JP5675100B2 - 多層の分離層を有する薬剤形 - Google Patents
多層の分離層を有する薬剤形 Download PDFInfo
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- JP5675100B2 JP5675100B2 JP2009521173A JP2009521173A JP5675100B2 JP 5675100 B2 JP5675100 B2 JP 5675100B2 JP 2009521173 A JP2009521173 A JP 2009521173A JP 2009521173 A JP2009521173 A JP 2009521173A JP 5675100 B2 JP5675100 B2 JP 5675100B2
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
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Description
EP0088951A2は、水中に分散されたコーティング剤を用いて薬剤形をコーティングする方法を記載している。カルボキシル基−含有(メタ)アクリレートコポリマーを粉末から再分散させて分散液にするために、カルボキシル基の部分中和が推奨されている。酸基の塩形成は、塩基との反応により開始する。塩基としては、アルカリ、例えば苛性ソーダ、苛性カリ、炭酸ナトリウム、炭酸カリウム、重炭酸ナトリウム、リン酸三ナトリウム、クエン酸三ナトリウム又はアンモニア又は生理学的に認容性のアミン、例えばトリエタノールアミン又はトリス(ヒドロキシメチル)−アミノエタンがこれに該当する。再分散に関連して、コポリマー中に含有されているカルボキシル基の0.1〜10質量%の中和度が好適である。
従来、腸溶性コーティングされた薬剤形の場合に作用物質放出の高い再現性を得ることが全く効果的に試みられており、ここでは、特異的pH−値の達成時にできるだけ迅速に溶解するコーティングを生じたが、本発明は、選択的構想から出発している。
作用物質含有コア
この薬剤形は、作用物質含有コアを有する。通常このコアは、作用物質5〜100、好ましくは10〜50質量%及び更なる製剤助剤95質量%まで、好ましくは50〜90質量%を含有している。
コアとコーティング層との間に、少なくとも2層に設計されている分離層が存在し、この際、撥水性物質を有している内層及びその上の膜形成性水溶性ポリマーを有している層が存在する。
膜形成性の水溶性ポリマーが、特別良好かつ迅速な水溶性であることが好ましく、このことは、コーティング層の溶解又は脱離のために好適である。従って、膜形成性の水溶性ポリマーからなる層のこの作用は、この短時間作用を意図している。
撥水性物質は、有利にpH5.5以上の生理学的条件下に、迅速にコアからミセル形で脱離する層を形成する。しかしながら、ミセル形での脱離は、周りの媒体と接触する場合に、その上に存在する膜形成性の水溶性ポリマーを含有している層の溶解の後に初めて起こる。従って、撥水性物質を有している層は、作用物質の放出が遅延される短時間作用を得るように設計されている。通常、撥水性物質はポリマーではない。
少なくとも2層の分離層は、本発明のもう一つの態様をもたらす。
本発明による薬剤形は、胃液抵抗性で腸液可溶性の(メタ)アクリレート−コポリマーからのコーティングを有する。アニオン性(メタ)アクリレート−コポリマーが好適である。
メタクリル酸及び/又はアクリル酸 20〜34質量%
アクリル酸メチル 20〜69質量%及び
アクリル酸エチル 0〜40質量%及び/又は場合により
他のビニル系共重合可能なモノマー 0〜10質量%
から成っているコポリマー(但し、ISO11357−2、セクシヨン3.3.3によるこのコポリマーのガラス転移温度は最大60℃であることを条件とする)が好適である。この(メタ)アクリレートコポリマーは、その良好な引裂き時の伸び特性の故に、殊にペレットから錠剤までの圧縮のために好適である。
メタクリル酸及び/又はアクリル酸 20〜33質量%
アクリル酸メチル 5〜30質量%及び
