JP2021530463A - mTOR阻害剤の無水組成物および使用方法 - Google Patents
mTOR阻害剤の無水組成物および使用方法 Download PDFInfo
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Abstract
Description
この出願は、2018年7月3日に出願された米国仮出願第62/693,635号、および2018年7月2日に出願された米国仮出願第62/693,283号に優先権を主張し、これらのそれぞれは、参照により本明細書に組み込まれる。
生体外皮膚浸透実験
皮膚薬物動態(DPK)研究
薬物摂取を評価するために:試験および/または参照薬物製品は、複数の部位で同時に適用される。適切な間隔の後、ティッシュまたは綿棒で3回軽く拭くことにより、特定の部位から余分な薬物を取り除く。パイロット研究からの情報を使用して、薬物摂取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。均一な圧力を使用して、粘着テープを2回貼り付け、最初の2つのテープストリップを廃棄する。同じ場所で剥離を続けて、さらに10個の角質層サンプルを収集する。他の場所への汚染を避けるために注意が払われる。この手順は、他の指定された時点で部位ごとに繰り返される。薬物は、組み合わされた10個の皮膚剥離から抽出され、検証済みの分析方法を使用して濃度が決定される。結果は、粘着テープの治療面積1平方cmあたりの薬剤の量として表される。
皮膚オープンフロー灌流(dOFM)では、細い中空の管が皮膚表面のすぐ下に挿入され、皮膚の幅数インチの部分を通り抜けて出て行く。体液と同様の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、皮膚の外層から塗布および吸収された薬物は、流れる液体に入り、分析のために収集される。dOFMは、皮膚科用医薬品の局所塗布後の皮膚内の薬物の変化量を確実に測定できる。
Claims (22)
- mTOR阻害剤の無水組成物であって、
有効量の1または複数のmTOR阻害剤と、1または複数の溶媒と、1または複数のゲル化剤と、1または複数の抗酸化剤と、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。 - 請求項1記載の無水組成物であって、ポリマー界面活性剤、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、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記載の無水組成物。
- 前記ポリマー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記載の無水組成物。
- 請求項1記載の無水組成物において、前記mTOR阻害剤は、ラパマイシン(シロリムス)、エベロリムス、ピメクロリムス、リダフォロリムス、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、ボクスタリシブ、オミパリシブ、アピトリシブ、ビストセルチブ、ゲダトリシブ、WYE−125132、BGT226、パロミド529、GDC−0349、XL388、CZ415、CC−223、SF1126、INK128、AZD8055、バイオリムスA9(ウミロリムス)、GSK2126458、OSI027、PP121、WYE−687、WAY−600、PI−103、KU−0063794、トルキニブ(PP242)、PF−04691502、RTB101、TAM−01、TAM−03、LY294002、およびこれらの組み合わせからなる群から選択される、無水組成物。
- 請求項1記載の無水組成物において、前記溶媒は、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、無水組成物。
- 請求項11記載の無水組成物において、前記溶媒は、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、無水組成物。
- 請求項1記載の無水組成物において、前記ゲル化剤は、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、無水組成物。
- 請求項1記載の無水組成物において、前記抗酸化剤は、アスコルビルパルミテート、没食子酸プロピル、α−トコフェロール、およびこれらの組み合わせから選択される、無水組成物。
- 前記組成物が局所用組成物である、請求項1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記載の無水組成物。
- それを必要とする対象において皮膚障害を治療する方法であって、有効量の1または複数のmTOR阻害剤と、1または複数の溶媒と、1または複数のゲル化剤と、1または複数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。
- 請求項17記載の方法において、前記障害は、足底角化症、水疱、結核性硬化症、脂漏性角化症、毛様体角化症、表皮水疱症、複数分指状角質増殖症、レンチキュラリス過角化症、鬱血性皮膚炎、限局性先端角質角化症、濾胞性角質増殖症、苔癬様角化症、毛包性角質増殖症、扁平苔癬、慢性びらん性口腔苔癬、コンラディ−エルティナーマン、表皮剥離性魚鱗癬、変異性紅斑角皮症、豪猪状魚鱗癬、KID症候群、ネザートン症候群、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、皮膚硬結、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、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、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、化膿性肉芽腫、本態性毛細血管拡張症、桜血管腫、ブルック・スパイグラー症候群、脂腺母斑、表皮性母斑、肉芽腫症、過成長症候群、歯肉肥大、色素性乾皮症、皮膚急性移植片対宿主病、皮膚慢性移植片対宿主病、硬化性皮膚移植片対宿主病、表皮剥離性掌蹠角化症、皮膚神経線維腫症、多発性毛包上皮腫、およびこれらの組み合わせからなる群から選択される、方法。
- 請求項18記載の方法において、前記皮膚障害は、先天性爪肥厚症またはその症状である、方法。
- 請求項18記載の方法において、前記皮膚障害は、血管線維腫である、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19記載の方法。
- 請求項17記載の方法において、前記組成物は、ポリマー界面活性剤、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有する、方法。
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EP3817743A4 (en) * | 2018-07-02 | 2022-07-06 | Palvella Therapeutics, Inc. | ANHYDROUS COMPOSITIONS OF MTOR INHIBITORS AND METHODS OF USE |
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2021
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US20210244713A1 (en) | 2021-08-12 |
US20200000778A1 (en) | 2020-01-02 |
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US11000513B2 (en) | 2021-05-11 |
US11679101B2 (en) | 2023-06-20 |
US20230263781A1 (en) | 2023-08-24 |
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