JP2012523427A - 薬物送達組成物 - Google Patents
薬物送達組成物 Download PDFInfo
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Abstract
Description
本出願は米国特許法119条(e)項に基づき米国仮出願No.61/168040、2009年4月9日の利益を主張し、その開示は、引用により全体として本明細書に取り込まれる。
実施例1
本発明による中性の化合物の典型的な薬物送達組成物は以下を含み:
実施例2は可溶化剤を含む薬物送達組成物と、可溶化剤を含まない薬物送達組成物と、及び可溶化剤、又は、半透性被膜のないナノ微粒子型の薬物の投与処方との間の比較である。
実施例3は本発明の薬物送達組成物の医薬タクロリムス処方対ナノ微粒子タクロリムス処方の薬物動態比較を示す。
実施例4は、例えば、商業的に利用可能である速放性のクロザピン錠剤等のクロザピン対照処方と比較した際の弱塩基性の化合物、クロザピン、及び、pH調節剤を含む典型的な薬物送達組成物を用いた液体環境での溶解薬物量を示す。
本発明の薬物送達組成物をサポートするための診断処方モデルシステムが確立された。このモデルシステムは、半透性膜と、医薬粒子と、可溶化剤とを包含した。前記モデルシステムは、本発明の薬物送達組成物をサポートするのに必要とされるかもしれない、広くさまざまな処方変数及び異なるインビトロ放出調節実験に対処する柔軟性を提供するために多数の特徴を伴って設計された。
本実施例では、塩基性薬物、カルベジロール、及び、適切な弱酸性のpH調節剤を含む実施例5によるモデルシステムが検討された。図6は溶解時間に対するmlあたりの溶解mg量のプロフィールプロットを示す。
本実施例では、弱酸性薬物であるボリノスタット及び弱塩基pH調節剤を利用する実施例5による代替システムが検討された。図7は溶解時間に対するmlあたりの溶解mg量の溶解プロフィールプロットを示す。
110: 不活性物質
120: 溶解剤層
130: ナノ微粒子クロザピン層
135: 溶解中のクロザピン粒子
140: 半透性被膜
142: 細孔
210: 液体
220: 溶解剤で溶解されたクロザピン
225: 矢印で示されている浸透圧で促進された対流及び/又は受動拡散のクロザピンの流れ
Claims (20)
- 半透性被膜と、医薬粒子と、可溶化剤とを含む組成物であって、前記医薬粒子は、約2μm又はそれ未満の有効平均粒径を有し、医薬粒子の表面に表面安定化剤が吸着されていることを特徴とする、組成物。
- 前記半透性被膜は、微多孔制御被膜と、水膨潤性被膜と、それらの混合物及び組み合わせとからなる群から選択されることを特徴とする、請求項1に記載の組成物。
- 前記半透性被膜は、使用環境において不溶性のポリマーと、前記使用環境において溶解性の細孔形成添加剤とを含む微多孔制御被膜であることを特徴とする、請求項1に記載の組成物。
- 前記ポリマーは、セルロース系ポリマー類と、メタクリル酸類と、フタル酸エステル類とからなる群から選択されること、及び、前記細孔形成添加剤が、HPMCと、PVPと、多価アルコール類と、糖類とからなる群から選択されることを特徴とする、請求項3に記載の組成物。
- 前記微多孔制御被膜中の前記細孔形成添加剤の重量あたり百分率は、0.5%、1.0%、1.5%、2.0%、2.5%、3.0%、3.5%、4%、4.5%、5%、6%、7%、8%、9%、10%、12%、13%、15%、17%、19%、21%、22%、24%、26%、28%、30%、32%、34%、36%、38%、41%、43%、45%、47%、49%、及び、50%からなる群から選択されることを特徴とする、請求項3に記載の組成物。
- 前記医薬は、人工妊娠中絶剤、ACE阻害剤、α−及びβ−アドレナリン作動剤、α−及びβ−アドレナリン遮断剤、副腎皮質抑制剤、副腎皮質刺激ホルモン、嫌酒剤、アルドース還元酵素阻害剤、アルドステロン拮抗剤、蛋白同化剤、鎮痛剤(麻薬性及び非麻薬性鎮痛剤を含む)、アンドロゲン、アンギオテンシンII受容体拮抗剤、食欲抑制剤、制酸剤、駆虫剤、抗アクネ剤、抗アレルギー剤、抗脱毛症剤、抗アメーバ剤、抗アンドロゲン剤、抗狭心症剤、抗不整脈剤、抗動脈硬化剤、抗関節炎/抗リウマチ剤、抗喘息剤、抗菌剤、抗菌補助剤、抗コリン剤、抗凝固剤、抗けいれん剤、抗うつ剤、抗糖尿病剤、止瀉剤、抗利尿剤、解毒剤、抗ジスキネジア剤、抗湿疹剤、