アクリル酸エチル 20〜40質量%及び
メタクリル酸ブチル 10〜30質量%及び場合により
他のビニル系共重合可能なモノマー 0〜10質量%
(この際、モノマーの割合の合計は100質量%になる)を有するコポリマー(但し、ISO11357−2、セクション3.3.3によるこのコポリマーのガラス転移温度(中央温度Tmg)は55〜70℃であることを条件とする)が好適である。このタイプのコポリマーは、その良好な機械特性に基づき、殊にペレットから錠剤までの圧縮のために好適である。
メタクリル酸メチル又はアクリル酸、好ましくはメタクリル酸
20〜33、好ましくは25〜32、特別好ましくは28〜31質量%、
アクリル酸メチル5〜30、好ましくは10〜28、特別好ましくは15〜25質量%、
アクリル酸エチル20〜40、好ましくは25〜35、特別好ましくは18〜22質量%
並びに
メタクリル酸ブチル10〜30、好ましくは15〜25、特別好ましくは18〜22質量%
から成っており、この際、モノマー組成は、コポリマーのガラス転移温度が55〜70℃、好ましくは59〜66、特別好ましくは60〜65℃であるように選択されている。
アニオン性(メタ)アクリレートコポリマーの製造は、自体公知の方法でモノマーのラジカル重合によって行うことができる(例えばEP0704207A2及びEP0704208A2参照)。本発明によるコポリマーは、自体公知の方法で、例えばDE−C2135073中に記載の方法によって、特にアニオン性乳化剤の存在下における水相でのラジカル乳化重合によって製造可能である。
有利な1実施形では、本発明による薬剤形の(メタ)アクリレート−コポリマーコーティングが部分中和された形で使用される。この部分中和は、薬剤形からのコーティング層の溶解又は脱離を促進する。これによって、第1工程での特異的pH−値におけるコーティング層の溶解又は脱離と直後に続いている作用物質放出との相互作用が好適になる。
部分中和度の調節の場合の方法技術的利点は、既に記載の混合物により生じることもできる。
コアを包囲する、胃液抵抗性で腸液可溶性の、かつ場合により部分中和された(メタ)アクリレート−コポリマーは、通常は更なるポリマーを混合することなしに使用することができる。しかしながら、この(メタ)アクリレート−コポリマーは、特性を変性するために他の製剤学的に使用されるコポリマーとの混合物を得るためにも好適である。混合物は、特別変性された放出像の調節の場合の当業者の設計自由範囲を高める。
メタクリル酸メチル及び/又はアクリル酸エチル及び場合により5質量%を下回るメタクリル酸からのコポリマー、メタクリル酸メチル、メタクリル酸ブチル及びメタクリル酸ジメチルエチルからのコポリマー、メタクリル酸メチル、アクリル酸エチル及びトリメチルアンモニウムメチルメタクリレートからのコポリマー、ポリビニルピロリドン(PVP)、ポリビニルアルコール、ポリビニルアルコール−ポリエチレングリコール−グラフト−コポリマー(Kollicoat(R))、澱粉及びその誘導体、ポリビニルアセテートフタレート(PVAP、Coateric(R))、ポリビニルアセテート(PVAc、Kollicoat)、酢酸ビニル−ビニルピロリドン−コポリマー(Kollidon(R)VA64)、酢酸ビニル:クロトン酸−コポリマー9:1(VAC:CRA、Kollicoat(R)VAC)、1000(g/モル)を上回る分子量を有するポリエチレングリコール、キトサン、架橋及び/又は非架橋のポリアクリル酸、Na−アルギネート及び/又はペクチン。
場合により部分中和された(メタ)アクリレート−コポリマーは、例えば固体分10〜50パーセントを有する水性分散液の形で存在することができる。
乳化重合体は、有利に10〜50−質量%の、殊に20〜40%の水性分散液の形で得られ、使用される。取り扱い形としては、30質量%の固体含有率が好ましい。加工処理のためにメタクリル酸−単位の部分的な中和が不可欠であるが、これは、例えばコーティング剤分散液の安定化又は濃化が望ましい場合には、5モル%まで又は10モル%までの範囲で可能である。重量平均値のラテックス−粒子寸法(半径)は、通常40〜100nm、有利には50〜70nmであり、これは1000mPa・sを下回る処理技術的に好適な粘度を保証する。粒子寸法は、レーザー回折によって、例えばMastersizer2000(Fa.Malvern)を用いて測定することができる。
