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
Links
Images
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 (enExample) | 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 (enExample) |
| EP (2) | EP2323629B1 (enExample) |
| JP (1) | JP5785077B2 (enExample) |
| CA (1) | CA2729972C (enExample) |
| ES (2) | ES2755029T3 (enExample) |
| WO (1) | WO2010017296A1 (enExample) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20090061033A (ko) * | 2006-10-03 | 2009-06-15 | 와이어쓰 | 동결건조 방법 및 장치 |
| 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 |
| CN101801405A (zh) | 2007-08-07 | 2010-08-11 | 先进科技及再生医学有限责任公司 | 包含于酸性水溶液中的gdf-5的蛋白质配方 |
| US7947649B2 (en) * | 2008-04-14 | 2011-05-24 | Advanced Technologies And Regenerative Medicine, Llc | Liquid buffered GDF-5 formulations |
| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
| WO2014140361A1 (en) | 2013-03-15 | 2014-09-18 | Takeda Gmbh | Formulation of an antibody and use thereof |
| TWI745671B (zh) | 2013-03-15 | 2021-11-11 | 美商百歐維拉提夫治療公司 | 因子ix多肽調配物 |
| EA038573B1 (ru) * | 2014-03-24 | 2021-09-16 | Биовератив Терапьютикс Инк. | Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения |
| 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 |
| IL318714A (en) | 2018-05-10 | 2025-03-01 | Regeneron Pharma | Formulations that include high concentrations of VEGF receptor fusion protein |
| 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 |
| JP7266108B2 (ja) | 2019-02-18 | 2023-04-27 | イーライ リリー アンド カンパニー | 治療用抗体製剤 |
| CA3168873A1 (en) | 2020-02-04 | 2021-08-12 | Regeneron Pharmaceuticals, Inc. | Target residual moisture content for lyophilized drug product |
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 |
| HUP0102812A3 (en) | 1998-03-03 | 2002-01-28 | Lilly Co Eli | Pharmaceutical compositions containing the phospholipase inhibitor sodium {[3-(2-amino-1,2-dioxoethyl)-2-ethyl-1-(phenylmethyl)-1h-indol-4-yl]oxy}acetate and process for pruducing them |
| DK2130554T3 (da) * | 1999-02-22 | 2012-12-03 | Univ Connecticut | 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 |
| PL1750760T3 (pl) * | 2004-06-02 | 2018-02-28 | Universal Stabilization Technologies, Inc. | Konserwacja za pomocą parowania |
| ES2349472T3 (es) * | 2004-08-12 | 2011-01-03 | Schering Corporation | Formulación estable de interferón pegilado. |
| 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 |
| JP5405122B2 (ja) * | 2005-12-21 | 2014-02-05 | ワイス・エルエルシー | 低粘度のタンパク質製剤およびその用途 |
| 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 |
-
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 EP EP09791186.1A patent/EP2323629B1/en active Active
- 2009-08-05 ES ES19181153T patent/ES2968301T3/es active Active
- 2009-08-05 JP JP2011522218A patent/JP5785077B2/ja active Active
- 2009-08-05 EP EP19181153.8A patent/EP3572073B1/en not_active Revoked
- 2009-08-05 WO PCT/US2009/052852 patent/WO2010017296A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| US9884019B2 (en) | 2018-02-06 |
| WO2010017296A1 (en) | 2010-02-11 |
| EP2323629A1 (en) | 2011-05-25 |
| EP3572073B1 (en) | 2023-12-20 |
| EP2323629B1 (en) | 2019-10-09 |
| ES2968301T3 (es) | 2024-05-08 |
| JP2011530524A (ja) | 2011-12-22 |
| US20100041870A1 (en) | 2010-02-18 |
| CA2729972C (en) | 2018-11-20 |
| CA2729972A1 (en) | 2010-02-11 |
| ES2755029T3 (es) | 2020-04-21 |
| EP3572073C0 (en) | 2023-12-20 |
| EP3572073A1 (en) | 2019-11-27 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP5785077B2 (ja) | 崩壊温度より高温での凍結乾燥 | |
| Pardeshi et al. | Process development and quality attributes for the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanomedicine delivery: a state-of-the-art review | |
| CN101855336B (zh) | 含艰难梭菌类毒素a和b的药物组合物 | |
| ES2434840T3 (es) | Formulación de proteína liofilizada isotónica estable | |
| CN110022855B (zh) | 室温稳定的冻干蛋白质 | |
| JP2013100329A (ja) | 薬学的製剤 | |
| KR20120027031A (ko) | 소형 모듈 면역제약용 동결건조 제제 | |
| JP7264986B2 (ja) | 抗Her2抗体薬物コンジュゲートの製剤 | |
| US11713922B2 (en) | Target residual moisture content for lyophilized drug product | |
| JP2012121894A (ja) | Il−1アンタゴニスト製剤 | |
| KR20090007588A (ko) | 니코틴-담체 백신 제제 | |
| JP2011530524A5 (enExample) | ||
| PT1771208E (pt) | Utilização de derivados de tioflavina radiorotulados em imagiologia amiloide para avaliar terapias anti-amiloide | |
| KR20210078514A (ko) | 항-rsv 항체의 제제 및 그의 사용 방법 | |
| KR20210113271A (ko) | 콜라게나제 제형 및 이의 제조 방법 | |
| AU2004206844A1 (en) | Parenteral formulations of a peptide for the treatment of systemic lupus erythematosus | |
| CN116033931A (zh) | 组织纤溶酶原激活剂制剂 | |
| WO2024172859A1 (en) | Peptide formulations | |
| CN113699120A (zh) | 耐热保护剂及其应用以及可室温保存的活病毒的保存方法 | |
| HK1230484A1 (en) | Pharmaceutical compositions containing clostridium difficile toxoids a and b | |
| CN105592857A (zh) | 糖疫苗制剂 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20120730 |
|
| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20120730 |
|
| RD04 | Notification of resignation of power of attorney |
Free format text: JAPANESE INTERMEDIATE CODE: A7424 Effective date: 20121122 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20121210 |
|
| A977 | Report on retrieval |
Free format text: JAPANESE INTERMEDIATE CODE: A971007 Effective date: 20131129 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20131209 |
|
| A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20140217 |
|
| A602 | Written permission of extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A602 Effective date: 20140224 |
|
| A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20140407 |
|
| A602 | Written permission of extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A602 Effective date: 20140414 |
|
| A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20140507 |
|
| A602 | Written permission of extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A602 Effective date: 20140514 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20140609 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20141125 |
|
| A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20150220 |
|
| A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20150423 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20150519 |
|
| TRDD | Decision of grant or rejection written | ||
| A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20150713 |
|
| A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20150723 |
|
| R150 | Certificate of patent or registration of utility model |
Ref document number: 5785077 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |
|
| R157 | Certificate of patent or utility model (correction) |
Free format text: JAPANESE INTERMEDIATE CODE: R157 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |