JP7288404B2 - モンテルカストおよびイガイ接着タンパク質との組み合わせを含む局所製剤 - Google Patents
モンテルカストおよびイガイ接着タンパク質との組み合わせを含む局所製剤 Download PDFInfo
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- JP7288404B2 JP7288404B2 JP2019572791A JP2019572791A JP7288404B2 JP 7288404 B2 JP7288404 B2 JP 7288404B2 JP 2019572791 A JP2019572791 A JP 2019572791A JP 2019572791 A JP2019572791 A JP 2019572791A JP 7288404 B2 JP7288404 B2 JP 7288404B2
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- 230000002792 vascular Effects 0.000 description 1
- 201000011531 vascular cancer Diseases 0.000 description 1
- 230000006711 vascular endothelial growth factor production Effects 0.000 description 1
- 230000002227 vasoactive effect Effects 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 239000004034 viscosity adjusting agent Substances 0.000 description 1
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- 229920001285 xanthan gum Polymers 0.000 description 1
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Description
(a)少なくとも1つのイガイ接着タンパク質またはその誘導体、例えばその医薬的に許容される誘導体と、
(b)モンテルカスト、またはその医薬的に許容される塩もしくは溶媒和物と、を含む、組み合わせ製品が提供され、
この組み合わせ製品は、以下「本発明による組み合わせ製品」と称される。
(1)少なくとも1つのMAPもしくはその誘導体と、モンテルカスト、またはその医薬的に許容される塩もしくは溶媒和物と、医薬的に許容されるアジュバント、希釈剤、または担体と、を含む、医薬製剤(この製剤は以下「組み合わせ製剤」と称される)と、
(2)以下の構成要素:
(A)少なくとも1つのイガイMAPまたはその誘導体を、医薬的に許容されるアジュバント、希釈剤、または担体との混合物において含む医薬製剤と、
(B)モンテルカスト、またはその医薬的に許容される塩もしくは溶媒和物を、医薬的に許容されるアジュバント、希釈剤、または担体との混合物において含む医薬製剤と、を含む、パーツキットと、がさらに提供され、
構成要素(A)および(B)が、他方と組み合わされた投与に好適である形態で各々提供される。
(i)別個の製剤(すなわち、互いに独立して)として提供され、その後、組み合わせ療法において、互いに組み合わせての使用のために一緒にされるか、または
(ii)組み合わせ療法において互いに組み合わせて使用するための「組み合わせパック」の別個の構成要素として一緒に包装され提供される。
(I)本明細書に定義される構成要素(A)および(B)のうちの1つを、
(II)その構成要素を2つの構成要素のうちの他方と組み合わせて使用するための指示書と共に含む、パーツキットがさらに提供される。
(a)口腔粘膜炎、アフタ性潰瘍、中耳炎、喉頭炎、気管炎、食道炎、胃炎、腸炎、および全腸炎(細菌性赤痢、慢性アメーバ性赤痢、住血吸虫症、非特異的潰瘍性大腸炎、および局所腸炎を含む)、子宮頸管炎および子宮内膜炎、子宮内膜炎、吸入傷害などによって引き起こされる炎症、ならびにがんに関連する粘膜の炎症、および口腔、鼻咽頭、耳、喉、気管、胃腸管、子宮頸部などの粘膜表面に影響を及ぼす、感染(例えば、風邪もしくはインフルエンザなどのウイルス感染)などの粘膜炎症。
(b)例えば、骨折、骨および関節の化膿性感染症、リウマチ性骨疾患による炎症、ならびに化膿性骨髄炎(急性、慢性、限局性、硬化性、外傷後)、化膿性関節炎、骨腫瘍(骨腫、類骨骨腫、軟骨腫)、骨嚢胞、破骨細胞腫、原発性骨肉腫(骨肉腫、軟骨肉腫、骨線維肉腫、ユーイング肉腫、非ホジキンリンパ腫、骨髄腫、脊索腫)、転移性骨腫瘍、骨の腫瘍様病変(骨嚢胞、動脈瘤骨嚢胞、好酸球性肉芽腫、線維性形成異常)、ならびにリウマチ性関節炎に関連する整形外科の炎症。
