JP2001519770A - 安定な液体インターフェロン処方物 - Google Patents
安定な液体インターフェロン処方物Info
- Publication number
- JP2001519770A JP2001519770A JP52905698A JP52905698A JP2001519770A JP 2001519770 A JP2001519770 A JP 2001519770A JP 52905698 A JP52905698 A JP 52905698A JP 52905698 A JP52905698 A JP 52905698A JP 2001519770 A JP2001519770 A JP 2001519770A
- Authority
- JP
- Japan
- Prior art keywords
- interferon
- liquid
- buffer
- liquid composition
- composition according
- 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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Abstract
Description
Claims (1)
- 【特許請求の範囲】 1. インターフェロン、ならびに酸性アミノ酸、アルギニンおよびグリシンか らなる群から選択されるアミノ酸である安定剤を約0.3重量%〜5重量%の間で含 む液体組成物であって、該液体組成物が予め凍結乾燥されていない、液体組成物 。 2. 前記液体組成物を含む容器をさらに含み、該容器がインターフェロンに対 して不活性な物質でコーティングされた少なくとも1つの表面を有する、請求項 1に記載の液体組成物。 3. 前記インターフェロンがインターフェロン−βまたは組換え産生されたイ ンターフェロンである、請求項1に記載の液体組成物。 4. 約4.0と約7.2の間とのpHを有する、請求項1に記載の液体組成物。 5. 4.8〜5.2のpHを有する、請求項4に記載の液体組成物。 6. 5.0のpHを有する、請求項5に記載の液体組成物。 7. 前記酸性アミノ酸がグルタミン酸である、請求項5に記載の液体組成物。 8. 前記アルギニンがアルギニン-HClである、請求項1に記載の液体組成物。 9. 約6IMU/mlと約50IMU/mlとの間のインターフェロン濃度を有する、請求項 1に記載の液体組成物。 10. 前記容器の前記少なくとも1つの表面が、シリコーンおよびポリテトラ フルオロエチレンからなる群から選択される物質でコーティングされる、請求項 2に記載の液体組成物。 11. 前記容器が注射器である、請求項10に記載の液体組成物。 12. インターフェロン−β、ならびに以下からなる群:(a)150mMアルギニン ;(b)100mM塩化ナトリウムおよび70mMグリシン;(c)150mMアルギニンおよび15mg /mlヒト血清アルブミン;(d)150mMアルギニンおよび界面活性剤;(d)140nM塩化 ナトリウム;(e)140mM塩化ナトリウムおよび15mg/mlヒト血清アルブミン;なら びに(f)140mM塩化ナトリウムおよび界面活性剤から選択される安定剤を含む20mM 、pH5.0の酢酸緩衝液であって、ここで、該緩衝液が予め凍結乾燥されていない 、緩衝液。 13. 前記界面活性剤が0.1%(w/v)Pluronic F-68である、請求項12に記載 の緩衝液。 14. 前記アルギニンがアルギニン−HClである、請求項12に記載の緩衝液 。 15. 前記緩衝液を含む容器をさらに含み、ここで該緩衝液と接触している該 容器の少なくとも1つの表面が、シリコーンおよびポリテトラフルオロエチレン からなる群から選択される物質でコーティングされている、請求項12に記載の 緩衝液。 16. 前記容器が注射器である、請求項15に記載の緩衝液。 17. pH5.0の液体組成物であって、インターフェロン-βおよび170mML-グル タミン酸を含み、該液体が予め凍結乾燥されていない、液体組成物。 18. アミノ酸グリシンを含み、そして塩をさらに含む、請求項1に記載の液 体組成物。 19. 15mg/mlのヒト血清アルブミンおよび0.1%(w/v)Pluronic F-68からなる 群から選択される成分をさらに含む、請求項17に記載の液体組成物。 20. インターフェロン−β、ならびに以下からなる群:(a)140mMアルギニン ;および(b)70mMグリシンと台わせた100mM塩化ナトリウムから選択される安定剤 を含む20mM、pH7.2のリン酸緩衝液であって、ここで該緩衝液が、予め凍結乾燥 されていない、緩衝液。 21. 前記液体を含む容器をさらに含み、ここで、該液体と接触している該容 器の少なくとも一つの表面がシリコーンおよびポリテトラフルオロエチレンから なる群から選択される物質でコーティングされている、請求項20に記載の液体 組成物。 22. 前記容器が注射器である、請求項20に記載の液体組成物。 23. 