JP2011509264A - 結腸内での活性物質放出が強化された、コーティングされた医薬製剤もしくはニュートラシューティカル製剤 - Google Patents
結腸内での活性物質放出が強化された、コーティングされた医薬製剤もしくはニュートラシューティカル製剤 Download PDFInfo
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- A—HUMAN NECESSITIES
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- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
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Abstract
Description
a)医薬活性物質を含有するコアと、
b)コアを包囲する内側制御層であって、85〜98質量%のアクリル酸もしくはメタクリル酸のラジカル重合可能なC1〜C4アルキルエステルと、15〜2質量%のアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーとのコポリマーまたはコポリマーの混合物を含む内側制御層と、
c)外側制御層であって、75〜95質量%のアクリル酸もしくはメタクリル酸のラジカル重合可能なC1〜C4アルキルエステルと、5〜25質量%のアルキル基中にアニオン性基を有する(メタ)アクリレートモノマーとのコポリマーを含む外側制御層とを含む。
a)医薬活性物質を含むコアと、
b)コアを包囲する内側制御層であって、カチオン性基またはカチオン性基に変換することができる基を担持する複数の(メタ)アクリレートコポリマーのうちの1つまたはこれらの混合物を含む内側制御層と、
c)アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物を含む外側制御層と、
を含む医薬製剤もしくはニュートラシューティカル製剤中の内側制御層中にアニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物を組み込むことによって、低いpHでは遅延放出を示すが、中性のpHでは、消化器系の体液中での医薬活性物質もしくはニュートラシューティカル活性物質の放出速度が上昇し、結腸内で、短縮された時間内に活性物質の実質的に完全な放出をもたらす医薬製剤が得られることを発見した。
a)医薬活性物質もしくはニュートラシューティカル活性物質を含むコアと、
b)コアを包囲する内側制御層であって、
i)カチオン性基またはカチオン性基に変換することができる基を担持する複数の(メタ)アクリレートコポリマーのうちの1つまたはこれらの混合物と、
ii)アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物と、を含む内側制御層と、
c)アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物を含む外側制御層と、
を含む医薬製剤もしくはニュートラシューティカル製剤によって達成された。
最も単純な例では、コアは有効成分のみから構成されていてもよいが、典型的には、担体、例えばノンパレイユと、従来の医薬賦形剤、例えば結合剤、例えばセルロースおよびその誘導体、またはポリビニルピロリドン(PVP)、湿潤剤、崩壊促進剤、潤滑剤、デンプンおよびその誘導体、多糖類、可溶化剤などをさらに含む。場合によっては、コーティングされるコアとして、ゼラチンカプセルまたはHPMCカプセルを用いることもできる。
−医薬活性成分もしくはニュートラシューティカル活性成分(コアの質量に対して、97.5〜2.5質量%、好ましくは80〜5質量%の量)。
−場合によっては、医薬賦形剤(コアの質量に対して、0〜95質量%、好ましくは10〜50質量%の量)
−場合によっては、担体(コア質量中の比率0〜95質量%、好ましくは10〜60質量%)。
