JP2008542353A - ビタミン製剤 - Google Patents
ビタミン製剤 Download PDFInfo
- Publication number
- JP2008542353A JP2008542353A JP2008514216A JP2008514216A JP2008542353A JP 2008542353 A JP2008542353 A JP 2008542353A JP 2008514216 A JP2008514216 A JP 2008514216A JP 2008514216 A JP2008514216 A JP 2008514216A JP 2008542353 A JP2008542353 A JP 2008542353A
- Authority
- JP
- Japan
- Prior art keywords
- vitamin
- water emulsion
- oil
- topical oil
- analog
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Abstract
【選択図】 図1
Description
[0001]本出願は、1998年9月11日に出願されたオーストラリア特許出願第PP 5831号の優先権を主張する、1999年9月8日に出願された国際出願第PCT/AU99/00735の国内段階出願として米国特許法第371条に基づき出願された、2001年1月30日に出願された米国特許第09/719,662号、現在米国特許第6,730,288号の継続である、2004年1月27日に出願された米国特許第10/766,202号、現在米国特許第7,029,659号の継続である、2005年12月16日に出願された米国特許第11/303,298号の一部継続である。本出願はさらに、米国特許法第119(e)条に基づいて、2005年6月1日に出願された米国仮特許出願第60/686,752号の利益を主張する。上述の出願のそれぞれの開示は、参照として本明細書に組み入れられている。
有効量の製薬活性成分であって、ビタミン又はその類似体である前記製薬活性成分と、
閉塞性物質と、
水性溶媒と、
有機共溶媒とを含み、
該製薬活性成分が水及び閉塞性物質の両方に不溶性であり、閉塞性物質が閉塞性層を皮膚上に形成するのに十分な量で存在する、製薬エアロゾルフォーム組成物を提供する。
ビタミン及びその類似体であって、ビタミン又はその類似体が水相に可溶化され、安定剤が油相に可溶化される、ビタミン又はその類似物質と、
乳化剤と、
閉塞性物質と、
有機共溶媒と、
を含む。
[0031]本発明は一部は、比較的少量の閉塞性物質を含むムース製剤が経皮水分損失をなお減少させることが可能であり、それゆえ理論的により高い薬物皮膚浸透を実施するために皮膚透過性を向上させて、同時に簡潔で消費者に許容される組成物を維持することができるという、驚くべき発見に基づいている。
スキーム1:ビタミンD3の合成及びその活性型カルシトリオールへの変換
[0065]一実施形態において、本発明は、ビタミン又はその類似体を含む局所水中油型エマルジョンを提供し、そこでビタミン又はその類似体は水相(連続相)中に安定化され、安定剤は油相(不連続相)中に安定化される。ある態様において、本発明のエマルジョンは乳化剤及び閉塞性物質をさらに含む。本発明の組成物は、加圧容器から放出されるときに組成物がフォームであるように加圧容器に収容され得る。あるいは本発明の組成物は、ローション、クリーム、軟膏、液剤、ゲル、ペーストであり得るか、又は皮膚パッチにより塗布され得る。
1.カルシポトリエン
[0080]カルシポトリエンは、プレカルシポトリエンとの平衡を生じて、平衡は製薬組成物中に存在するカルシポトリエンの量を低下させるのはもちろんのこと、組成物の有効性も低下させる。本発明の水中油型エマルジョンへの安定剤及び保存料の添加は、活性剤の分解の防止を補助する。予想しなかったことに、本製剤は、他の相(水相)への活性ビタミン又はその類似体(例えばカルシポトリエン)と共に、1つの相(油相)へのトコフェロール又はトコフェロール誘導体などの安定剤の添加によって向上した安定性を与える。本発明の予想外の好都合な性質は、一部は、例えば安定剤が全く別の相に添加されても、安定剤(例えばトコフェロール又はトコフェロール誘導体)によって与えられた追加の安定性によるものである。本発明の到来の前に、有効にするためには、活性成分が溶解されている相に安定剤を添加しなければならないと考えられていた。本発明の製剤は、活性成分が溶解されている相以外の相への安定剤の添加にもかかわらず、向上した安定性を所有する。