(c)末梢多発神経炎、顔面神経炎、末梢神経炎、皮下神経炎、尺骨神経炎、肋間神経炎などの神経炎症。
(d)筋炎、靭帯炎、腱炎、嚢胞炎、リンパ節炎、腺窩炎、扁桃炎、滑膜炎、筋膜炎などの、皮下および粘膜下の軟部組織の炎症、ならびに筋肉、靭帯、筋膜、腱、滑膜、脂肪、関節嚢、およびリンパ組織の損傷、挫傷、または裂傷によって引き起こされる軟部組織の炎症。
(e)アレルギー性白血球破砕性血管炎、アレルギー性皮膚血管炎、結節性多発動脈炎、血栓性血管炎、肉芽腫性血管炎、リンパ球性血管炎、血液組成の異常を伴う血管炎、およびリウマチ性血管炎などの血管炎症、ならびにアレルギー性白血球破砕性血管炎、結節性多発動脈炎、血栓性血管炎、肉芽腫性血管炎、リンパ球性血管炎、血液組成の異常を伴う血管炎、およびリウマチ性血管炎によって引き起こされる血管がんに関連する血管炎症。
(f)心膜炎、心筋炎、心内膜炎、肺炎、肝炎、脾炎、腎炎膵炎、膀胱炎、卵巣炎、前立腺炎および胃潰瘍の治療を含むが、これらに限定されない、心臓、胃、腸、肺、肝臓、脾臓、腎臓、膵臓、膀胱、卵巣、および前立腺などの内臓器官の炎症。
・ゲル製剤(これに関する適切なゲルマトリックス材料には、セルロース誘導体、カルボマーおよびアルギン酸塩、トラミカンガム、ゼラチン、ペクチン、カラギーナン、ジェランガム、デンプン、キサンタンガム、カチオン性グアーガム、寒天、非セルロース多糖類、ビニルポリマー、アクリル樹脂、ポリビニルアルコール、カルボキシポリマー、特に、ヒアルロン酸が含まれる)、
・ローション(凝縮物、これに関する適切なマトリックス材料には、セルロース誘導体、グリセリン、非セルロース多糖類、種々の分子量のポリエチレングリコール、およびプロパンジオールが含まれる)、
・ペーストまたは軟膏(これに関する適切なペーストマトリックス材料には、グリセリン、ワセリン、パラフィン、種々の分子量のポリエチレングリコールなどが含まれる)、
・クリームまたは発泡体(これに関する適切な賦形剤(例えば、発泡剤)には、ヒドロキシプロピルメチルセルロース、ゼラチン、種々の分子量のポリエチレングリコール、ドデシル硫酸ナトリウム、脂肪アルコールポリオキシエチレンエーテルスルホン酸ナトリウム、コーングルテン粉末、およびアクリルアミドが含まれる)、
・粉末エアロゾル(これに関する適切な賦形剤には、マンニトール、グリシン、デキストリン、デキストロース、スクロース、ラクトース、ソルビトール、およびポリソルベートが含まれる)、ならびに/または
・経口用または吸入用の液体(エアロゾル)スプレー(これに関する適切な賦形剤には、ヒアルロン酸などの粘度調整剤、乳化剤、緩衝剤、アルコール、水、保存剤、甘味料、香料が含まれる)。
空気嚢モデルI
体重20~30gの健康な成体雄C57BL/6マウスは、Changzhou Cvens Experimental Animal Co. Ltd (Changzhou, Jiangsu Province, China)から供給された。実験を行う前に、マウスを標準化された条件下(一定温度または22±2℃で、12時間の明暗を交互に繰り返す)で飼育し、約1週間、水を含む標準的なマウス飼料を与えた。
空気嚢モデルII
上述の実施例1に記載されたのと同一のプロトコールに従って、マウス(Comparative Medicine Centre,Yangzhou University,Jiangsu Province,China)を以下の表6に従って試験試料またはビヒクルを投与することにより処理するさらなる比較実験を実施した。
熱傷モデル
健康な成体雄のSprague-Dawleyラットの体重は200~300gであり、Beijing Vital River Laboratory Animal Technology Co.Ltd,Beijing,Chinaから供給された。
WCR=(A0-At)/A0×100%
式中、A0とAtは、それぞれ時間tの初期領域と創傷領域を指す。
熱傷スコアを以下の表12に示し、図3に示す。皮膚試料は、Department of Pathology of Nanjing Hospital of Chinese Medicine,Chinaに送られた。試料を固定して包埋し、組織切片を切断して染色した。染色された切片を光学顕微鏡で検査し、写真を撮影した。すべての写真は、次の基準に従って解釈され、スコア付けされた。第1度-表皮が損傷し、基質が無傷のままである(スコア1ポイント)表層第2度-表皮が完全に損傷し、乳頭層が損傷した(1.5ポイント);深い第2度-真皮は網状層まで損傷し、真皮をいくらか保持している(2.5ポイント);第3度-真皮が完全に損傷し、筋肉および/または骨が影響を受けている(3ポイント)。
