JP5630942B2 - 不利な生物物理学的環境によりもたらされる有益な物質の経皮送達 - Google Patents
不利な生物物理学的環境によりもたらされる有益な物質の経皮送達 Download PDFInfo
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- JP5630942B2 JP5630942B2 JP2007509552A JP2007509552A JP5630942B2 JP 5630942 B2 JP5630942 B2 JP 5630942B2 JP 2007509552 A JP2007509552 A JP 2007509552A JP 2007509552 A JP2007509552 A JP 2007509552A JP 5630942 B2 JP5630942 B2 JP 5630942B2
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Description
本願は、2004年4月19日に出願された発明の名称が「Flow Assisted Transdermal Preparations of Ephedra and Ephedra Components to Avoid Adverse Effects」であるE.T.Fosselによる米国仮特許出願第60/563,573号;2004年4月19日に出願された発明の名称が「Flow Assisted Transdermal Delivery of Anabolic Steroids」であるE.T.Fosselによる米国仮特許出願第60/563,575号;2004年4月19日に出願された発明の名称が「Augmented Flow Assisted Transdermal Delivery of Anabolic Sterodis」であるE.T.Fosselによる米国仮特許出願第60/563,574号;2004年4月19日に出願された発明の名称が「Flow Assisted Topical Transdermal Methods of Drug Delivery」であるE.T.Fosselによる米国仮特許出願第60/563,558号;2004年4月19日に出願された発明の名称が「Transdermal Delivery of Pharmaceutical Agents Effected by a Hostile Biophysical Environment」であるE.T.Fosselによる米国仮特許出願第60/563,559号;2004年4月19日に出願された発明の名称が「Transdermal Drug Delivery by Means of a High Ionic Strength Environment」であるE.T.Fosselによる米国仮特許出願第60/563,560号;2004年4月19日に出願された発明の名称が「Transdermal Delivery of Ephedra and Ephedra Components by Use of A Hostile Biophysical Environment」であるE.T.Fosselによる米国仮特許出願第60/563,576号;2004年4月19日に出願された発明の名称が「An Augmented Flow Assisted Preparation to Increase Muscle Size and Performance」であるE.T.Fosselによる米国仮特許出願第60/563,572号;2004年4月19日に出願された発明の名称が「A Flow Assisted Preparation to Increase Muscle Size and Performance」であるE.T.Fosselによる米国仮特許出願第60/563,564号;2004年4月19日に出願された発明の名称が「Transdermal Preparations to Improve Muscle Function and Size」であるE.T.Fosselによる米国仮特許出願第60/563,570号;2004年4月19日に出願された発明の名称が「Use of a Silicon Based Matrix for Transdermal Delivery of L−Arginine and Adjuncts to Cause Beneficial Effects」であるE.T.Fosselによる米国仮特許出願第60/563,561号;2004年4月19日に出願された発明の名称が「Transdermal Preparation of Ibuprofen to Reduce Pain and Inflammation」であるE.T.Fosselによる米国仮特許出願第60/563,562号;2004年4月19日に出願された発明の名称が「A Transdermal Augmented L−Arginine Preparation for Treatment of Headache」であるE.T.Fosselによる米国仮特許出願第60/563,567号;2004年4月19日に出願された発明の名称が「Flow Assisted Topical Transdermal Methods of Drug Delivery of Drugs with