JP2009540001A5 - - Google Patents
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- JP2009540001A5 JP2009540001A5 JP2009515517A JP2009515517A JP2009540001A5 JP 2009540001 A5 JP2009540001 A5 JP 2009540001A5 JP 2009515517 A JP2009515517 A JP 2009515517A JP 2009515517 A JP2009515517 A JP 2009515517A JP 2009540001 A5 JP2009540001 A5 JP 2009540001A5
- Authority
- JP
- Japan
- Prior art keywords
- polysorbate
- formulation
- vegf antagonist
- sodium phosphate
- phosphate buffer
- 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.)
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- 239000000203 mixture Substances 0.000 claims description 18
- 102000009524 Vascular Endothelial Growth Factor A Human genes 0.000 claims description 16
- 108010073929 Vascular Endothelial Growth Factor A Proteins 0.000 claims description 16
- 238000009472 formulation Methods 0.000 claims description 16
- 230000003042 antagnostic Effects 0.000 claims description 14
- 239000005557 antagonist Substances 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 6
- 238000004108 freeze drying Methods 0.000 claims description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 12
- 229950008882 Polysorbate Drugs 0.000 claims 7
- 229920000136 polysorbate Polymers 0.000 claims 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 6
- 239000011780 sodium chloride Substances 0.000 claims 6
- 239000012064 sodium phosphate buffer Substances 0.000 claims 6
- 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 5
- 239000002202 Polyethylene glycol Substances 0.000 claims 5
- 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 5
- 229920001223 polyethylene glycol Polymers 0.000 claims 5
- 239000005720 sucrose Substances 0.000 claims 5
- DNIAPMSPPWPWGF-UHFFFAOYSA-N propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 4
- 239000007951 isotonicity adjuster Substances 0.000 claims 3
- 239000003381 stabilizer Substances 0.000 claims 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- FBPFZTCFMRRESA-KAZBKCHUSA-N D-Mannitol Natural products OC[C@@H](O)[C@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KAZBKCHUSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N Trehalose Chemical compound 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 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products 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 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 229940071643 Prefilled Syringe Drugs 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000006184 cosolvent Substances 0.000 claims 1
- 239000001103 potassium chloride Substances 0.000 claims 1
- 235000011164 potassium chloride Nutrition 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- 102000037240 fusion proteins Human genes 0.000 description 2
- 108020001507 fusion proteins Proteins 0.000 description 2
- 238000001035 drying Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
Description
別の局面において、本発明は、本発明の凍結乾燥可能な製剤を凍結乾燥に供し、凍結乾燥製剤を生成する工程を含む、VEGF特異的な融合タンパク質アンタゴニストの凍結乾燥製剤を製造する方法を特徴とする。凍結乾燥製剤は当技術分野において公知の、液体を凍結乾燥させるための任意の方法を用いて凍結乾燥され得る。
別の関連した局面においては、本発明は、本発明の凍結乾燥された製剤を再構成された製剤に再構成する工程を含む、VEGFアンタゴニストの再構成された凍結乾燥製剤を製造する方法を特徴とする。1つの態様において、再構成された製剤の濃度は凍結乾燥前製剤の濃度の2倍であり、例えば、本発明の方法は以下の工程を含む：（a）VEGF特異的な融合タンパク質アンタゴニストの凍結乾燥前製剤を製造する工程；（b）工程（a）の凍結乾燥前製剤を凍結乾燥に供する工程；および（c）工程（b）の凍結乾燥された製剤を再構成する工程。
