JP2013500947A5 - - Google Patents
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- JP2013500947A5 JP2013500947A5 JP2012522158A JP2012522158A JP2013500947A5 JP 2013500947 A5 JP2013500947 A5 JP 2013500947A5 JP 2012522158 A JP2012522158 A JP 2012522158A JP 2012522158 A JP2012522158 A JP 2012522158A JP 2013500947 A5 JP2013500947 A5 JP 2013500947A5
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- her2 antibody
- highly concentrated
- formulation
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- 108090001123 antibodies Proteins 0.000 claims 41
- 102000004965 antibodies Human genes 0.000 claims 41
- 239000000203 mixture Substances 0.000 claims 27
- 238000009472 formulation Methods 0.000 claims 22
- 239000008194 pharmaceutical composition Substances 0.000 claims 11
- 201000010099 disease Diseases 0.000 claims 10
- 229960002885 Histidine Drugs 0.000 claims 9
- 108010074224 Hyaluronoglucosaminidase Proteins 0.000 claims 9
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 9
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 8
- PZVLBICKVLYSRO-INJDEQCRSA-N (2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-3,4,5-triol;hydrate Chemical group O.O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 PZVLBICKVLYSRO-INJDEQCRSA-N 0.000 claims 7
- 108010010691 Trastuzumab Proteins 0.000 claims 7
- 229960000575 trastuzumab Drugs 0.000 claims 7
- 108010042024 pertuzumab Proteins 0.000 claims 6
- 229960002087 pertuzumab Drugs 0.000 claims 6
- 239000002736 nonionic surfactant Substances 0.000 claims 5
- 239000003381 stabilizer Substances 0.000 claims 5
- 238000007920 subcutaneous administration Methods 0.000 claims 5
- CZMRCDWAGMRECN-UGDNZRGBSA-N D-sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 4
- 229920001213 Polysorbate 20 Polymers 0.000 claims 4
- 229940068977 Polysorbate 20 Drugs 0.000 claims 4
- CZMRCDWAGMRECN-GDQSFJPYSA-N Sucrose Natural products O([C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1)[C@@]1(CO)[C@H](O)[C@@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-GDQSFJPYSA-N 0.000 claims 4
- 201000011510 cancer Diseases 0.000 claims 4
- 239000003814 drug Substances 0.000 claims 4
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 238000002347 injection Methods 0.000 claims 3
- 239000007924 injection Substances 0.000 claims 3
- 238000010254 subcutaneous injection Methods 0.000 claims 3
- 239000007929 subcutaneous injection Substances 0.000 claims 3
- 206010006187 Breast cancer Diseases 0.000 claims 2
- 206010055113 Breast cancer metastatic Diseases 0.000 claims 2
- 206010017758 Gastric cancer Diseases 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N HCl Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- 229950008882 Polysorbate Drugs 0.000 claims 2
- 229910000041 hydrogen chloride Inorganic materials 0.000 claims 2
- 230000003211 malignant Effects 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 201000011549 stomach cancer Diseases 0.000 claims 2
- 102100016662 ERBB2 Human genes 0.000 claims 1
- 101700025368 ERBB2 Proteins 0.000 claims 1
- 229940068968 Polysorbate 80 Drugs 0.000 claims 1
- 101710037934 QRSL1 Proteins 0.000 claims 1
- 230000002421 anti-septic Effects 0.000 claims 1
- 239000002246 antineoplastic agent Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000007710 freezing Methods 0.000 claims 1
- 125000003372 histidine group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229920005606 polypropylene copolymer Polymers 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 238000010257 thawing Methods 0.000 claims 1
