JP6941137B2 - イオン性液体を含有する液状タンパク質製剤 - Google Patents
イオン性液体を含有する液状タンパク質製剤 Download PDFInfo
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- JP6941137B2 JP6941137B2 JP2019108536A JP2019108536A JP6941137B2 JP 6941137 B2 JP6941137 B2 JP 6941137B2 JP 2019108536 A JP2019108536 A JP 2019108536A JP 2019108536 A JP2019108536 A JP 2019108536A JP 6941137 B2 JP6941137 B2 JP 6941137B2
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- 229950005018 vericiguat Drugs 0.000 description 1
- 229940103766 vimizim Drugs 0.000 description 1
- 239000011345 viscous material Substances 0.000 description 1
- 230000004393 visual impairment Effects 0.000 description 1
- 108010047303 von Willebrand Factor Proteins 0.000 description 1
- 102100036537 von Willebrand factor Human genes 0.000 description 1
- 229960001134 von willebrand factor Drugs 0.000 description 1
- IGYWDDBBJPSOTG-WBAGYEQSSA-N vosoritide Chemical compound CC[C@H](C)[C@@H]1NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](CSSC[C@H](NC(=O)CNC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@H](CO)NC(=O)[C@H](CCSC)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)O)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)[C@H](Cc3ccc(O)cc3)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](C)NC(=O)[C@H](CC(=O)N)NC(=O)[C@@H]4CCCN4C(=O)[C@H](Cc5cnc[nH]5)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)N)NC(=O)CNC(=O)[C@@H]6CCCN6 IGYWDDBBJPSOTG-WBAGYEQSSA-N 0.000 description 1
- 229940018782 wilate Drugs 0.000 description 1
- 125000001834 xanthenyl group Chemical group C1=CC=CC=2OC3=CC=CC=C3C(C12)* 0.000 description 1
- 229940018272 xeomin Drugs 0.000 description 1
- 229940099073 xolair Drugs 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 229950009002 zanolimumab Drugs 0.000 description 1
- 239000004246 zinc acetate Substances 0.000 description 1
- 239000011592 zinc chloride Substances 0.000 description 1
- 235000005074 zinc chloride Nutrition 0.000 description 1
