JP2009507838A5 - - Google Patents
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- JP2009507838A5 JP2009507838A5 JP2008530034A JP2008530034A JP2009507838A5 JP 2009507838 A5 JP2009507838 A5 JP 2009507838A5 JP 2008530034 A JP2008530034 A JP 2008530034A JP 2008530034 A JP2008530034 A JP 2008530034A JP 2009507838 A5 JP2009507838 A5 JP 2009507838A5
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- 239000000203 mixture Substances 0.000 claims 39
- 238000009472 formulation Methods 0.000 claims 29
- 108090001123 antibodies Proteins 0.000 claims 28
- 102000004965 antibodies Human genes 0.000 claims 28
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 8
- 239000011780 sodium chloride Substances 0.000 claims 8
- 239000006179 pH buffering agent Substances 0.000 claims 7
- 239000006174 pH buffer Substances 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 5
- 239000004094 surface-active agent Substances 0.000 claims 5
- 229950008882 Polysorbate Drugs 0.000 claims 4
- 229940068968 Polysorbate 80 Drugs 0.000 claims 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 4
- 229920000136 polysorbate Polymers 0.000 claims 4
- 229920000053 polysorbate 80 Polymers 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- VMHLLURERBWHNL-UHFFFAOYSA-M sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 4
- 235000017281 sodium acetate Nutrition 0.000 claims 4
- 239000001632 sodium acetate Substances 0.000 claims 4
- 229940029358 Orthoclone OKT3 Drugs 0.000 claims 2
- 238000001990 intravenous administration Methods 0.000 claims 2
- 239000002563 ionic surfactant Substances 0.000 claims 2
- 206010003816 Autoimmune disease Diseases 0.000 claims 1
- 206010052779 Transplant rejections Diseases 0.000 claims 1
- 239000003945 anionic surfactant Substances 0.000 claims 1
- 201000009596 autoimmune hypersensitivity disease Diseases 0.000 claims 1
- 238000002513 implantation Methods 0.000 claims 1
- 200000000018 inflammatory disease Diseases 0.000 claims 1
- 230000001988 toxicity Effects 0.000 claims 1
- 231100000419 toxicity Toxicity 0.000 claims 1
- 238000002054 transplantation Methods 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000002888 zwitterionic surfactant Substances 0.000 claims 1
Claims (40)
- ａ．３．０〜６．２の範囲で有効となるｐＨ緩衝剤；
ｂ．塩；
ｃ．界面活性剤；及び
ｄ．薬学的有効量の抗ＣＤ３抗体
で本質的に構成される抗ＣＤ３抗体の医薬品製剤。 - 前記塩が塩化ナトリウムである、請求項１に記載の製剤。
- 前記界面活性剤が、イオン、陰イオン、又は両性イオン界面活性剤である、請求項１に記載の製剤。