保存容器内に含まれる薬学的液体組成物であって、該液体が哺乳動物へ の非経口投与に適切であり、かつ有効量のインターフェロン−β、4.0から6.0の 範囲内でpHを維持する緩衝剤、およびアミノ酸安定剤を含み、ここで該インター フェロン−βが予備凍結乾燥に供されておらず、そして該保存容器が、シリコー ンおよびポリテトラフルオロエチレンからなる群から選択される物質でコーティ ングされている該液体組成物と接触する、少なくとも一つのその表面を有する、 薬学的液体組成物。 24. 前記保存容器が酸素含有/液体接触面を欠く、請求項23に記載の液体 組成物。 25. 前記インターフェロン−βが、約2℃と約25℃との間の温度で少なく とも2ヶ月間にわたる保存の間、本質的にその抗ウイルス活性を維持する、請求 項23に記載の液体組成物。 26. 前記インターフェロン−βが予備空洞化に供されていない、請求項23 に記載の液体組成物。 27. 前記緩衝液が、クエン酸緩衝液、酒石酸緩衝液、フマル酸緩衝液、グル コン酸緩衝液、シュウ酸緩衝液、乳酸緩衝液および酢酸緩衝液からなる群から選 択される有機酸緩衝液である、請求項23に記載の液体組成物。 28. 前記アミノ酸安定剤が、酸性アミノ酸、グリシンおよびアルギニンから なる群から選択されるアミノ酸である、請求項23に記載の液体組成物。 29. 前記アミノ酸が組成物の約0.3重量%〜約5.0重量%の量で加えられる、 請求項28に記載の液体組成物。 30. 前記液体組成物のpHが4.5〜5.5の範囲である、請求項23に記載の液体 組成物。 31. 前記液体組成物のpHが5.0である、請求項30に記載の液体組成物。 32. 滅菌されている、請求項23に記載の液体組成物。 33. 血液に対し等張性である、請求項23に記載の液体組成物。 34. 前記インターフェロン−βがヒト組換えインターフェロンβである、請 求項23に記載の液体組成物。 35. 前記ヒト組換えインターフェロン−βの活性が6〜50IMU/mlタンパク質 の範囲である、請求項34に記載の液体組成物。 36. インターフェロンならびに、酸性アミノ酸、アルギニンおよびグリシン からなる群から選択されるアミノ酸である安定剤を約0.3重量%と3.13重量%と の間で含む凍結液体組成物であって、ここで該組成物が予め凍結乾燥されていな い、組成物。 37. 液体インターフェロン処方物の非経口投与のためのキットであって、こ こで、該キットが:a)pHが4と6との間の液体処方物を含む容器であって、該液 体が予め凍結乾燥されていない薬学的有効量のインターフェロン−β、およびア ミノ酸安定剤を約3.1重量%未満で含む容器;ならびにb)その使用についての説 明書を含む、キット。 38. さらに:c)アルコール綿棒;d)針;および少なくとも1つの接着ガー ゼ包帯を含む、請求項37に記載のキット。 39. 前記容器が該液体処方物と接触している少なくとも1つの表面を有し、 該表面が、シリコーンおよびポリテトラフルオロエチレンからなる群から選択さ れる物質でコーティングされている注射器である、請求項37に記載のキット。 40. 前記容器が注射器であり、そして該注射器に含まれる液体処方物が酸素 含有/液体接触面を欠く、請求項39に記載のキット。 41. 液体薬学的組成物においてインターフェロン−βを安定化させ、その結 果約2℃と約25℃の間との温度で少なくとも3ヶ月間にわたる保存の間、本質 的にその抗ウイルス活性を維持する方法であって、以下:a)インターフェロン −β;b)4.0〜7.2の範囲内でpHを維持する緩衝剤;およびc)アミノ酸安定剤 を混合する工程であって、ここで該液体が予め凍結乾燥されておらずかつ空洞化 されていない、工程を包含する、 方法。 42. 塩を混合して、適切なイオン強度を提供する工程をさらに包含する、請 求項41の方法。 43. 前記塩が塩化ナトリウムである、請求項42の方法。
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US3435396P | 1996-12-24 | 1996-12-24 | |
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PCT/US1997/023817 WO1998028007A1 (en) | 1996-12-24 | 1997-12-23 | Stable liquid interferon formulations |
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JP2007133540A Division JP2007204501A (ja) | 1996-12-24 | 2007-05-18 | 安定な液体インターフェロン処方物 |
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JP2011002557A Expired - Lifetime JP5851695B2 (ja) | 1996-12-24 | 2011-01-07 | 安定な液体インターフェロン処方物 |
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