JP2007535537A - プロスタミド含有生分解性眼内インプラント - Google Patents
プロスタミド含有生分解性眼内インプラント Download PDFInfo
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Abstract
Description
本発明の説明のために、用語の文脈が異なる意味を示す場合を除いて、このセクションで定義されるように以下の用語を使用する。
Aは、2〜6個の炭素原子を有するアルキレンまたはアルケニレン基であり、該基は、1つ以上のオキシド基により中断されていてよく、また1つ以上のヒドロキシ、オキソ、アルキルオキシまたはアルキルカルボキシ基(ここで、アルキル基は1〜6個の炭素原子を有する。)で置換されていてよい。
Bは、3〜7個の炭素原子を有するシクロアルキル基、または4〜10個の炭素原子を有するヒドロカルビルアリールおよびヘテロアリール基(ここで、ヘテロ原子は、窒素、酸素および硫黄原子からなる群から選択される。)からなる群から選択されるアリール基である。
Xは、−OR4および−N(R4)2(ここで、R4は、水素原子、1〜6個の炭素原子を有する低級アルキル基からなる群から選択される基である。)、式:
Zは、=Oまたは2つの水素原子である。
R1およびR2の一方は、=O、−Oまたは−O(CO)R6であり、他方は、−OHまたは−O(CO)R6であるか、若しくはR1が=Oであり、R2が水素原子である(ここで、R6は、1〜約20個の炭素原子を有する置換または未置換非環式炭化水素基、または−(CH2)mR7(この式中、mは0または1〜10の整数であり、R7は3〜7個の炭素原子を有するシクロアルキル基または先に定義したヒドロカルビルアリールまたはヘテロアリール基もしくはそれらの医薬的に許容される塩である。)で示される基である。)。
ただし、Bが側鎖へテロ原子含有基で置換されておらず、Zが=Oである場合、Xは−OR4ではない。]
で示される化合物を含む。
Yは、アルキル、ハロ、ニトロ、アミノ、チオール、ヒドロキシ、アルキルオキシ、アルキルカルボキシおよびハロ置換アルキル(該アルキル基は1〜6個の炭素原子を有する。)である。
nは、0または1〜3の整数である。
R3は、=O、−OHまたは−O(CO)R6である。]
で示される。
で示され、その例は、式(V):
非滲出性老化関連黄斑変性(ARMD)、滲出性老化関連黄斑変性(ARMD)、脈絡膜新生血管形成、糖尿病性網膜症、急性斑状視神経網膜疾患、中心性漿液性脈絡網膜症、類嚢胞黄斑浮腫、糖尿病性黄斑浮腫。
急性多発性斑状色素上皮症、ベーチェット病、バードショット(Birdshot)網膜脈絡膜症、感染症(梅毒、ライム病、結核、トキソプラズマ症)、中間部ブドウ膜炎(扁平部炎)、多病巣性脈絡膜炎、多発性一過性白点症候群(Multiple Evanescent White Dot Syndrome)(MEWDS)、眼類肉腫症、後強膜炎、ほ行性脈絡膜炎、網膜下線維症およびブドウ膜炎症候群、フォークト−コヤナギ−ハラダ(VKH)症候群。
コーツ病、傍中心窩(parafoveal)毛細管拡張症、乳頭静脈炎、霜状分岐血管炎、鎌状赤血球網膜症および他の異常ヘモグロビン症、網膜色素線条症、家族性滲出性硝子体網膜症。
交感神経性眼炎、ブドウ膜炎網膜疾患、網膜剥離、外傷、レーザー、PDT、光凝固、手術時低灌流、放射線性網膜症、骨髄移植性網膜症。
増殖性硝子体網膜症および網膜上膜、増殖性糖尿病性網膜症。