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Description
本願は、2014年7月29日出願の「Low-Viscosity Protein Formulations Containing Hydrophobic Salts」との表題の米国仮出願第62/030,521号;2014年7月18日出願の「Low-Viscosity Protein Formulations Containing GRAS Viscosity-Reducing Agents」との表題の米国仮出願第62/026,497号;2014年6月5日出願の「Low-Viscosity Protein Formulations Containing Ionic Liquids」との表題の米国仮出願第62/008,050号;2014年5月2日出願の「Low-Viscosity Protein Formulations Containing Organophosphates」との表題の米国仮出願第61/988,005号;2014年2月28日出願の「Concentrated, Low-Viscosity Infliximab Formulations」との表題の米国仮出願第61/946,436号;2014年2月21日出願の「Concentrated, Low-Viscosity, High-Molecular-Weight-Protein Formulations」との表題の米国仮出願第61/943,197号;2014年2月14日出願の「Concentrated, Low-Viscosity High-Molecular-Weight Protein Formulations」との表題の米国仮出願第61/940,227号、および2013年9月11日出願の「Concentrated, Low-Viscosity, High-Molecular-Weight Protein Formulations」との表題の米国仮出願第61,876,621号の優先権を主張し、かつその利益を主張する。これらの出願の開示は、本明細書に参考として明白に援用される。
本発明は、一般に、高濃度タンパク質の注射可能な低粘度医薬製剤、ならびにその作製方法および使用方法の分野におけるものである。
モノクローナル抗体(mAb)は、がん、感染症、炎症および自己免疫疾患などの様々なヒト疾患を処置するための、重要なタンパク質をベースとする治療薬である。20種を超えるmAb製品が、米国食品医薬品局(FDA)によって承認されており、臨床試験において現在、評価されているバイオ医薬品の約20%が、mAbである(Daughertyら、Adv. Drug Deliv. Rev. 58巻:686〜706頁、2006年、およびBussら、Curr. Opinion in Pharmacol. 12巻:615〜622頁、2012年)。
特定の実施形態では、例えば以下が提供される:
(項目1)
(i)1種または複数のタンパク質;
(ii)1種または複数の粘度低下性イオン性液体;
(iii)薬学的に許容される溶媒
を含む、注射用医薬製剤であって、
該タンパク質が、注射に適した体積で溶媒および粘度低下性イオン性液体と組み合わされた場合、該製剤が、円錐平板粘度計を使用して測定すると、25℃において絶対粘度約1cP〜約50cPを有しており、該製剤の該絶対粘度が、該粘度低下性イオン性液体の代わりに等量のリン酸ナトリウムを含む他は同じ製剤の該絶対粘度よりも低く、
各場合において、該絶対粘度が外挿したゼロせん断粘度である、
注射用医薬製剤。
(項目2)
前記タンパク質(複数可)が、約70kDa〜100kDaの間、約100kDa〜約250kDa、または約250kDa〜約500kDaの間の分子量を有する高分子量タンパク質である、項目1に記載の製剤。
(項目3)
前記タンパク質が、約120kDa〜約250kDaの分子量を有する、項目1および2のいずれか一項に記載の製剤。
(項目4)
前記タンパク質の少なくとも1種が、酵素、抗体もしくは抗体断片、融合タンパク質、またはPEG化タンパク質である、項目1から3のいずれかに記載の製剤。
(項目5)
前記タンパク質(複数可)が、1mLあたり約100mg〜約2,000mg(mg/mL)、任意選択で約150mg/mLより多い合わせた量で存在する、項目1から4のいずれか一項に記載の製剤。
(項目6)
少なくとも2種の異なるタンパク質を含み、好ましくは、該タンパク質の両方が、少なくとも約50kDaの分子量を有する、項目1から5のいずれか一項に記載の製剤。