制御層(b)は、カチオン性基とカチオン性基に変換可能な基を有する(メタ)アクリレートコポリマーと、アニオン性基および/またはアニオン性基に変換可能な基を有するポリマーまたはコポリマーとの組み合わせを含有し、場合によっては従来の医薬賦形剤、例えば可塑剤、顔料、湿潤剤などを含有する。制御層(b)は、好ましくはコアを直接包み、コアとコーティング層との間にさらなる層は存在しない。特に、薬学的に許容されるポリマー、ワックス、樹脂、および/またはタンパク質を含むさらなる制御層は、コア(a)と制御層(b)との間に配置されない。制御コーティング(b)中のポリマーはフィルム形成性のものであり、このコーティングは、場合によっては存在する賦形剤と一緒にフィルムに変換されて、連続したコーティングまたはコーティングフィルムを形成する。内側制御層(b)は外側制御層(c)と一緒になって、全体として有効成分の放出を制御する。
本発明の一実施形態によると、成分i)によるコポリマーは、(メタ)アクリルコポリマーの質量に対して80〜98質量%の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、(メタ)アクリルコポリマーの質量に対して2〜20質量%のアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される(メタ)アクリレートコポリマーを含む。本発明の成分i)によるコポリマー中に含まれる、アルキル基中に4級アンモニウム基を含有する構造単位は、好ましくは、2−トリメチルアンモニウムエチルメタクリレートクロリドから誘導される。
‐(メタ)アクリルコポリマーの質量に対して93〜98質量%の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、(メタ)アクリルコポリマーの質量に対して2〜7質量%のアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される、混合物の総質量に対して40〜99質量%の(メタ)アクリレートコポリマーと、
‐(メタ)アクリルコポリマーの質量に対して85質量%以上93質量%未満の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、(メタ)アクリルコポリマーの質量に対して7質量%を上回り15質量%までのアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される、混合物の総質量に対して1〜60質量%の(メタ)アクリレートコポリマーと、
の混合物を含む。
さらに、制御層(b)は、成分ii)として、アニオン性基またはアニオン性基に変換可能な基を含有するポリマーまたはコポリマーを含み、これは好ましくは、カルボキシル官能性(メタ)アクリルポリマーまたはコポリマー、ならびにカルボキシル官能性多糖類およびその少なくとも部分的な中和の生成物から選択される。
20〜34質量%のメタクリル酸および/またはアクリル酸と、
20〜69質量%のメチルアクリレートと、
0〜40質量%のエチルアクリレートと、および/または適切な場合には、
0〜10質量%のビニル共重合が可能なさらなるモノマーと、
から構成されるコポリマーは、ISO 11357−2の下位条項3.3.3によるコポリマーのガラス転移温度が60℃以下であるという条件で適している。この(メタ)アクリレートコポリマーは、良好な破断点伸び特性を有するため、ペレットを圧縮して錠剤にするのに特に適している。
20〜33質量%のメタクリル酸および/またはアクリル酸と、
5〜30質量%のメチルアクリレートと、
20〜40質量%のエチルアクリレートと、
10質量%を上回り30質量%までのブチルメタクリレートと、適切な場合には、
0〜10質量%のビニル共重合が可能なさらなるモノマーと、
から構成され、モノマーの比率の合計が100質量%になるコポリマーは、ISO 11357−2の下位条項3.3.3によるコポリマーのガラス転移温度(融点Tmg)が55〜70℃であるという条件で適している。この種のコポリマーは、良好な機械的特性を有するため、ペレットを圧縮して錠剤にするのに特に適している。
20〜33質量%、好ましくは25〜32質量%、特に好ましくは28〜31質量%のメタクリル酸またはアクリル酸、好ましくはメタクリル酸と、