[0081]本発明で有用な別のビタミン類似体はトレチノインである。化学的に、トレチノインは、(all−E)−3,7−ジメチル−9−(2,6,6−トリメチル−1−シクロヘキセン−1−イル)−2,4,6,8−ノナテトラエン酸としても知られている、オールトランスレチノイン酸である。トレチノインは、化合物のレチノイドファミリの一員であり、天然発生型ビタミンAの代謝産物である。トレチノインは300.44の分子量を有する。トレチノインは次の構造を有する。
なお別の態様において、アシトレチンは本発明で有用なビタミン類似体である。化学的にアシトレチンは、all−trans−9−(4−メトキシ−2,3,6−トリメチルフェニル)−3,7−ジメチル−2,4,6,8−ノナテトラエン酸(レチノイド)である。アシトレチンは、エトレチナートの代謝産物であり、レチノイン酸及びレチノール(ビタミンA)の両方に関連している。アシトレチンは、分子量が326.44の黄色〜緑がかった黄色の粉末である。構造式は、
である。アシトレチンはビタミンAの形である。アシトレチンが作用する正確な方法は未知である。アシトレチンは、他の治療に応答しなかった重症の乾癬を治療するのに使用される。アシトレチンの安定性を向上させるために、トコフェロール又はその誘導体などの安定剤が製剤に添加される。
[0087]他の実施形態において、本発明は、本発明の局所エマルジョン組成物であって、加圧容器から放出されたときにフォームである組成物を、皮膚障害を治療するために投与するステップを備える、哺乳類の皮膚障害を治療する方法を含む。
[0090]他の実施形態において、本発明は、ビタミン又はその類似体を供給する第1のステップであって、ビタミン又はその類似体は水相に可溶化される第1のステップを備え、局所エマルジョン組成物中でビタミン又はその類似体を安定化する方法を提供する。局所エマルジョン組成物中でビタミン又はその類似体を安定化する本発明の方法は、油相に可溶化された安定剤を供給する第2のステップをさらに備え、ここでビタミン又はその類似体は、驚くべきことに安定剤が別の相中に存在したとしても、安定剤の存在によって安定化される。活性ビタミン又はその類似体を安定化する方法はそれゆえ、従来の調合知識とは反対であり、全く予想外である。
[0091]ここで、本発明を添付の図及び実施例を参照してさらに十分に説明する。以下の説明は例示のためのみであり、決して上述の説明の一般性を制限するとして解釈されるべきではない。
[0093]目的 本研究の目的は、
I.上昇する濃度のワセリンが潜在的な閉塞性物質及び浸透促進剤として含まれているムース製剤の局所塗布後にステロイドクロベタゾールのヒト表皮への浸透を決定すること、
II.無傷表皮及び該薬物が臨床的に使用される皮膚状態に見られる損傷された角質層バリア機能をモデル化するためにテープによって3回剥離された表皮への塗布後のクロベタゾール浸透を評価すること、
である。
[0100]目的 研究の目的は、局所ムース製剤中のワセリンの濃度を上昇させることが、下にある皮膚を効果的に閉塞でき、それにより次に適切な薬物の経皮浸透を改善することが知られている局所水和の上昇をもたらし得るかどうかを判定することであった。
[0105]第2部 目的 本研究の第2部の目的は、多数の健常被験者での50%ワセリンムース製剤によって与えられた閉塞性の程度を評価することであった。
[0110]カルシポトリエンフォームは、炭化水素(プロパン/ブタン)噴霧体と共に加圧される、アルミニウム容器内に包装された油及び水エマルジョンである。
1.油相の開始時に、白色ワセリン、軽鉱油、イソプロピルミリステート、ソルビタンモノラウラート、セチルアルコール及びフェノキシエタノールの必要量をそれぞれ主配合容器に添加する。混合中、油相を加熱して、シクロメチコンの必要量を添加する。溶液が均質になるまで成分を混合する。
2.水相の開始時に精製水、エデト酸2ナトリウム2水和物及び無水第2リン酸ナトリウムの必要量をそれぞれ水相容器に添加する。混合中、水相を加熱して、ポリオキシル20セトステアリルエーテルの必要量を添加する。完全に溶解するまで成分を混合する。
3.pH相の開始時に精製水及び水酸化ナトリウムの必要量をそれぞれpH相容器に添加する。完全に溶解するまで成分を混合する。