空気嚢モデル:局所投与対経口投与
本質的に実施例1に記載されているように実験を実施した(ただし、この場合、C57BL/6マウスはNanjing Biomedical Research Institute of Nanjing University(NBRI)から供給された)。
空気嚢モデル:モンテルカストの組み合わせ
上記の実施例1に記載したのと同じプロトコールに従って、マウス(Changzhou Cvens Experimental Animal Co. Ltd.により供給)を以下の表18に従って試験試料またはビヒクルを投与することにより処理するさらなる比較実験を実施した。
急性創傷モデル
6~8週齢の雄のC57BL/6マウスは、Changzhou Cvens Experimental Animal Co.Ltd.から供給された。実験を行う前に、マウスを標準化された条件下(一定温度または22±2℃で、12時間の明暗を交互に繰り返す)で飼育し、約1週間、水を含む標準的なマウス飼料を与えた。
At/A0×100%、
式中、A0とAtはそれぞれ、0日目の初期領域と測定日(時間t)の創傷領域を指す。
糖尿病性創傷モデル
上述の実施例6に記載されているプロトコールと本質的に同じプロトコールを使用した同様の実験を、8~12週齢の雄db/dbマウス(C57BL/KsJ-db/db、体重35~45g/マウス、Changzhou Cvens Experimental Animal Co.Ltd.により供給された)で実施した。
モンテルカストクリームI
次の成分からなるモンテルカストナトリウムに基づくクリームが作製された:モンテルカストナトリウム(200mg、Arromax Pharmatech Co.,Ltd,Suzhou,China)、ステアリン酸(2g)、モノステアリン酸グリセリン(2g)、ヘキサデカノール(2g)、グリセリン(5g)および水酸化ナトリウム(0.25g)(すべてSinopharm Chemical Reagent Co.Ltd,Shanghai,China)、アンモニウムアクリロイルジメチルタウレート/VPコポリマー(0.13g、Clariant Chemical(Guangzhou)Co.,Ltd.,Guangzhou,China)、フェノキシエタノール(0.3g)およびエチルヘキシルグリセリン(0.1g)(両方ともShanghai Rayson Chemicals Co.,Ltd.,Shanghai,China)、ならびに精製水(88.42g)。
モンテルカストクリームII
上述の実施例8に記載された手順と同様の手順に従って、第2のクリームを生成した。
モンテルカストクリームIII
上述の実施例8に記載されている手順と同様の手順に従って、第3のクリームを生成した。
モンテルカスト軟膏I
軟膏は、最初にポリエチレングリコール3350(21.3g、Sinopharm Chemical Reagent Co.Ltd)をポリエチレングリコール400(58.5g、Sinopharm Chemical Reagent Co.Ltd)に攪拌しながら60℃に加熱して溶解することにより作製した。モンテルカストナトリウム(200mg)を攪拌しながらポリエチレングリコール400(20.0g)に溶解した。
モンテルカスト軟膏II
ポリエチレングリコール4000(21.3g、Sinopharm Chemical Reagent Co.Ltd)を同量のポリエチレングリコール400(58.5g)に溶解したことを除いて、実施例11に記載のようにさらなる軟膏を作製した。
モンテルカストエアロゾル粉末スプレー
モンテルカストナトリウム(200mg)をエタノール(70g、Sinopharm Chemical Reagent Co.Ltd)に添加し、完全に溶解するまで攪拌しながら、エアゾール粉末スプレーベースのものを作製した。
モンテルカスト包帯
上述の実施例12に記載のように調製したモンテルカストナトリウム軟膏をガーゼ(Shanghai Health Materials Factory Co.,Ltd,Shanghai,China)上に平らなプレートで均一にコーティングし、室温まで冷却することにより、包帯を作成した。
腫脹性耳モデル
Changzhou Cvens Experimental Animal Co.Ltd.から供給された6~8週齢で平均体重18~25gの健康なBALB/cマウス12匹を、実験前に約1週間飼育し、世話をした。飼育舎の温度は25~27℃、湿度は74%で、12時間の明暗を交互に繰り返し、食料と水を自由に摂取させた。マウスは、表28に記載されているように、各群に3匹ずつでランダムに4つの群に分けられた。
腫脹率=(右耳の重量-左耳の重量)/左耳の重量×100%