- 前記イオン界面活性剤がポリソルベートである、請求項３に記載の製剤。
- 前記ポリソルベートがポリソルベート８０である、請求項４に記載の製剤。
- 前記ｐＨ緩衝剤が１０ｍＭ〜５０ｍＭの範囲で有効である、請求項１に記載の製剤。
- 前記ｐＨ緩衝剤が５．０〜６．０の範囲のｐＨを提供する、請求項１に記載の製剤。
- 前記ｐＨ緩衝剤が５．２〜５．８の範囲のｐＨを提供する、請求項７に記載の製剤。
- 前記ｐＨ緩衝剤が５．４〜５．６の範囲のｐＨを提供する、請求項７に記載の製剤。
- 前記ｐＨ緩衝剤が５．５のｐＨを提供する、請求項７に記載の製剤。
- 前記ｐＨ緩衝剤が酢酸ナトリウムを含む、請求項１に記載の製剤。
- 前記塩が１００ｍＭ〜１４０ｍＭの範囲である、請求項１に記載の製剤。
- 前記界面活性剤が０．０２重量／容積％である、請求項１に記載の製剤。
- 前記薬学的有効量の前記抗ＣＤ３抗体が、１回の投与量あたり０．０５ｍｇ〜１０ｍｇの範囲の量の抗ＣＤ３抗体を提供するように配合される、請求項１に記載の製剤。
- 前記薬学的有効量の前記抗ＣＤ３抗体が、１回の投与量あたり０．１ｍｇ〜５．０ｍｇの範囲の量の抗ＣＤ３抗体を提供するように配合される、請求項１に記載の製剤。
- 前記薬学的有効量の前記抗ＣＤ３抗体が、１回の投与量あたり０．５ｍｇ〜３．０ｍｇの範囲の量の抗ＣＤ３抗体を提供するように配合される、請求項１に記載の製剤。
- 前記抗ＣＤ３抗体が、２８Ｆ１１、２７Ｈ５、２３Ｆ１０、１５Ｃ３、オルソクローンＯＫＴ３、ヒトＯＫＴ３γ１（ＨＯＫＴ３γ１）、又はＣｈＡｇｌｙＣＤ３である、請求項１に記載の製剤。
- ａ．３．０〜６．２の範囲で有効となる酢酸ナトリウムを含むｐＨ緩衝剤；
ｂ．塩化ナトリウム；
ｃ．ポリソルベートを含む界面活性剤；及び
ｄ．薬学的有効量の抗ＣＤ３抗体
で本質的に構成される抗ＣＤ３抗体の医薬品製剤。 - 前記ポリソルベートがポリソルベート８０である、請求項１８に記載の製剤。
- 前記ｐＨ緩衝剤が１０ｍＭ〜５０ｍＭの範囲で有効である、請求項１８に記載の製剤。
- 前記ｐＨ緩衝剤が５．０〜６．０の範囲のｐＨを提供する、請求項１８に記載の製剤。
- 前記ｐＨ緩衝剤が５．２〜５．８の範囲のｐＨを提供する、請求項２１に記載の製剤。
- 前記ｐＨ緩衝剤が５．４〜５．６の範囲のｐＨを提供する、請求項２１に記載の製剤。
- 前記ｐＨ緩衝剤が５．５のｐＨを提供する、請求項２１に記載の製剤。
- 前記塩が１００ｍＭ〜１４０ｍＭの範囲である、請求項１８に記載の製剤。
- 前記界面活性剤が０．０２重量／容積％である、請求項１８に記載の製剤。
- 前記薬学的有効量の前記抗ＣＤ３抗体が、１回の投与量あたり０．０５ｍｇ〜１０ｍｇの範囲の量の抗ＣＤ３抗体を提供するように配合される、請求項１８に記載の製剤。
- 前記薬学的有効量の前記抗ＣＤ３抗体が、１回の投与量あたり０．１ｍｇ〜５．０ｍｇの範囲の量の抗ＣＤ３抗体を提供するように配合される、請求項１８に記載の製剤。
- 前記薬学的有効量の前記抗ＣＤ３抗体が、１回の投与量あたり０．５ｍｇ〜３．０ｍｇの範囲の量の抗ＣＤ３抗体を提供するように配合される、請求項１８に記載の製剤。
- 前記抗ＣＤ３抗体が、２８Ｆ１１、２７Ｈ５、２３Ｆ１０、１５Ｃ３、オルソクローンＯＫＴ３、ヒトＯＫＴ３γ１（ＨＯＫＴ３γ１）、又はＣｈＡｇｌｙＣＤ３である、請求項１８に記載の製剤。
- ａ．１回の投与量あたり０．５ｍｇ〜３．０ｍｇの範囲の有効量の抗ＣＤ３抗体；
ｂ．１ｍｇ〜３ｍｇの酢酸ナトリウム；
ｃ．５ｍｇ〜９ｍｇの塩化ナトリウム；及び
ｄ．０．１マイクログラム〜０．３マイクログラムのポリソルベート８０
を含む、抗ＣＤ３抗体の医薬品製剤であって、前記製剤が水で１．０ｍＬに調節される、医薬品製剤。 - 前記製剤が、２．０５ｍｇの酢酸ナトリウム、７．３１ｍｇの塩化ナトリウム、及び０．２１６マイクログラムのポリソルベート８０を含む、請求項３１に記載の医薬品製剤。
- 前記製剤が５．５のｐＨを有する、請求項３１に記載の医薬品製剤。
- 対象における自己免疫疾患又は炎症性疾患を処置するための組成物であって、１日あたり１回の投与量あたり０．０５ｍｇ〜１０ｍｇの範囲の量の抗ＣＤ３抗体を５日にわたり提供するように配合された有効投与量の抗ＣＤ３抗体を含む、組成物。
- 前記有効投与量の抗ＣＤ３抗体が、１日あたり１回の投与量あたり０．１ｍｇ〜５．０ｍｇの範囲の量の抗ＣＤ３抗体を５日にわたり提供するように配合される、請求項３４に記載の組成物。
- 前記有効投与量の抗ＣＤ３抗体が、１日あたり１回の投与量あたり０．５ｍｇ〜３．０ｍｇの範囲の量の抗ＣＤ３抗体を５日にわたり提供するように配合される、請求項３４に記載の組成物。
- 前記投与が静脈内投与である、請求項３４に記載の組成物。
- 対象における移植拒絶反応を処置又は防止するための組成物であって、有効投与量の抗ＣＤ３抗体を含み、該組成物は、移植後又は移植と同時に投与され、該投与量は、その後ＴＣＲ−ＣＤ３が５０％以上飽和するまで毎日増やされ、その後５日間毎日の投与が続けられるが、全処置期間は８日を超えないように投与されることを特徴とする、組成物。
- 前記投与が静脈内投与である、請求項３８に記載の組成物。
- 前記有効投与量の抗ＣＤ３抗体により、サイトカイン放出レベルが、ＷＨＯの毒性評価基準で３未満になる、請求項３８に記載の組成物。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US71631105P | 2005-09-12 | 2005-09-12 | |