(項目7)
粘度低下イオン性液体を添加する前の、同じ前記タンパク質濃度における初期絶対粘度が、約50cPを超える、約80cPを超える、または約100cPを超える、項目1から6のいずれか一項に記載の製剤。
(項目8)
液状の前記製剤が、約5.0〜約8.0の間のpHを有する水性である、項目1から7のいずれか一項に記載の製剤。
(項目9)
約0.01M〜約1.0Mの濃度で存在する前記イオン性液体を含む、項目1から8のいずれか一項に記載の製剤。
(項目10)
0.3M未満、または0.15M未満の量で存在する前記イオン性液体を含む、項目1から9のいずれか一項に記載の製剤。
(項目11)
皮下または筋肉注射用の1種または複数の薬学的に許容される賦形剤であって、糖または糖アルコール、緩衝剤、保存剤、担体、酸化防止剤、キレート剤、天然または合成ポリマー、凍結保護剤、凍結乾燥保護剤、界面活性剤、増量剤および安定化剤からなる群から選択される、1種または複数の薬学的に許容される賦形剤を含む、項目1から10のいずれか一項に記載の製剤。
(項目12)
前記賦形剤の1種または複数が、ポリソルベート、ポロキサマー188、ラウリル硫酸ナトリウム、マンニトールおよびソルビトールなどの糖アルコール、ポリ(エチレングリコール)、グリセロール、プロピレングリコールおよびポリ(ビニルアルコール)からなる群から選択されるポリオールからなる群から選択される、項目11に記載の製剤。
(項目13)
約10mg/mL未満の量で存在する界面活性剤を含む、項目11に記載の製剤。
(項目14)
約2mg/mL〜約900mg/mLの量で存在しているポリオールを含む、項目12に記載の製剤。
(項目15)
前記絶対粘度が、25℃において、約5cP〜約50cPである、項目1から14のいずれか一項に記載の製剤。
(項目16)
前記絶対粘度が、前記イオン性液体をほぼ同じ濃度の適切な緩衝剤に置き換えた以外同一条件下で測定した場合、該イオン性液体を含まない製剤の該絶対粘度よりも少なくとも約30%低い、項目1から15のいずれか一項に記載の製剤。
(項目17)
前記絶対粘度が、前記イオン性液体をほぼ同じ濃度の適切な緩衝剤に置き換えた以外同一条件下で測定した場合、該イオン性液体を含まない製剤の該絶対粘度よりも少なくとも約2倍または4倍低い、項目1から16のいずれか一項に記載の製剤。
(項目18)
単位用量バイアル、容器またはプレフィルドシリンジ中の、項目1から17のいずれか一項に記載の製剤。
(項目19)
前記タンパク質、粘度低下イオン性液体および/または賦形剤が乾燥形態にあり、好ましくは凍結乾燥されている、項目18に記載の製剤。
(項目20)
イオン性液体、タンパク質および溶媒を組み合わせた場合の前記製剤の体積が、SC注射の場合、約1.5mL未満であり、IM注射の場合、約3mL未満である、項目1から19のいずれかに記載の製剤。
(項目21)
ヒト血清に等張である、項目1から20のいずれか一項に記載の製剤。
(項目22)
それを必要とするヒトに投与される条件下で、レオロジー的に、本質的にニュートン液体として挙動する、項目1から21のいずれか一項に記載の製剤。
(項目23)
静脈内注入により投与される同じ用量の前記タンパク質と比べて、治療有効な投与量を実現する、項目1から22のいずれか一項に記載の製剤。
(項目24)
前記イオン性液体が、皮下注射または筋肉内注射により投与される場合、毒性または注射部位の刺激の有意な徴候を引き起こさない濃度で存在する、項目1から23のいずれか一項に記載の製剤。
(項目25)
前記製剤の前記絶対粘度が、円錐平板粘度計を使用して測定される場合、少なくとも約0.5s−1のせん断速度で測定される、項目1から24のいずれかに記載の製剤。
(項目26)
前記製剤の前記絶対粘度が、マイクロ流体粘度計を使用して測定した場合、少なくとも約1.0s−1のせん断速度で、測定される、項目1から24のいずれか一項に記載の製剤。
(項目27)
項目1から26のいずれか一項に記載の製剤の、皮下注射または筋肉内注射を含む、治療有効量のタンパク質を投与する方法。
(項目28)
前記皮下注射または筋肉内注射が、加熱シリンジ、自己混合式シリンジ、オートインジェクター、プレフィルドシリンジ、およびそれらの組合せからなる群から選択されるシリンジを用いて行われる、項目27に記載の方法。
(項目29)
前記シリンジが、加熱シリンジであり、前記製剤が、25℃〜40℃の間の温度で投与される、項目28に記載の方法。
(項目30)
