JP2013540737A - 難水溶性医薬及び化粧品有効成分のための過飽和送達媒体 - Google Patents
難水溶性医薬及び化粧品有効成分のための過飽和送達媒体 Download PDFInfo
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- JP2013540737A JP2013540737A JP2013528659A JP2013528659A JP2013540737A JP 2013540737 A JP2013540737 A JP 2013540737A JP 2013528659 A JP2013528659 A JP 2013528659A JP 2013528659 A JP2013528659 A JP 2013528659A JP 2013540737 A JP2013540737 A JP 2013540737A
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- 235000010384 tocopherol Nutrition 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
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- QKHROXOPRBWBDD-UHFFFAOYSA-N tribromometacresol Chemical compound CC1=C(Br)C=C(Br)C(O)=C1Br QKHROXOPRBWBDD-UHFFFAOYSA-N 0.000 description 1
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- LNPDTQAFDNKSHK-UHFFFAOYSA-N valdecoxib Chemical compound CC=1ON=C(C=2C=CC=CC=2)C=1C1=CC=C(S(N)(=O)=O)C=C1 LNPDTQAFDNKSHK-UHFFFAOYSA-N 0.000 description 1
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- 235000019158 vitamin B6 Nutrition 0.000 description 1
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Abstract
‐ 実質的に難水溶性の医薬又は化粧品有効成分;及び
‐ ナノ多孔性葉酸材料
を含み、ここで医薬有効成分が、粒子のナノ多孔性チャンネル内部に組み込まれる、医薬又は化粧品組成物に関する。
Description
‐ 実質的に難水溶性の医薬又は化粧品有効成分;及び
‐ ナノ多孔性葉酸材料
を含み、ここで医薬有効成分が、粒子のナノ多孔性チャンネル内部に組み込まれる。
すべての実質的に難水溶性の有効成分は、過飽和状態を得るためのナノ多孔性材料の使用に適している。これらの有効成分は、抗真菌剤、鎮痛剤、コレステロール吸収阻害剤、解熱剤、抗炎症剤、充血除去剤、抗ヒスタミン剤、抗レトロウィルス薬、及び抗がん剤、並びにこれらの化合物の誘導体が挙げられる。
過飽和は熱力学的に不安定な状態であり、そして沈殿のための駆動力である。腔内過飽和の生成をうまく利用するために、この状態は、沈殿を一時的に抑制することにより十分な経上皮輸送を可能にする期間、安定化しなければならない。さまざまな種類の賦形剤が、沈殿阻害剤として研究されてきた。
現在の文書において開示される医薬品有効成分は、水性媒体中に難溶性であるが、それらは、それらの様々な構造式により非常に異なった行動を取る。例えば、それらのいくつかは、水性媒体中でpH依存性の溶解度を有し、それらのいくつかは、極性溶媒に溶解でき、そしてそれらのいくつかは、非極性溶媒に溶解できる。従って、本発明は、それらの物理化学的性質に関係なく、様々な医薬有効成分のための汎用的方法を提供する。
本発明による医薬又は化粧品製剤は、適切な充填剤、結合剤、崩壊剤、滑沢剤、流動促進剤、膨潤性浸食親水性物質(swellable erodible hydrophilic material)、不溶性食用材料、矯味剤、及び臭気マスキング剤などの従来の医薬補助物質をさらなる成分として、さらに含んでもよい。
本発明は、上記のような特定の臨界直径(d*)未満である本発明のナノ多孔性材料の細孔径に起因する結晶化の抑制モデルと矛盾しない。表面エネルギー及び熱力学的考察の両方が、ナノ細孔内の医薬化合物の結晶化を抑制し、そして過飽和状態を実現する化合物の溶解性に関して全体的なエネルギー障壁を減少する。実現され得る放出の薬物動態速度は、使用される薬物化合物に依拠するヒグチモデル及び放出のベキ乗則モデルの両方と矛盾しない。
難溶性薬物のロード及び放出特性を試験するために、異なる細孔径を有する3つのナノ多孔性材料をモデルとして選択した。Ia3d立方晶構造を有するSTA‐11及びAMS‐6、並びに六方晶細孔構造を有するNFM‐1を、報告において適用し、そしてそれらのすべては、焼成されたサンプルである。
ナノ多孔性材料におけるATVのアモルファス状態を示すために、図3は、本発明におけるナノ多孔性材料内のATVのアモルファス性を示す1.5年の期間後に記録された、遊離アタザナビル(ATV)、STA‐11‐ATV、AMS‐6‐ATV、及びNFM‐1‐ATVの高角度(high angle)X線回折パターンを示す。
