JP5841062B2 - 担体組成物 - Google Patents
担体組成物 Download PDFInfo
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- JP5841062B2 JP5841062B2 JP2012545015A JP2012545015A JP5841062B2 JP 5841062 B2 JP5841062 B2 JP 5841062B2 JP 2012545015 A JP2012545015 A JP 2012545015A JP 2012545015 A JP2012545015 A JP 2012545015A JP 5841062 B2 JP5841062 B2 JP 5841062B2
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- Prior art keywords
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- phosphate
- compound
- formulation
- tocopheryl
- Prior art date
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- -1 phosphate compound Chemical class 0.000 claims description 79
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- 239000010452 phosphate Substances 0.000 claims description 54
- ZAKOWWREFLAJOT-ADUHFSDSSA-N [2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] acetate Chemical group CC(=O)OC1=C(C)C(C)=C2OC(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-ADUHFSDSSA-N 0.000 claims description 38
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- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 description 1
- 239000009637 wintergreen oil Substances 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- 239000003064 xanthine oxidase inhibitor Substances 0.000 description 1
- 229960004764 zafirlukast Drugs 0.000 description 1
- 229960005332 zileuton Drugs 0.000 description 1
- MWLSOWXNZPKENC-SSDOTTSWSA-N zileuton Chemical compound C1=CC=C2SC([C@H](N(O)C(N)=O)C)=CC2=C1 MWLSOWXNZPKENC-SSDOTTSWSA-N 0.000 description 1
- 229960005111 zolpidem tartrate Drugs 0.000 description 1
- UBQNRHZMVUUOMG-UHFFFAOYSA-N zonisamide Chemical compound C1=CC=C2C(CS(=O)(=O)N)=NOC2=C1 UBQNRHZMVUUOMG-UHFFFAOYSA-N 0.000 description 1
- 229960002911 zonisamide Drugs 0.000 description 1
- 229960000820 zopiclone Drugs 0.000 description 1
- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
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Description
驚くべきことに、電子移動剤のホスフェート化合物及び比較的高濃度の極性プロトン性溶媒を含む担体組成物が生理活性化合物の送達を改善することができることが発見された。
1つの実施態様においては、該極性プロトン性溶媒は、ケトンであることができる。より具体的には、該ケトンは、メチルイソブチルケトン又はアセトンであることができる。
1つの実施態様においては、該極性プロトン性溶媒は、ニトリルである。より具体的には、該ニトリルは、アセトニトリルであることができる。
本発明の担体組成物は、電子移動剤のホスフェート化合物及び比較的高濃度の極性プロトン性溶媒を含む。生理活性化合物は、本発明の担体組成物とともに製剤化されて、製剤を提供することができる。
「電子移動剤」という用語は、リン酸化されることができる化合物であって、かつ、非リン酸化形態においては、電子を受容して比較的安定な分子ラジカルを生成することができるか又は2つの電子を受容して該化合物が可逆的な還元系に参加することを可能とする化合物をさす。電子移動剤の例は、抗酸化剤及びその誘導体を包含する。
有機溶媒は、非極性又は極性非プロトン性溶媒、及び極性プロトン性溶媒としてグループ分けされることができる。
「生理活性化合物」という用語は、医学的、治療的、美容的及び獣医学的目的のための、ヒト又は動物における生物学的効果を有する任意の化学物質をさし、かつ、薬物、薬用化粧品、栄養補助食品(nutraceuticals)、及び栄養剤を包含する医薬品を含む。いくつかの生理活性化合物がこれらのクラスの1つ以上に分類可能であることは理解されるであろう。
ベンゾカイン、クロロプロカイン、コカイン、レセルピン、グアネチジン、シクロメチカイン、ジメトカイン、ラロカイン、プロポキシカイン、プロカイン/ノボカイン、プロパラカイン、テトラカイン/アメトカイン、アルチカイン、ブピバカイン、カルチカイン、シンコカイン/ジブカイン、エチドカイン、レボブピバカイン、リドカイン/リグノカイン、メピバカイン、ピペロカイン、プリロカイン、ロピバカイン、トリメカイン、プロポフォール、ハロタン、エンフルランバルビツレート、ベンゾジアゼピン、ネオスチグミン及びケタミンなどのアミノエステル型及びアミノアミド型麻酔薬を包含する。
カルムスチン、シクロホスファミド、イフォスファミド、ストレプトゾトシン及びメクロレタミンを包含する。
アムロジピン、アラニジピン、アゼルニジピン、バルニジピン、ベニジピン、シルニジピン、クレビジピン、クロニジピン、ダロジピン、デクスニグルジピン、エホニジピン、エルナジピン、エルゴジピン、フェロジピン(felodipine)、フロルジピン、フルニジピン、イガニジピン、イスラジピン、ラシジピン、レミルジピン、レルカニジピン、マニジピン、メスルジピン(mesuldipine)、ニカルジピン、ニフェジピン、ニルジピン、ニルバジピン、ニモジピン、ニソルジピン、ニトレンジピン、オルラジピン、オキソジピン、パロニジピン、プラニジピン、サガンジピン、ソルニジピン、テルジピン、チアムジピン、トロンボジピン(trombodipine)、ワタニジピン、ベラパミル、ガロパミル、ベンゾチアゼピン、ジルチアゼム、ミベフラジル、ベプリジル、フルスピリレン及びフェンジリンを包含する。
アミオダロン、ジソピラミド、酢酸フレカイニド、キニジン硫酸塩、ニトログリセリン、ラノラジン、アミオダロン、イソソルビド及びアルテプラーゼを包含する。
アモキシシリン、アンピシリン、アジスロマイシン、ベネタミンペニシリン、ブレオマイシン、過酸化ベンゾイル、シノキサシン、クロラムフェニコール、ダウノルビシン、プリカマイシン、フルオロキノロン、シプロフロキサシン、クラリスロマイシン、クリンダマイシン、クリンデッセ(clindesse)、クロファジミン、グルコン酸クロルヘキシジン、クロキサシリン、デメクロシクリン、ドキシサイクリン、エリスロマイシン、エチオナミド、イミペネム、インドメタシン、リモサイクリン(lymocycline)、ミノサイクリン、ナリジクス酸、ニトロフラントイン、ペニシリン、リファンピシン、スピラマイシン、スルファセタミドナトリウム、スルファベンズアミド(sulphabenzamide)、スルファドキシン、スルファメラジン、スルファセタミド、スルファジアジン、スルファフラゾール、スルファメトキサゾール、スルファピリジン、テトラサイクリン、セファレキシン、セフジニル、トリクロサン、オフロキサシン、バンコシン、グリブリド、ムピロシン、セフプロジル、セフロキシム・アキセチル、ノルフロキサシン、イソニアジド、ルプロン、D-ペニシラミン、レボフロキサシン、ガチフロキサシン、及びトリメトプリムを包含する。
ドキソルビシン、6−チオグアニン、パクリタキセル、ドセタキセル、カンプトテシン、酢酸メゲストロール、ナベルビン、シタラビン、フルダラビン、6−メルカプトプリン、5−フルオロウラシル、テニポシド、ビンブラスチン、ビンクリスチン、シスプラチン、コルヒチン、カルボプラチン、プロカルバジン及びエトポシドを包含する。
アルプラゾラム、アモキサピン、ベンタゼパム、ブロマゼパム、クロラジピン、クロバザム、クロチアゼパム、ジアゼパム、ロラゼパム、フルニトラゼパム、フルラゼパム、ロルメタゼパム、メダゼパム、ニトラゼパム、オキサゼパム、テマゼパム、マプロチリン、ミアンセリン、ノルトリプチリン、リスペリドン、セルトラリン、トラゾドン、バロペリドール、マレイン酸トリミプラミン、フルオキセチン、オンダンセトロン、ミダゾラム、クロルプロマジン、ハロペリドール、トリアゾラム、クロザピン、フルオプロマジン、フルフェナジンデカノエート、フルアニソン、ペルフェナジン、ピモジド、プロクロルペラジン、スルピリド、チオリダジン、パロキセチン、シタロプラム、ブプロピオン、フェネルジン、オランザピン、ジバルプロエクスナトリウム、及びベンラファキシンを包含する。
モルヒネ、デポモルヒネ(depomorphine)、エトルフィン、ジアセチルモルヒネ、ヒドロモルフォン、オキシモルフォン、レボルファノール、メタドン、レボメタジル、メペリジン、フェンタニル、スフェンタニル、アルフェンタニル、コデイン、ヒドロコドン、オキシコドン、テバイン、デソモルヒネ、ニコモルフィン、ジプロパノイルモルフィン、ベンジルモルフィン、エチルモルフィン、ペチジン、メタドン、トラマドール、デクストロプロポキシフェン;ナロキソン及びナルトレキソン;ブプレノルフィン、ナルブフィン、ブトルファノール、ペンタゾシン及びエチルケトシクラゾシンを含む、オピオイド受容体アゴニスト及びアンタゴニスト、アゴニスト/アンタゴニスト混合薬活性を示す化合物及び部分アゴニスト活性を示す化合物を包含する。