眼ヒストプラスマ症候群、眼トキソカラ症、推定眼ヒストプラスマ症候群(POHS)、眼内炎、トキソプラスマ症、HIV感染関連網膜疾患、HIV感染関連脈絡膜疾患、HIV感染関連ブドウ膜炎疾患、ウイルス性網膜炎、急性網膜壊死、進行性外網膜壊死、真菌性網膜疾患、眼梅毒、眼結核、広汎性片側性亜急性視神経網膜炎、ハエウジ病。
網膜ジストロフィー関連全身性疾患、先天性停在夜盲症、錐体ジストロフィー、黄色斑眼底、ベスト病、網膜色素上皮のパターンジストロフィー(Pattern Dystrophy of the Retinal Pigmented Epithelium)、X染色体性網膜分離、ソーズビー眼底ジストロフィー、良性同心性黄斑症、ビエッティ結晶性ジストロフィー(Bietti's Crystalline Dystrophy)、弾性線維性仮性黄色腫。
網膜剥離、斑状円孔、巨大網膜断裂。
腫瘍、RPEの先天性肥大、後部ブドウ膜黒色腫、脈絡膜血管腫、脈絡膜骨腫、脈絡膜転移、網膜および網膜色素上皮の複合過誤腫、網膜芽細胞腫、眼底の血管増殖性腫瘍、網膜星状細胞腫、眼内リンパ系腫瘍。
点状内脈絡膜症、急性後多発性斑状色素上皮症、近視性網膜変性、急性網膜色素上皮炎等。
生分解性インプラントは、ビマトプロストを生分解性ポリマー組成物と組み合わせることにより製造した。800mgのポリ乳酸(PLA)を、200mgのビマトプロストと組み合わせた。組み合わせ物を25mLのジクロロメタンに溶解した。混合物を、45℃で減圧下に一夜置き、ジクロロメタンを蒸発させた。生成した混合物は、キャストシート形状であった。キャストシートを切り出し、ドライアイスを用いた高剪断グラインダーにより、粒子が約125μmの孔径を有する篩を通過することができるまで、粉砕した。微粒子中に存在するビマトプロストの割合は、高圧液体クロマトグラフィ(HPLC)を用いて分析した。微粒子からのビマトプロストの放出割合は、透析を使用して記録した。回収した粒子中に残存しているビマトプロストの割合は、HPLCにより分析した。
ビマトプロストを、乳鉢中で、生分解性ポリマー組成物と組み合わせる。その組み合せ物を、96RPMに設定したシェーカーで15分間混合する。粉末ブレンドを、乳鉢の壁からこすり取り、次に、さらに15分間再混合する。混合した粉末ブレンドを、所定の温度で合計30分間にわたって半溶融状態に加熱し、ポリマー/薬剤メルトを形成する。
両眼に緑内障を患っている72歳の女性のそれぞれの眼に、ビマトプロストおよびPLA/PLGAの組み合わせを含む眼内インプラントを入れる。インプラントは、約1mgであり、500mgのビマトプロストを含む。1つのインプラントを、注射器により、それぞれの眼の硝子体に配置する。約2日後、患者は、眼の状態が実質的に改善されたことを報告する。検査によれば、眼圧が低下し、午前8時00分に測定した平均眼圧は、28mmHgから14.3mmHgに低下している。患者を、約6ヶ月にわたり毎月観察する。眼圧水準は、6ヶ月間、15mmHg未満に維持され、患者は、眼の不快感が少なくなったと報告する。
62歳の男性は、左眼の眼圧が33mmHgである。左眼の硝子体に、400mgのビマトプロストおよび600mgのPLAを含むインプラントを、トロカールにより挿入する。患者の眼圧を、1週間にわたり毎日、その後は毎月、観察する。移植から1日後、眼圧は18mmHgに低下する。移植から7日目まで、眼圧は、14mmHgで比較的安定している。患者は、2年間、眼圧上昇の徴候を経験しない。
Claims (48)
- プロスタミド成分、およびインプラントを眼に配置してから少なくとも約1週間、治療有効量のプロスタミド成分の放出を持続させるのに有効な速度で薬剤を放出する生分解性ポリマーマトリックスを含んでなる、生分解性眼内インプラント。
- プロスタミド成分が、単一タイプのプロスタミド誘導体を含む請求項1に記載のインプラント。