4.活性相の開始時にプロピレングリコールの必要量を活性相容器に添加する。混合中、カルシポトリエンの必要量を添加する。活性相を加熱して、完全に溶解するまで混合する。
5.水相の約70%を主配合容器内の油相に添加する。混合物を混合及び加熱する。水相の残り(約30%)を冷却する。
6.主配合容器内の内容物を絶えず混合して、ゆっくり冷却する。
7.水相混合物の残り(約30%)を次に主配合容器に添加して同時に冷却する。
8.pH相を主配合容器内の混合物に絶えず混合しながら添加する。
9.活性相を主配合容器内の混合物に絶えず混合しながら添加する。バッチ製剤混合物を絶えず混合して冷却する。
10.バッチ製剤の適量を各缶に分配する。
11.各缶にバルブを設置して、次に真空圧着する。
12.次に缶を防炎気体処理区域に運搬して、そこでバルブを介して噴霧体(プロパン/ブタン)の適量を缶に注入する。
13.アクチュエータを装着して、缶上部にカバーキャップを取り付ける。
[0115]インビトロ皮膚浸透研究を使用して、0%、10%又は20%プロピレングリコールを含有するフォーム製剤からのカルシポトリエンの皮膚浸透を、軟膏製剤の皮膚浸透と比較する。この比較は、フォーム製剤に関して、文献に記載された非臨床及びヒト薬物動態学的データの関連性への洞察を可能にする。
[0119]結果は、本発明のフォームがカルシポトリエンの測定可能な量を表皮及び真皮内へ送達したことを示す。その上、本発明の製剤中のプロピレングリコールの濃度と、皮膚中のカルポシトリエンの蓄積量との間に相関がある。フォーム物質の低粘度は、市販のクリームと比較して展着/吸収を好都合に改善する。さらに本発明の製剤は非結晶性であり、それゆえ活性成分がクリーム製剤と比較して高速で浸透する。
1.油相の開始時に、周囲温度にて、C16アルコール及びC18アルコール、軽鉱油、白色ワセリン、移送プロピルミリステート、ポリオキシル20セトステアリルエーテル並びにビタミンEの必要量をそれぞれ主配合タンクに添加する。
2.混合中、油相を加熱する。溶液が均質になるまで成分を混合する。
3.水相の開始時に、周囲温度にて、精製水、エデト酸2ナトリウム2水和物及び無水第2リン酸ナトリウムの必要量をそれぞれ水相ステンレス鋼タンクに添加する。
4.混合中、油相を加熱する。完全に溶解するまで成分を混合する。
5.活性相の開始時に、周囲温度にて、プロピレングリコールの必要量を活性相ステンレス鋼タンクに添加する。
6.活性相ステンレス鋼タンクを黒色プラスチックで覆う。黄色光下での混合中、プロピレングリコールを加熱する。混合を継続する間に、カルシポトリエンの必要量を添加する。完全な溶解が起こるまで、活性相を混合する。
7.混合しながら、水相を主配合タンク内の油相に添加する。
8.主配合タンク内の内容物を絶えず混合する。
9.活性相を主配合タンク内の混合物に添加する。均質な混合物が得られるまで、バルクエマルジョン混合物を絶えず混合する。
10.周囲温度にて、バルクエマルジョンの適量を各缶に分配する。
[0122]ある例において、本発明のフォーム製剤は、実質的にエタノールを含まない、そして実質的にイソプロパノールを含まない製剤である(例えば5%以下)。予期しなかったことに、安定剤としてのアルファトコフェロールは油相に添加されたときに、安定性向上をもたらし、他の安定剤よりも少ないカルシポトリエン分解を生じる。本発明のエマルジョンは、カルシポトリエン及び安定剤が異なる相に添加されるという点で、驚くべき予想外の利点を真に所有する。該エマルジョンは、従来技術の製剤では不可能である高度の安定性の向上を可能にする。
Claims (47)
- 製薬エアロゾルフォーム組成物であって、
有効量の製薬活性成分であって、ビタミン又はその類似体である前記製薬活性成分と、
閉塞性物質と、
水性溶媒と、
有機共溶媒とを含み、
前記製薬活性成分が水及び閉塞性物質の両方に不溶性であり、前記閉塞性物質が使用中に閉塞性層を皮膚上に形成するのに十分な量で存在する、製薬エアロゾルフォーム組成物。 - 安定剤をさらに含む、請求項1に記載の製薬エアロゾルフォーム組成物。
- 前記安定剤がビタミンE又はその誘導体である、請求項2に記載の製薬エアロゾルフォーム組成物。
- 前記ビタミン又はその類似体がカルシポトリエンである、請求項1に記載の製薬エアロゾルフォーム組成物。
- 前記ビタミン又はその類似体がトレチノインである、請求項1に記載の製薬エアロゾルフォーム組成物。
- 前記ビタミン又はその類似体がアシトレチンである、請求項1に記載の製薬エアロゾルフォーム組成物。