5〜30質量%、好ましくは10〜28質量%、特に好ましくは15〜25質量%のメチルアクリレートと、
20〜40質量%、好ましくは25〜35質量%、特に好ましくは18〜22質量%のエチルアクリレートと、
10質量%を上回り30質量%まで、好ましくは15〜25質量%、特に好ましくは18〜22質量%のブチルメタクリレートと、
のラジカル重合した単位から構成され、このモノマー組成は、コポリマーのガラス転移温度が55〜70°C、好ましくは59〜66°C、特に好ましくは60〜65°Cとなるように選定される。
外側制御層c)は、アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物を含む。
コアおよび/またはコーティングは、さらなる薬学的に有用な賦形剤を含んでもよい。さらなる添加剤は、具体的には加工助剤として、信頼でき、かつ再現可能な製造プロセスと、良好な長期保存安定性とを確保することを目的としている。これらはコーティングの透過性に影響を与えることができ、適切な場合には、付加的な制御パラメータとして用いることができる。上記に述べたように、医薬活性成分に加えてコア中に含まれうる医薬賦形剤は、例えば、結合剤、例えばセルロースおよびその誘導体、ポリビニルピロリドン(PVP)、ゼラチン、(メタ)アクリレート、デンプンおよびその誘導体、または糖類であってよい。
可塑剤は、具体的にはコーティング中またはコーティングの(メタ)アクリルコポリマー中に含まれてもよい。可塑剤として適した物質は、通常は、分子量100〜20,000を有し、分子中に、例えばヒドロキシル基、エステル基、またはアンモニウム基などの親水性基を1つまたは複数含む。これらはしばしば、室温で液体であるエステル類、例えばクエン酸エステル、フタル酸エステル、セバシン酸エステル、またはヒマシ油である。適切な可塑剤の例には、クエン酸アルキル、例えばクエン酸トリエチル、グリセロールエステル、フタル酸アルキル、セバシン酸アルキル、ショ糖エステル、ソルビタンエステル、セバシン酸ジエチル、セバシン酸ジブチル、および分子量4,000〜20,000のポリエチレングリコールがある。好適な可塑剤は、クエン酸トリエチルおよびクエン酸アセチルトリエチルである。可塑剤は、コーティングのポリマーに対して、例えば5〜25質量%の量で含まれていてよい。
通常は親油性を有するこれらの物質は、噴霧懸濁液に添加して、フィルムコーティング中にコアの凝集を防ぐことができる。例えば、タルク、シリカ、カオリン、ステアリン酸マグネシウム、またはステアリン酸カルシウム、あるいはHLB3〜8の非イオン性乳化剤、例えばモノステアリン酸グリセロールを使用することが可能である。使用する通常量は、コアの質量に対して0.5〜100質量%である。あるいは、粘着防止剤をコーティング中に、好ましくはコーティング中のポリマーの総質量に対して0.5〜100質量%の量で使用することもできる。
自体公知の方法で添加することができるさらなる薬学的に有用な賦形剤は、例えば、薬学的に許容される安定剤、着色剤、抗酸化剤、湿潤剤、細孔形成剤、顔料、光沢剤などである。
本発明の多層医薬剤形は、原則としていかなる医薬活性成分にも適している。使用する薬用物質は、例えばRote ListeまたはMerck Indexなどの参考資料に記載されている。
1.疾患、健康状態、身体的障害、または病的症状を治癒、緩和、予防、または診断するため、
2.健康状態、身体の状況もしくは機能、または精神状態を明らかにするため、
3.ヒトまたは動物の身体により生成された活性物質または体液を置換するため、
4.病原体、寄生体、または外因性物質を撃退、排除、または無害化するため、あるいは
5.身体の状態、状況、もしくは機能、または精神状態に影響を与えるために、
ヒトまたは動物の身体上または体内に使用することを目的としている。