- プロスタミド成分が、ビマトプロスト、その塩およびそれらの混合物からなる群から選択されるプロスタミド誘導体である請求項1に記載のインプラント。
- プロスタミド成分が、ビマトプロストから本質的になる請求項1に記載のインプラント。
- プロスタミド成分が、2種以上の異なるプロスタミド誘導体を含む請求項1に記載のインプラント。
- プロスタミド成分が、ビマトプロストとラタノプロストの組み合わせを含む請求項5に記載のインプラント。
- プロスタミド成分が、ビマトプロストとトラバプロストの組み合わせを含む請求項5に記載のインプラント。
- プロスタミド成分が、ビマトプロストを含み、インプラントが、さらにβ−アドレナリン受容体拮抗剤を含む請求項1に記載のインプラント。
- β−アドレナリン受容体拮抗剤が、チモロールである請求項8に記載のインプラント。
- プロスタミド成分が、ビマトプロストを含み、インプラントが、さらに炭酸脱水素酵素阻害剤を含む請求項1に記載のインプラント。
- 炭酸脱水素酵素阻害剤が、ドルゾラミドである請求項10に記載のインプラント。
- プロスタミド成分が、生分解性ポリマーマトリックス中に分散されている請求項1に記載のインプラント。
- プロスタミド成分が、インプラントの約0.1〜約90重量%の量で供給されたビマトプロストを含む請求項1に記載のインプラント。
- プロスタミド成分が、式(I):
Aは、2〜6個の炭素原子を有するアルキレンまたはアルケニレン基であり、該基は、1つ以上のオキシド基により中断されていてよく、また1つ以上のヒドロキシ、オキソ、アルキルオキシまたはアルキルカルボキシ基(ここで、アルキル基は1〜6個の炭素原子を有する。)で置換されていてよい。
Bは、3〜7個の炭素原子を有するシクロアルキル基、または4〜10個の炭素原子を有するヒドロカルビルアリールおよびヘテロアリール基(ここで、ヘテロ原子は、窒素、酸素および硫黄原子からなる群から選択される。)からなる群から選択されるアリール基である。
Xは、−OR4および−N(R4)2(ここで、R4は、水素原子、1〜6個の炭素原子を有する低級アルキル基からなる群から選択される基である。)、式:
Zは、=Oまたは2つの水素原子である。
R1およびR2の一方は、=O、−Oまたは−O(CO)R6であり、他方は、−OHまたは−O(CO)R6であるか、若しくはR1が=Oであり、R2が水素原子である(ここで、R6は、1〜約20個の炭素原子を有する置換または未置換非環式炭化水素基、または−(CH2)mR7(この式中、mは0または1〜10の整数であり、R7は3〜7個の炭素原子を有するシクロアルキル基または先に定義したヒドロカルビルアリールまたはヘテロアリール基もしくはそれらの医薬的に許容される塩である。)で示される基である。)。
ただし、Bが側鎖へテロ原子含有基で置換されておらず、Zが=Oである場合、Xは−OR4ではない。]
で示される化合物である請求項1に記載のインプラント。 - マトリックスが、2種の異なる生分解性ポリマーの混合物を含み、各ポリマーは、ポリ乳酸、ポリグリコール酸、ポリラクチド−コ−グリコリド、それらの誘導体およびそれらの混合物からなる群から選択される請求項1に記載のインプラント。
- マトリックスが、2種の異なるポリ乳酸の混合物を含む請求項19に記載のインプラント。
- マトリックスが、ポリ乳酸とポリラクチド−コ−グリコリドの混合物を含む請求項19に記載のインプラント。
- マトリックスが、それぞれ異なる固有粘度を有する異なる生分解性ポリマーの混合物を含む請求項1に記載のインプラント。
- マトリックスが、それぞれ異なる分子量を有する異なる生分解性ポリマーの混合物を含む請求項1に記載のインプラント。