Claims (39)
- ａ．５０から３５０ｍｇ／ｍｌの抗ＨＥＲ２抗体；
ｂ．５．５±２．０のｐＨを与える１から１００ｍＭの緩衝剤；
ｃ．１から５００ｍＭの安定剤又は二以上の安定剤の混合物；
ｄ．０．０１から０．０８％の非イオン性界面活性剤；及び
ｅ．１５０より多く最大１６０００Ｕ／ｍｌまでのヒアルロニダーゼ酵素
を含有する、薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な皮下注射用薬学的製剤。 - ２０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する請求項１に記載の薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な薬学的製剤。
- １２０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する請求項１に記載の薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な薬学的製剤。
- １０００から１６０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する請求項１に記載の薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な薬学的製剤。
- 抗ＨＥＲ２抗体濃度がそれぞれ１００から１５０ｍｇ／ｍｌ；１２０±１８ｍｇ／ｍｌ；１１０ｍｇ／ｍｌ；１２０ｍｇ／ｍｌ；又は１３０ｍｇ／ｍｌである、請求項１から４の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 緩衝剤が１から５０ｍＭの濃度である請求項１から５の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 緩衝剤が５．５±０．６のｐＨを与える請求項１から６の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 緩衝剤がヒスチジンバッファーである請求項１から７の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- ヒスチジンバッファーが２０ｍＭのヒスチジン／ＨＣｌである請求項８に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 安定剤が糖である請求項１から９の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 糖がα，α−トレハロース二水和物又はスクロースである請求項１０に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 安定剤がそれぞれ１５から２５０ｍＭ；又は２１０ｍＭの濃度である請求項１から１１の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- メチオニンが第二安定剤として使用される請求項１から１２の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- メチオニンが５から２５ｍＭの濃度である請求項１３に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 非イオン性界面活性剤が、ポリソルベート２０、ポリソルベート８０、及びポリエチレン・ポリプロピレン共重合体からなる群から選択されるポリソルベートである請求項１から１４の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- ポリソルベートの濃度がそれぞれ０．０２％（ｗ／ｖ）、０．０４％（ｗ／ｖ）又は０．０６％（ｗ／ｖ）である請求項１５に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 抗ＨＥＲ２抗体が、トラスツズマブ、ペルツズマブ及びＴ−ＤＭ１又はそれらの組み合わせの群から選択される請求項１から１６の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- １００から１５０ｍｇ／ｍｌの、トラスツズマブ、ペルツズマブ及びＴ−ＤＭ１からなる群から選択される抗ＨＥＲ２抗体；１から５０ｍＭのヒスチジンバッファー；１５から２５０ｍＭのα，α−トレハロース二水和物又はスクロース；０．０１から０．０８％の非イオン性界面活性剤；及び１５０から１６０００Ｕ／ｍｌ、又は１０００から１６０００Ｕ／ｍｌ、又は２０００Ｕ／ｍｌ、又は１２０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する、薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な皮下注射用薬学的製剤。
- １２０±１８ｍｇ／ｍｌの、トラスツズマブ、ペルツズマブ及びＴ−ＤＭ１からなる群から選択される抗ＨＥＲ２抗体；１０から３０ｍＭ、又は２０ｍＭのヒスチジンバッファー；１５０から２５０ｍＭ、又は２１０ｍＭのα，α−トレハロース二水和物又はスクロース；０．０１から０．０８％の非イオン性界面活性剤；及び１０００から１６０００Ｕ／ｍｌ、又は１５００から１２０００Ｕ／ｍｌ、又は２０００Ｕ／ｍｌ、又は１２０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する、薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な皮下注射用薬学的製剤。
- １２０ｍｇ／ｍｌの、トラスツズマブ、ペルツズマブ及びＴ−ＤＭ１からなる群から選択される抗ＨＥＲ２抗体；１０から３０ｍＭ、又は２０ｍＭのヒスチジンバッファー；１５０から２５０ｍＭ、又は２１０ｍＭのα，α−トレハロース二水和物又はスクロース；０．０１から０．０８％の非イオン性界面活性剤；及び１０００から１６０００Ｕ／ｍｌ、又は１５００から１２０００Ｕ／ｍｌ、又は２０００Ｕ／ｍｌ、又は１２０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する、薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な皮下注射用薬学的製剤。
- １２０ｍｇ／ｍｌの、トラスツズマブ、ペルツズマブ及びＴ−ＤＭ１からなる群から選択される抗ＨＥＲ２抗体；２０ｍＭのヒスチジンバッファー；２１０ｍＭのα，α−トレハロース二水和物又はスクロース；０．０４％又は０．０６％のポリソルベート２０；及び１２０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する、薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な皮下注射用薬学的製剤。
- １２０ｍｇ／ｍｌの、トラスツズマブ、ペルツズマブ及びＴ−ＤＭ１からなる群から選択される抗ＨＥＲ２抗体；２０ｍＭのヒスチジンバッファー；２１０ｍＭのα，α−トレハロース二水和物又はスクロース；０．０４％又は０．０６％のポリソルベート２０；及び２０００Ｕ／ｍｌのヒアルロニダーゼ酵素を含有する、薬学的に活性な抗ＨＥＲ２抗体の高度に濃縮された安定な皮下注射用薬学的製剤。
- ５から２５ｍＭ、又は５から１５ｍＭ、又は１０ｍＭの濃度のメチオニンを更に含む、請求項１８から２２の何れか一項に記載の薬学的製剤。