- 乳化剤をさらに含む、請求項1に記載の製薬エアロゾルフォーム組成物。
- 前記閉塞性物質がワセリンである、請求項1に記載の製薬エアロゾルフォーム組成物。
- 前記エアロゾルフォームが約55%のプロパン、30%のn−ブタン、及び15%のイソブタンの噴霧体ブレンドを有する、請求項1に記載の製薬エアロゾルフォーム組成物。
- 局所水中油型エマルジョンであって、前記水中油型エマルジョンが水相及び油相を有し、
ビタミン又はその類似体であって、前記ビタミン又はその類似体が前記水相に可溶化され、そして安定剤が前記油相に可溶化されるビタミン又はその類似体と、
乳化剤と、
閉塞性物質と、
有機共溶媒と、
を含む局所水中油型エマルジョン。 - 前記エマルジョンがエアロゾルエマルジョンであり、前記エアロゾルエマルジョンが加圧容器から放出されるときにフォームである、請求項10に記載の局所水中油型エマルジョン。
- 前記ビタミン又はその類似体がビタミンA、ビタミンD、及びその類似体から成る群より選択される一員である、請求項10に記載の局所水中油型エマルジョン。
- 前記ビタミン又はその類似体がビタミンD又はその類似体である、請求項12に記載の局所水中油型エマルジョン。
- 前記ビタミンD又はその類似体がカルシポトリエンである、請求項13に記載の局所水中油型エマルジョン。
- 前記ビタミン又はその類似体がビタミンA又はその類似体である、請求項12に記載の局所水中油型エマルジョン。
- 前記ビタミンA又はその類似体がトレチノインである、請求項15に記載の局所水中油型エマルジョン。
- 前記ビタミンA又はその類似体がアシトレチンである、請求項15に記載の局所水中油型エマルジョン。
- 前記ビタミン又はその類似体が水溶性有機溶媒に最初に可溶化される、請求項10に記載の局所水中油型エマルジョン。
- 前記水溶性有機溶媒がプロピレングリコールである、請求項18に記載の局所水中油型エマルジョン。
- 前記安定剤がビタミンE又はその誘導体である、請求項10に記載の局所水中油型エマルジョン。
- 前記ビタミン又はその類似体がカルシポトリエン及びトレチノインの組合せであり、前記安定剤がビタミンEである、請求項10に記載の局所水中油型エマルジョン。
- 前記ビタミン又はその類似体が前記組成物の総重量に基づいて、約0.0001重量%〜約10重量%の量で存在する、請求項10に記載の局所水中油型エマルジョン。
- 前記エマルジョンが前記組成物の総重量に基づいて、最大90%w/wの量で水を含む、請求項10に記載の局所水中油型エマルジョン。
- 前記エマルジョンが前記組成物の総重量に基づいて、約40%〜約60%w/wの量で水を含む、請求項23に記載の局所水中油型エマルジョン。
- 前記乳化剤が非イオン性、カチオン性又はアニオン性界面活性剤、脂肪アルコール、脂肪酸及びその脂肪酸塩から成る群より選択される、請求項10に記載の局所水中油型エマルジョン。
- 前記乳化剤がC14〜C22アルコール及びポリオキシエチレン脂肪アルコールエーテルの混合物である、請求項25に記載の局所水中油型エマルジョン。
- 前記C14〜C22アルコールがセチルアルコール、ステアリルアルコール、及びその混合物から成る群より選択される、請求項26に記載の局所水中油型エマルジョン。
- 前記C14〜C22アルコールがセチルアルコール及びステアリルアルコールの混合物である、請求項27に記載の局所水中油型エマルジョン。
- 前記エマルジョンが前記組成物の総重量に基づいて、約1〜15重量%の量で存在する、請求項10に記載の局所水中油型エマルジョン。
- 存在する前記C14〜C22アルコールの量が前記組成物の総重量に基づいて、約0.5%〜約5%w/wである、請求項26に記載の局所水中油型エマルジョン。
- 前記閉塞性物質が鉱油、グリース、ワセリン、脂肪酸、動物脂肪、植物脂肪、非水溶性ポリマー及びその混合物から成る群より選択される、請求項10に記載の局所水中油型エマルジョン。
- 前記閉塞性物質が前記組成物の総重量に基づいて、約1%〜約55重量%の量で存在する、請求項10に記載の局所水中油型エマルジョン。
- 前記閉塞性物質が前記組成物の総重量に基づいて、約1%〜約10重量%の量で存在する、請求項32に記載の局所水中油型エマルジョン。
- 前記閉塞性物質が前記組成物の総重量に基づいて、約5%〜約55重量%の量で存在する、請求項32に記載の局所水中油型エマルジョン。
- 緩衝剤をさらに含む、請求項10に記載の局所水中油型エマルジョン。