Systemic Toxicity」であるE.T.Fosselによる米国仮特許出願第60/563,552号;2004年4月19日に出願された発明の名称が「Transdermal Delivery of Systematically Toxic Pharmaceutical Agents Effected by a Hostile Biophysical Environment」であるE.T.Fosselによる米国仮特許出願第60/563,569号;および2004年4月19日に出願された発明の名称が「Transdermal Flow Assisted Localized Delievery of Chemotherapeutic Agents」であるE.T.Fosselによる米国仮特許出願第60/563,571号の恩恵を主張する。
本発明は、一般的には、物質の経皮送達に関する。
薬物の局所的経皮送達は、望ましいが、現行の技術によって制限される。ほんの少数の薬学的実体しか、有効投与量で首尾よく経皮送達されていない。例えば、限定数の薬物(例えば、ステロイド、ニコチン、およびニトログリセリン(これらは、非荷電であり、水素結合を形成しない))が、受動拡散によって首尾よく送達された。この受動拡散は、フィックの第一拡散法則に従って因子を送達するために、皮膚の外側と内側との間の濃度勾配に依存した。単純な拡散を介して送達され得る薬剤の量もまた、限定される。例えば、一旦、角質層の内側の濃度がその外側と等しくなると、薬剤の流れは停止し得る。従って、局所的または全身的な物質の経皮送達の改善が、必要である。
本発明は、一般的には、局所的または全身的な物質の経皮送達に関し、いくつかの実施形態においては、不利な(hostile)生物物理学的環境による有益な物質の経皮送達に関する。本発明の主題は、ある場合には、相互関係する製品、特定の課題に対する代替的解決法、ならびに/または1つ以上のシステムおよび/もしくは方法の複数の種々の使用を含む。
本発明は、一般的には、物質の経皮送達に関し、いくつかの実施形態においては、不利な生物物理学的環境による有益な物質の経皮送達に関する。一局面においては、有益な物質の経皮送達のための種々の方法が、開示される。不利な生物物理学的環境を作製することによって、有益な物質が、特定の実施形態に従えば、皮膚の角質層を通って身体中へと送達され得る。有益な物質としては、薬剤、薬物、ビタミン、補因子、ペプチド、食事サプリメントなどが挙げられるが、これらに限定はされない。開示される有益な効果としては、例えば、疼痛および炎症の軽減、皮膚潰瘍の予防および治癒、頭痛の軽減、性機能の改善および享受、頭皮における毛髪成長、筋肉の大きさおよび/もしくは機能の改良、身体の脂肪および/もしくはセルライトの除去、癌の処置、ウイルス感染の処置などが挙げられる。不利な生物物理学的環境はまた、一組の実施形態に従えば、局所的血流を増大するためのシステムおよび方法と組み合わせて使用され得る。例えば、一酸化窒素ドナー(例えば、L−アルギニン)を使用することによって、局所的血流は、例えば、一酸化窒素前駆体を経皮送達することによって、増大され得る。上記一酸化窒素ドナーは、血流増大の唯一の原因であり得るか、または添加物(例えば、テオフィリン)を補充され得る。
本実施例において、手および指において重篤な関節炎を有する57歳の老女が、その手に、不利な生物物理学的環境を10%(w/v)イブプロフェンおよび12.5%(w/v)L−アルギニンとともに含むクリームを適用した。彼女は、そのクリームを、完全に吸収されるまで自分の手および指の皮膚に擦り込んだ。10分間以内に、彼女は、疼痛のかなりの軽減に気付いた。30分間以内に、その疼痛は完全になくなった。疼痛の軽減は、数時間持続した。
この実施例では、肩に痛みをもつ37歳の男性に、10%w/vのイブプロフェンおよび12.5%のw/vのL−アルギニンとともに、不利な生物物理学的環境を含むクリームを痛みのある肩に付与した。彼は、このクリームをそれが完全に吸収されるまで塗り込んだ。30分以内に、痛みは完全になくなった。痛みは決して戻らなかった。
右のこめかみに重篤な頭痛をもつ54歳の女性に、10%w/vのイブプロフェンおよび12.5%のw/vL−アルギニンとともに、不利な生物物理学的環境を負含むクリームを痛みのあるこめかみに付与した。彼女は、このクリームをそれが完全に吸収されるまで塗り込んだ。10分以内に、頭痛の実質的軽減が達成された。20分以内に痛みはなくなった。痛みは決して戻らなかった。
性器のヘルペス感染の病歴をもつ33歳の女性は、アシクロビルの局所的経皮調製物で処置した。ヘルペスは、赤色の、しばしばかゆみの領域として開始し、そして開いたただれへの進行の発生によって特徴付けられる。このアシクロビル調製物は、不利な生物物理学的環境、2.5w/vのアシクロビル、および12.5%w/vのL−アルギニンを含んだ。この調製物は、赤色およびしばしばかゆみ領域が出現するやいなや付与された。この処置は、愚鈍なヘルペス発生の退行を生じ、この領域を2日以内に正常に戻し、そして開いたただれが進行するのを防いだ。
下腿の跛行を患う58歳の男性に、浸透ベース中に、塩酸L−アルギニン(12.5%w/v)、塩酸コリン(10%w/v)、塩化マグネシウム(5%w/v)、および塩化ナトリウム(5%w/v)を含むクリームを、毎夜、かれの脚に付与した。それを3日間の間毎日用いた後、跛行からの痙攣は、彼が、このクリームの毎日の使用を継続している限り、決して再発しなかった。
