JP2022104987A - mTOR阻害剤の無水組成物およびその使用方法 - Google Patents
mTOR阻害剤の無水組成物およびその使用方法 Download PDFInfo
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Abstract
Description
ヒトのドナーの皮膚を上部区画と下部区画の間に置いた。下部区画はレシーバー液で満たした。様々なラパマイシン組成物を上部区画に面する皮膚の表面に適用し(11製剤(すなわち、O3、NA21、NA22、NA21、NA17、TD201、NA19、NA25、AG14、NA26、およびNA24)、n=6再現、用量10mg/cm2)、24時間放置した。容積式ピペットを用いて前記製剤(~10mg/cm2)を1mLシリンジのプランジャーに適用した。前記製剤(10±0.5mg)を皮膚表面に塗布し、前記プランジャーを用いて拡散領域上に広げた。この塗布の前後に、前記プランジャーの重量を記録し、この値から細胞当たりの用量を計算した。
皮膚薬物動態(DPK)試験
皮膚薬物動態(DPK)アプローチは、角質層に適用される血液、血漿、尿のPKアプローチに相当する。DPKは時間に関する薬物濃度測定を包含し、角質層濃度-時間曲線に基づいて角質層からの薬物取り込み、見かけの定常状態レベル、および薬物消失に関する情報を提供する。
薬物取り込みの評価:試験および/または参照薬品は、複数の部位で同時に適用される。適切な間隔の後、特定の部位からの余分な薬物はティッシュまたは綿棒で3回軽く拭くことによって取り除かれる。予備的研究からの情報を使用して、薬物取り込みを評価するためのサンプル収集の適切な時期が決定される。接着テープの適用は、最初の2本のテープストリップを捨て、均一な圧力で2回繰り返される。同じ部位で剥離を続けてさらに10個の角質層サンプルを集める。他の部位でコンタミネーションが起きないように注意する。この手順は、他の指定された時点で各部位に対して繰り返される。薬物は、組み合わされた10個の剥離皮膚から抽出され、濃度は有効な分析方法を用いて決定される。結果は、粘着テープの1平方センチメートルの治療面積当たりの薬物の量として表される。
皮膚オープンフロー微小灌流(dOFM)では、細い中空のチューブが皮膚表面の真下に挿入され、皮膚の数インチ幅の部分を通って外部に出る。体液に似た液体がチューブに注入される。皮膚の下のチューブの一部は多孔質であるため、皮膚の外層を通して塗布され、かつ吸収されたあらゆる薬物は流れる液体に入り、それは続いて分析のために集められる。dOFMは、皮膚用医薬品の局所塗布後に皮膚内の変化する薬物の量を確実に測定することができる。
Claims (22)
- mTOR阻害剤の無水組成物であって、
有効量の1またはそれ以上のmTOR阻害剤と、1またはそれ以上の溶媒と、1またはそれ以上のゲル化剤と、1またはそれ以上の抗酸化剤と、選択的に薬学的に許容される賦形剤と
を有する、無水組成物。 - 前記組成物が、高分子界面活性剤、保湿剤、冷却剤、レオロジー調整剤、pH調整剤、防腐剤、およびこれらの組み合わせをさらに有する、請求項1に記載の無水組成物。
- 前記mTOR阻害剤が全組成物の約0.1重量%~約20重量%を占める、請求項1に記載の無水組成物。
- 前記溶媒が全組成物の約1重量%~約99.9重量%を占める、請求項1に記載の無水組成物。
- 前記ゲル化剤が全組成物の約0.1重量%~約5重量%を占める、請求項1に記載の無水組成物。
- 前記抗酸化剤が全組成物の約0.001重量%~約1重量%を占める、請求項1に記載の無水組成物。
- 前記冷却剤が全組成物の約0.5重量%~約10重量%を占める、請求項2に記載の無水組成物。
- 前記高分子界面活性剤が全組成物の約0.1重量%~約50重量%を占める、請求項2に記載の無水組成物。
- 前記保湿剤が全組成物の約0.5重量%~約10重量%を占める、請求項2に記載の無水組成物。
- 前記mTOR阻害剤が、ラパマイシン(シロリムス)、エベロリムス、ピメクロリムス、リダホロリムス、テムシロリムス、ゾタロリムス、ラパマイシンプロドラッグAP-23573、AP-23481、トリン-1、トリン-2、WYE-354、ダクトリシブ、BGT226、SF1126、PKI-587、INK128、AZD8055、NVPBE235、AZD2014、トルキニブ(PP242)、PP30、KU-0063794、WAY-600、WYE-687、WYE-354、OS1027、オミパリシブ、ウォルトマンニン、LY294002、PI-103、XL765、およびこれらの組み合わせからなる群から選択される、請求項1に記載の無水組成物。