アゾチオピン(azothiopine)、アミトリプチリン、ファモチジン、プロメタジン、パロキサチン(paroxatine)、オクスカルバザピン(oxcarbazapine)及びメルタザピン(mertazapine)を包含する。
アセトヘキサミド、クロルプロパミド、グリベンクラレード(glibenclaraide)、グリクラジド、グリピジド、メトホルミン、トラザミド、グリブリド、グリメピリド及びトルブタミドを包含する。
ベクラミド、カルバマゼピン、ガパペンチン(gapapentin)、チアガビン、ビガバトリン、トピラマート、クロナゼパム、エトトイン、メトイン、メトスクシミド、メチルフェノバルビトン、オキスカルバゼピン、パラメタジオン、フェナセミド、フェノバルビトン、フェニロイン(phenyloin)、フェンスクシミド、プリミドン、スルチアミン、フェニトインナトリウム、ニロフラントインモノハイドレート(nirofurantoin monohydrate)、ガバペンチン、ラモトリジン、ゾニサミド、エトスクシミド及びバルプロ酸を包含する。
酒石酸ゾルピデム、アミロバルビトン、バルビトン、ブトバルビトン、ペントバルビトン、ブロチゾラム、カルブロマール、クロルジアゼポキシド、クロルメチアゾール、エチナメート、メプロバメート、メタカロム(methaqualome)、シクロベンザプレン(cyclobenzaprene)、シクロベンザプリン、チザニジン、バクロフェン、ブタルビタール、ゾピクロン、アトラクリウム、ツボクラリン及びフェノバルビタールを包含する。
アンフォテリシン、硝酸ブトコナゾール、クロトリマゾール、硝酸エコナゾール、フルコナゾール、フルシトシン、グリセオフルビン、イトラコナゾール、ケトコナゾール、ミコナゾール、ナタマイシン、ナイスタチン、硝酸スルコナゾール、テルコナゾール、チオコナゾール及びウンデカン酸;ベンズニダゾール、クリオキノール、デコキネート、ジヨードヒドロキシキノリン、ジロキサニドフロエート、ジニトルミド、フラゾリドン(furzolidone)、メトロニダゾール、ニモラゾール、ニトロフラゾン、オルニダゾール、テルビナフィン、クロトリマゾール、クロロキン、メフロキン、イトラコナゾール、ピリメタミン、プラジカンテル、キナクリン、メベンダゾール及びチニダゾールを包含する。
カンデサルタン、ヒドララジン、クロニジン、トリアムテレン、フェロジピン、ゲムフィブロジル、フェノフィブラート、ニフェジカル(nifedical)、プラゾシン、メカミラミン、ドキサゾシン、ドブタミン及びシレキセチルを包含する。
メシル酸ジヒドロエルゴタミン、酒石酸エルゴタミン、マレイン酸メチセルギド、マレイン酸ピゾチフェン及びコハク酸スマトリプタンを包含する。
アトロピン、ベンズヘキソール、ビペリデン、エトプロパジン、ヒヨスチアミン、臭化メペンゾラート、オキシブチニン、オキシフェンサイクリミン(oxyfencylcimine)及びトロピカミドを包含する。
アミノグルテチミド、アムサクリン、アザチオプリン、ブスルファン、クロラムブシル、シクロスポリン、ダカルバジン、エストラムスチン、エトポシド、ロムスチン、メルファラン、メルカプトプリン、メトトレキセート、マイトマイシン、ミトタン、ミトザントロン(mitozantrone)、プロカルバジン、クエン酸タモキシフェン、テストラクトン、タクロリムス、メルカプトプリン及びシロリムスを包含する。
メシル酸ブロモクリプチン、レボドーパ、トルカポン、ロピニロール、ブロモクリプチン、及びスルホニルウレア、ビグアナイド、α−グルコシダーゼ阻害薬、チアゾリジンジオンなどの血糖低下薬、カベルゴリン、カルビドーパ及びマレイン酸リスリドを包含する。
カルビマゾール及びプロピルチオウラシルを包含する。
アマンタジン、レチノビル、シドフォビル、アシクロビル、ファムシクロビル、リバビリン、アムプレナビル、インジナビル、リマンタジン及びエファビレンツ、ペンシクロビル、ガンシクロビル、ビダラビン、アバカビル、アデフォビル、アンプレナビル、デラビルジン、ジダノシン、スタブジン、ザルシタビン、ジドブジン、エンフビルチド及びインターフェロンを包含する。
アムリノン、ミルリノン、ジギトキシン、ジゴキシン、エノキシモン、ラナトシドC及びメジゴキシンを含む。
フェノフィブレート、クロフィブレート、プロブコール、エゼチミベ及びトルセトラピブを包含する。
メオキシカム(meoxicam)、トリアムシノロン、クロモリン、ネドクロミル、ヒドロキシクロロキン、モンテルカスト、ジレウトン、ザフィルルカスト及びメロキシカムを包含する。
フェキソフェナジン、抱水クロラール、ヒドロキシジン、プロメタジン、セチラジン(cetirazine)、シメチジン、シクリジン、メクリジン、ジメンヒドリナート、ロラタジン、ニザタジン及びプロメタジンを包含する。
オメプラゾール、ランソプラゾール、パントプラゾール及びラニチジンを包含する。
ヒドロクロロチアジド、アミロリド、アセタゾラミド、フロセミド及びトルセミドを包含する。
