JP2013507430A - 改善された医薬エアゾール製剤 - Google Patents
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Abstract
Description
下記の表3に示した組成物を作製し、フルチカゾン、ホルモテロールおよびクロモリンナトリウムのフロキュールの密度を種々の温度範囲にわたって算出し、液相(1.43%w/wの無水エタノールとHFA227とからなる)の計算密度と比較した。
表6に示したバッチを作製し、試験した(10〜30℃の「使用温度」の範囲)。
以下のバッチを、実施例1に記載した方法を用いて作製した。
実施例1に記載の方法を用いて以下のバッチを作製した。
Claims (31)
- a)微粒化β2−刺激薬と、
b)微粒化コルチコステロイドと、
c)準治療量の水分捕捉賦形剤と、
d)HFA噴射剤とを含み、
ここで(a)、(b)および(c)ならびにその各々の相対量は、これらが会合してHFA噴射剤のものと実質的に同じ密度を有するフロキュールを形成するように選択されることを特徴とするMDI投与用の医薬エアゾール懸濁液製剤。 - 前記フロキュールの平均密度が、噴射剤の密度の±0.2g/cm3、好ましくは±0.1g/cm3、より好ましく±0.05g/cm3とほぼ同じである請求項1に記載の医薬エアゾール懸濁液製剤。
- 前記HFA噴射剤がHFA227である請求項1または2に記載の医薬エアゾール懸濁液製剤。
- 前記β2−刺激薬が、フマル酸ホルモテロールもしくはその薬学的に許容し得る塩または誘導体である前記請求項のいずれか一項に記載の医薬エアゾール懸濁液製剤。
- 前記β2−刺激薬が、製剤の全重量に対し0.003〜0.04重量%、好ましくは0.004〜0.03重量%、さらに好ましくは0.005〜0.02重量%の量で存在する前記請求項のいずれか一項に記載の医薬エアゾール懸濁液製剤。
- 前記コルチコステロイドが、プロピオン酸フルチカゾンもしくはその薬学的に許容し得る塩または誘導体である前記請求項のいずれか一項に記載の医薬エアゾール懸濁液製剤。
- 前記コルチコステロイドが、製剤の全重量に対し0.01〜0.6重量%、好ましくは0.02〜0.5重量%、さらに好ましくは0.03〜0.4重量%の量で存在する前記請求項のいずれか一項に記載の医薬エアゾール懸濁液製剤。
- 前記水分捕捉賦形剤が、クロモリンナトリウムである前記請求項のいずれか一項に記載の医薬エアゾール懸濁液製剤。
- 前記水分捕捉賦形剤が、製剤の全重量に対し0.01〜0.1重量%、好ましくは0.016〜0.09重量%、さらに好ましくは0.02〜0.08重量%、さらに好ましくは0.025〜0.07重量%、さらに好ましくは0.03〜0.05重量%、さらに好ましくは0.03〜0.04重量%の量で存在する前記請求項のいずれか一項に記載の医薬エアゾール懸濁液製剤。
- 湿潤剤をさらに含む前記請求項のいずれか一項に記載の医薬エアゾール懸濁液製剤。
- 前記湿潤剤が無水アルコールである請求項10に記載の医薬エアゾール懸濁液製剤。
- 前記湿潤剤がエタノールである請求項11に記載の医薬エアゾール懸濁液製剤。
- 前記アルコールが、製剤の全重量に対し0.01〜3重量%、好ましくは0.05〜2.5重量%、さらに好ましくは1.0〜2.0重量%の量で存在する請求項11または12に記載の医薬エアゾール懸濁液製剤。
- a)0.01〜0.6重量%の微粒化コルチコステロイドと、
b)0.003〜0.04重量%の微粒化β2−刺激薬と、
c)0.01〜0.1重量%のクロモリンナトリウムとを含む薬学組成物。 - 前記コルチコステロイドが微粒化プロピオン酸フルチカゾンである請求項14に記載の薬学組成物。
- 前記微粒化β2−刺激薬が微粒化フマル酸ホルモテロール二水和物である請求項14または15に記載の薬学組成物。
- 湿潤剤をさらに含む請求項14〜16のいずれかに記載の薬学組成物。
- 前記湿潤剤が無水アルコール、好ましくはエタノールであり、また製剤の全重量に対し0.01〜3重量%、好ましくは0.05〜2.5重量%、さらに好ましくは1.0〜2.0重量%の量で存在する請求項14〜17のいずれかに記載の薬学組成物。