- 前記溶媒が、プロピレングリコール、ベンジルアルコール、DMSO、ジグリコール、プロピレングリコールモノカプリレート、ジエチレングリコールモノエチルエーテル、テトラヒドロフルフリルアルコールポリエチレングリコールエーテル、ブチレングリコール、ジエチレングリコール、トリエチレングリコール、ポリエチレングリコール、アジピン酸ジイソプロピル、イソプロピルアルコール、グリセロール、およびこれらの組み合わせからなる群から選択される、請求項1に記載の無水組成物。
- 前記溶媒が、プロピレングリコール、ジエチレングリコールモノエチルエーテル、アジピン酸ジイソプロピル、グリセロール、ポリエチレングリコール、イソプロピルアルコール、およびこれらの組み合わせからなる群から選択される、請求項11に記載の無水組成物。
- 前記ゲル化剤が、ヒドロキシプロピルセルロース、カルボマー981、カルボマー934P、グリセリルトリス12-ヒドロキシステアレート、ヒドロキシステアリン、プロピレンカーボネート、ポリビニルピロリジン、およびこれらの組み合わせから選択される、請求項1に記載の無水組成物。
- 前記抗酸化剤が、アスコルビルパルミテート、プロピルガレート、α-トコフェロール、およびこれらの組み合わせからなる群から選択される、請求項1に記載の無水組成物。
- 前記組成物が局所用組成物である、請求項1に記載の無水組成物。
- 前記組成物がアルコールを含まない、請求項2に記載の無水組成物。
- それを必要とする対象において皮膚疾患を治療する方法であって、
有効量の1またはそれ以上のmTOR阻害剤と、1またはそれ以上の溶媒と、1またはそれ以上のゲル化剤と、1またはそれ以上の抗酸化剤とを有する有効量の無水組成物を局所投与する工程を有する、方法。 - 前記皮膚疾患が、足底角化症、水疱、結節性硬化症、脂漏性角化症、毛孔性角化症、表皮水疱症、多発性微小角化症、レンチキュラ性角膜症、鬱血性皮膚炎、限局性先端角化症、濾胞性角化症、苔癬様角化症(扁平苔癬、硬化性苔癬)、慢性侵食性口腔苔癬、コンラディ-エルティナーマン、表皮剥離性魚鱗癬、エリスロケラトデルマ・ビアビリス、魚鱗癬症、KID症候群、ネザートン症候群、オルムステッド症候群、レフサム病、シェーグレンラルソン症候群、光線性角化症、先天性爪肥厚症、多汗症、いぼ、角質症、皮膚炎(接触性皮膚炎、薬物性皮膚炎、アレルギー性皮膚炎、貨幣状皮膚炎、口囲皮膚炎、神経皮膚炎、脂漏性皮膚炎、およびアトピー性皮膚炎)、乾癬、にきび、カルブンケル症、蜂巣炎、せつ腫症、肉芽腫、黒色表皮症、水虫、細菌性膣炎、亀頭炎、隆起性皮膚線維肉腫、基底細胞癌、扁平上皮細胞癌、黒色腫、メルケル細胞癌、ケロイド、嚢胞性リンパ管腫、海綿状リンパ管腫、静脈奇形、表皮母斑、臭汗症、皮膚糸状菌症、カンジダ症、爪甲真菌症、白癬(ティネアアルバ(tinea alba)、足白癬、爪白癬、手白癬、頑癬、体部白癬、頭部白癬、顔白癬、白癬性毛瘡、渦状癬、黒癬、癜風、ティネアインコグニト(tinea incognito))、湿疹、発汗異常性湿疹、褥瘡性潰瘍、膿瘡、丹毒、多形性紅斑、膿痂疹、虫刺され、性器疣贅、血管腫、ヘルペス、じんましん、多汗症、フィラリア症、黒子、狼瘡、汗疹、搾乳者結節、伝染性軟属腫、ハエうじ症、疥癬、皮膚幼虫移行症、せつ性ハエ幼虫症、移動性ハエうじ症、シラミ寄生症、星芒状血管腫、脂肪織炎、爪周囲炎、類天疱瘡、粃糠疹、外陰掻痒症、酒さ、トリコモナス症、膣内イースト菌感染症、白斑、乾皮症、血管線維腫、バナヤン・ライリー・ルバルカバ症候群、基底細胞母斑症候群、バート・ホッグ・デュベ症候群、青色ゴムまり様母斑症候群、カウデン病、皮膚T細胞性リンパ腫、びまん性小球性リンパ管形成異常、単純型表皮水疱症、乳房外ページェット、家族性多発性円板状線維腫、ヘイリーヘイリー病、乳児血管腫、若年性ポリポーシス症候群、カポジ肉腫、カポジ型血管内皮腫、ケロイド瘢痕病、レルミット・ダクロス症候群、転移性黒色腫、ミュア・トール症候群、神経線維腫症、非黒色腫皮膚癌、口腔移植片対宿主病、尋常性天疱瘡、ポイツ・ジェガース症候群、ポートワイン母斑、プロテウス症候群、プロテウス様症候群、マフッチ症候群の難治性血管内皮腫、スタージ・ウェーバー症候群、イヌの遺伝性足蹠角化症(HFH)、皮膚サルコイドーシス、皮膚キャッスルマン病、水疱性類天疱瘡、およびこれらの組み合わせからなる群から選択される、請求項16に記載の方法。
- 前記皮膚疾患が先天性爪肥厚症またはその症状である、請求項16に記載の方法。
- 前記皮膚疾患が血管線維腫である、請求項16に記載の方法。
- 疼痛、かゆみ、またはこれらの組み合わせから選択される先天性爪肥厚症の症状が軽減される、請求項18に記載の方法。
- 前記組成物が、高分子界面活性剤、保湿剤、冷却剤、レオロジー調整剤、非水性pH調整剤、防腐剤、およびこれらの組み合わせをさらに含む、請求項16に記載の方法。
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