JP2023026517A - 改善された医薬エアゾール製剤 - Google Patents
改善された医薬エアゾール製剤 Download PDFInfo
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- JP2023026517A JP2023026517A JP2022209895A JP2022209895A JP2023026517A JP 2023026517 A JP2023026517 A JP 2023026517A JP 2022209895 A JP2022209895 A JP 2022209895A JP 2022209895 A JP2022209895 A JP 2022209895A JP 2023026517 A JP2023026517 A JP 2023026517A
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Abstract
Description
a)微粒化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と、
b)微粒化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誘導体と、
c)準治療量のクロモリンナトリウムを含む水分捕捉賦形剤と、
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。
[本発明1002]
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とほぼ同じである本発明1001の医薬エアゾール懸濁液製剤。
[本発明1003]
前記HFA噴射剤がHFA227である本発明1001または1002の医薬エアゾール懸濁液製剤。
[本発明1004]
前記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%の量で存在する本発明1001~1003のいずれかの医薬エアゾール懸濁液製剤。
[本発明1005]
前記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%の量で存在する本発明1001~1004のいずれかの医薬エアゾール懸濁液製剤。
[本発明1006]
前記クロモリンナトリウムが、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%の量で存在する本発明1001~1005のいずれかの医薬エアゾール懸濁液製剤。
[本発明1007]
湿潤剤をさらに含む本発明1001~1006のいずれかの医薬エアゾール懸濁液製剤。
[本発明1008]
前記湿潤剤が無水アルコールである本発明1007の医薬エアゾール懸濁液製剤。
[本発明1009]
前記湿潤剤がエタノールである本発明1008の医薬エアゾール懸濁液製剤。
[本発明1010]
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%の量で存在する本発明1008または1009の医薬エアゾール懸濁液製剤。
[本発明1011]
a)0.01~0.6重量%の微粒化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と、
b)0.003~0.04重量%の微粒化フマル酸ホルモテロール二水和物もしくはその薬学的に許容し得る塩または誘導体と、
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。
[本発明1012]
湿潤剤をさらに含む本発明1011の薬学組成物。
[本発明1013]
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%の量で存在する本発明1011または1012の薬学組成物。
[本発明1014]
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%のクロモリンナトリウムと、
d)約0.01~3重量%の無水アルコールとを含む薬学懸濁液製剤。
[本発明1015]
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。
[本発明1016]
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。
[本発明1017]
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との微粒子とを含む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。
[本発明1018]
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とほぼ同じである本発明1016または1017の使用。
[本発明1019]
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本発明1016~1018のいずれかの使用。
[本発明1020]
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。
[本発明1021]
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。
[本発明1022]
1.43w/wのエタノールをさらに含む本発明1020または1021の薬学組成物。
[本発明1023]
HFA噴射剤中の微粒子化フマル酸ホルモテロール二水和物および微粒子化プロピオン酸フルチカゾン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、ここで微粒子化フマル酸ホルモテロール二水和物、微粒子化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。
[本発明1024]
前記長期間の保管が3、6、9、12または18ヶ月である本発明1023の方法。
[本発明1025]
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の範囲内である本発明1023または1024の方法。
本発明の実施例を添付図面を参照して例示として以下説明する。
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 (11)
- a)0.01~0.6重量%の微粒化プロピオン酸フルチカゾンと、
b)0.003~0.04重量%の微粒化フマル酸ホルモテロール二水和物と、
c)0.02~0.08重量%のクロモリンナトリウムと、
d)HFA噴射剤と
を含む薬学組成物であって、
無水アルコールをさらに含む、薬学組成物。 - 無水アルコールがエタノールである、請求項1に記載の薬学組成物。
- a)0.003~0.04重量%のフマル酸ホルモテロール二水和物と、
b)0.01~0.6重量%のプロピオン酸フルチカゾンと、
c)0.02~0.08重量%のクロモリンナトリウムと、
d)0.01~3重量%の無水アルコールと
e)HFA噴射剤と
を含む、薬学懸濁液製剤であって、
無水アルコールがエタノールである、薬学懸濁液製剤。 - 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)1.43w/wの無水アルコールと、
e)残余のHFA227噴射剤と
を含む薬学組成物。 - MDI投与用の医薬エアゾール懸濁液製剤の保管寿命を延ばす方法であって、該製剤が下記の成分:
a)0.003~0.04重量%の微粒化フマル酸ホルモテロールと、
b)0.01~0.6重量%の微粒化プロピオン酸フルチカゾンと、
c)0.02~0.08重量%のクロモリンナトリウムと、
d)HFA227噴射剤と
を含む、方法。 - MDI投与用の医薬エアゾール懸濁液製剤ためのプロピオン酸フルチカゾンおよびフマル酸ホルモテロールの送達用量の偏差を減らす方法であって、該製剤が下記の成分:
a)0.003~0.04重量%の微粒化フマル酸ホルモテロールと、
b)0.01~0.6重量%の微粒化プロピオン酸フルチカゾンと、
c)0.02~0.08重量%のクロモリンナトリウムと、
d)HFA227噴射剤と
を含む、方法。 - MDI投与用の医薬エアゾール懸濁液製剤における均一性を高める方法であって、該製剤が下記の成分:
a)0.003~0.04重量%の微粒化フマル酸ホルモテロールと、
b)0.01~0.6重量%の微粒化プロピオン酸フルチカゾンと、
c)0.02~0.08重量%のクロモリンナトリウムと、
d)HFA227噴射剤と
を含む、方法。 - MDIのキャニスタまたは絞り弁の内壁面への、MDI投与用の医薬エアゾール懸濁液製剤の成分の付着を減らす方法であって、該製剤が下記の成分:
a)0.003~0.04重量%の微粒化フマル酸ホルモテロールと、
b)0.01~0.6重量%の微粒化プロピオン酸フルチカゾンと、
c)0.02~0.08重量%のクロモリンナトリウムと、
d)HFA227噴射剤と
を含む、方法。 - 0.003~0.04重量%のフマル酸ホルモテロールと、0.01~0.6重量%のプロピオン酸フルチカゾン微粒子と、無水アルコールとを含むHFA噴射剤中の薬学懸濁液製剤の調製における、該製剤の微粒子画分を安定させるための0.02~0.08重量%のクロモリンナトリウムの使用。
- 0.003~0.04重量%のフマル酸ホルモテロールと、0.01~0.6重量%のプロピオン酸フルチカゾン微粒子と、無水アルコールとを含むHFA噴射剤中の薬学懸濁液製剤の調製における、該製剤の保管寿命を改善するための0.02~0.08重量%のクロモリンナトリウムの使用。
- 無水アルコールがエタノールである、請求項9または10に記載の使用。
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