DK2198007T3 - Farmaceutiske sammensætninger, som indeholder clostridium difficile-toksoiderne a og b - Google Patents
Farmaceutiske sammensætninger, som indeholder clostridium difficile-toksoiderne a og b Download PDFInfo
- Publication number
- DK2198007T3 DK2198007T3 DK08830210.4T DK08830210T DK2198007T3 DK 2198007 T3 DK2198007 T3 DK 2198007T3 DK 08830210 T DK08830210 T DK 08830210T DK 2198007 T3 DK2198007 T3 DK 2198007T3
- Authority
- DK
- Denmark
- Prior art keywords
- toxoid
- composition
- toxoids
- sodium
- sucrose
- Prior art date
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Claims (16)
1. Sammensætning, som omfatter et toksoid fra Clostridium difficile og farmaceutisk acceptable excipienser, der omfatter (a) en buffer valgt blandt en natrium- eller kaliumcitratbuffer og en natrium- eller kaliumphosphatbuffer; og (b) saccharose, hvor de farmaceutisk acceptable excipienser forøger den termiske stabilitet af toksoidet og/eller reducerer eller udsætter aggregering af toksoidet i forhold til en sammensætning, der er uden de farmaceutisk acceptable excipienser.
2. Sammensætning ifølge krav 1, som endvidere omfatter formaldehyd i en koncentration på 0,001 til 0,020%.
3. Sammensætning ifølge krav 1 eller 2, hvor: (a) de farmaceutisk acceptable excipienser reducerer eller udsætter aggregering af toksoidet med 50% eller mere i forhold til en sammensætning, der er uden de farmaceutisk acceptable excipienser; eller (b) de farmaceutisk acceptable excipienser forøger den termiske stabilitet af toksoidet med 0,5°C eller mere i forhold til en sammensætning, der er uden de farmaceutisk acceptable excipienser.
4. Sammensætning ifølge et hvilket som helst af kravene 1-3, hvor sammensætningen omfatter et toksoid af C. difficile-toksinerne A og B.
5. Sammensætning ifølge krav 4, hvor: (a) toksoiderne A og B er til stede i sammensætningen i et forhold på fra 5:1 (A:B) til 1:5 (A:B); eller (b) toksoiderne A og B er til stede i sammensætningen i et forhold på fra 3:1 til 3:2 eller 1:1 (A:B).
6. Sammensætning ifølge et hvilket som helst af kravene 1-5, hvor sammensætningen er en farmaceutisk sammensætning.
7. Sammensætning ifølge et hvilket som helst af kravene 1-6, som endvidere omfatter en adjuvans.
8. Sammensætning ifølge krav 7, hvor adjuvansen omfatter en aluminiumforbindelse, hvor aluminiumforbindelsen eventuelt er en aluminiumhydroxidforbindelse.
9. Sammensætning ifølge et hvilket som helst af kravene 1-8, hvor sammensætningen foreligger (a) på væskeform eller (b) på tør pulverform, lyofiliseret, frysetørret, spraytørret eller skumtørret.
10. Sammensætning ifølge et hvilket som helst af kravene 1-9, hvor (a) citratbufferen er natriumcitrat; eller (b) phosphatbufferen er natriumphosphat.
11. Sammensætning ifølge et hvilket som helst af kravene 1-9, hvor sammensætningen omfatter: (a) Clostridium difficile-toksoiderne A og B, 5-100 mM natrium- eller kaliumcitrat, 2-20% saccharose og ^ 0,020% formaldehyd, pH 5,5-8,5; (b) Clostridium difficile-toksoiderne A og B, 10-30 mM natrium- eller kaliumcitrat, 2-10% saccharose og ^ 0,020% formaldehyd, pH 6, 5-8,0; (c) Clostridium difficile-toksoiderne A og B, 20 mM natriumcitrat, 5% saccharose og 0,016% formaldehyd, pH 7,5; (d) Clostridium difficile-toksoiderne A og B, 5-100 mM natrium- eller kaliumphosphat, 2-20% saccharose og ^ 0,020% formaldehyd, pH 5,5-8,5; (e) Clostridium difficile-toksoiderne A og B, 10-30 mM natrium- eller kaliumphosphat, 2-10% saccharose og > 0,020% formaldehyd, pH 6,5-8,0; eller (f) Clostridium difficile-toksoiderne A og B, 20 mM kaliumphosphat, 5% saccharose og 0,016% formaldehyd, pH 7,5.
12. Sammensætning ifølge et hvilket som helst af kravene 1-9, hvor sammensætningen foreligger i lyofiliseret form og omfatter: (a) Clostridium difficile-toksoiderne A og B, 10-30 mM natrium- eller kaliumcitrat, 2-10% saccharose og t 0,020% formaldehyd, pH 6,5-8,0; eller (b) Clostridium difficile-toksoiderne A og B, 20 mM natriumcitrat, 5% saccharose og 0,016% formaldehyd, pH 7,5.