ジクロフェナック、アセクロフェナック、アセメタシン、アルクロフェナック、ブロムフェナック、エトドラック、インドメタシン、インドメタシンファルネシル、ナブメトン、オキサメタシン、プログルメタシン、スリンダック及びトルメチンを包含するアリールアルカン酸亜群;アルミノプロフェン、ベノキサプロフェン、カルプロフェン、デクスイブプロフェン、デクスケトプロフェン、フェンブフェン、フェノプロフェン、フルノキサプロフェン、フルルビプロフェン、イブプロフェン、イブプロキサム、インドプロフェン、ケトプロフェン、ケトロラック(ketrolac)、ロキソプロフェン、ミロプロフェン、ナプロキセン、オキサプロジン、ピルプロフェン、スプロフェン、タレンフルルビル(tarenflurbil)及びチアプロフェン酸を包含する2−アリールプロピオン酸(プロフェン)亜群;並びに、フルフェナム酸、メクロフェナム酸、メフェナム酸及びトルフェナム酸を包含するN−アリールアンスラニル酸(フェナム酸)亜群;トロメタミン、セレコキシブ、ネパフェナック、アスピリン、ロフェコキシブ、ナプロキセン、スリンダック、ピロキシカム、フェニルブタゾン、トルメチン、インドメタシン、アセトミノフェン(acetominophen)(パラセタモール)、トラマドール及びプロポキシフェンを包含する。
レチノール、レチナール、トレチノイン(レチノイン酸、Retin-A)、イソトレチノイン及びアリトレチノインなどの第一世代レチノイド;エトレチネート及びその代謝物アシトレチンなどの第二世代レチノイド;タザロテン、ベキサロテン及びアダパレンなどの第三世代レチノイドを包含する。
副腎皮質刺激ホルモン(ACTH)、抗利尿ホルモン(バソプレッシン)、心房性ナトリウム利尿因子(ANF)、ベクロメタゾン、コルチゾン、スコポラミン、ドパミン、エピネフリン、カテコールアミン、コレシストキニン、クエン酸クロミフェン、ダナゾール、デキサメタゾン、ジエチルスチルベストロール(DES)、エチニルエストラジオール、フルドロコルチゾン、フィナステリド、卵胞刺激ホルモン、ガストリン、ヒドロキシプロゲステロン、レプチン、黄体形成ホルモン、酢酸メドロキシプロゲステロン、メストラノール、キネストロール、メチルテストステロン、ナンドロロン、ノルエチンドロン、ノルエチステロン、ノルゲストレル、エストラジオール、接合エストロゲン、オキサンドロロン、オキシトシン、プレドニソン、プロゲステロン、プロラクチン、プロトガルンジン(protogalndins)、ソマトスタチン、スタノゾロール、スチベストロール、チロキシン、リン酸プレドニソロン、トリアムシノロン、ミフェプリストンアセトニド、ブデソニド、レボチロキシン、テストステロン、テストステロンシピオネート、フルオキシメステロン、フルタミド、フランカルボン酸モメタゾン、シプロテロン、フルロメタロン(fluromethalone)、ゴセレリン、ロイプロリド、カルシトニン、ハロベタゾール、ヒドロコルチゾール及びチボロンを包含する。
アトルバスタチン、フラバスタチン、ロバスタチン、ニスタチン、ロスバスタチン、プラバスタチン、オルリスタット及びシンバスタチンを包含する。
アンフェタミン、フェンテルミン、チラミン、エフェドリン、メタラミノール、フェニレフリン、デクスアンフェタミン、デクスフェンフルラミン、フェンフルラミン、ニコチン、カフェイン及びマジンドールを包含する。
デスモプレシンを包含する。
カルベジロール、テラゾシン、フェントラミン及びメントールを包含する。
レベチラセタム、レビチラセタム(levitiracetam)及びドネペジルを包含する。
ベンザプリル、エナラプリル、ラミプリル、フォシノプリルナトリウム、リシノプリル、ミノキシジル、イソソルビド、ラムプリル(rampril)及びキナプリルを包含する。
アテノロール、チモロール、ピンドロール、プロパノロールハイドロクロライド(propanolol hydrochloride)、ビソプロロール、エスモロール、コハク酸メトプロロール、メトプロロール及び酒石酸メトプロロールを包含する。
ロサルタンを包含する。
アブシキシマブ、クロピドロゲル(clopidrogel)、チロフィバン及びアスピリンを包含する。
トラマドール、トラマドール塩酸塩、アロプリノール、カルシトリオール、シロスタゾール、ソルタロール、ウラソジオール(urasodiol)ブロムペリドール(bromperidol)、ドロペリドール、デカン酸フルペンチキソール(flupenthixol)、アルブテロール、硫酸アルブテロール、カリソプロドール、クロベタソール、ロピニロール、ラベタロール及びメトカルバモールを包含する。
アミオデロン(amioderone)、フルチカゾン(fluticasone)、スピロノラクトン、プレドニゾン、トリアゾドン、デスオキシメタゾン、メチルプレドニスドン(methyl perdnisdone)、ベンゾナテート(benzonatate)、ナブメトン及びブスピロンを包含する。
メトクロプラミドを包含する。
ドルゾラミド、ブリモニジン、オロパタジン、シクロペントレート、ピロカルピン及びエコチオフェートを包含する。
ワーファリン、エノキサパリン及びレピルジンを包含する。
プロベネシド及びスルフィンピラゾンを包含する。
イプラトロピウムを包含する。
ラロキシフェン、パミドロネート及びリセドロネートを包含する。
−低下した副作用(すなわち、不必要な全身的作用を最小化すること);
