JP5785077B2 - 崩壊温度より高温での凍結乾燥 - Google Patents
崩壊温度より高温での凍結乾燥 Download PDFInfo
- Publication number
- JP5785077B2 JP5785077B2 JP2011522218A JP2011522218A JP5785077B2 JP 5785077 B2 JP5785077 B2 JP 5785077B2 JP 2011522218 A JP2011522218 A JP 2011522218A JP 2011522218 A JP2011522218 A JP 2011522218A JP 5785077 B2 JP5785077 B2 JP 5785077B2
- Authority
- JP
- Japan
- Prior art keywords
- temperature
- freeze
- collapse
- less
- 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.)
- Active
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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 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2011530524A JP2011530524A (ja) | 2011-12-22 |
| JP2011530524A5 JP2011530524A5 (https=) | 2012-09-13 |
| JP5785077B2 true JP5785077B2 (ja) | 2015-09-24 |
Family
ID=41401614
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011522218A Active JP5785077B2 (ja) | 2008-08-05 | 2009-08-05 | 崩壊温度より高温での凍結乾燥 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US9884019B2 (https=) |
| EP (2) | EP2323629B1 (https=) |
| JP (1) | JP5785077B2 (https=) |
| CA (1) | CA2729972C (https=) |
| ES (2) | ES2755029T3 (https=) |
| WO (1) | WO2010017296A1 (https=) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008042408A2 (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 |
| JP5323832B2 (ja) | 2007-08-07 | 2013-10-23 | アドバンスト・テクノロジーズ・アンド・リジェネレイティブ・メディスン・エルエルシー | 酸性水溶液中にgdf−5を含むタンパク質製剤 |
| BRPI0911048A2 (pt) * | 2008-04-14 | 2015-12-29 | Atrm Llc | formulações líquidas tamponadas de gdf-5 |
| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
| US11576863B2 (en) | 2013-03-15 | 2023-02-14 | Takeda Pharmaceutical Company Limited | Formulation of an antibody and use thereof |
| WO2014144549A1 (en) | 2013-03-15 | 2014-09-18 | Biogen Idec Ma Inc. | Factor ix polypeptide formulations |
| AU2015236340B2 (en) | 2014-03-24 | 2020-02-06 | 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 |
| DK4364724T3 (da) | 2018-05-10 | 2025-12-22 | Regeneron Pharma | Formuleringer med høj koncentration af VEGF-receptorfusionsprotein |
| 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 |
| BR112022015272A2 (pt) | 2020-02-04 | 2022-09-20 | Regeneron Pharma | Teor de umidade residual alvo para produto de fármaco liofilizado |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| DE69928500T2 (de) | 1998-03-03 | 2006-08-03 | Eli Lilly And Co., Indianapolis | Pharmazeutische zusammensetzung enthaltend den phospholipase inhibitor natrium-[[3-(2-amino-1,2-dioxoethyl)-2-ethyl-1-phenylmethyl)-1 h-indol-4-yl]oxy]acetat |
| DK1820516T3 (da) * | 1999-02-22 | 2013-10-28 | Univ Connecticut | Nye albuminfrie faktor VIII-præparater |
| 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 |
| EP1750760B1 (en) * | 2004-06-02 | 2017-06-28 | Universal Stabilization Technologies, Inc. | Preservation by vaporization |
| CA2576549C (en) * | 2004-08-12 | 2011-01-18 | 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 |
| BRPI0620316A2 (pt) * | 2005-12-21 | 2011-11-08 | Wyeth Corp | formulações de proteìnas com viscosidades reduzida e seus usos |
| JP2011526356A (ja) | 2008-06-26 | 2011-10-06 | ワイス・エルエルシー | 凍結乾燥サイクルのロバスト性(robustness)方策 |
| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
-
2009
- 2009-08-05 CA CA2729972A patent/CA2729972C/en active Active
- 2009-08-05 US US12/536,321 patent/US9884019B2/en active Active
- 2009-08-05 ES ES09791186T patent/ES2755029T3/es active Active
- 2009-08-05 ES ES19181153T patent/ES2968301T3/es active Active
- 2009-08-05 EP EP09791186.1A patent/EP2323629B1/en active Active
- 2009-08-05 JP JP2011522218A patent/JP5785077B2/ja active Active
- 2009-08-05 WO PCT/US2009/052852 patent/WO2010017296A1/en not_active Ceased
- 2009-08-05 EP EP19181153.8A patent/EP3572073B1/en not_active Revoked
Also Published As
| Publication number | Publication date |
|---|---|
| CA2729972C (en) | 2018-11-20 |
| EP3572073C0 (en) | 2023-12-20 |
| JP2011530524A (ja) | 2011-12-22 |
| EP2323629A1 (en) | 2011-05-25 |
| EP3572073B1 (en) | 2023-12-20 |
| WO2010017296A1 (en) | 2010-02-11 |
| ES2968301T3 (es) | 2024-05-08 |
| CA2729972A1 (en) | 2010-02-11 |
| ES2755029T3 (es) | 2020-04-21 |
| EP2323629B1 (en) | 2019-10-09 |
| EP3572073A1 (en) | 2019-11-27 |
| US20100041870A1 (en) | 2010-02-18 |
| US9884019B2 (en) | 2018-02-06 |
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