ロピナビル、ロラタジン、ロルノキシカム、ロサルタン、ルメファントリン、ルトロピン、マグネシウム塩、マクロライド系抗生物質、マンガホジピール、マプロチリン、メベンダゾール、メベベリン、メクロジン、メフェナム酸、メフロキン、メロキシカム、メマンチン、メピンドロール、メプロバメート、メロペネム、メサラジン、メスクシミド、メタミゾール、メトホルミン、メサドン、メトトレキサート、メチル5−アミノ−4−オキソペンタノエート、メチルナロキソン、メチルナロキソン、メチルナルトレキソン、メチルフェニデート、メチルプレドニゾロン、メチキセン、メトクロプラミド、メトプロロール、メトロニダゾール、ミアンセリン、ミベフラジル、ミコナゾール、ミフェプリストン、ミグリトール、ミグルスタット、ミノサイクリン、ミノキシジル、ミソプロストール、マイトマイシン、ミゾラスチン、モダフィニル、モエキシプリル、モンテルカスト、モロクトコグ、モルフィナン、モルヒネおよびモルヒネ誘導体、モキシフロキサシン、麦角アルカロイド、ナルブフィン、ナロキソン、ナプロキセン、ナラトリプタン、ナルコチン、ナタマイシン、ナテグリニド、ネビボロール、ネファゾドン、ネルフィナビル、ネオスチグミン、ネラメキサン、ネビラピン、ニセルゴリン、ニケタミド、ニフェジピン、ニフルミン酸、ニモジピン、ニモラゾール、ニムスチン、ネシリチド、ニソルジピン、ノルフロキサシン、ノバミンスルホン、ノスカピン、ニスタチン、オフロキサシン、オクトトライド、オランザピン、オルメサルタン、オルサラジン、オセルタミビル、オメプラゾール、オモコナゾール、オンダンセトロン、オルリスタット、オセルタミビル、オキサセプロール、オキサシリン、オキサリプラチン、オキサプロジン、オキシカルバゼピン、オキシコドン、オキシコナゾール、オキシメタゾリン、パリビズマブ、パロノセトロン、パントプラゾール、パラセタモール、パレコキシブ、パロキセチン、ペガスパルガーゼ、ペグインターフェロン、ペグフィルグラスチム、ペンシクロビル、経口ペニシリン、ペンタゾシン、ペンチフィリン、ペントキシフィリン、ペプチド抗生物質、ペリンドプリル、ペルフェナジン、ペチジン、植物抽出物、フェナゾン、フェニラミン、フェニル酪酸、フェニトイン、フェノチアジン、フェンセリン、フェニルブタゾン、フェニトイン、ピメクロリムス、ピモジド、ピンドロール、ピオグリタゾン、ピペラジン、ピラセタム、ピレンゼピン、ピリベジル、ピルリンドール、ピロキシカム、プラミペキソール、プラムリンチド、プラバスタチン、プラゾシン、プロカイン、プロマジン、プロピベリン、プロプラノロール、プロピオン酸誘導体、プロピフェナゾン、プロスタグランジン、プロチオナミド、プロキシフィリン、クエチアピン、キナプリル、キナプリラート、キヌプリスチン、ラミプリル、ラニチジン、ラベプラゾール、ラロキシフェン、ラノラジン、ラスブリカーゼ、レボキセチン、レパグリニド、レプロテロール、レセルピン、レボフロキサシン、リバビリン、リファンピシン、リルゾール、リメキソロン、リセドロネート、リスペリドン、リトナビル、リツキシマブ、リバスチメン、リザトリプタン、ロフェコキシブ、ロピニロール、ロピバカイン、ロシグリタゾン、ロキサチジン、ロキシスロマイシン、ルスコゲニン、ロスバスタチン、ルトシドおよびルトシド誘導体、サバディラ、サルブタモール、サリチル酸塩、サルメテロール、サペルコナゾール、甲状腺ホルモン、スコポラミン、セレギリン、セルタコナゾール、セルチンドール、セルトラリン、セベラマー、シブトラミン、シルデナフィル、ケイ酸塩、シンバスタチン、シロリムス、シトステロール、ソタロール、スパグルム酸、スパルフロキサシン、スペクチノマイシン、スピラマイシン、スピラプリル、スピロノラクトン、スタブジン、ストレプトマイシン、スクラルファート、スフェンタニル、スルバクタム、スルホンアミド、スルファサラジン、スルピリド、スルタミシリン、スルチアム、スマトリプタン、塩化スキサメトニウム、タクリン、タクロリムス、タダラフィル、タリオロール、タルサクリジン、タモキシフェン、タソネルミン、タザロテン、テガフール、テガセロッド、テリスロマイシン、テルミサルタン、テモポルフィン、テモゾロミド、テナトプラゾール、テネクテプラーゼ、テニポシド、テノフォビル、テノキシカム、テリパラチド、テラゾシン、テルビナフィン、テルブタリン、テルフェナジン、テリパラチド、テルリプレシン、テルタトロール、テストステロンおよびテストステロン誘導体、テトラサイクリン、テトリゾリン、テゾセンタン、テオブロミン、テオフィリン、テオフィリン誘導体、チアマゾール、チオテパ、thr.