JP5349302B2 - 炎症性肺疾患の治療のためのHMG−CoAレダクターゼインヒビターとホスホジエステラーゼ4インヒビターとの組合せ物 - Google Patents
炎症性肺疾患の治療のためのHMG−CoAレダクターゼインヒビターとホスホジエステラーゼ4インヒビターとの組合せ物 Download PDFInfo
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Description
スタチン類は、コレステロール降下性治療剤として広く知られている。それらは、コレステロール合成を調節する主要な酵素である3−ヒドロキシ−3−メチルグルタリル補酵素A(HMG−CoA)レダクターゼの競合阻害によってコレステロールレベルを下げる。また、スタチン類のコレステロール降下作用は、細胞内コレステロール枯渇の結果としての細胞によるコレステロール摂取の増加と、低密度リポタンパク質(LDL)受容体の高められた発現によるものである。
ここで、PDE4インヒビターとHMG−CoAレダクターゼインヒビターとの組合せ使用は、各成分単独の抗炎症性作用を増強することが判明した。
構成材料:(A)PDE4インヒビターもしくはそれらの製剤学的に認容性の塩;(B)HMG−CoAレダクターゼインヒビターもしくはそれらの製剤学的に認容性の塩とを含む組合せ製品であって、前記の第一の量と第二の量とが、一緒になって、炎症性肺疾患の予防的もしくは治療的な処置のための有効量を構成し、かつ構成材料(A)及び(B)のそれぞれが、少なくとも1つの製剤学的に認容性の助剤との混合物で製剤化されている組合せ製品。
(A)PDE4インヒビターもしくはそれらの製剤学的に認容性の塩の量;
(B)HMG−CoAレダクターゼインヒビターもしくはそれらの製剤学的に認容性の塩の量
を含む組合せ製品をそれを必要とする患者に投与することを含み、前記の第一の量と第二の量とが、一緒になって、炎症性肺疾患の予防的もしくは治療的な処置のための有効量を構成し、構成材料(A)と(B)のそれぞれが少なくとも1つの製剤学的に認容性の助剤との混合物で製剤化されており、かつ構成材料(A)と(B)が同時に、連続的にもしくは別々に投与される方法である。
a)第一工程でそれ自体混合し、次いで少なくとも1つの製剤学的に認容性の助剤と一緒に加工し、最後に、例えばタブレットもしくはカプレットへと加工してよく、又は
b)第一工程で別々に少なくとも1つの製剤学的に認容性の助剤と共に加工して、それぞれ2つの活性剤の1つだけを含有する顆粒もしくはペレットを得て、該ペレットもしくは顆粒をその一部について好適な比率で混合し、そして場合により他の製剤学的に認容性の助剤と共に圧縮して、例えばタブレットもしくはカプレットを得るか、もしくはカプセル中に緩い形で充填してよい。
アトルバスタチンのヘミカルシウムセスキ水和物と2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミド(化合物A)との組合せ物による、ラットにおけるLPSに誘発される全身性のTNFα放出の相乗的阻害
動物:雄のスプラグ・ダウレイラット200〜280g
薬剤:アトルバスタチンのヘミカルシウムセスキ水和物(Alexis Pharmaceuticals,San Diego,CA,USA)及び化合物A(ALTANA Pharma,Konstanz, Germany)
方法:薬剤は、LPS(0.1mg/kg)の静脈内投与の1時間前に、メトセル(methocel)/ポリエチレングリコール400懸濁液として胃管栄養によって投与した。90分後に、ペントバルビタール(48mg/kg)及びヘパリン(1000U/kg)の注射によって安楽死を誘発させた。ヘパリン化された血液を心臓穿刺によって得た。血液を遠心分離(21000×g、4℃、15分)し、血漿サンプルを、TNFαレベルを市販のELISA(Quantakine(登録商標)M,ラットTNFαイムノアッセイ、R&D,MN,USA)により決定するまで、−80℃で凍結させ続けた。
図面において、アトルバスタチンのヘミカルシウムセスキ水和物は、単に"アトルバスタチンCa"として示している。
図2:アトルバスタチンのヘミカルシウムセスキ水和物による、ラットにおけるLPSに誘発される(全身性)TNFα放出の阻害
図3:化合物Aとアトルバスタチンのヘミカルシウムセスキ水和物との組合せ物による、ラットにおけるLPSに誘発される(全身性)TNFα放出の阻害
Claims (22)
- PDE4インヒビターと、HMG−CoAレダクターゼインヒビターと、少なくとも1つの製剤学的に認容性の助剤とを含む医薬製剤を含む医薬組成物であって、その際、PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミド又はその製剤学的に認容性の塩であり、HMG−CoAレダクターゼインヒビターが、アトルバスタチン又はその製剤学的に認容性の塩である、炎症性肺疾患の予防的又は治療的な処置のための医薬組成物。
- 構成材料:(A)PDE4インヒビターと;(B)HMG−CoAレダクターゼインヒビターとを含む炎症性肺疾患の予防的又は治療的な処置のための組合せ製品であって、その際、構成材料(A)及び(B)のそれぞれが、少なくとも1つの製剤学的に認容性の助剤との混合物で製剤化され、その際、PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミド又はその製剤学的に認容性の塩であり、HMG−CoAレダクターゼインヒビターが、アトルバスタチン又はその製剤学的に認容性の塩である組合せ製品。
- 構成材料:(A)PDE4インヒビターを、少なくとも1つの製剤学的に認容性の助剤との混合物で含む医薬製剤;(B)HMG−CoAレダクターゼインヒビターを、少なくとも1つの製剤学的に認容性の助剤との混合物で含む医薬製剤を含む炎症性肺疾患の予防的又は治療的な処置のためのキットであって、その際、PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミド又はその製剤学的に認容性の塩であり、HMG−CoAレダクターゼインヒビターが、アトルバスタチン又はその製剤学的に認容性の塩であるキット。
- PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミドである請求項1記載の炎症性肺疾患の予防的又は治療的な処置のための医薬組成物。
- HMG−CoAレダクターゼインヒビターが、アトルバスタチンヘミ−カルシウムセスキ−水和物である請求項1又は4のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のための医薬組成物。
- PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミドである請求項2記載の炎症性肺疾患の予防的又は治療的な処置のための組合せ製品。
- HMG−CoAレダクターゼインヒビターが、アトルバスタチンヘミ−カルシウムセスキ−水和物である請求項2又は6のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のための組合せ製品。
- PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミドである請求項3記載の炎症性肺疾患の予防的又は治療的な処置のためのキット。
- HMG−CoAレダクターゼインヒビターが、アトルバスタチンヘミ−カルシウムセスキ−水和物である請求項3又は8のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のためのキット。
- 炎症性肺疾患が、喘息、COPD、硬化症、肺胞炎、類肉腫症、突発性肺線維症及び肺高血圧からなる群から選択される請求項1、4又は5のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のための医薬組成物。
- 炎症性肺疾患が、COPDである請求項1、4又は5のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のための医薬組成物。
- 炎症性肺疾患が、喘息、COPD、硬化症、肺胞炎、類肉腫症、突発性肺線維症及び肺高血圧からなる群から選択されることを特徴とする請求項2、6又は7のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のための組合せ製品。
- 炎症性肺疾患が、COPDである請求項2、6又は7のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のための組合せ製品。
- 炎症性肺疾患が、喘息、COPD、硬化症、肺胞炎、類肉腫症、突発性肺線維症及び肺高血圧からなる群から選択される請求項3、8又は9のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のためのキット。
- 炎症性肺疾患が、COPDである請求項3、8又は9のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のためのキット。
- PDE4インヒビター及びHMG−CoAレダクターゼインヒビターを、炎症性肺疾患の予防的又は治療的な処置のための医薬品の製造のために用いる使用であって、その際、PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミド又はその製剤学的に認容性の塩であり、HMG−CoAレダクターゼインヒビターが、アトルバスタチン又はその製剤学的に認容性の塩であることを特徴とする使用。
- PDE4インヒビター及びHMG−CoAレダクターゼインヒビターを、連続的に又は別々に同時投与可能な炎症性肺疾患の予防的又は治療的な処置のための医薬品の製造のために用いる使用であって、その際、PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミド又はその製剤学的に認容性の塩であり、HMG−CoAレダクターゼインヒビターが、アトルバスタチン又はその製剤学的に認容性の塩であることを特徴とする使用。
- PDE4インヒビターが、2−{4−[(4aS,8aR)−4−(3,4−ジメトキシフェニル)−1−オキソ−4a,5,8,8a−テトラヒドロ−1H−フタラジン−2−イル]−ピペリジン−1−イル}−アセトアミドであることを特徴とする請求項16又は17のいずれか1項に記載の使用。
- HMG−CoAレダクターゼインヒビターが、アトルバスタチンヘミ−カルシウムセスキ−水和物であることを特徴とする請求項16〜18のいずれか1項に記載の使用。
- 請求項16〜19までのいずれか1項に記載の使用であって、炎症性肺疾患が、喘息、COPD、硬化症、肺胞炎、類肉腫症、突発性肺線維症及び肺高血圧からなる群から選択されることを特徴とする使用。
- 請求項16〜19までのいずれか1項に記載の使用であって、炎症性肺疾患がCOPDであることを特徴とする使用。
- 請求項1,4,5,10又は11のいずれか1項に記載の炎症性肺疾患の予防的又は治療的な処置のための医薬組成物の製造方法であって、PDE4インヒビター又はその製剤学的に認容性の塩と、HMG−CoAレダクターゼインヒビター又はその製剤学的に認容性の塩とを混合することを含む製造方法。
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JP2012225892A Division JP2013035871A (ja) | 2006-07-05 | 2012-10-11 | 炎症性肺疾患の治療のためのHMG−CoAレダクターゼインヒビターとホスホジエステラーゼ4インヒビターとの組合せ物 |
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