- a)約0.003〜0.04重量%のフマル酸ホルモテロール二水和物と、
b)約0.01〜0.6重量%のプロピオン酸フルチカゾンと、
c)約0.01〜0.1重量%の懸濁剤と、
d)約0.01〜3重量%の無水アルコールとを含む薬学エアゾール懸濁液製剤。 - 前記懸濁剤がクロモリンナトリウムである請求項19に記載の薬学エアゾール懸濁液製剤。
- 炎症、特に喘息およびアレルギー性鼻炎の治療に同時、分離してまたは連続的に使用する組合せ調剤としてフマル酸ホルモテロール二水和物、プロピオン酸フルチカゾンおよびクロモリンナトリウムを含む製品。
- HFA噴射剤のものと実質的に同じ密度を有するフマル酸ホルモテロール二水和物、プロピオン酸フルチカゾンおよびクロモリンナトリウムのフロキュールを形成するためのフマル酸ホルモテロール二水和物と、プロピオン酸フルチカゾン微粒子とを含むHFA噴射剤中の薬学懸濁液製剤の調製へのクロモリンナトリウムの使用。
- HFA噴射剤のものと実質的に同じ密度を有するフマル酸ホルモテロール二水和物、プロピオン酸フルチカゾンおよびクロモリンナトリウムのフロキュールを形成するための0.003〜0.004%のフマル酸ホルモテロール二水和物と、0.01〜0.6%のプロピオン酸フルチカゾン微粒子とを含むHFA噴射剤中の薬学懸濁液製剤の調製への0.01〜0.1%のクロモリンナトリウムの使用。
- 前記フロキュールの平均密度が、噴射剤の密度の±0.2g/cm3、好ましくは±0.1g/cm3、より好ましく±0.05g/cm3とほぼ同じである請求項22または23に記載の使用。
- 前記薬学懸濁液製剤が、湿潤剤、好ましくは無水アルコール、より好ましくはエタノールをさらに含む請求項22〜24のいずれか一項に記載の使用。
- a)0.0071w/wのフマル酸ホルモテロール二水和物と、
b)0.0357w/w、0.0714w/w、0.1784w/wまたは0.3570w/wのプロピオン酸フルチカゾンと、
c)0.0343w/wのクロモリンナトリウムと、
d)残余のHFA227噴射剤とを含む薬学組成物。 - a)0.0142w/wのフマル酸ホルモテロール二水和物と、
b)0.0357w/wのプロピオン酸フルチカゾンと、
c)0.0343w/wまたは0.0686w/wのクロモリンナトリウムと、
d)残余のHFA227噴射剤とを含む薬学組成物。 - 1.43w/wのエタノールをさらに含む請求項26または27に記載の薬学組成物。
- HFA噴射剤中の微粒子化β2−刺激薬および微粒子化コルチコステロイドの医薬エアゾール懸濁液製剤の安定性を長期間の保管わたり増大する方法において、準治療量のクロモリンナトリウムを添加することを備え、微粒子化β2−刺激薬、微粒子化コルチコステロイドおよびクロモリンナトリウムの各々の相対量は、これらが会合してHFA噴射剤のものと実質的に同じ密度を有するフロキュールを形成するように選択されることを特徴とする方法。
- 前記長期間の保管が3、6、9、12または18ヶ月である請求項29に記載の方法。
- 前記長期間保管後の懸濁液製剤の含水量が、500ppm〜800ppm、好ましくは600ppm〜700ppmの範囲内である請求項29または30に記載の方法。
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GBGB0918149.6A GB0918149D0 (en) | 2009-10-16 | 2009-10-16 | Improved medicinal aerosol formulation |
GB0918149.6 | 2009-10-16 | ||
PCT/EP2010/065573 WO2011045432A1 (en) | 2009-10-16 | 2010-10-15 | Improved medicinal aerosol formulations |
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