| PCT/US2006/035615 WO2007033230A2 (en) | 2005-09-12 | 2006-09-12 | Anti-cd3 antibody formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2009507838A JP2009507838A (ja) | 2009-02-26 |
| JP2009507838A5 true JP2009507838A5 (ja) | 2009-10-15 |
Family
ID=37865544
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008530034A Pending JP2009507838A (ja) | 2005-09-12 | 2006-09-12 | 抗ｃｄ３抗体製剤 |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US20070065437A1 (ja) |
| EP (2) | EP1933868A2 (ja) |
| JP (1) | JP2009507838A (ja) |
| KR (1) | KR20080042905A (ja) |
| CN (1) | CN101309703A (ja) |
| AR (1) | AR057807A1 (ja) |
| AU (1) | AU2006291005A1 (ja) |
| BR (1) | BRPI0615745A2 (ja) |
| CA (1) | CA2625815A1 (ja) |
| EA (1) | EA014025B1 (ja) |
| IL (1) | IL189876A0 (ja) |
| NO (1) | NO20081124L (ja) |
| SG (1) | SG174779A1 (ja) |
| UA (1) | UA92505C2 (ja) |
| WO (1) | WO2007033230A2 (ja) |
| ZA (1) | ZA200802051B (ja) |
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-
2006
- 2006-09-12 CA CA002625815A patent/CA2625815A1/en not_active Abandoned
- 2006-09-12 AU AU2006291005A patent/AU2006291005A1/en not_active Abandoned
- 2006-09-12 EP EP06790218A patent/EP1933868A2/en not_active Withdrawn
- 2006-09-12 UA UAA200803005A patent/UA92505C2/ru unknown
- 2006-09-12 EP EP10184453A patent/EP2354162A1/en not_active Withdrawn
- 2006-09-12 WO PCT/US2006/035615 patent/WO2007033230A2/en active Application Filing
- 2006-09-12 EA EA200800812A patent/EA014025B1/ru not_active IP Right Cessation
- 2006-09-12 CN CNA2006800334114A patent/CN101309703A/zh active Pending
- 2006-09-12 SG SG2011064219A patent/SG174779A1/en unknown
- 2006-09-12 BR BRPI0615745-9A patent/BRPI0615745A2/pt not_active Application Discontinuation
- 2006-09-12 US US11/520,312 patent/US20070065437A1/en not_active Abandoned
- 2006-09-12 KR KR1020087007421A patent/KR20080042905A/ko not_active Application Discontinuation
- 2006-09-12 AR ARP060103968A patent/AR057807A1/es unknown
- 2006-09-12 US US11/991,811 patent/US20100209437A1/en not_active Abandoned
- 2006-09-12 JP JP2008530034A patent/JP2009507838A/ja active Pending
-
2008
- 2008-03-02 IL IL189876A patent/IL189876A0/en unknown
- 2008-03-04 ZA ZA200802051A patent/ZA200802051B/xx unknown
- 2008-03-04 NO NO20081124A patent/NO20081124L/no not_active Application Discontinuation
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