- マトリックスが、インプラントを眼の硝子体に配置した時点から1ヶ月を超える期間、インプラントからのプロスタミド成分の放出を持続させるのに有効な速度で薬剤を放出する請求項1に記載のインプラント。
- プロスタミド成分がビマトプロストであり、マトリックスが、約3ヶ月の期間、治療有効量のビマトプロストの放出を持続させるのに有効な速度で薬剤を放出する請求項1に記載のインプラント。
- プロスタミド成分の治療有効量が、インプラントを配置した眼における房水の流出を刺激するのに有効な量である請求項1に記載のインプラント。
- さらに、プロスタグランジン類似体を含む請求項1に記載のインプラント。
- プロスタグランジン類似体が、ウノプロストンである請求項27に記載のインプラント。
- さらに、プロスタミド誘導体以外の眼圧低下剤を含む請求項1に記載のインプラント。
- インプラントが、眼の硝子体に配置されるように構成されている請求項1に記載のインプラント。
- 押出法により形成された請求項1に記載のインプラント。
- プロスタミド成分および生分解性ポリマー成分の混合物を押出して、インプラントを配置した眼へのインプラントからのプロスタミド成分の放出を持続させるのに有効な速度で薬剤を放出する生分解性物質を形成する工程を含んで成る生分解性眼内インプラントの製造方法。
- プロスタミド成分が、ビマトプロスト、その塩およびそれらの混合物からなる群から選択される少なくとも1種のプロスタミド誘導体である請求項32に記載の方法。
- プロスタミド成分が、ビマトプロストから本質的になる請求項32に記載の方法。
- 押出工程の前に、プロスタミン成分をポリマー成分と混合する工程をさらに含んで成る請求項32に記載の方法。
- プロスタミン成分およびポリマー成分が、粉末形態である請求項32に記載の方法。
- ポリマー成分が、2種の異なる生分解性ポリマーの混合物を含み、各ポリマーは、ポリ乳酸、ポリグリコール酸、ポリラクチド−コ−グリコリド、それらの誘導体およびそれらの混合物からなる群から選択される請求項32に記載の方法。
- ポリマー成分が、それぞれ異なる固有粘度を有する2種の異なる生分解性ポリマーの混合物を含む請求項32に記載の方法。
- 生分解性眼内インプラントを患者の眼に配置することによって、眼症状を治療するための生分解性眼内インプラントであって、該インプラントは、プロスタミド成分、および眼症状を防止または軽減するのに有効なプロスタミド成分を供給するためにインプラントからのプロスタミド成分の放出を持続させるのに有効な速度で薬剤を放出する生分解性ポリマーマトリックスを含んでなる、薬剤。
- 緑内障を治療するのに有効である請求項39に記載の薬剤。
- インプラントの眼への配置が眼における眼圧の低下に有効である請求項39に記載の薬剤。
- インプラントを眼の後部に配置する請求項39に記載の薬剤。
- トロカールを使用してインプラントを眼に配置する請求項39に記載の薬剤。
- 注射器を使用してインプラントを眼に配置する請求項39に記載の薬剤。
- プロスタミド成分に加えて、治療薬を患者に投与する請求項41に記載の薬剤。
- プロスタミド成分が、ビマトプロスト、その誘導体、その塩およびそれらの混合物からなる群から選択される少なくとも1種のプロスタミドである請求項39に記載の医薬。
- 眼へのインプラントの配置が房水の流出を増加するのに有効である請求項39に記載の医薬。
- プロスタミド成分の放出が、眼への配置後少なくとも2週間有効である請求項47に記載の医薬。
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