制吐剤、抗エストロゲン剤、抗線維化剤、抗鼓腸剤、抗真菌剤、抗緑内障剤、抗ゴナドトロピン剤、抗痛風剤、抗ヒスタミン剤、抗多動性剤、抗高脂血症剤、抗高リン血症剤、抗高血圧剤、抗甲状腺剤、昇圧剤、抗甲状腺機能低下剤、抗炎症剤、抗マラリア剤、抗躁剤、抗メトヘモグロビン血症剤、抗片頭痛剤、抗ムスカリン剤、抗マイコバクテリア剤、抗新生物剤及び補助剤、抗好中球減少剤、抗骨粗しょう症剤、抗ページェット病剤、抗パーキンソン病剤、抗褐色細胞腫剤、抗ニューモシスティス剤、抗前立腺肥大症剤、抗原虫剤、鎮痒剤、抗乾癬剤、抗精神病剤、解熱剤、抗リケッチア剤、抗脂漏剤、消毒剤/殺菌剤、鎮痙剤、駆梅剤、抗血小板血症剤、抗血栓剤、鎮咳剤、抗潰瘍剤、抗尿結石症剤、抗蛇毒素、抗ウイルス剤、抗不安剤、アロマターゼ阻害剤、収斂剤、ベンゾジアゼピン拮抗剤、骨吸収阻害剤、抗徐脈剤、ブラジキニン拮抗剤、気管支拡張剤、カルシウムチャンネル遮断剤、カルシウム調節剤、炭酸脱水酵素阻害剤、強心剤、CCK拮抗剤、キレート剤、胆石溶解剤、利胆剤、コリン作動剤、コリンエステラーゼ阻害剤、コリンエステラーゼ再活性化剤、中枢神経刺激剤、避妊剤、COX−I及びCOX−II阻害剤、清拭剤、うっ血除去剤、脱色剤、疱疹状皮膚炎抑制剤、消化補助剤、利尿剤、ドパミン受容体作動剤、ドパミン受容体拮抗剤、外部寄生生物撲滅剤、催吐剤、エンケファリナーゼ阻害剤、酵素、酵素補因子、エストロゲン、去痰剤、フィブリノーゲン受容体拮抗剤、フッ素サプリメント、胃及び膵臓分泌刺激剤、胃細胞保護剤、胃プロトンポンプ阻害剤、胃分泌阻害剤、胃腸管運動促進剤、グルココルチコイド、α‐グルコシダーゼ阻害剤、性腺刺激因子、成長ホルモン阻害剤、成長ホルモン放出因子、成長刺激物質、造血剤(hematinics)、造血剤(hematopoietics)、溶血剤、止血剤、ヘパリン拮抗剤、肝酵素誘発剤、肝保護剤、ヒスタミンH2受容体拮抗剤、HIVプロテアーゼ阻害剤、HMGCoAレダクターゼ阻害剤、免疫調節剤、免疫抑制剤、インスリン増感剤、イオン交換樹脂、角質溶解剤、乳汁分泌刺激ホルモン、緩下剤/下剤、ロイコトリエン拮抗剤、LH−RH作動剤、脂肪作用剤、5−リポキシゲナーゼ阻害剤、エリテマトーデス抑制剤、マトリクスメタロプロテイナーゼ阻害剤、鉱質コルチコイド、縮瞳剤、モノアミンオキシダーゼ阻害剤、粘液溶解剤、筋弛緩剤、散瞳剤、麻剤拮抗剤、神経保護剤、向知性剤、非ステロイド性抗炎症剤、卵巣ホルモン、分娩誘発剤、ペプシン阻害剤、色素沈着物質、血漿容積膨張剤、カリウムチャンネル活性化剤/オープナー、プロゲストゲン、プロラクチン阻害剤、プロスタグランジン、プロテアーゼ阻害剤、放射医剤品、5α−レダクターゼ阻害剤、呼吸刺激剤、逆転写酵素阻害剤、鎮静剤/催眠剤、抗攻撃性剤、セロトニンノルアドレナリン再取込阻害剤、セロトニン受容体作動剤、セロトニン受容体拮抗剤、セロトニン取込阻害剤、ソマトスタチン類似体、血栓溶解剤、トロンボキサンA2受容体拮抗剤、甲状腺ホルモン、甲状腺刺激ホルモン、子宮収縮抑制剤、トポイソメラーゼI及びII阻害剤、尿酸排泄促進剤、血管拡張剤及び血管収縮剤を含む血管調節剤、血管保護剤、キサンチンオキシダーゼ阻害剤からなる群から選択される医薬の分類から選択されることを特徴とする、請求項1に記載の組成物。
- 前記医薬は、使用環境において難溶性であることを特徴とする、請求項1に記載の組成物。
- 前記有効平均粒径は、約1900nm又はそれ未満、約1800nm又はそれ未満、約1700nm又はそれ未満、約1600nm又はそれ未満、約1500nm又はそれ未満、約1400nm又はそれ未満、約1300nm又はそれ未満、約1200nm又はそれ未満、約1100nm又はそれ未満、約1000nm(1μm)又はそれ未満、約900nm又はそれ未満、約800nm又はそれ未満、約700nm又はそれ未満、約600nm又はそれ未満、約500nm又はそれ未満、約400nm又はそれ未満、約300nm又はそれ未満、約200nm又はそれ未満、約150nm又はそれ未満、約100nm又はそれ未満、約75nm又はそれ未満、及び、約50nm又はそれ未満からなる群から選択されることを特徴とする、請求項1に記載の組成物。