ダサチニブは、イマチニブ処置及びフィラデルフィア染色体陽性急性リンパ性白血病(Ph+ALL)の後の慢性骨髄性白血病(CML)患者での使用が承認された経口デュアルBCR/ABL及びSrcファミリーチロシンキナーゼ阻害剤である抗がん剤である。薬物は、水性媒体においてpH依存溶解性であり、そしてそれは、pH値が2.6である場合、最も大きな溶解性を有する。従って、2.6のpH値を有するグリシン/HCl緩衝液を、ダサチニブの組み込みのために適用する。この緩衝液は、毒性がなく、そして薬物よりもより少ない要求されるような吸着特性である。
ケトコナゾールは、薬効範囲が広い合成抗菌剤であり、そしてそれはまた、難水溶性薬物である。ケトコナゾールは、ダサチニブと非常によく似た溶解特性を有し、従って、ダサチニブと同じ組み込み方法をケトコナゾールに対して適用している。
プロトンポンプ(H+)阻害剤は、HIV薬物療法後の一般的な二次的影響である胸焼け及び胃痛の症状を処置するためにHIV患者に使用される。抗レトロウィルス薬物の生物学的利用能のこの減少の原因は、中性条件下での薬物の沈殿、及びその低下した溶解性によって引き起こされる。従って、ATVをH+‐阻害剤と一緒に同時投与した場合、高い生物学的利用能を維持できる製剤の開発が、患者の安心及びHIV患者の処置の有効性の大幅な向上につながる可能性がある。以下の実施例では、薬物を特許請求の範囲において開示されたようなさまざまなナノ多孔性シリカ材料中に、簡単な方法を介して封入する場合、本発明が、過飽和の医薬活性ATVの溶出速度の加速度及び安定性を通じて、この問題にどのように対処するかを示す。
メソ多孔性シリカ材料として、Ia3d立方晶細孔構造、及び小さな細孔径(約4nm平均)を有するAMS‐6を、本実施例では選択した。ロードの前に、内側/外側表面の疎水性を増加するために、AMS‐6を熱処理した。10gの焼成AMS‐6をオーブンに置き、そして600℃で12時間の間加熱した。
Claims (17)
- 医薬又は化粧品組成物であって、以下:
実質的に難水溶性の医薬有効成分;及び
ナノ多孔性葉酸材料
を含み、ここで前記医薬有効成分が、粒子のナノ多孔性チャンネル内部に組み込まれる、組成物。 - 前記実質的に難水溶性の医薬有効成分が、抗真菌剤、鎮痛剤、コレステロール吸収阻害剤、解熱剤、抗炎症剤、充血除去剤、抗ヒスタミン剤、抗レトロウィルス薬、及び抗がん剤の群から選択される一つ以上の種類からなる、請求項1に記載の組成物。
- 前記実質的に難水溶性の化粧品有効成分が、脂溶性ビタミン及びプロビタミン、並びに安定化ビタミン及び安定化プロビタミンの群から選択される一つ以上からなる、請求項1に記載の組成物。
- 前記難水溶性の医薬又は化粧品有効成分が、ナノ多孔性材料の全重量の約0.1重量%〜90重量%、及び好ましくは15〜55重量%の間で存在する、請求項1〜3のいずれか一項に記載の組成物。
- 前記難水溶性の化合物が、25℃で水に10g/L未満、及び好ましくは1g/L未満の溶解性を有し、又は2超の分配定数を有する、若しくはリピンスキーのルール オブ ファイブ(Lipinski’s rule of five)の少なくとも一つを破る有効成分である、請求項1〜4のいずれか一項に記載の組成物。
- 前記ナノ多孔性材料の粒子径が、50nm〜100μmの間の範囲である、請求項1〜5のいずれか一項に記載の組成物。
- 前記ナノ多孔性材料の細孔径が、1nm〜50nmである、請求項1〜6のいずれか一項に記載の組成物。
- 前記ナノ多孔性材料の細孔容積が、0.2cm3/g〜2cm3/gである、請求項1〜7のいずれか一項に記載の組成物。
- 製剤中の前記ナノ多孔性材料の全重量の0.1wt%〜50wt%の範囲で存在する沈殿阻害剤をさらに含む、請求項1〜8のいずれか一項に記載の組成物。
- 前記実質的に難水溶性の医薬有効成分が、前記製剤中の全ナノ多孔性材料の1〜50wt%の間の濃度で、オメプラゾール、ランソプラゾール、デクスランソプラゾール、エソメプラゾール、パントプラゾール、ラベプラゾール、及びレバプラザンの群のプロトンポンプ阻害剤を含む、請求項1〜9のいずれか一項に記載の組成物。
- 前記実質的に難水溶性の医薬有効成分が、アタザナビル(Atazanivir)及び/又はその重硫酸塩アナログである、請求項1〜10のいずれか一項に記載の組成物。
- 前記ナノ多孔性組成物を有しない医薬又は化粧品組成物と比較して、水における溶解性の向上を有する請求項1〜11のいずれか一項に記載の医薬又は化粧品組成物を含む過飽和送達システム。
- 前記ナノ多孔性組成物を有しない医薬又は化粧品組成物と比較して、安定性の向上を有する請求項1〜11のいずれか一項に記載の医薬又は化粧品組成物を含む過飽和送達システム。
- 前記ナノ多孔性組成物を有しない医薬組成物と比較して、pH1.8〜8で好ましくは2〜100倍高い、インビボ生物学的利用能の向上を有する請求項1〜11のいずれか一項に記載の医薬又は化粧品組成物を含む過飽和送達システム。
- 請求項1〜11のいずれか一項に記載の医薬又は化粧品組成物の調製方法であって、湿式含浸(wet impregnation)技術、ロータリーエバポレーション技術、共噴霧乾燥(co‐spray drying)技術、又は凍結乾燥技術を含む、方法。
- 前記湿式含浸技術が、前記医薬又は化粧品有効成分の溶液にナノ多孔性材料の量を添加し、及び溶媒の蒸発の際の毛細管現象を介して、ナノ細孔中に前記有効成分を閉じ込めた前記ナノ多孔性材料を作製することを含む、請求項15に記載の方法。
- 前記共噴霧乾燥技術が、エタノール、メタノール、及びアセトンなどの有機溶媒中、一般に、C1〜C6アルカノール、ケトン、エステル、エーテル、脂肪族炭化水素、芳香族炭化水素、ハロゲン化溶媒、脂環式溶媒、芳香族複素環溶媒、及びそれらの混合物を含む適切な溶媒又は共溶媒中に、難水溶性の医薬又は化粧品有効成分を溶解することを含む、請求項15に記載の方法。
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