成長因子、チアガビン、チアプリド、チボロン、チクロピジン、チリジン、チモロール、チニダゾール、チオコナゾール、チオグアニン、チオトロピウム、チオキソロン、チラゼタム、チロプラミド、チロフィバン、チザニジン、トラゾリン、トルブタミド、トルカポン、トルナフテート、トルペリゾン、トルテロジン、トピラマート、トポテカン、トラセミド、トラマドール、トラマゾリン、トランドラプリル、トラニルシプロミン、トラピジル、トラスツズマブ、トラボプロスト、トラゾドン、トレプロスチニル、トリアムシノロンおよびトリアムシノロン誘導体、トリアムテレン、トリフルペリドール、トリフルリジン、トリメタジジン、トリメトプリム、トリミプラミン、トリペレナミン、トリプロリジン、トリフォスファミド、トロマンタジン、トロメタモール、トロパルピン、トロバフロキサシン、トロキセルチン、ツロブテロール、トリプシン、チラミン、チロトリシン、ウラピジル、ウルソデオキシコール酸、テオフィリンウルソデオキシコール酸、バラシクロビル、バルデコキシブ、バルガンシクロビル、バルプロ酸、バルサルタン、バンコマイシン、バルデナフィル、塩化ベクロニウム、ベンラファクシン、ベラパミル、ベルテポルフィン、ビダラビン、ビガバトリン、ビロキサジン、ビンブラスチン、ビンカミン、ビンクリスチン、ビンデシン、ビノレルビン、ビンポセチン、ビキジル、ビタミンDおよびビタミンD誘導体、ボリコナゾール、ワルファリン、ニコチン酸キサンチノール、キシメラガトラン、キシパミド、ザフィルルカスト、ザルシタビン、ザレプロン、ザナミビル、ジドブジン、ジプラシドン、ゾレドロン酸、ゾルミトリプタン、ゾルピデム、ゾプリコン、ゾテピンなどがある。
ニュートラシューティカルは、ヒトの健康に対して医療効果があると言われている食品の抽出物と定義することができる。ニュートラシューティカルは、通常は、カプセル、錠剤、または粉剤などの医薬剤形に処方量で含まれる。ニュートラシューティカルの例には、ブドウ製品由来の抗酸化剤としてのレスベラトロル、高コレステロール血症を軽減するための水溶性食物繊維製品、例えばオオバコ種子殻、癌予防剤としてのブロッコリー(スルファン)、および動脈の健康を改善するための大豆またはクローバー(イソフラボノイド)がある。その他のニュートラシューティカルの例には、フラボノイド、抗酸化剤、亜麻仁由来のα−リノール酸、マリーゴールドの花弁由来のβ−カロテン、またはベリー類由来のアントシアニンがある。neutraceuticalという表現が、nutraceutical(ニュートラシューティカル)の同義語として用いられることもある。
塗布プロセスは、有機溶液または水性分散液からの噴霧塗布、あるいは溶融もしくは直接粉末塗布から選択することができる。この場合、均一で細孔のないコーティングを製造することが実施に不可欠である。有機溶液と比較して、水性分散液の塗布は、特に厳格なVOC要件を満足しなければならない国では好適であるが、有機溶液を用いたコーティング塗布を適用することも可能である。
−Voigt, R. (1984), Lehrbuch der pharmazeutischen Technologie; Verlag Chemie Weinheim − Beerfield Beach/Florida − Basle
−Sucker, H., Fuchs, P., Speiser, P.: Pharmazeutische Technologie, Georg Thieme Verlag Stuttgart (1991)、特に第15章および第16章(626〜642ページ)
−Gennaro, A., R. (Editor), Remington’s Pharmaceutical Sciences, Mack Publishing Co., Easton Pennsylvania (1985)、第88章(1567〜1573ページ)
−List, P. H. (1982): Arzneiformenlehre, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart
制御層(b)は、好ましくは、制御層(b)の総質量が、コア(a)の総質量に対して2.5〜100質量%、好ましくは10〜70質量%、特に好ましくは15〜40質量%となるような量でコアに塗布する。