−生理活性化合物の分布を特定の領域へ限定すること(例えば、薬物ターゲティング);
−患者のコンプライアンスの改善(例えば、より少量の使用、より少ない適用);
−美的感覚の改善(例えば、迅速な乾燥):及び
−作用の持続時間の増加及び/又は作用発現の短縮
を提供することができる。
投与経路は、効果によって広く3つのカテゴリー、すなわち、所望の効果が局部的であり、その作用が望まれるところに直接物質が適用される「局所」、所望の効果が全身性(非局部的)であり、消化管を介して物質が与えられる「腸内」、そして、所望の効果が全身性であり、消化管以外の経路によって物質が与えられる「腸管外」に分割されることができる。
本発明の担体組成物は、様々な技術によって調製されることができる。
担体組成物を上記の好ましい方法にしたがって調製した。
5つの担体組成物のそれぞれが、1%w/wのモノ−(トコフェリル)ホスフェート及びジ−(トコフェリル)ホスフェートの8:2の比率の混合物及び水、並びに以下の極性プロトン性溶媒濃度を含んだ。
担体組成物を、3サイクルの、約12時間約5℃での冷蔵そして約12時間約30℃の温度、に供した。各温度変化の間では、担体組成物を室温に3時間放置し、任意の濁り及び沈澱について観察した。
この実施例は、本発明の製剤(製剤2A)及び低濃度の極性プロトン性溶媒を含む製剤(製剤2B)を用いて、インビトロでのオキシコドン経皮送達を比較する。各製剤の詳細は以下のとおりである。
製剤2Aを、上記の好ましい方法にしたがって調製した。製剤2Bを同様に調製した。
完全な厚さのラット腹部皮膚を、12ml垂直フランツ拡散セル(PermeGear、PA)中で使用した。CO2ガスを用いる窒息によってラットを殺し、そして、腹部領域を注意深く毛を剃って切除した。すべての皮下脂肪及び結合組織を除去した。皮膚を、アルミニウムホイルのシートの間に平らにして凍結し、実験の朝まで−20℃で保存した。
極性プロトン性溶媒の濃度が70%w/wである製剤2Aが、5%w/wのオキシコドンの濃度を維持できたことがわかった。一方、極性プロトン性溶媒の濃度が20%w/wである製剤2Bは、1.5%w/wのオキシコドンの最高濃度を維持したにすぎなかった。
本発明の製剤(製剤2A)は、製剤2Bに比べて増加したオキシコドン濃度を可能とした。製剤2Aは、速度及び総オキシコドン送達量の両方に関するオキシコドンのより良好な経皮吸収、並びに優れたバイオアベイラビリティーも示した。
この実施例は、本発明の製剤(製剤3A)及び水性製剤(製剤3B)の性能を比較して、それらの用量に応じた相対的挙動を決定する、用量応答試験である。各製剤の詳細は以下のとおりである:
製剤3Aを、上記の好ましい方法にしたがって調製した。製剤3Bを、同様に調製した。
完全な厚さのラット腹部皮膚を、12ml垂直フランツ拡散セル(PermeGear、PA)中で使用した。CO2ガスを用いる窒息によってラットを殺し、そして、腹部領域を注意深く毛を剃って切除した。すべての皮下脂肪及び結合組織を除去した。皮膚を、アルミニウムホイルのシートの間に平らにして凍結し、実験の朝まで−20℃で保存した。
製剤3Aは、製剤3Bに比較して増加した経皮フラックスを有した。高濃度の極性プロトン性溶媒の使用(製剤3A)は、同等量の好ましい形態のオキシコドン(塩基;5%w/w)が製剤されることを可能とした。
この用量応答試験は、特に、本発明の製剤(製剤3A)が、用量応答においてより広いダイナミックレンジを可能とすることを示している。
この実施例は、本発明の製剤(製剤4A)と低濃度の極性プロトン性溶媒を含む製剤(製剤4B)の安定性、皮膚沈着及び他の性質を比較する。各製剤の詳細は以下のとおりである:
製剤4Aを、上記の好ましい方法にしたがって調製した。製剤4Bを、同様に調製した。
視覚的な安定性試験の結果は、3日間の貯蔵後、製剤4Aについて注目される物理的変化はなかったが、製剤4Bでは沈澱が生成したことを示した。
4時間の投与後、図3に示すとおり、製剤4Aでは、製剤4Bに比べて顕著な皮膚沈着(μg)があった。
結果は、本発明の製剤(製剤4A)が、製剤4Bに比べて安定であり、かつ、改善した送達を有したことを示した。
この実施例は、本発明の製剤(製剤5A)と低濃度の極性プロトン性溶媒を含む製剤(製剤5B)の安定性、皮膚沈着及び他の性質を比較する。各製剤の詳細は以下のとおりである:
ジクロフェナック製剤5Aを、上記の好ましい方法にしたがって調製した。製剤5Bを同様に調製した。
視覚的な安定性試験の結果は、3日間の貯蔵後、製剤5Aについて注目される物理的変化はなかったが、製剤5Bでは沈澱が生成したことを示した。
4時間の投与後、図4に示すとおり、製剤5Aでは、製剤5Bに比べて顕著な皮膚沈着(μg)があった。図4においては、製剤5A及び5Bを、ジクロフェナックVoltaren(登録商標)を含む市販の製品に対しても比較した。
結果は、本発明の製剤(製剤5A)が、製剤5Bに比べて安定であり、かつ、改善した送達を有したことを示した。
この実施例は、本発明の製剤(製剤6A)と低濃度の極性プロトン性溶媒を含む製剤(製剤6B)の安定性、皮膚透過及び他の性質を比較する。各製剤の詳細は以下のとおりである:
製剤6Aを、上記の好ましい方法にしたがって調製した。製剤6Bを同様に調製した。
実施例2について実施した皮膚透過試験も上記製剤について実施した。