PADの12年の病歴、および彼を重篤に耐えられなくする跛行をもつ72歳の男性をこの実施例で処置した。彼は、浸透基剤中に、塩酸L−アルギニン(12.5%w/v)、塩酸コリン(10%w/v)、塩化マグネシウム(5%w/v)、および塩化ナトリウム(5%w/v)を含むクリームの彼の下腿への毎日の使用を始めた。使用の3日後、発作の頻度は顕著に減少し、そして10日後、発作は止んだ。継続したクリームの毎日の使用は、発作を防ぎ続けた。
循環器損傷およびその続発症は、糖尿病の腫瘍な合併症であることが長く知られている。例えば、糖尿病では、内皮一酸化窒素(NO)/一酸化窒素シンターゼ(eNOS)システムの機能性が損なわれることが示されている。NOは、酵素eNOSによるアミノ酸L−アルギニンの酸化を通じて内皮に生成される。NOは、血管平滑筋を弛緩させ、増加した血流を生じる。eNOSの基質であることに加えて、L−アルギニンは、eNOSの2つの同じサブユニットのダイマー化を容易にし、ホモダイマーを形成する。この酵素は、ダイマー形態でのみ活性である。適正な条件下で、ダイマー化が、分のタイムスケールで迅速に起こる。一旦形成されたダイマーは、一般に安定である。
中足(゜F) p対訪問1 足の親指(゜F) p対訪問1
訪問1 82.0±2.3 74.4±4.2
訪問2 84.1±3.4 0.004 77.7±5.3 0.01
訪問3 87.0±2.4 <0.0001 83.6±4.9 <0.0001
訪問4 86.1±2.4 <0.0001 80.6±5.4 <0.0001
訪問5 86.9±2.4 <0.0001 82.4±4.8 <0.0001
(表2.経皮的L−アルギニンクリームの流れに対する影響)
中足(AU) p対訪問1 アキレス(AU) p対訪問1
訪問1 8.7±4.3 8.4±2.5
訪問2 10.8±5.9 NS 8.5±3.9 NS
訪問3 10.8±4.8 0.05 9.2±3.9 NS
訪問4 11.6±8.3 NS 10.0±4.2 0.06
訪問5 11.6±5.5 <0.0001 11
(実施例8)
この実施例は、イブプロフェンを含む本発明の経皮処方物を調製する1つの方法を示す。最終組成物を表3に示す。勿論、当業者は、本発明のその他の実施形態に従って、以下に列挙されるもの以外の%もまた可能であることを理解する。
水 49%
塩酸L−アルギニン 7.5%
イブプロフェン(ナトリウム塩) 7.5%
塩化ナトリウム 10%
塩化カリウム 5%
ステアリン酸グリセリル(SE) 7%
セチルアルコール 7%
スクアレン 2%
ミリスチン酸イソプロピル 1%
オレイン酸 1%
Tween20 2%
ブタンジオール 1%。
AとBとの両方(必要に応じてその他の要素を含む);など。
Claims (29)
- 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、少なくとも1Mであるイオン強度を有し、該薬剤は、イブプロフェンである、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、0.25M〜15Mであるイオン強度を有し、該薬剤は、イブプロフェンである、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、少なくとも1Mであるイオン強度を有し、該薬剤は、イブプロフェンであり、かつ、医学的状態を処置することが可能であり、該医学的状態は、片頭痛または関節炎のうちの1種以上である、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、0.25M〜15Mであるイオン強度を有し、該薬剤は、イブプロフェンであり、かつ、医学的状態を処置することが可能であり、該医学的状態は、片頭痛または関節炎のうちの1種以上である、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、少なくとも1Mであるイオン強度を有し、該薬剤は、イブプロフェンであり、かつ医学的状態を処置することが可能であり、該医学的状態は、疼痛、関節痛、筋肉痛および関節炎からなる群より選択される、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、0.25M〜15Mであるイオン強度を有し、該薬剤は、イブプロフェンであり、かつ医学的状態を処置することが可能であり、該医学的状態は、疼痛、関節痛、筋肉痛および関節炎からなる群より選択される、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、少なくとも1Mであるイオン強度を有し、該薬剤は、アシクロビルであり、かつ、医学的状態を処置することが可能であり、該医学的状態は、ウイルス感染またはヘルペスである、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー、および
被験体の皮膚の一部に対して適用するために適している不利な生物物理学的環境中にある薬剤