- 前記医薬粒子のD90が、約5000nm又はそれ未満、4900nm又はそれ未満、約4800nm又はそれ未満、約4700nm又はそれ未満、約4600nm又はそれ未満、約4500nm又はそれ未満、約4400nm又はそれ未満、約4300nm又はそれ未満、約4200nm又はそれ未満、約4100nm又はそれ未満、約3000nm又はそれ未満、約3900nm又はそれ未満、約3800nm又はそれ未満、約3700nm又はそれ未満、約3600nm又はそれ未満、約3500nm又はそれ未満、約3400nm又はそれ未満、約3300nm又はそれ未満、約3200nm又はそれ未満、約3100nm又はそれ未満、約3000nm又はそれ未満、約2900nm又はそれ未満、約2800nm又はそれ未満、約2700nm又はそれ未満、約2600nm又はそれ未満、約2500nm又はそれ未満、約2400nm又はそれ未満、約2300nm又はそれ未満、約2200nm又はそれ未満、約2150nm又はそれ未満、約2100nm又はそれ未満、約2075nm又はそれ未満、及び、約2000nm又はそれ未満からなる群から選択されることを特徴とする、請求項1に記載の組成物。
- 前記表面安定化剤は、ヒドロキシプロピルメチルセルロース(HPMC)と、スルホコハク酸ジオクチルナトリウム(DOSS)と、ラウリル硫酸ナトリウム(SLS)と、ヒドロキシプロピルセルロースと、ポリビニルピロリドンと、デオキシコール酸ナトリウムと、エチレンオキシド及び酸化プロピレンに基づくブロック共重合体類と、ビニルピロリドン及び酢酸ビニルの共重合体類と、レシチンと、ポリオキシエチレンソルビタン脂肪酸エステル類と、アルブミンと、リゾチームと、ゼラチンと、マクロゴール15ヒドロキシステアリン酸と、チロキサポールと、ポリエトキシル化ヒマシ油とからなる群から選択されることを特徴とする、請求項1に記載の組成物。
- 前記可溶化剤は、使用環境への前記医薬の送達前に、前記組成物内の前記医薬粒子を溶解するのに十分な種類と量が存在することを特徴とする、請求項1に記載の組成物。
- 前記可溶化剤は、界面活性剤、又は、pH調節剤であることを特徴とする、請求項11に記載の組成物。
- 前記界面活性剤は、陰イオン性、陽イオン性、両イオン性、及び、非イオン性界面活性剤からなる群から選択されることを特徴とする、請求項11に記載の組成物。
- 前記可溶化剤はpH調節剤であり、前記使用環境の液体へ曝露されるときに、前記医薬の電離型に好ましいように前記組成物内のpH環境を調節することを特徴とする、請求項12に記載の組成物。
- 前記可溶化剤は、弱酸又は弱塩基から選択されるpH調節剤であることを特徴とする、請求項12に記載の組成物。
- 前記弱酸は、アジピン酸と、アスコルビン酸と、クエン酸と、フマル酸と、没食子酸と、グルタル酸と、乳酸と、リンゴ酸と、マイレン酸と、コハク酸と、酒石酸と、これらの混合物及び組み合わせとからなる群から選択されることを特徴とする、請求項15に記載の組成物。
- 前記弱塩基は、アルギニン、リジン、トロメタミン(TRIS)、メグルミン、ジエタノールアミン、及び、トリエタノールアミンと、薬学的に許容可能な弱酸類との共役塩基類と、それらの混合物及び組み合わせとからなる群から選択されることを特徴とする、請求項15に記載の組成物。
- 前記薬学的に許容可能な弱酸との共役塩基類は、炭酸ナトリウム、リン酸ナトリウム、リン酸カルシウム、クエン酸三ナトリウム、及び、アスコルビン酸ナトリウムと、それらの混合物又は組み合わせとからなる群から選択されることを特徴とする、請求項17に記載の組成物。
- 前記薬物送達組成物は、使用環境における前記医薬の本来の溶解度によって定義されるよりも高い濃度で医薬の溶液を使用環境へ送達することを特徴とする、請求項1に記載の組成物。
- 前記濃度が、使用環境における医薬の本来の溶解度によって定義されるよりも、5%、10%、20%、30%、40%、50%、60%、70%、80%、90%、100%、110%、120%、130%、140%、150%、160%、170%、180%、190%、200%、210%、220%、230%、240%、250%、260%、270%、280%、290%、300%、310%、320%、330%、340%、350%、360%、370%、380%、390%、400%、410%、420%、430%、440%、450%、460%、470%、480%、490%、500%、510%、520%、530%、540%、550%、560%、570%、580%、590%、600%、700%、800%、又は、1000%高いことを特徴とする、請求項19に記載の組成物。
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