前記製剤が、ドレイズ評点システムを使用して評価した場合、3未満の一次刺激インデックスを生じる、項目27から29のいずれか一項に記載の方法。
(項目31)
射出力が、前記イオン性液体を含まないがそれ以外は同じ製剤を同じ様式で投与した場合の射出力よりも、少なくとも10%または20%小さい、項目27から30のいずれか一項に記載の方法。
(項目32)
前記注射が、直径がゲージ27〜31の間の針を使用して施行され、かつ該ゲージ27の針を使用した場合、前記射出力が30N未満である、項目27から31のいずれか一項に記載の方法。
(項目33)
項目1から26のいずれかに記載のタンパク質、溶媒およびイオン性液体を合わせるステップを含む、医薬製剤を調製する方法。
(項目34)
前記製剤が、プレフィルドシリンジまたはカートリッジ内にある、項目33に記載の方法。
(項目35)
項目1、または7から10のいずれかに記載のイオン性液体の有効量を、タンパク質溶液に加えて、該タンパク質溶液の前記粘度を低下させることを含む、タンパク質の精製を容易にする方法。
(項目36)
前記タンパク質−イオン性液体溶液が、限外ろ過/ダイアフィルトレーション、タンジェンシャルフローろ過、遠心濃縮、および透析からなる群から選択される方法を使用して精製または濃縮される、項目35に記載の方法。
タンパク質の、低粘度で低体積の濃縮液状医薬製剤を開発した。こうした製剤は、長時間の静脈内注入によるよりもむしろ、皮下または筋肉内注射によって、迅速かつ便利に投与することができる。これらの製剤には、mAbなどの低分子量および/または高分子量タンパク質、ならびに粘度低下イオン性液体が含まれる。
本明細書において一般に使用される、用語「タンパク質」とは、ペプチド結合により互いに連結されて、その鎖長が少なくとも検出可能な三次元構造を生じるのに十分な、ポリペプチドを形成する、アミノ酸のポリマーを指す。約100kDaを超える分子量(kDaで表され、ここで、「Da」は「ダルトン」を表し、1kDa=1,000Daである)を有する、タンパク質は、「高分子量タンパク質」と称することができる一方、約100kDa未満の分子量を有するタンパク質は、「低分子量タンパク質」と称することができる。用語「低分子量タンパク質」は、タンパク質と見なすのに必要な少なくとも三次元の構造という要件を欠く、小さなペプチドを除外する。タンパク質の分子量は、質量分析法(例えば、ESI、MALDI)または公知のアミノ酸配列およびグリコシル化からの計算を含むがこれらに限定されない、当業者に公知の標準方法を使用して決定することができる。タンパク質は、天然に存在するかまたは天然に存在しないもの、合成によるものまたは半合成によるものとすることができる。
R1は、C1〜12アルキル、C3〜12シクロアルキル、C6〜12アリール、C1〜12ヘテロアリールおよびC2〜12ヘテロシクリルから独立して選択され、
C1〜12アルキルはそれぞれ、C3〜12シクロアルキル、C6〜12アリール、C1〜12ヘテロアリール、C2〜12ヘテロシクリル、−OH、NH2、(=O)、(=NR4a)、−F、−Cl、−Br、−I、−NO2、−CN、−C(=O)R4a、−C(=NR4a)R4、−C(=O)OH、−C(=O)OR4、−OC(=O)R4、−OC(=O)OR4、−SO3H、−SO2N(R4a)2、−SO2R4、−SO2NR4aC(=O)R4、−PO3H2、−R4aC(=NR4a)N(R4a)2、−NHC(=NR4a)NH−CN、−NR4aC(=O)R4、−NR4aSO2R4、−NR4aC(=NR4a)NR4aC(=NR4a)N(R4a)2、−NR4aC(=O)N(R4a)2、−C(=O)NH2、−C(=O)N(R4a)2、−OR4、−SR4aまたは−N(R4a)2により、1回または複数回、置換されていてもよく、
C3〜12シクロアルキルはそれぞれ、C1〜12アルキル、C6〜12アリール、C1〜12ヘテロアリール、C2〜12ヘテロシクリル、−OH、NH2、−F、−Cl、−Br、−I、−NO2、−CN、−C(=O)R4a、−C(=NR4a)R4、−C(=O)OH、−C(=O)OR4、−OC(=O)R4、−OC(=O)OR4、−SO3H、−SO2N(R4a)2、−SO2R4、−SO2NR4aC(=O)R4、−PO3H2、−R4aC(=NR4a)N(R4a)2、−NHC(=NR4a)NH−CN、−NR4aC(=O)R4、−NR4aSO2R4、−NR4aC(=NR4a)NR4aC(=NR4a)N(R4a)2、−NR4aC(=O)N(R4a)2、−C(=O)NH2、−C(=O)N(R4a)2、−OR4、−SR4aまたは−N(R4a)2により、1回または複数回、置換されていてもよく、