結果を表29に示す。
ラット熱傷モデルI
250~300gの平均体重を持つ6~8週齢のオスのSprague Dawleyラットは、Changzhou Cvens Experimental Animal Co.Ltd.から供給された。実験を行う前に、ラットを標準化された条件下(一定温度または22±2℃で、12時間の明暗を交互に繰り返す)で飼育し、約1週間、水を含む標準的なマウス飼料を与えた。
TBSA(cm2)=K×W×2/3
ここで、Kは所与の種の補正係数(体重/形状に対する表面積)定数(ラットの場合は9.1)、Wはラットの体重(g単位)である。
ラット熱傷モデルII
8匹のSprague Dawleyラットを4匹の2つの群に分けた。上述の実施例16に記載されている方法と本質的に同じ方法で、以下の表30に示す温度および時間で熱湯を適用する(または必要に応じて適用しない)ことにより、熱傷を適用した。
熱傷患者の浮腫を治療するためのモンテルカストクリームの臨床例
モンテルカストクリームは、上述の実施例8に記載されているのと同じ方法に従って調製された。クリーム中のモンテルカストナトリウムの濃度は5mg/gであった。
熱傷瘢痕のかゆみを治療するためのモンテルカストクリームの臨床例
モンテルカストクリーム(5mg/g濃度のモンテルカストナトリウムを含む)は、上述の実施例8に記載されているのと同じ方法に従って調製された。
メラニン関連皮膚疾患を治療するためのモンテルカストクリームの臨床例I
モンテルカストクリーム(5mg/g濃度のモンテルカストナトリウムを含む)は、上述の実施例9に記載されているのと同じ方法に従って調製された。
メラニン関連皮膚疾患を治療するためのモンテルカストクリームの臨床例II
モンテルカストクリーム(5mg/g濃度のモンテルカストナトリウムを含む)は、上述の実施例9に記載されているのと同じ方法に従って調製された。
ステロイド依存性皮膚炎を治療するためのモンテルカストクリームの臨床例
モンテルカストクリーム(5mg/g濃度のモンテルカストナトリウムを含む)は、上述の実施例9に記載されているのと同じ方法に従って調製された。
Claims (34)
- 局所投与用の医薬製剤の使用であって、開放創もしくは熱傷または痔疾へ前記医薬製剤を直接、局所投与することによる、皮膚または粘膜の前記開放創もしくは熱傷または痔疾から選択される炎症を特徴とする状態の治癒または回復のための医薬製剤の製造のための、モンテルカストまたはその医薬的に許容される塩もしくは溶媒和物を、医薬的に許容される局所アジュバント、希釈剤、または担体との混合物において含む、医薬製剤の使用。
- 前記開放創が、擦過傷、引っ掻き傷、切開、裂傷、皮膚穿刺、剥離、および水疱からなる群から選択される、請求項1に記載の使用。
- 前記状態が、痔疾である、請求項1に記載の使用。
- 前記状態が、熱、化学物質、日焼け、しもやけ、または凍傷によって引き起こされる開放創または熱傷である、請求項1または2に記載の使用。
- 前記開放創が、疾患または障害の結果である、請求項1または2に記載の使用。
- 前記開放創が、前記皮膚または前記粘膜の潰瘍である、請求項5に記載の使用。
- 前記潰瘍が、治療することが困難な皮膚の潰瘍または胃潰瘍である、請求項6に記載の使用。
- 前記疾患または障害が、潰瘍性大腸炎である、請求項5または請求項6に記載の使用。
- 前記疾患または障害が、食道炎または胃炎である、請求項5または請求項6に記載の使用。
- 前記開放創が、内部または外部の損傷から生じたものである、請求項1~9のいずれか1項に記載の使用。
- 前記開放創または熱傷が、膜表面の内部または外部の損傷から生じたものであるか、表皮または真皮へのおよび/またはその下の損傷を含む、請求項1~10のいずれか1項に記載の使用。
- 前記損傷が、筋肉、骨、関節、および/または内蔵器官への損傷を含む、請求項11に記載の使用。
- 前記医薬製剤が、前記状態、またはそれに関連する治癒プロセスに関連するもしくは疼痛および/またはかゆみをさらに治療する、請求項1~12のいずれか1項に記載の使用。
- 前記医薬製剤が、体液の滲出および/または前記状態に起因する感染のリスクをさらに予防し、かつ/または治癒プロセスに起因する生理学的反応をさらに予防する、請求項1~13のいずれか1項に記載の使用。
- 前記生理学的反応が、瘢痕化および/またはメラニン色素沈着を含む、請求項14に記載の使用。
- 前記メラニン色素沈着が、肝斑、そばかす、メラノーシス、頬部発疹、別の色素沈着症、メラノーマを伴う皮膚がん、および/または日光への曝露によって引き起こされる色素沈着症に関連する、請求項15に記載の使用。
- 前記局所投与が、皮膚へのものである、請求項1~6または10~16のいずれか1項に記載の使用。
