JP2019504043A - コラーゲン7組成物及びそれを用いる方法 - Google Patents
コラーゲン7組成物及びそれを用いる方法 Download PDFInfo
- Publication number
- JP2019504043A JP2019504043A JP2018533834A JP2018533834A JP2019504043A JP 2019504043 A JP2019504043 A JP 2019504043A JP 2018533834 A JP2018533834 A JP 2018533834A JP 2018533834 A JP2018533834 A JP 2018533834A JP 2019504043 A JP2019504043 A JP 2019504043A
- Authority
- JP
- Japan
- Prior art keywords
- composition
- collagen
- arginine
- certain embodiments
- polysorbate
- 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.)
- Granted
Links
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Classifications
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Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
- Public Health (AREA)
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- Birds (AREA)
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Abstract
Description
特定の実施形態では、リン酸ナトリウムは、100mM〜1mM、50mM〜5mM、25mM〜5mM、10mM〜5mM、10mM〜1mMの範囲又は約10mMの量で存在する。
特定の実施形態では、アルギニンは、200mM〜5mM、150mM〜50mM、100mM〜75mMの範囲、又は約100mMの量で存在する。
コラーゲン7組成物は、増加した安定性を有する。特定の実施形態では、組成物は、1リットルのポリカーボネートボトル内(組成物500mL)、−65±5℃又は−20±5℃で貯蔵後、3か月間安定である。特定の実施形態では、組成物は、10cm3(10cc)のガラスバイアル内(組成物5.5mL)、−65±5℃又は−20±5℃で貯蔵後、6か月間安定である。特定の実施形態では、組成物は、25±3℃で2週間の貯蔵後、安定である。特定の実施形態では、組成物は、5±3℃で最大1か月間の貯蔵後、安定である。
別の態様は、DEBを治療する方法であって、本明細書に記載されるような組換えコラーゲン7組成物を有効量でそれを必要とする対象に投与するステップを含む、方法を対象とする。
凍結/解凍特性及び熱安定性を比較するため、以前に用いたPBS製剤を含む5つの製剤を選択した。これらの製剤を表1に列挙する。
rC7を血流中に静脈内注射するときに何が生じるかを知ることは困難である。しかし、10%ウシ血清を含有し、37℃で保持される緩衝液などのより生理学的関連条件にタンパク質が曝露するときの任意の変化について監視することにより、生成物の品質変化についての可能性を評価することは可能である。rC7タンパク質は、可溶性凝集及び沈殿の傾向がある。これらの事象は、一般的な分析技術を通じて監視することができる。タンパク質含量における変化について監視するため、A280の吸光度を用いる。不可溶性微粒子の形成に起因する混濁度における変化について監視するため、A320の吸光度を用いる。HMW及び/又はLMW種が形成する場合の可溶性タンパク質における変化について監視するため、SEC−HPLCを用いる。血清効果の影響を最大化するため、緩衝液を等量の血清で希釈し、0.5mg/mLの最終タンパク質濃度、(第I相製剤中)rC7の存在下でインキュベートした。体温をシミュレートするため、全試料を37℃で1時間保持した。これらの結果のまとめを表5に列挙する。その結果によると、生理学的培地への37℃で1時間の曝露後、タンパク質含量(A280)、又は混濁度(A320)に変化がないことが示された。したがって、データは、血清へのrC7送達の希釈時に即時性の溶解度制限が明白でないことを示唆している。
SEC−HPLC特性によると、様々な試験緩衝液マトリックスに37℃で1時間曝露後、不可溶性凝集体の増加が認められないことが確認された。図5。様々な緩衝液への曝露により、おそらくはαヘリックスの可動性の増加に起因して、ピークの低分子量側領域における初期変化が惹起される。
実施例2
初期開発研究に基づき、10mMのリン酸ナトリウム、5mMのクエン酸ナトリウム、70mMの塩化ナトリウム、100mMのアルギニン、50mMのスクロース、0.05%のポリソルベート20、及び約7.1のpHを含む製剤を、DEBのマウスモデルにおけるCol7a1−/−マウスへの投与に用いた。
舌における表皮と真皮との間の完全な閉鎖(すなわち分離なし)を伴うマウスの割合は、被験物質1、被験物質2、及び溶媒対照を投与したCol7a1−/−マウスにおいて各々、50%(26中12)、63%(26中15)、及び10%(10中1)であった。真皮−上皮分離の完全な閉鎖を伴うCol7a1−/−マウスの割合は、rC7治療マウスにおいて、溶媒対照よりも高かった(被験物質1対溶媒、フィッシャーp=0.06、被験物質2対溶媒、フィッシャーp=0.02)。真皮−上皮分離の閉鎖を伴うCol7a1−/−マウスの割合は、rC7治療マウス間で異ならなかった(フィッシャーp=0.58)。
この試験では、DEBの新生児マウスモデルでの試験対象のrC7組成物における有効性が実証された。詳細には、舌及び皮膚における真皮−上皮BMZに対して分布した両被験物質が、真皮−上皮分離を修正し、その結果、Col7a1−/−マウスにおける単回静脈内注射後、生存において、溶媒対照と比べて統計学的に有意な改善をもたらした。
Claims (9)
- 組換えコラーゲン7、約10mMのリン酸ナトリウム、約5mMのクエン酸ナトリウム、約70mMの塩化ナトリウム、約100mMのアルギニン、約50mMのスクロース、及び約0.05%のポリソルベート20を含んでなる、組成物。
- 7.0〜7.2のpHを有する、請求項1に記載の組成物。
- 前記組換えコラーゲン7がヒトコラーゲン7である、請求項1又は2に記載の組成物。
- 組換えコラーゲン7、約10mMのリン酸ナトリウム、約5mMのクエン酸ナトリウム、約70mMの塩化ナトリウム、約100mMのアルギニン、約50mMのスクロース、約0.05%のポリソルベート20及び1つ以上の薬学的に許容できる賦形剤を含んでなる、医薬組成物。
- 7.0〜7.2のpHを有する、請求項4に記載の組成物。
- 前記組換えコラーゲン7がヒトコラーゲンである、請求項4又は5に記載の組成物。
- (a)前記組成物500mLが1リットルのポリカーボネートボトル内で貯蔵されるとき、−65±5℃又は−20±5℃で3か月間;
(b)前記組成物5.5mLが10cm3(10cc)のガラスバイアル内で貯蔵されるとき、−65±5℃又は−20±5℃で6か月間;
(c)25±3℃で2週間;及び
(d)5±3℃で最大1か月間、
のうちの少なくとも1つの条件で安定である、請求項1〜6のいずれか一項に記載の組成物。 - 栄養障害型表皮水疱症の治療に用いられる、請求項1〜7のいずれか一項に記載の組成物。
- 栄養障害型表皮水疱症を治療する方法であって、請求項1〜8のいずれか一項に記載の組成物を有効量でそれを必要とする対象に投与するステップを含む、方法。
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