C6〜12アリールはそれぞれ、C1〜12アルキル、C3〜12シクロアルキル、C1〜12ヘテロアリール、C2〜12ヘテロシクリル、−OH、NH2、−F、−Cl、−Br、−I、−NO2、−CN、−C(=O)R4a、−C(=NR4a)R4、−C(=O)OH、−C(=O)OR4、−OC(=O)R4、−OC(=O)OR4、−SO3H、−SO2N(R4a)2、−SO2R4、−SO2NR4aC(=O)R4、−PO3H2、−R4aC(=NR4a)N(R4a)2、−NHC(=NR4a)NH−CN、−NR4aC(=O)R4、−NR4aSO2R4、−NR4aC(=NR4a)NR4aC(=NR4a)N(R4a)2、−NR4aC(=O)N(R4a)2、−C(=O)NH2、−C(=O)N(R4a)2、−OR4、−SR4a、または−N(R4a)2により、1回または複数回、置換されていてもよく、
C1〜12ヘテロアリールはそれぞれ、C1〜12アルキル、C3〜12シクロアルキル、C6〜12アリール、C2〜12ヘテロシクリル、−OH、NH2、−F、−Cl、−Br、−I、−NO2、−CN、−C(=O)R4a、−C(=NR4a)R4、−C(=O)OH、−C(=O)OR4、−OC(=O)R4、−OC(=O)OR4、−SO3H、−SO2N(R4a)2、−SO2R4、−SO2NR4aC(=O)R4、−PO3H2、−R4aC(=NR4a)N(R4a)2、−NHC(=NR4a)NH−CN、−NR4aC(=O)R4、−NR4aSO2R4、−NR4aC(=NR4a)NR4aC(=NR4a)N(R4a)2、−NR4aC(=O)N(R4a)2、−C(=O)NH2、−C(=O)N(R4a)2、−OR4、−SR4a、または−N(R4a)2により、1回または複数回、置換されていてもよく、
C2〜12ヘテロシクリルはそれぞれ、C1〜12アルキル、C3〜12シクロアルキル、C6〜12アリール、C1〜12ヘテロアリール、−OH、NH2、−F、−Cl、−Br、−I、−NO2、−CN、−C(=O)R4a、−C(=NR4a)R4、−C(=O)OH、−C(=O)OR4、−OC(=O)R4、−OC(=O)OR4、−SO3H、−SO2N(R4a)2、−SO2R4、−SO2NR4aC(=O)R4、−PO3H2、−R4aC(=NR4a)N(R4a)2、−NHC(=NR4a)NH−CN、−NR4aC(=O)R4、−NR4aSO2R4、−NR4aC(=NR4a)NR4aC(=NR4a)N(R4a)2、−NR4aC(=O)N(R4a)2、−C(=O)NH2、−C(=O)N(R4a)2、−OR4、−SR4a、または−N(R4a)2により、1回または複数回、置換されていてもよく、
R4は、C1〜12アルキル、C3〜12シクロアルキル、C6〜12アリール、C1〜12ヘテロアリールおよびC2〜12ヘテロシクリルから独立して選択され、これらはそれぞれ、−OH、−NH2、−F、−Cl、−Br、−I、−NO2、−CN、−C(=O)OH、−SO3H、−PO3H2または−C(=O)NH2により、1回または複数回、置換されていてもよく、
R4aは、R4または水素であってもよく、
R2、R3、R4およびR4a基のいずれか2つまたはそれ超が、一緒になって環を形成していてもよい。
を含有することもできる。
アルコキシ、ヘテロアルコキシ、アルキル、ヘテロアルキル、アリール、アリールオキシ、アラルキル、アラルキルオキシ、アルケニルおよびアルキニル基から独立して選択される。一部の実施形態では、本イオン性液体は、式XIIIによる構造を有する、陽イオン性構成物を含有し、Arは、置換されているかまたは無置換のベンジル基であり、R15は、置換されているかもしくは無置換のC1〜C12アルキル基であるか、またはその両方である。一部の実施形態では、式XIIIの化合物は、−COOH、−SO3Hおよび−PO3H2から選択される、少なくとも1つの基の存在により特徴付けられる。
イオン性液体は、バイオシミラーAVASTIN(登録商標)の濃縮水溶液の粘度を低下させる。