- 前記局所投与が、粘膜表面へのものである、請求項1~10、13、または14のいずれか1項に記載の使用。
- 前記医薬製剤が、水溶液、ゲル、クリーム、軟膏、ローション、凝縮物、発泡体またはペーストの形態である、請求項1~18のいずれか1項に記載の使用。
- 前記医薬製剤が、ポリエチレングリコールをさらに含む、請求項19に記載の使用。
- 前記ポリエチレングリコールが、ポリエチレングリコール400である、請求項20に記載の使用。
- 前記生理学的反応が、瘢痕化を含む、請求項15に記載の使用。
- 前記局所投与が、粘膜表面への肺投与である、請求項18または請求項22に記載の使用。
- 前記肺投与が、気管または気管支による、請求項23に記載の使用。
- 前記肺投与が、吸入傷害を治療するためである、請求項23または請求項24に記載の使用。
- 前記医薬製剤が、吸入のための液体スプレーの形態である、請求項23~26のいずれか1項に記載の使用。
- 前記局所投与が、口腔、鼻、眼、膣、子宮頸部または肛門直腸の粘膜表面へのものである、請求項18または請求項22に記載の使用。
- 前記局所投与が、膣、子宮頸部または肛門直腸の表面へのものである、請求項27に記載の使用。
- 前記医薬製剤が、ゲルの形態である、請求項28に記載の使用。
- 前記医薬製剤が、少なくとも1つのイガイ接着タンパク質またはその配列Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lysのペプチドである誘導体をさらに含む、請求項1~29のいずれか1項に記載の使用。
- 前記医薬製剤が、少なくとも1つのイガイ接着タンパク質またはその配列Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lysのペプチドである誘導体を含む医薬製剤を、医薬的に許容されるアジュバント、希釈剤、または担体との混合物においてさらに含むパーツキットの一部であり、前記2つの医薬製剤が、他方と組み合わされた投与に好適である形態で各々提供される、請求項1~29のいずれか1項に記載の使用。
- 前記2つの医薬製剤が、前記状態の治療における逐次的な、別個の、および/または同時の使用に好適である、請求項31に記載の使用。
- 前記少なくとも1つのイガイ接着タンパク質が、mefp-1、mefp-2、mefp-3、mefp-4、mefp-5、mefp-6、およびそれらの組み合わせの群から選択される、請求項30~32のいずれか1項に記載の使用。
- 前記少なくとも1つのイガイ接着タンパク質が、mefp-1を含む、請求項33に記載の使用。
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PCT/CN2018/094441 WO2019007356A1 (en) | 2017-07-05 | 2018-07-04 | TOPICAL FORMULATIONS COMPRISING MONTELUKAST AND COMBINATIONS WITH MOLD ADHESION PROTEINS |
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WO2019007356A1 (en) | 2019-01-10 |
CA3068818A1 (en) | 2019-01-10 |
CN115300508A (zh) | 2022-11-08 |
TW201919633A (zh) | 2019-06-01 |
SG11201911841PA (en) | 2020-01-30 |
KR20200039677A (ko) | 2020-04-16 |
CN113491696A (zh) | 2021-10-12 |
EP3648767A4 (en) | 2021-04-28 |
CN110312513B (zh) | 2022-07-08 |
MA52924A (fr) | 2021-04-28 |
CN110312513A (zh) | 2019-10-08 |
US11672792B2 (en) | 2023-06-13 |
MX2020000029A (es) | 2020-08-06 |
US20230404992A1 (en) | 2023-12-21 |
JP2020527134A (ja) | 2020-09-03 |
US20210145819A1 (en) | 2021-05-20 |
AU2018295944B2 (en) | 2023-12-14 |
AU2018295944A1 (en) | 2020-02-20 |
EP3648767A1 (en) | 2020-05-13 |
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