本発明の医薬製剤もしくはニュートラシューティカル製剤は、場合によっては、いかなる放出制御機能も有さないトップコートを含んでもよい。好ましくは、トップコートは、顔料または潤滑剤の担体として機能する水溶性層である。適切なトップコート材料は、多糖類から選択することができる。
原則として、本発明による医薬製剤もしくはニュートラシューティカル製剤は、経口投与によって直接使用することが可能である。しかしながら、好ましくは、医薬剤形を製造するための既知の方法で、さらなる加工工程が続く。製剤は、例えば、薬学的に有用な賦形剤を用いて、自体公知の方法で、多粒子医薬剤形、特にペレットを含有する錠剤、小型錠剤、カプセル、サシェ、または再構成可能な粉剤に加工することができる着色された形態で存在してもよい。
実施例では、以下のコポリマーを使用した。
65質量%のメチルメタクリレートと、30質量%のエチルアクリレートと、5質量%の2−トリメチルアンモニウムエチルメタクリレートクロリドとからなるコポリマー1(EUDRAGIT(登録商標) RS)。コポリマーを30%の水性分散液(EUDRAGIT(登録商標) RS 30D)から塗布する。
60質量%のメチルメタクリレートと、30質量%のエチルアクリレートと、10質量%の2−トリメチルアンモニウムエチルメタクリレートクロリドとからなるコポリマー2(EUDRAGIT(登録商標) RL)。コポリマーを30%の水性分散液(EUDRAGIT(登録商標) RL 30D)から塗布する。
50質量%のメチルメタクリレートと、50質量%のメタクリル酸とからなるコポリマー3(EUDRAGIT(登録商標) L)を中和せずに使用。コポリマーを水に懸濁した固体ポリマー(EUDRAGIT(登録商標) L 100)から塗布する。
25質量%のメチルメタクリレートと、65質量%のメチルアクリレートと、10質量%のメタクリル酸とからなるコポリマー4(EUDRAGIT(登録商標) FS)を中和せずに使用。コポリマーを30%の水性分散液(EUDRAGIT(登録商標) FS 30D)から塗布する。
モデル薬物
試験は、モデル薬物としてメサラミン(5−ASA)を用いて実施した。
賦形剤
全ての賦形剤は、医薬品質のものを使用した。
溶解試験
コーティングしたペレットをUSP 28−NF23, General Chapter <711>, Dissolutionに従ってテストした。
溶解パラメータ:
装置:USP Type−1(バスケット)
RPM:100/分
温度:37.5±0.5℃
溶解量:900ml
取り出し量:5mlをピペットを用いて手動で取り出し、媒体の補充はしない。
取り出し量間隔:開始時、1.0時間、2.0時間、3.0時間、4.0時間、5.0時間、6.0時間、7.0時間、8.0時間、10.0時間、11.0時間、および12.0時間。
検出法:HPLC
溶解媒体1:
0.1モル塩酸(HCl)、(ヨーロッパ薬局方=EP)
溶解媒体2:
リン酸緩衝液、pH7.5(ヨーロッパ薬局方=EP)
処方詳細
流動層処理装置内で、355〜500ミクロンのコア(糖球体など)にメサラミンを下部噴霧を用いて付与した。ポリビニルピロリドンを結合剤として使用した。
適切な容器内で穏やかに攪拌しながら、EUDRAGIT(登録商標)分散液を混合する。高せん断力を与えて、潤滑剤とさまざまなポリマーを水中に溶解または分散させる。
適当な条件下(噴霧速度:コア1kg当たりのコーティング懸濁液およそ20g/分、流動層温度:およそ25〜28℃)の流動層装置内で、薬物積層ペレットをさまざまなコーティング懸濁液でコーティングした。コーティング後、流動層処理装置内で、ペレットを50℃で1時間流動化させた。
Claims (21)
- 医薬製剤もしくはニュートラシューティカル製剤であって、
a)医薬活性物質もしくはニュートラシューティカル活性物質を含有するコアと、
b)前記コアを包囲する内側制御層であって、
i)カチオン性基またはカチオン性基に変換することができる基を担持する複数の(メタ)アクリレートコポリマーのうちの1つまたはこれらの混合物と、
ii)アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物と、を含む内側制御層と、