- ヒアルロニダーゼ酵素がｒＨｕＰＨ２０である請求項１から２３の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- １２０ｍｇ／ｍｌのトラスツズマブ、２０ｍＭのｐＨ５．５のＬ−ヒスチジン／ＨＣｌ、２１０ｍＭのα，α−トレハロース二水和物、１０ｍＭのメチオニン、０．０４％のポリソルベート２０及び２０００Ｕ／ｍｌのｒＨｕＰＨ２０を含有する、高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 凍結及び解凍時に安定である請求項１から２５の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 皮下又は筋肉内投与のための請求項１から２６の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 液体形態である請求項１から２７の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 凍結乾燥形態である請求項１から２７の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤。
- 被検体における抗ＨＥＲ２抗体での治療を受け入れられる疾患又は障害の治療に有用な医薬の調製における、請求項１から２９の何れか一項に記載の製剤の使用。
- 疾患又は障害が、抗ＨＥＲ２抗体での治療を受け入れられる癌又は非悪性疾患である、請求項３０に記載の使用。
- 癌が、胃癌、転移性乳癌又は早期乳癌である、請求項３１に記載の使用。
- 請求項１から２９の何れか一項に記載の高度に濃縮された安定な薬学的抗ＨＥＲ２抗体製剤を含む注射デバイス。
- 製剤が化学療法剤と同時に又は連続して共投与される請求項３３に記載の注射デバイス。
- 請求項１から２９の何れか一項に記載の製剤を含む一又は複数のバイアルと患者に対する製剤の皮下投与のための指示書とを含むキット。
- 患者に対する製剤の皮下投与のための注射デバイスを更に含む請求項３５に記載のキット。
- 請求項１から２９の何れか一項に記載の製剤を含む、被検体における抗ＨＥＲ２抗体での治療を受け入れられる疾患又は障害の治療に有用な医薬。
- 疾患又は障害が、抗ＨＥＲ２抗体での治療を受け入れられる癌又は非悪性疾患である、請求項３７に記載の医薬。
- 癌が、胃癌、転移性乳癌又は早期乳癌である、請求項３８に記載の医薬。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09167025 | 2009-07-31 | ||
| EP09167025.7 | 2009-07-31 | ||
| PCT/EP2010/060930 WO2011012637A2 (en) | 2009-07-31 | 2010-07-28 | Subcutaneous anti-her2 antibody formulation |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013123231A Division JP5878144B2 (ja) | 2009-07-31 | 2013-06-11 | 皮下抗ｈｅｒ２抗体製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2013500947A JP2013500947A (ja) | 2013-01-10 |
| JP2013500947A5 true JP2013500947A5 (ja) | 2013-08-01 |
| JP5462944B2 JP5462944B2 (ja) | 2014-04-02 |
Family
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| Application Number | Title | Priority Date | Filing Date |
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| JP2012522158A Active JP5462944B2 (ja) | 2009-07-31 | 2010-07-28 | 皮下抗ｈｅｒ２抗体製剤 |
| JP2013123231A Active JP5878144B2 (ja) | 2009-07-31 | 2013-06-11 | 皮下抗ｈｅｒ２抗体製剤 |
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| Application Number | Title | Priority Date | Filing Date |
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| JP2013123231A Active JP5878144B2 (ja) | 2009-07-31 | 2013-06-11 | 皮下抗ｈｅｒ２抗体製剤 |
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| NZ578824A (en) | 2007-03-02 | 2012-03-30 | Genentech Inc | Predicting response to a her dimerisation inhibitor based on low her3 expression |
| TWI472339B (zh) | 2008-01-30 | 2015-02-11 | Genentech Inc | 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物 |
| BRPI0812682A2 (pt) | 2008-06-16 | 2010-06-22 | Genentech Inc | tratamento de cáncer de mama metastático |
| JP5540095B2 (ja) * | 2009-07-24 | 2014-07-02 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | 抗体製造の最適化 |
| US9345661B2 (en) | 2009-07-31 | 2016-05-24 | Genentech, Inc. | Subcutaneous anti-HER2 antibody formulations and uses thereof |
| AR078161A1 (es) | 2009-09-11 | 2011-10-19 | Hoffmann La Roche | Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento. |
| JP2013515754A (ja) * | 2009-12-29 | 2013-05-09 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | 新規な抗体製剤 |
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| PT2773671T (pt) | 2011-11-04 | 2021-12-14 | Zymeworks Inc | Geração de anticorpo heterodimérico estável com mutações no domínio fc |
| AR090244A1 (es) * | 2012-03-08 | 2014-10-29 | Hoffmann La Roche | Formulacion de anticuerpo anti-selectina p |
| US20160002624A1 (en) * | 2012-05-17 | 2016-01-07 | Isis Pharmaceuticals, Inc. | Antisense oligonucleotide compositions |
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