JP5982360B2 - 眼房内ビマトプロスト注入物による眼圧低下 - Google Patents
眼房内ビマトプロスト注入物による眼圧低下 Download PDFInfo
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- JP5982360B2 JP5982360B2 JP2013505123A JP2013505123A JP5982360B2 JP 5982360 B2 JP5982360 B2 JP 5982360B2 JP 2013505123 A JP2013505123 A JP 2013505123A JP 2013505123 A JP2013505123 A JP 2013505123A JP 5982360 B2 JP5982360 B2 JP 5982360B2
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- prostamide
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Description
本発明の目的に即して、以下に定義されているような用語が使われるが、その用語の文脈が別の意味を示唆する場合には、その定義に限定されない。
Aは2〜6個の炭素原子を有するアルキレン又はアルケニレン基であり、1つ以上のオキシド基が介在していてもよく、1つ以上のヒドロキシ、オキソ、アルコキシ、あるいはアルキルカルボキシ基で置換されていてもよく、該アルキル基は1〜6個の炭素原子を含んでおり;
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個の炭素原子を有し、ヘテロ原子が窒素、酸素及び硫黄原子から成る群から選択される、ハイドロカルビルアリール及びヘテロアリールから成る群から選択されるアリール基であり;
Xは−N(R4)2で、R4は水素と1〜6個の炭素原子を有する低級アルキル基から成る群から独立に選択され;
Zは=Oであり、R1及びR2のうちの1つは=O、−OHまたは−O(CO)R6基であり、他方が−OHまたは−O(CO)R6基であるか、あるいはR1が=Oで、R2がHであって、R6は1〜約20個の炭素原子を有する飽和または不飽和の非環式炭化水素基か、あるいは、−(CH2)mR7で、mは0〜10であり、R7が3〜7個の炭素原子を有するシクロアルキル基であるか、または上記のハイドロカルビルアリールかヘテロアリールである]
で示される化合物、あるいはその薬学的に許容される塩を含んでなる。
Resomer モノマー比率 個別dL/g
RG502 50:50ポリ (D,L−ラクチド−コ−グルコリド) 0.2
RG502H 50:50ポリ (D,L−ラクチド−コ−グルコリド) 0.2
RG503 50:50ポリ (D,L−ラクチド−コ−グルコリド) 0.4
RG504 0.5
RG505 0.7
RG506 0.8
RG752 75:25ポリ (D,L−ラクチド−コ−グルコリド) 0.2
RG755 75:25ポリ (D,L−ラクチド−コ−グルコリド) 0.6 (40000)
RG756 0.8
RG858 85:15ポリ (D,L−ラクチド−コ−グルコリド) 1.4
R202H ポリ(D,L−ラクチド) 0.3
R203 ポリ(D,L−ラクチド) 1.0 (40000)
R206 ポリ(D,L−ラクチド)、酸末端 0.2
R104 ポリ(D,L−ラクチド) (3500)
ビマトプロストを30%、R203Sを45%、R202Hを20%、PEG3350を5%を含むビマトプロスト注入物を総重量で900mg(薬剤負荷270ug)製造した。この注入物のイン・ビトロでの放出速度を図8に示す。この注入物は、最初に30日間に約70%を放出する。薬剤負荷が270ugの注入物は最初の30日間に189ug、あるいは1日あたり6.3ugを放出する。その注入物内の薬剤の残量(81ug)が次の4ヶ月間にわたり放出される(つまり、1日あたり675ng)。
正常なビーグル犬を通常の麻酔にかけ、3mm幅のナイフを右目の前房に挿入した。眼房内ビマトプロスト注入物をその前眼房に入れたところ、24時間以内に下角内に定着した。図5に示すように、IOPは基底レベルから約60%程度低下して、この状態が少なくとも5ヶ月間持続された(図5参照)。図4に示されているように、上強膜血管が拡張される。