13. Fremgangsmåde til fremstilling af en sammensætning, som omfatter et toksoid fra Clostridium difficile og farmaceutisk acceptable excipienser, der omfatter (a) en buffer valgt blandt en natrium- eller kaliumcitratbuffer og en natrium- eller kaliumphosphatbuffer; og (b) saccharose, hvor de farmaceutisk acceptable excipienser forøger den termiske stabilitet af toksoidet og/eller reducerer eller udsætter aggregering af toksoidet i forhold til en sammensætning, der er uden de farmaceutisk acceptable excipienser, hvilken fremgangsmåde omfatter tilvejebringelse af et toksoid fra Clostridium difficile og blanding af toksoidet fra Clostridium difficile med de farmaceutisk acceptable excipienser.
14. Sammensætning ifølge et hvilket som helst af kravene 1-12 til anvendelse ved en fremgangsmåde til forebyggelse eller behandling af C. difficile-infektion eller -sygdom hos et individ.
15. Anvendelse af en kombination af (a) en buffer valgt blandt en natrium- eller kaliumcitratbuffer og en natrium- eller kaliumphosphatbuffer; og (b) saccharose, til at forøge den termiske stabilitet og/eller reducere eller udsætte aggregeringen af et toksoid fra Clostridium difficile in vitro.
16. Anvendelse ifølge krav 15, hvor komponenterne (a) og (b) tilvejebringes i en sammensætning, hvilken sammensætning er som defineret ifølge et hvilket som helst af kravene 1-12.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US97249607P | 2007-09-14 | 2007-09-14 | |
| PCT/US2008/010767 WO2009035707A1 (en) | 2007-09-14 | 2008-09-15 | Pharmaceutical compositions containing clostridium difficile toxoids a and b |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2198007T3 true DK2198007T3 (da) | 2018-01-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08830210.4T DK2198007T3 (da) | 2007-09-14 | 2008-09-15 | Farmaceutiske sammensætninger, som indeholder clostridium difficile-toksoiderne a og b |
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| EP (3) | EP2198007B1 (da) |
| JP (3) | JP5503543B2 (da) |
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| RU (1) | RU2550271C2 (da) |
| SI (1) | SI2198007T1 (da) |
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Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2198007T3 (pl) | 2007-09-14 | 2018-03-30 | Sanofi Pasteur Biologics, Llc | Kompozycje farmaceutyczne zawierające toksoidy A i B Clostridium difficile |
| PL2753352T5 (pl) | 2010-09-03 | 2022-10-17 | Valneva Austria Gmbh | Izolowany polipeptyd białek toksyny a i toksyny b z c. difficile i jego zastosowania |
| GB201105981D0 (en) * | 2011-04-08 | 2011-05-18 | Glaxosmithkline Biolog Sa | Novel process |
| TWI815599B (zh) * | 2011-04-22 | 2023-09-11 | 美商惠氏有限責任公司 | 與難養芽胞梭菌（Ｃｌｏｓｔｒｉｄｉｕｍ ｄｉｆｆｉｃｉｌｅ）之突變毒素有關之組成物及彼之方法 |
| KR101135486B1 (ko) * | 2011-05-25 | 2012-04-13 | 함종욱 | 보툴리눔 에이형 독소의 액상제품 |
| BR122016023101B1 (pt) | 2012-10-21 | 2022-03-22 | Pfizer Inc | Polipeptídeo, composição imunogênica que o compreende, bem como célula recombinante derivada de clostridium difficile |
| CN104903349B (zh) | 2012-11-08 | 2018-10-19 | 十一生物治疗股份有限公司 | Il-6拮抗剂及其应用 |
| WO2014086787A1 (en) | 2012-12-05 | 2014-06-12 | Glaxosmithkline Biologicals S.A. | Immunogenic composition |
| AP2015008733A0 (en) | 2013-03-14 | 2015-09-30 | Takeda Vaccines Inc | Compositions and methods for live, attenuated alphavirus formulations |
| KR20150133771A (ko) * | 2013-03-15 | 2015-11-30 | 사노피 파스퇴르 인코포레이티드 | 톡소이드, 조성물 및 관련 방법 |
| US20160045586A1 (en) * | 2013-03-15 | 2016-02-18 | Sanofi Pasteur, Inc. | Toxoid, Compositions and Related Methods |
| AU2014277981B2 (en) | 2013-06-14 | 2019-06-20 | Sanofi Pasteur Inc. | Compositions and methods of immunizing against C. difficile |
| RS57864B1 (sr) | 2013-06-17 | 2018-12-31 | De Staat Der Nederlanden Vert Door De Minister Van Vws Ministerie Van Volksgezondheid Welzijn En Spo | Postupci za sprečavanje agregacije virusnih komponenti |
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