視覚的な安定性試験の結果は、3日間の貯蔵後、製剤6Aについて注目される物理的変化はなかったが、製剤6Bでは沈澱が生成したことを示した。
4時間の投与後、図5に示すとおり、製剤6Aでは、製剤6Bに比べて顕著な皮膚沈着(μg)があった。
結果は、本発明の製剤(製剤6A)が、製剤6Bに比べて安定であり、かつ、改善した送達を有したことを示した。
この実施例は、本発明の製剤(製剤7A)と低濃度の極性プロトン性溶媒を含む製剤(製剤7B)の安定性及び他の性質を比較する。各製剤の詳細は以下のとおりである:
製剤7Aを、上記の好ましい方法にしたがって調製した。製剤7Bを同様に調製した。
視覚的な安定性試験の結果は、3日間の貯蔵後、製剤7Aについて注目される物理的変化はなかったが、製剤7Bでは沈澱が生成したことを示した。
4時間の投与後、製剤7Aでは、製剤7Bに比べて顕著な皮膚沈着(μg)があった。
結果は、本発明の製剤(製剤7A)が、製剤7Bに比較して安定であり、かつ、改善した送達を有することを示した。
本発明の分野の当業者は、本発明の精神及び範囲から離れることなく、多くの変更が行われうることを理解するだろう。
Claims (33)
- 電子移動剤のホスフェート化合物、及びエタノール、n−プロパノール、イソプロパノール、エチレングリコール、プロピレングリコール、ポリエチレングリコール及びジエチレングリコールモノエチルエーテルからなる群から選択される非環式アルコールを含む、生理活性化合物の送達のための担体組成物であって、ここで、前記非環式アルコールの濃度が、前記担体組成物の総濃度の60%w/w〜90%w/wの範囲内にある、前記担体組成物。
- 前記非環式アルコールの濃度が、65%w/w〜85%w/wの範囲内にある、請求項1に記載の担体組成物。
- 前記非環式アルコールの濃度が、70%w/w〜80%w/wの範囲内にある、請求項1に記載の担体組成物。
- 前記非環式アルコールの濃度が、60%w/w〜70%w/wの範囲内にある、請求項1に記載の担体組成物。
- 前記非環式アルコールの濃度が、80%w/w〜90%w/wの範囲内にある、請求項1に記載の担体組成物。
- 前記電子移動剤がヒドロキシクロマンである、請求項1に記載の担体組成物。
- 前記ヒドロキシクロマンが、トコフェロールまたはトコトリエノールである、請求項6に記載の担体組成物。
- 前記トコフェロールのホスフェート化合物が、以下の:モノ−(トコフェリル)ホスフェート、モノ−(トコフェリル)ホスフェート一ナトリウム塩、モノ−(トコフェリル)ホスフェート一カリウム塩、モノ−(トコフェリル)ホスフェート二ナトリウム塩、モノ−(トコフェリル)ホスフェート二カリウム塩、ジ−(トコフェリル)ホスフェート、ジ−(トコフェリル)ホスフェート一ナトリウム塩、ジ−(トコフェリル)ホスフェート一カリウム塩、及びそれらの混合物から成る群から選ばれる、請求項7に記載の担体組成物。
- 前記トコフェロールのホスフェート化合物が、モノ−(トコフェリル)ホスフェートとジ−(トコフェリル)ホスフェートの混合物である。請求項8に記載の担体組成物。
- 前記モノ−(トコフェリル)ホスフェートとジ−(トコフェリル)ホスフェートの混合物が、少なくとも2:1の比率にある、請求項9に記載の担体組成物。
- 前記モノ−(トコフェリル)ホスフェートとジ−(トコフェリル)ホスフェートの混合物が、4:1〜1:4の範囲内の比率にある、請求項9に記載の担体組成物。
- 前記モノ−(トコフェリル)ホスフェートとジ−(トコフェリル)ホスフェートの混合物が、6:4〜8:2の範囲内の比率にある、請求項9に記載の担体組成物。
- 前記電子移動剤のホスフェート化合物が、前記担体組成物の総濃度の0.01%w/w〜20%w/wの範囲内の量で存在する、請求項1に記載の担体組成物。
- 前記電子移動剤のホスフェート化合物が、前記担体組成物の総濃度の0.01%w/w〜10%w/wの範囲内の量で存在する、請求項1に記載の担体組成物。
- 前記電子移動剤のホスフェート化合物が、前記担体組成物の総濃度の0.01%w/w〜5%w/wの範囲内の量で存在する、請求項1に記載の担体組成物。
- 前記電子移動剤のホスフェート化合物が、前記担体組成物の総濃度の0.01%w/w〜2%w/wの範囲内の量で存在する、請求項1に記載の担体組成物。
- 前記電子移動剤のホスフェート化合物が、前記担体組成物の総濃度の5%w/w〜10%w/wの範囲内の量で存在する、請求項1に記載の担体組成物。
- 前記電子移動剤のホスフェート化合物が、前記担体組成物の総濃度の10%w/w〜15%w/wの範囲内の量で存在する、請求項1に記載の担体組成物。
- 前記電子移動剤のホスフェート化合物が、前記担体組成物の総濃度の0.05%w/w、0.1%w/w又は1%w/wの量で存在する、請求項1に記載の担体組成物。
- 担体組成物の製造における、電子移動剤のホスフェート化合物及びエタノール、n−プロパノール、イソプロパノール、エチレングリコール、プロピレングリコール、ポリエチレングリコール及びジエチレングリコールモノエチルエーテルからなる群から選択される非環式アルコールの使用であって、ここで、前記非環式アルコールの濃度が、前記担体組成物の総濃度の60%w/w〜90%w/wの範囲内にある、前記使用。