を含み、該不利な生物物理学的環境は、0.25M〜15Mであるイオン強度を有し、該薬剤は、アシクロビルであり、かつ、医学的状態を処置することが可能であり、該医学的状態は、ウイルス感染またはヘルペスである、送達ビヒクル。 - 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記不利な生物物理学的環境は、尿素または糖質を含む、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記不利な生物物理学的環境は、少なくとも9であるpHまたは5未満であるpHを有する、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記不利な生物物理学的環境は、少なくとも1000であるオクタノール−水分配係数を有する成分または10−3未満であるオクタノール−水分配係数を有する成分を含む、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、医学的状態を処置するために有効投与量の前記薬剤を輸送するために十分な期間の間適用されるのに適していることを特徴とする、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記不利な生物物理学的環境は、角質層を通るように前記薬剤を駆動可能である、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記不利な生物物理学的環境は、3〜11であるpHを有する、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記不利な生物物理学的環境は、イオン性塩を含む、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記不利な生物物理学的環境は、塩化ナトリウム、塩化コリン、塩化マグネシウム、塩化カルシウムのうちの1種以上を含む、送達ビヒクル。
- 請求項5または6に記載の送達ビヒクルであって、前記医学的状態は、疼痛である、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、該送達ビヒクルは、添加剤をさらに含む、送達ビヒクル。
- 請求項18に記載の送達ビヒクルであって、前記添加剤は、テオフィリンを含む、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、前記一酸化窒素ドナーは、L−アルギニンを含む、送達ビヒクル。
- 請求項20に記載の送達ビヒクルであって、前記一酸化窒素ドナーは、皮膚中の血流を増大するために有効な量で存在する、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、該送達ビヒクルは、クリーム、ゲル、またはローションである、送達ビヒクル。
- 請求項1〜8のうちのいずれか1項に記載の送達ビヒクルであって、該送達ビヒクルは、水、鉱油、グリセリルステレアート、スクアレン、プロピレングリコールステアレート、麦芽油、ステアリン酸グリセリル、ミリスチン酸イソプロピル、ステアリン酸ステリル、ポリソルベート60、プロピレングリコール、オレイン酸、酢酸トコフェロール、コラーゲン、ステアリン酸ソルビタン、ビタミンA、ビタミンD、トリエタノールアミン、メチルパラベン、アロエベラ抽出物、イミダゾリジニル尿素、プロピルパラベン、PND、またはBHAのうちの1種以上をさらに含む、送達ビヒクル。
- 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー;および
疼痛、片頭痛および関節炎からなる群より選択される1種以上の医学的状態を処置するための、不利な生物物理学的環境中にある薬剤;
を含み、該不利な生物物理学的環境は、少なくとも1Mであるイオン強度を有し、該薬剤はイブプロフェンである、送達ビヒクル。 - 送達ビヒクルであって、
L−アルギニンまたは塩酸L−アルギニンから選択される一酸化窒素ドナー;および
疼痛、片頭痛および関節炎からなる群より選択される1種以上の医学的状態を処置するための、不利な生物物理学的環境中にある薬剤;
を含み、該不利な生物物理学的環境は、0.25M〜15Mであるイオン強度を有し、該薬剤はイブプロフェンである、送達ビヒクル。 - 請求項24または25に記載の送達ビヒクルであって、前記一酸化窒素ドナーは、L−アルギニンを含む、送達ビヒクル。
- 請求項24または25に記載の送達ビヒクルであって、前記医学的状態は、疼痛、および関節炎からなる群より選択される、送達ビヒクル。
- 請求項24または25に記載の送達ビヒクルであって、水、鉱油、グリセリルステレアート、スクアレン、プロピレングリコールステアレート、麦芽油、ステアリン酸グリセリル、ミリスチン酸イソプロピル、ステアリン酸ステリル、ポリソルベート60、プロピレングリコール、オレイン酸、酢酸トコフェロール、コラーゲン、ステアリン酸ソルビタン、ビタミンA、ビタミンD、トリエタノールアミン、メチルパラベン、アロエベラ抽出物、イミダゾリジニル尿素、プロピルパラベン、PND、またはBHAのうちの1種以上をさらに含む、送達ビヒクル。
- 前記薬剤が、少なくとも1重量%の濃度で存在する、請求項1〜28のいずれか1項に記載の送達ビヒクル。
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