c)アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物を含む外側制御層と、
を含む、医薬製剤もしくはニュートラシューティカル製剤。 - 前記内側制御層(b)中に、成分i)が50〜92質量%の量で含まれ、成分ii)が8〜50質量%の量で含まれる(質量%は、前記層中に含まれるポリマーの総質量に基づく)、請求項1記載の製剤。
- 前記内側制御層(b)中に、成分i)が55〜80質量%の量で含まれ、成分ii)が20〜45質量%の量で含まれる(質量%は、前記層中に含まれるポリマーの総質量に基づく)、請求項2記載の製剤。
- 前記内側制御層b)中の成分i)が、前記(メタ)アクリルコポリマーの質量に対して80〜98質量%の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、前記(メタ)アクリルコポリマーの質量に対して2〜20質量%のアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される複数の(メタ)アクリレートコポリマーのうちの1つまたはこれらの混合物を含む、請求項1から3までのいずれか1項に記載の製剤。
- 成分i)よるコポリマーが、前記(メタ)アクリルコポリマーの質量に対して93〜98質量%の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、前記(メタ)アクリルコポリマーの質量に対して2〜7質量%のアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される(メタ)アクリレートコポリマーを含む、請求項4記載の製剤。
- 成分i)よるコポリマーが、前記(メタ)アクリルコポリマーの質量に対して85質量%以上93質量%未満の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、前記(メタ)アクリルコポリマーの質量に対して7質量%を上回り15質量%までのアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される(メタ)アクリレートコポリマーを含む、請求項4記載の製剤。
- 成分i)よるコポリマーが、
前記(メタ)アクリルコポリマーの質量に対して93〜98質量%の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、前記(メタ)アクリルコポリマーの質量に対して2〜7質量%のアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される、混合物の総質量に対して60〜99質量%の(メタ)アクリレートコポリマーと、
前記(メタ)アクリルコポリマーの質量に対して85質量%以上93質量%未満の(メタ)アクリル酸のC1〜C4アルキルエステルから誘導された構造単位と、前記(メタ)アクリルコポリマーの質量に対して7質量%を上回り15質量%までのアルキル基中に4級アンモニウム基を有する(メタ)アクリレートモノマーから誘導された構造単位とから構成される、混合物の総質量に対して1〜40質量%の(メタ)アクリレートコポリマーと、
の混合物を含む、請求項4記載の製剤。 - 前記アルキル基中に4級アンモニウム基を含有する構造単位が、トリエチルアンモニウムエチルメタクリレートクロリドから誘導される、請求項4から7までのいずれか1項に記載の製剤。
- 層b)および層c)中の前記アニオン性基またはアニオン性基に変換することができる基を担持するポリマーまたはコポリマーが、カルボキシル官能性(メタ)アクリルポリマーまたはコポリマー、ならびにカルボキシル官能性多糖類およびそれらの少なくとも部分的な中和の生成物から独立して選択される、請求項1から8までのいずれか1項に記載の製剤。
- 層b)および層c)中の前記アニオン性基またはアニオン性基に変換することができる基を担持するポリマーまたはコポリマーが、カルボキシル官能性(メタ)アクリルポリマーまたはコポリマー、およびそれらの少なくとも部分的な中和の生成物から独立して選択される、請求項1から9までのいずれか1項に記載の製剤。
