CA2729972C - Lyophilization above collapse - Google Patents
Lyophilization above collapse Download PDFInfo
- Publication number
- CA2729972C CA2729972C CA2729972A CA2729972A CA2729972C CA 2729972 C CA2729972 C CA 2729972C CA 2729972 A CA2729972 A CA 2729972A CA 2729972 A CA2729972 A CA 2729972A CA 2729972 C CA2729972 C CA 2729972C
- Authority
- CA
- Canada
- Prior art keywords
- collapse
- temperature
- pharmaceutical substance
- lyophilized
- primary drying
- Prior art date
- Legal status (The legal status 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 status listed.)
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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
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US8642608P | 2008-08-05 | 2008-08-05 | |
| US61/086,426 | 2008-08-05 | ||
| PCT/US2009/052852 WO2010017296A1 (en) | 2008-08-05 | 2009-08-05 | Lyophilization above collapse |
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| CA2729972A1 CA2729972A1 (en) | 2010-02-11 |
| CA2729972C true CA2729972C (en) | 2018-11-20 |
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| AU2007305255A1 (en) * | 2006-10-03 | 2008-04-10 | Wyeth | Lyophilization methods and apparatuses |
| AU2007234612B2 (en) * | 2006-12-14 | 2013-06-27 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein stabilization formulations |
| US7678764B2 (en) | 2007-06-29 | 2010-03-16 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein formulations for use at elevated temperatures |
| US8058237B2 (en) | 2007-08-07 | 2011-11-15 | Advanced Technologies & Regenerative Medicine, LLC | Stable composition of GDF-5 and method of storage |
| CN102026619A (zh) * | 2008-04-14 | 2011-04-20 | 先进科技及再生医学有限责任公司 | 液体缓冲的gdf-5制剂 |
| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
| CN105189559B (zh) | 2013-03-15 | 2021-07-13 | 塔科达有限责任公司 | 抗体制剂及其用途 |
| WO2014144549A1 (en) | 2013-03-15 | 2014-09-18 | Biogen Idec Ma Inc. | Factor ix polypeptide formulations |
| SG10201913735SA (en) | 2014-03-24 | 2020-03-30 | Bioverativ Therapeutics Inc | Lyophilized factor ix formulations |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| EP3323410A1 (en) * | 2016-11-22 | 2018-05-23 | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.a. | Pharmaceutical parenteral formulation containing carglumic acid |
| CN107543373B (zh) * | 2017-09-06 | 2019-04-26 | 华派生物工程集团有限公司 | 一种活疫苗的冷冻干燥方法 |
| KR20210021299A (ko) | 2018-05-10 | 2021-02-25 | 리제너론 파아마슈티컬스, 인크. | 고농도 vegf 수용체 융합 단백질 함유 제제 |
| CN109369821B (zh) * | 2018-11-28 | 2021-12-14 | 四川恒通动保生物科技有限公司 | 一种黄芪多糖的高效提取制备方法 |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| US11525629B2 (en) * | 2020-02-04 | 2022-12-13 | Regeneron Pharmaceuticals, Inc. | Target residual moisture content for lyophilized drug product |
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| US5298261A (en) | 1992-04-20 | 1994-03-29 | Oregon Freeze Dry, Inc. | Rapidly distintegrating tablet |
| BR9507909A (pt) * | 1994-06-03 | 1997-08-12 | Procter & Gamble | Formas de dosagem de rápida dissolução |
| RU2111426C1 (ru) | 1995-11-03 | 1998-05-20 | Государственный научный центр вирусологии и биотехнологии "Вектор" | Способ лиофильной сушки биопрепарата |
| ES2253877T3 (es) | 1998-03-03 | 2006-06-01 | SHIONOGI & CO., LTD. | Composiciones farmaceuticas que contienen el inhibidor de fosfolipasa((3-(2-amino-1,2-dioxoetil)-2-etil-1-(fenilmetil)-1h-indol-4-il)oxi)acetato de sodio. |
| EP2193809B1 (en) * | 1999-02-22 | 2015-04-08 | University of Connecticut | Albumin-free factor VIII formulations |
| GB9908014D0 (en) * | 1999-04-08 | 1999-06-02 | Scherer Corp R P | Pharmaceutical compositions |
| GB0404586D0 (en) * | 2004-03-01 | 2004-04-07 | Britannia Pharmaceuticals Ltd | Improvements in or relating to organic materials |
| CA2569276C (en) | 2004-06-02 | 2018-01-23 | Victor Bronshtein | Preservation by vaporization |
| US7632491B2 (en) * | 2004-08-12 | 2009-12-15 | Schering Corporation | Stable pegylated interferon formulation |
| WO2006029467A1 (en) * | 2004-09-16 | 2006-03-23 | Btf Pty Ltd | Rapid freeze drying process |
| WO2006081320A2 (en) | 2005-01-27 | 2006-08-03 | Human Genome Sciences, Inc. | Pharmaceutical formulation |
| CN101378782A (zh) * | 2005-12-21 | 2009-03-04 | 惠氏公司 | 粘度降低的蛋白质制剂及其用途 |
| CA2726837A1 (en) | 2008-06-26 | 2009-12-30 | Wyeth Llc | Lyophilization cycle robustness strategy |
| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
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| EP3572073C0 (en) | 2023-12-20 |
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| US9884019B2 (en) | 2018-02-06 |
| WO2010017296A1 (en) | 2010-02-11 |
| CA2729972A1 (en) | 2010-02-11 |
| EP3572073A1 (en) | 2019-11-27 |
| JP2011530524A (ja) | 2011-12-22 |
| ES2968301T3 (es) | 2024-05-08 |
| ES2755029T3 (es) | 2020-04-21 |
| EP2323629B1 (en) | 2019-10-09 |
| EP3572073B1 (en) | 2023-12-20 |
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