医薬品用賦形剤(ポリソルベート20、リン酸およびクエン酸緩衝液、マンニトールおよびNaCl)を含有する、商業的に得たバイオシミラーAVASTIN(登録商標)を精製した。まず、DETERGENT−OUT(登録商標)TWEENメディカラム(G−Biosciences)を使用して、ポリソルベート20を除去した。次に、得られた溶液を、20mMのリン酸ナトリウム緩衝液(PB)または20mMの粘度低下性イオン性液体溶液に十分に緩衝液交換し、Jumbosep遠心濃縮器(Pall Corp.)で、10mL未満の最終体積まで濃縮した。4−エチル−4−メチルモルホリニウムメチルカーボネート(EMMC)を含有する試料の場合、タンパク質は、2mMのPB(pH7.0)に完全に緩衝液交換した。20mMのPB(PB対照試料)または20mMの粘度低下性イオン性液体に緩衝液交換した試料の場合、採集したタンパク質溶液を冷凍乾燥した。タンパク質および緩衝塩または粘度低下性イオン性液体剤を含有する、乾燥タンパク質ケーキを、約0.10〜1.30mLの最終体積まで再構成した。これらの試料を、適宜、PBの最終濃度を0.25Mに、および以下の表に示されている粘度低下性イオン性液体の最終濃度にするのに十分な、追加のPB(pH7.0)または粘度低下性イオン性液体(pH7.0)を使用して再構成した。2mMのPBに緩衝液交換した試料を、まずアリコートに分けた。次に、適量の粘度低下性イオン性液体の溶液(pH7.0)を、それぞれのアリコートに加え、それにより水による再構成の際の最終賦形剤の濃度を0.1〜0.5Mにした。次に、タンパク質溶液を冷凍乾燥した。タンパク質および粘度低下性イオン性液体(および、無視できる量の緩衝塩)を含有する乾燥タンパク質ケーキを再構成して、最終体積約0.1mLおよび以下の表に示されている粘度低下性イオン性液体の濃度にした。溶液中のmAbの最終濃度は、実験的に決定した吸光係数1.7L/g・cmを使用して、280nmにおける吸光度により決定し、報告されている粘度は、RheoSense mVROCマイクロ流体粘度計で測定した。
イオン性液体は、バイオシミラーRITUXAN(登録商標)の濃縮水溶液の粘度を低下させる。
イオン性液体は、TYSABRI(登録商標)の濃縮水溶液の粘度を低下させる。
4−(3−ブチル−1−イミダゾリオ)−1−ブタンスルホネートにより、濃縮REMICADE(登録商標)およびVECTIBIX(登録商標)溶液の粘度が低下する。
イオン性液体は、HERCEPTIN(登録商標)の濃縮水溶液の粘度を低下させる。
バイオシミラーERBITUX(登録商標)の水溶液についての、粘度低下効果のイオン性液体濃度に対する依存性
粘度低下は、皮下注射した場合に、毒性の徴候を示さない。
Claims (26)
- (i)抗体;
(ii)最大0.5Mの1−ブチル−1−メチルピロリジニウムクロリド(BMPクロリド)もしくは薬学的に許容されるその塩;または、
最大0.4Mの4−エチル−4−メチルモルホリニウムメチルカーボネート(EMMC)もしくは薬学的に許容されるその塩を含む、
1種または複数の粘度低下性イオン性液体;
(iii)薬学的に許容される溶媒
を含む、注射用液状医薬製剤であって、
注射に適した体積での場合、該液状医薬製剤が、円錐平板粘度計またはマイクロ流体粘度計を使用して測定すると、25℃において絶対粘度約1cP〜約100cPを有しており、該液状医薬製剤の該絶対粘度が、該抗体および該薬学的に許容される溶媒を含むが、1種または複数の粘度低下性イオン性液体を含まない対照組成物の絶対粘度よりも低く、
該絶対粘度は、外挿したゼロせん断粘度であり、
該液状医薬製剤は、該粘度低下性イオン性液体がBMPクロリドもしくはその薬学的に許容される塩を含む場合には、約210mg/ml〜約249mg/mlの該抗体を含み、
該液状医薬製剤は、該粘度低下性イオン性液体がEMMCもしくはその薬学的に許容される塩を含む場合には、約217mg/ml〜約253mg/mlの該抗体を含む、
注射用液状医薬製剤。 - 前記粘度低下性イオン性液体が、BMPクロリドまたは薬学的に許容されるその塩を含む、請求項1に記載の液状医薬製剤。
- 前記粘度低下性イオン性液体が、EMMCまたは薬学的に許容されるその塩を含む、請求項1に記載の液状医薬製剤。
- 前記抗体が、モノクローナル抗体である、請求項1に記載の液状医薬製剤。
- 前記抗体が、約120kDa〜約250kDaの分子量を有する、請求項1から4のいずれか一項に記載の液状医薬製剤。
- 前記薬学的に許容される溶媒が水性である、請求項1から5のいずれか一項に記載の液状医薬製剤。
- 1種または複数の薬学的に許容される賦形剤であって、糖、糖アルコール、緩衝剤、保存剤、担体、酸化防止剤、キレート剤、天然ポリマー、合成ポリマー、凍結保護剤、凍結乾燥保護剤、界面活性剤、増量剤、安定化剤、またはそれらの任意の組合せを含む該1種または複数の薬学的に許容される賦形剤をさらに含む、請求項1から6のいずれか一項に記載の液状医薬製剤。
