |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997004801A1 (en) * | 1995-07-27 | 1997-02-13 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
| 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/en active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997004801A1 (en) * | 1995-07-27 | 1997-02-13 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
| 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 |
|---|---|
| WO2006014965A2 (en) | 2006-02-09 |
| WO2006014965A9 (en) | 2006-03-30 |
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