- 請求項1に記載の担体組成物の調製方法であって、前記電子移動剤のホスフェート化合物と前記非環式アルコールを完全な均一化が達成されるまで混合するステップを含む、前記方法。
- 請求項1に記載の担体組成物及び生理活性化合物を含む製剤。
- 前記生理活性化合物が脂溶性であり、1〜5の範囲内のlogP値を有する、請求項22に記載の製剤。
- 前記生理活性化合物が、比較的低い分子質量及び/または比較的低い融点を有する、請求項22に記載の製剤。
- 前記生理活性化合物が、前記担体組成物の総濃度の30%w/w以下の量で存在する、請求項22に記載の製剤。
- 前記生理活性化合物が、リドカイン、ジクロフェナック、ケトロラック、プリロカイン、ハロベタゾール、ヒドロコルチゾール、及びそれらの組み合わせから成る群から選ばれる、請求項25に記載の製剤。
- 前記生理活性化合物が、前記担体組成物の総濃度の5%w/w以下の量で存在する、請求項26に記載の製剤。
- 生理活性化合物を請求項1に記載の担体組成物に添加するステップを含む、請求項22に記載の製剤の調製方法。
- 前記担体組成物とともに製剤化される生理活性化合物の送達の改善に用いるための、請求項1に記載の担体組成物。
- 生理活性化合物のA.D.M.E.特性の変更に用いるための、請求項1に記載の担体組成物。
- 対象における生理活性化合物のバイオアベイラビリティーの改善に用いるための、請求項1に記載の担体組成物。
- 病的状態に関してヒト以外の対象を治療するための方法であって、前記病的状態を治療する生理活性化合物の有効量を、それを必要とする対象に投与することを含み、ここで、前記生理活性化合物が請求項1に記載の担体組成物中に製剤化されている、前記方法。
- 病的状態に関して対象を治療するための製剤であって、前記病的状態を治療する生理活性化合物の有効量と請求項1に記載の担体組成物を含み、ここで、前記生理活性化合物が前記担体組成物中に製剤化されており、さらにここで、前記製剤がそれを必要とする対象に投与される、前記製剤。
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PCT/AU2010/001719 WO2011075775A1 (en) | 2009-12-23 | 2010-12-22 | Carrier composition |
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ES (1) | ES2643643T3 (ja) |
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EP2531047A4 (en) | 2010-02-05 | 2014-03-19 | Phosphagenics Ltd | CARRIER WITH AN UNINUTRALIZED TOCOPHERYL PHOSPHATE |
MX2012011355A (es) | 2010-03-30 | 2012-11-30 | Phosphagenics Ltd | Parche de suministro transdermico. |
US9561243B2 (en) | 2011-03-15 | 2017-02-07 | Phosphagenics Limited | Composition comprising non-neutralised tocol phosphate and a vitamin A compound |
JP6449554B2 (ja) * | 2014-03-30 | 2019-01-09 | 小林製薬株式会社 | 外用医薬組成物 |
CA3007587C (en) * | 2015-12-09 | 2023-12-05 | Phosphagenics Limited | Pharmaceutical formulation |
KR20190032265A (ko) * | 2015-12-09 | 2019-03-27 | 포스파제닉스 리미티드 | 약제학적 제형 |
WO2017143360A1 (en) * | 2016-02-18 | 2017-08-24 | Drabinsky Michael Earl | Treatment for microbial borne illness |
JP7198754B2 (ja) | 2016-12-21 | 2023-01-04 | アベーチョ バイオテクノロジー リミテッド | 方法 |
US12059486B2 (en) | 2021-01-13 | 2024-08-13 | Rodan &Fields, LLC | Cosmetic compositions |
KR20240068806A (ko) * | 2022-10-28 | 2024-05-20 | 주식회사 오가시스 | κ-오피오이드 수용체의 아고니스트를 포함하는 피부 미백용 조성물 |
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FR2657526B1 (fr) * | 1990-01-31 | 1994-10-28 | Lvmh Rech | Utilisation d'un phosphate d'alpha-tocopherol, ou de l'un de ses derives, pour la preparation de compositions cosmetiques, dermatologiques, ou pharmaceutiques; compositions ainsi obtenues. |