- 前記組成物のpHが約pH4.0〜約pH9.0である、請求項35に記載の局所水中油型エマルジョン。
- 粘度低下剤をさらに含む、請求項10に記載の局所水中油型エマルジョン。
- 保湿剤をさらに含む、請求項10に記載の局所水中油型エマルジョン。
- 前記エマルジョンが、炭化水素、クロロフルオロカーボン、ジメチルエーテル、ヒドロフルオロカーボン及びその混合物から成る群より選択されるエアロゾル噴霧体をさらに含む、請求項10に記載の局所水中油型エマルジョン。
- 前記エアロゾル噴霧体が炭化水素の混合物を含む、請求項39に記載の局所水中油型エマルジョン
- 前記エマルジョンが、クリーム、軟膏、ゲル、後発泡ゲル、ペースト、及びローションから成る群より選択される一員である、請求項10に記載の局所水中油型エマルジョン。
- 哺乳類における皮膚障害を治療する方法であって、
前記皮膚障害を治療するために請求項10〜41のいずれか一項に記載の局所水中油型エマルジョンを投与するステップ、
を含む方法。 - 前記皮膚障害が乾癬である、請求項42に記載の方法。
- 水相及び油相を有する局所水中油型エマルジョン中にビタミン又はその類似体を安定化する方法であって、
ビタミン又はその類似体を提供するステップであって、前記ビタミン又はその類似体は水相に可溶化されるステップと、
前記油相に可溶化される安定剤を提供するステップであって、前記ビタミン及びその類似体が、前記油相に可溶化された前記安定剤の存在によって前記水相中に安定化されるステップと、
を含む方法。 - 前記ビタミン又はその類似体が水溶性有機溶媒に最初に可溶化される、請求項44に記載の方法。
- 前記水溶性有機溶媒がプロピレングリコールである、請求項45に記載の方法。
- 皮膚障害の治療のための薬剤の製造における、請求項10〜41のいずれか一項に記載の局所水中油型エマルジョンの使用。
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JP2016204323A (ja) * | 2015-04-27 | 2016-12-08 | フジ日本精糖株式会社 | 骨形成促進剤 |
JP2022502149A (ja) * | 2018-09-27 | 2022-01-11 | アイアイエーエー リミテッド | 皮膚分析装置 |
JP7394846B2 (ja) | 2018-09-27 | 2023-12-08 | アイアイエーエー リミテッド | 皮膚分析装置 |
Also Published As
Publication number | Publication date |
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US8298515B2 (en) | 2012-10-30 |
JP5612263B2 (ja) | 2014-10-22 |
EP2526930B1 (en) | 2013-12-25 |
EP1917072A2 (en) | 2008-05-07 |
EP2526930A1 (en) | 2012-11-28 |
CA2611147A1 (en) | 2006-12-07 |
NZ563560A (en) | 2009-11-27 |
EP1917072A4 (en) | 2010-10-13 |
US20130101525A1 (en) | 2013-04-25 |
AU2006253913B2 (en) | 2010-09-16 |
ES2407407T3 (es) | 2013-06-12 |
CA2611147C (en) | 2013-04-09 |
ES2447301T3 (es) | 2014-03-11 |
AU2006253913A1 (en) | 2006-12-07 |
PL1917072T3 (pl) | 2014-01-31 |
EP1917072B1 (en) | 2013-02-27 |
PL2526930T3 (pl) | 2014-05-30 |
WO2006129161A2 (en) | 2006-12-07 |
US8629128B2 (en) | 2014-01-14 |
US20110014135A1 (en) | 2011-01-20 |
WO2006129161A3 (en) | 2007-02-08 |
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