ビマトプロストを20%、R203Sを45%、R202Hを10%、RG752Sを20%,PEG3350を5%を含むビマトプロスト注入物を総重量300ugあるいは600ug(薬剤負荷がそれぞれ60あるいは120ug)製造した。この注入物のイン・ビトロでの放出量を図9に示す。この注入物は最初の1ヶ月間にわたり薬剤負荷の約15%を放出する。60ug薬剤負荷の注入物は最初の30日間に9ug、あるいは1日当たり300ngを放出し、その後、60日間にわたり約50ug、あるいは1日当たり約700ngの放出を行う。実施例1の場合と同様、上強膜の血管の拡張が認められた。
以下の実験は、6匹のビーグル犬に以下で記載する注入物を挿入して行った。
注入物の処方:
アプリケータ内に長さ2mmのビマトプロスト注入物を入れたもの(20%ビマトプロスト、45%R203s、20%RG752s、10%R202H、5%PEG−3350)
アプリケータに長さ2mmの偽薬注入物を入れたもの(56.25%R203s、25%RG752s、12.25%R202H、6.25%PEG−3350)
イヌ1、2、3: API注入物眼房内OD(長さ2mmの注入物1個)、OS偽薬注入物
イヌ4、5、6: API注入物眼房内OD(長さ2mmの注入物2個)、OS偽薬注入物
外科的手順:注入物を25G UTW針を有する特注アプリケータに装填した。通常の麻酔をかけてから、正常なビーグル犬の前眼房に角膜経由で注入物を挿入して、傷を自然に治癒させた。アプリケータは米国特許出願第20080033351号に掲載されているものであり、参照によりその全体が本明細書に組み込まれる。
実験結果を図10及び11に示す。眼房内ビマトプロスト注入物によって、最大40%のIOP低下が認められ、2つの注入物を用いた例ではほとんどの時点でより大きな平均IOP低下が観察される。図6に示すように、この実施例3では、活性注入物を用いた動物では上強膜流出血管の拡張は認められたが、実施例1で用いられたより速く薬剤を放出する注入物で治療された動物と比較すると、その拡張量は低かった。
事前に装填したアプリケータを用いて、1回の投与時に4匹のイヌに注入物を投与した(なお、米国特許出願第20080033351号に開示されているBimato IC DDSはアミドを放出するだけである。図12と13に、注入物の投与量を変えた場合のPKが示されている。なお、用量反応はあり、特にICBでの優れた種はアミドである)。
Aは2〜6個の炭素原子を有するアルキレン又はアルケニレン基で、この基は1つ以上のオキシド基が介在していてもよく、1つ以上のヒドロキシ、オキソ、アルコキシ、あるいはアルキルカルボキシ基で置換されていてもよく、該アルキル基は1〜6個の炭素原子を含んでおり;
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個の炭素原子を有し、ヘテロ原子が窒素、酸素及び硫黄原子から成る群から選択される、ハイドロカルビルアリール及びヘテロアリールから成る群から選択されるアリール基であり;
Xは−N(R4)2で、R4は水素と1〜6個の炭素原子を有する低級アルキル基から成る群から独立に選択され;
Zは=Oであり、R1及びR2のうちの1つは=O、−OHあるいは−O(CO)R6基であり、他方が−OHあるいは−O(CO)R6基であるか、あるいはR1が=Oで、R2がHであって、R6は1〜約20個程度の炭素原子を有する飽和あるいは不飽和非環式炭化水素基か、あるいは、−(CH2)mR7で、mは0〜10であり、R7が3〜7個の炭素原子を有するシクロアルキル基であるか、または上記のハイドロカルビルアリールかヘテロアリールである]
で示される化合物、あるいはその薬学的に許容される塩を含んでいる。
Claims (12)
- 眼症状を治療するための眼内注入物であって、該注入物が、眼症状を予防あるいは緩和するのに有効な量のプロスタミドを放出する生物分解性ポリマーマトリクスと組み合わせて、プロスタミドを含有し、ここで、該眼症状が眼圧上昇であり、該注入物が眼房内の6時方向の位置に挿入されて、それによって対流を通じて前部領域全体にわたりプロスタミドがよく混合されて、シュレム管からの眼の流出経路を拡張することを特徴とする、眼内注入物。
- 前記注入物が上強膜及び結膜静脈叢の血管を拡張するために眼房内に入れられる、請求項1記載の眼内注入物。