- 前記カルボキシル官能性(メタ)アクリルコポリマーが、コポリマーの質量に対して5〜85質量%のカルボキシル基を含有する構造単位と、コポリマーの質量に対して95〜15質量%の(メタ)アクリル酸のアルキルエステルから誘導された構造単位とから構成される(メタ)アクリレートコポリマーから選択される、請求項10記載の製剤。
- 前記カルボキシル基を含有する構造単位が、アクリル酸もしくはメタクリル酸から誘導される、請求項1から11までのいずれか1項に記載の製剤。
- 前記内側制御層b)中の成分ii)によるコポリマーが、コポリマーの質量に対して41〜60質量%のメチルメタクリレートもしくはエチルアクリレートから誘導された構造単位と、コポリマーの質量に対して40〜59質量%のアクリル酸もしくはメタクリル酸およびそれらの少なくとも部分的な中和の生成物から誘導された構造単位とから構成される、請求項1から12までのいずれか1項に記載の製剤。
- 前記外側制御層c)のコポリマーが、コポリマーの質量に対して60〜95質量%のメチルメタクリレートもしくはエチルアクリレートから誘導された構造単位と、コポリマーの質量に対して5〜40質量%のアクリル酸もしくはメタクリル酸およびそれらの少なくとも部分的な中和の生成物から誘導された構造単位とから構成される、請求項1から13までのいずれか1項に記載の製剤。
- 前記外側制御層c)のコポリマーが、コポリマーの質量に対して85〜95質量%のメチルメタクリレートもしくはエチルアクリレートから誘導された構造単位と、コポリマーの質量に対して5〜15質量%のアクリル酸もしくはメタクリル酸およびそれらの少なくとも部分的な中和の生成物から誘導された構造単位とから構成される、請求項1から14までのいずれか1項に記載の製剤。
- 請求項1から15までのいずれか1項に記載の医薬製剤もしくはニュートラシューティカル製剤を含む錠剤。
- 請求項1から15までのいずれか1項に記載の医薬製剤もしくはニュートラシューティカル製剤を含むゼラチンカプセルまたはHPMCカプセル。
- a)医薬活性物質もしくはニュートラシューティカル活性物質を含有するコアと、
b)カチオン性基またはカチオン性基に変換することができる基を担持する複数の(メタ)アクリレートコポリマーのうちの1つまたはこれらの混合物を含む、前記コアを包囲する内側制御層と、
c)アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物を含む外側制御層と、
を含む医薬製剤もしくはニュートラシューティカル製剤中の内側制御層の製造における、水性液および生理液中で前記医薬活性物質もしくはニュートラシューティカル活性物質の放出速度を向上させる目的での、アニオン性基またはアニオン性基に変換することができる基を担持する複数のポリマーまたはコポリマーのうちの1つまたはこれらの混合物の使用。 - 前記内側制御層(b)中に、前記カチオン性基またはカチオン性基に変換することができる基を担持する(メタ)アクリレートコポリマーが、50〜92質量%の量で含まれ、前記アニオン性基またはアニオン性基に変換することができる基を担持するポリマーまたはコポリマーが、8〜50質量%の量で含まれる(質量%は、前記層中に含まれるポリマーの総質量に基づく)、請求項18記載の使用。
- 前記内側制御層(b)中に、前記カチオン性基またはカチオン性基に変換することができる基を担持する(メタ)アクリレートコポリマーが、55〜80質量%の量で含まれ、前記アニオン性基またはアニオン性基に変換することができる基を担持するポリマーまたはコポリマーが、20〜45質量%の量で含まれる(質量%は、前記層中に含まれるポリマーの総質量に基づく)、請求項18記載の使用。
- 前記アニオン性基および/またはアニオン性基に変換可能な基を含有する構造単位を含有するコポリマーは、請求項9から13までのいずれか1項の記載と同様に定義され、前記カチオン性基またはカチオン性基に変換することができる基を担持するコポリマーは、請求項4から8までのいずれか1項の記載と同様に定義される、請求項18から20までのいずれか1項に記載の使用。
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