Claims (10)
- （a）配列番号：4のアミノ酸配列を含む、1〜100 mg/mlのVEGFアンタゴニスト；
（b）ポリソルベート、ポリエチレングリコール（PEG）、およびプロピレングリコールの内の1つまたは複数である、0.01〜5％の1つまたは複数の有機共溶媒；
（c）塩化ナトリウムまたは塩化カリウムから選択される、30〜150 mMの等張化剤；および
（d）5〜40 mMのリン酸ナトリウム緩衝液
を含み；ならびに
スクロース、ソルビトール、グリセロール、トレハロース、またはマンニトールからなる群より選択される1.0〜7.5％の安定剤を任意でさらに含み、
pHが約5.8〜7.0の間である、
血管内皮増殖因子（vascular endothelial growth factor, VEGF）アンタゴニストの眼科用製剤。 - 約1〜100 mg/ml、好ましくは10〜80 mg/mlのVEGFアンタゴニスト、10 mMリン酸ナトリウム緩衝液、40 mM NaCl、0.03％ポリソルベート、および5％スクロースを含み、pHが約6.2〜6.3である、請求項1記載の眼科用製剤。
- 10 mg/ml、20 mg/ml、40 mg/ml、および80 mg/mlからなる群より選択される濃度のVEGFアンタゴニストを含む、請求項2記載の眼科用製剤。
- 10〜80 mg/mlのVEGFアンタゴニスト、10 mMのリン酸ナトリウム、0.03％のポリソルベート、および135 mMの塩化ナトリウムを含み、pHが約6.2〜6.3である、前記請求項のいずれか一項記載の眼科用製剤。
- （a）配列番号：4のアミノ酸配列を含む、5〜50 mg/ml、好ましくは5 mg/ml、10 mg/ml、20 mg/ml、または40 mg/mlのVEGFアンタゴニスト；
（b）pHが約5.8〜7.0である、5〜25 mMのリン酸ナトリウム緩衝液；
（c）ポリソルベート、ポリエチレングリコール（PEG）、プロピレングリコール、およびこれらの組み合わせからなる群より選択される、0.01〜0.15％の有機共溶媒；ならびに任意で
（d）スクロース、ソルビトール、グリセロール、トレハロース、およびマンニトールからなる群より選択される1〜10％の安定剤；もしくは20〜150 mMの等張化剤、好ましくは塩化ナトリウム；または1〜10％の安定剤および20〜150 mMの等張化剤
を含む、
血管内皮増殖因子（VEGF）アンタゴニストの凍結乾燥可能な製剤。 - 約20 mg/mlのVEGFアンタゴニスト、約10 mMのリン酸ナトリウム緩衝液、約0.03％のポリソルベート、約0.1％のPEG、および約2.5％のスクロースを含み、pHが約6.2〜6.3である、請求項5記載の凍結乾燥可能な製剤。
- 約20 mg/mlのVEGFアンタゴニスト、約5 mMのリン酸ナトリウム緩衝液、約0.015％のポリソルベート、約2.5％のスクロースを含み、および約20mMの塩化ナトリウムをさらに含み、pHが約6.2〜6.3である、請求項5記載の凍結乾燥可能な製剤。
- 約20 mg/mlのVEGFアンタゴニスト、約5 mMのリン酸ナトリウム緩衝液、約0.015％のポリソルベートを含み、および約67.5mMの塩化ナトリウムをさらに含み、pHが約6.2〜6.3である、請求項6記載の凍結乾燥可能な製剤。
- 請求項5〜8のいずれか一項記載の凍結乾燥前製剤を凍結乾燥に供し、凍結乾燥製剤を生成する工程を含む、VEGFアンタゴニストの凍結乾燥製剤を製造する方法。
- 請求項1記載の製剤を含む、硝子体内投与に適した予め充填されたシリンジ。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US81448406P | 2006-06-16 | 2006-06-16 | |
| US60/814,484 | 2006-06-16 | ||
| PCT/US2007/014085 WO2007149334A2 (en) | 2006-06-16 | 2007-06-14 | Vegf antagonist formulations suitable for intravitreal administration |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013040234A Division JP5597271B2 (ja) | 2006-06-16 | 2013-03-01 | 硝子体内投与に適したｖｅｇｆアンタゴニスト製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2009540001A JP2009540001A (ja) | 2009-11-19 |
| JP2009540001A5 true JP2009540001A5 (ja) | 2013-02-07 |
| JP5216002B2 JP5216002B2 (ja) | 2013-06-19 |
Family
ID=38834013
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2009515517A Active JP5216002B2 (ja) | 2006-06-16 | 2007-06-14 | 硝子体内投与に適したｖｅｇｆアンタゴニスト製剤 |
| JP2013040234A Active JP5597271B2 (ja) | 2006-06-16 | 2013-03-01 | 硝子体内投与に適したｖｅｇｆアンタゴニスト製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013040234A Active JP5597271B2 (ja) | 2006-06-16 | 2013-03-01 | 硝子体内投与に適したｖｅｇｆアンタゴニスト製剤 |
Country Status (22)
| Country | Link |
|---|---|
| US (14) | US7608261B2 (ja) |
| EP (4) | EP2029103A2 (ja) |
| JP (2) | JP5216002B2 (ja) |
| KR (1) | KR101406811B1 (ja) |
| CN (2) | CN101478949A (ja) |
| AU (1) | AU2007261536B2 (ja) |
| BR (1) | BRPI0713749B8 (ja) |
| CA (1) | CA2654510C (ja) |
| CY (2) | CY1114244T1 (ja) |
| DK (2) | DK2364691T3 (ja) |
| ES (2) | ES2406764T3 (ja) |
| HK (1) | HK1204580A1 (ja) |
| HU (1) | HUE053612T2 (ja) |
| IL (1) | IL195788A (ja) |
| LT (1) | LT2944306T (ja) |
| MX (1) | MX2008016124A (ja) |
| PL (2) | PL2944306T3 (ja) |
| PT (2) | PT2944306T (ja) |
| RU (1) | RU2432155C3 (ja) |
| SI (2) | SI2944306T1 (ja) |
| WO (1) | WO2007149334A2 (ja) |
| ZA (1) | ZA200809827B (ja) |
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