- 前記注入物が眼の前眼房に入れられる、請求項1記載の眼内注入物。
- 前記注入物が眼の虹彩角膜角に入れられる、請求項1記載の眼内注入物。
- 前記注入物が眼球注入物送達装置を用いて眼に入れられる、請求項1〜4のいずれか一項に記載の眼内注入物であって、該眼球注入物送達装置が、(a)外壁と、近接端と、近接端開口部と、遠端と、遠端開口部と、その内部を通じて延びているルーメンを有するカニューラ;(b)眼内に挿入するのに適した寸法と構造を有しており、ルーメン内に配置される眼内注入物、および(c)遠端が閉鎖されており、上記カニューラの外壁と直接接触しており、カニューラの遠端及び遠端開口部を覆っており、カニューラが眼に入れられた際にそのカニューラの遠端及び遠端開口部が通過できるような構造になっているキャップを含んでなる、眼内注入物。
- 前記プロスタミドが化学式(1)
Aは2〜6個の炭素原子を有するアルキレン又はアルケニレン基であり、1つ以上のオキシド基が介在していてもよく、1つ以上のヒドロキシ、オキソ、アルコキシ、あるいはアルキルカルボキシ基で置換されていてもよく、該アルキル基は1〜6個の炭素原子を含んでおり;
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個の炭素原子を有し、ヘテロ原子が窒素、酸素及び硫黄原子から成る群から選択されるハイドロカルビルアリール及びヘテロアリールから成る群から選択されるアリール基であり;
Xは−N(R4)2で、R4は水素と1〜6個の炭素原子を有する低級アルキル基から成る群から独立に選択され;
Zは=Oであり、R1及びR2のうちの1つは=O、−OHあるいは−O(CO)R6基であり、他方が−OHあるいは−O(CO)R6基であるか、あるいはR1が=Oで、R2がHであって、R6は1〜20個の炭素原子を有する飽和または不飽和の非環式炭化水素基か、あるいは、−(CH2)mR7で、mは0〜10であり、R7が3〜7個の炭素原子を有するシクロアルキル基であるか、または前記ハイドロカルビルアリールまたはヘテロアリールである]
で示される化合物、あるいはその薬学的に許容される塩である、請求項1〜5のいずれか一項に記載の眼内注入物。 - 前記プロスタミドがビマトプロスト、その塩、及びその混合物を含む、請求項1〜7のいずれか一項に記載の眼内注入物。
- 眼圧が基底レベルから少なくとも60%低下する、請求項1〜8のいずれか一項に記載の眼内注入物。
- 眼圧が局所的なビマトプロストで得られるより大きく低下する、請求項1〜9のいずれか一項に記載の眼内注入物。
- プロスタミドの放出が眼に入れられてから少なくとも2週間は有効である、請求項1〜10のいずれか一項に記載の眼内注入物。
- プロスタミドを用いて、シュレム管からの眼の流出経路を拡張することによって、患者の眼の眼圧を低下させるための眼内注入物であって、前記注入物を眼房内の6時方向の位置に挿入することにより対流を通じて前部領域全体にわたりプロスタミドがよく混合されて、前記シュレム管からの眼の流出経路の拡張が生じることを特徴とする眼内注入物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US12/761,765 US8673341B2 (en) | 2004-04-30 | 2010-04-16 | Intraocular pressure reduction with intracameral bimatoprost implants |
US12/761,765 | 2010-04-16 | ||
PCT/US2011/032393 WO2011130462A2 (en) | 2010-04-16 | 2011-04-14 | Intraocular pressure reduction with intracameral bimatoprost implants |
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JP2016111665A Division JP6416154B2 (ja) | 2010-04-16 | 2016-06-03 | 眼房内ビマトプロスト注入物による眼圧低下 |
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