CA2426852C (en) * | 2000-11-14 | 2010-01-26 | Vital Health Sciences Pty Ltd | Formulation containing phosphate derivatives of electron transfer agents |
AUPR549901A0 (en) * | 2001-06-06 | 2001-07-12 | Vital Health Sciences Pty Ltd | Topical formulation containing tocopheryl phosphates |
US8008345B2 (en) * | 2001-07-27 | 2011-08-30 | Vital Health Sciences Pty. Ltd. | Dermal therapy using phosphate derivatives of electron transfer agents |
CA2466536C (en) * | 2001-12-13 | 2012-02-07 | Vital Health Sciences Pty Ltd | Transdermal transport of compounds |
AU2002950713A0 (en) * | 2002-08-09 | 2002-09-12 | Vital Health Sciences Pty Ltd | Carrier |
FR2846651B1 (fr) * | 2002-10-30 | 2006-06-16 | Rhodia Polyamide Intermediates | Procede de fabrication d'acides carboxyliques |
KR20050086954A (ko) * | 2003-01-17 | 2005-08-30 | 바이탈 헬스 사이언시즈 피티와이 리미티드 | 항증식성 화합물 |
CA2611831C (en) * | 2005-06-17 | 2014-09-16 | Vital Health Sciences Pty Ltd. | A carrier comprising one or more di and/or mono-(electron transfer agent) phosphate derivatives or complexes thereof |
RU2373957C2 (ru) * | 2006-10-13 | 2009-11-27 | Александр Метталинович Тишин | Носитель для лекарственных средств и биологически активных веществ для лечения и диагностики и применение его для создания лекарственных средств и способа регулируемой управляемой доставки лекарственного средства или биологически активного вещества с регулируемой десорбцией его |
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EP2516011A1 (en) | 2012-10-31 |
US20160331838A1 (en) | 2016-11-17 |
IL220490A0 (en) | 2012-08-30 |
WO2011075775A1 (en) | 2011-06-30 |
MX2012007412A (es) | 2012-07-17 |
CN102686279A (zh) | 2012-09-19 |
RU2577233C2 (ru) | 2016-03-10 |
JP2013515012A (ja) | 2013-05-02 |
ES2643643T3 (es) | 2017-11-23 |
NZ600773A (en) | 2014-04-30 |
BR112012015682A2 (pt) | 2019-09-24 |
KR20120107963A (ko) | 2012-10-04 |
US20120202780A1 (en) | 2012-08-09 |
AU2010336018A1 (en) | 2012-07-05 |
AU2010336018B2 (en) | 2015-10-01 |
CA2785242A1 (en) | 2011-06-30 |
CN102686279B (zh) | 2015-07-15 |
SG181808A1 (en) | 2012-07-30 |
EP2516011B1 (en) | 2017-07-12 |
ZA201204369B (en) | 2013-02-27 |
EP2516011A4 (en) | 2013-07-03 |
RU2012126143A (ru) | 2014-01-27 |
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