- 前記1種または複数の薬学的に許容される賦形剤が、ポリソルベート、ポロキサマー188、ラウリル硫酸ナトリウム、ポリオール、ポリ(エチレングリコール)、グリセロール、プロピレングリコールまたはポリ(ビニルアルコール)である、請求項7に記載の液状医薬製剤。
- 前記糖アルコールが、ソルビトールまたはマンニトールである、請求項7に記載の液状医薬製剤。
- 単位用量バイアル、複数回用量バイアルまたはプレフィルドシリンジ中の、請求項1から9のいずれか一項に記載の液状医薬製剤。
- 前記液状医薬製剤がヒト血清に等張である、請求項1から10のいずれか一項に記載の液状医薬製剤。
- 前記絶対粘度が、円錐平板粘度計を使用して測定される場合、少なくとも約0.5s−1のせん断速度で測定されるか、またはマイクロ流体粘度計を使用して測定した場合、少なくとも約1.0s−1のせん断速度で測定される、請求項1から11のいずれか一項に記載の液状医薬製剤。
- 前記液状医薬製剤が、凍結乾燥した組成物から再構成される、請求項1から12のいずれか一項に記載の液状医薬製剤。
- 前記液状医薬製剤が対象に投与され、該投与が皮下注射または筋肉内注射を含むことを特徴とする、請求項1から13のいずれか一項に記載の液状医薬製剤。
- 前記注射が、シリンジを用いて行われる、請求項14に記載の液状医薬製剤。
- 前記シリンジが、加熱シリンジ、自己混合式シリンジ、オートインジェクター、プレフィルドシリンジ、またはそれらの組合せである、請求項15に記載の液状医薬製剤。
- 前記シリンジが、加熱シリンジであり、前記液状医薬製剤が、25℃〜40℃の間の温度を有する、請求項15または16に記載の液状医薬製剤。
- 前記液状医薬製剤が、ドレイズ評点システムを使用して評価した場合、3未満の一次刺激インデックスを生じる、請求項14から17のいずれか一項に記載の液状医薬製剤。
- 前記液状医薬製剤が、前記抗体および前記薬学的に許容される溶媒を含むが、前記1種または複数の粘度低下性イオン性液体を含まない、液状医薬製剤の射出力よりも少なくとも10%小さい射出力によって注射される、請求項14から18のいずれか一項に記載の液状医薬製剤。
- 前記液状医薬製剤が、前記抗体および前記薬学的に許容される溶媒を含むが、前記1種または複数の粘度低下性イオン性液体を含まない、液状医薬製剤の射出力よりも少なくとも20%小さい射出力によって注射される、請求項14から18のいずれか一項に記載の液状医薬製剤。
- 前記注射が、直径がゲージ27〜31の間の針を使用して行われ、かつ該ゲージ27の針を使用した場合、前記射出力が30N未満である、請求項14から20のいずれか一項に記載の液状医薬製剤。
- 前記抗体、前記薬学的に許容される溶媒、および前記1種または複数の粘度低下性イオン性液体を合わせるステップを含む、請求項1から13のいずれか一項に記載の液状医薬製剤を調製する方法。
- (i)抗体;
(ii)1−ブチル−1−メチルピロリジニウムクロリド(BMPクロリド)もしくは薬学的に許容されるその塩;または、
4−エチル−4−メチルモルホリニウムメチルカーボネート(EMMC)もしくは薬学的に許容されるその塩を含む、
1種または複数の粘度低下性イオン性液体;
(iii)薬学的に許容される賦形剤
を含む、凍結乾燥された組成物。 - 再構成されたら、前記抗体が、少なくとも100mg/mlの濃度を有する、請求項23に記載の凍結乾燥された組成物。
- 前記粘度低下性イオン性液体が、BMPクロリドまたは薬学的に許容されるその塩を含む、請求項23または24に記載の凍結乾燥された組成物。
- 前記粘度低下性イオン性液体が、EMMCまたは薬学的に許容されるその塩を含む、請求項23または24に記載の凍結乾燥された組成物。
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US10812184B1 (en) | 2019-04-03 | 2020-10-20 | Board Of Trustees Of The University Of Alabama, For And On Behalf Of The University Of Alabama In Huntsville | Signal analysis systems and methods |
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