Mw>150を有するカチオン性の有機塩基又はリシンで部分中和されたアニオン性(メタ)アクリレート−コポリマーを、本発明の薬剤形のコーティング剤として有利に使用することができる。この場合に、含有作用物質の約90%、好ましくは95〜100%がUSP28による放出試験で、pH1.2で2時間及び作用物質放出の開始のpH−値までの引き続く再緩衝の後に、同じポリマーコーティングを有するが他の塩基により中和されていない又は部分中和されていない比較可能な薬剤形中で経過する時間の最大90%、好ましくは最大75%、殊に最大50%で放出される。
1.放出装置の容器に0.1M−HCl(pH 1.2)各360mlを充填し、水浴の温度を37±0.5℃に調節する、
2.羽根攪拌機を100rpmの回転速度でスイッチを入れる、
3.装置の各容器中にペレット1gを加える。ペレット−表面上には気泡がないように注意する、
4.120分後に、リン酸塩−緩衝液(37℃まで加熱された)140mlを添加して、500mlの最終量中で、所望のpH−値を生じさせる:pH 5.5;5.6;5.7;5.8又は7.0、
5.作用物質に応じて、例えばテオフィリンの場合には、100%の作用物質放出の時点を、217nmでの光度測定法により、回転法で測定する。
本発明は、胃液抵抗性で腸液可溶性の(メタ)アクリレート−コポリマーから成るコーティング層で包囲されている作用物質含有コアを含有している薬剤形(この際、コアとコーティング層との間に、膜形成性の水溶性ポリマーを含有している分離層が存在する)に関し、この分離層は、少なくとも2層に設計されている(この際、撥水性物質を有している1内層及びその上に膜形成性の水溶性ポリマーを有する1層が存在する)ことを特徴としている。
更に本発明は、製剤学的に慣用の方法を用いる自体公知の方法で、例えば直接圧縮、乾燥−、湿潤−又は焼結顆粒の圧縮、押出し及び引き続く丸み付け、湿式又は乾式造粒又は直接ペレット化又は粉末の結合(粉末成層)により、作用物質不含の球又は中性コア(ノンパレイル)又は作用物質粒子上への懸濁液又は溶液の吹き付けにより、かつスプレー法でのポリマーコーティングの適用によって又は流動床造粒によって、本発明による薬剤形を製造する方法に関する。
本発明は、殊に多粒子薬剤形の製造のために好適である。それというのも、包囲する(メタ)アクリレート−コポリマーは、ペレットと充填物質と一緒の圧縮の際の高い圧力に耐えるからである。
適用法は、有機溶液又は好ましくは水性分散液からのスプレー適用を用い、溶融又は直接粉末適用によって行なわれる。この場合に、この実施のためには、一様な孔不含のコーティングが生じることが重要である。
− Voigt,R.(1984):Lehrbuch der pharmazeutischen Technologie;Verlag Chemie Weinheim-Beerfield Beach/Florida-Basel.
− Sucker,H.,Fuchs,O.,Speiser,P.:Pharmazeutische Technologie,Georg Thieme Verlag Stuttgart(1991),殊にKapitel 15及び16,625-642頁.
− Gennaro,A.R.(Editor),Remington'sPharmaceutical Sciences,Mack Publishing Co.,Easton Pennsylvania(1985),Chapter 88,S.1567-1573.
− List,P.H.(1982):Arzneiformenlehre,Wissenschaftliche Verlagsgesellschaft mbH,Stuttgart.
本発明による製剤に、製造時に慣用の助剤又は添加剤を添加することができる。原則的に全ての使用される物質は、勿論毒物学的無害であり、殊に薬剤形で患者に対する危険なしに使用可能であるべきである。
離型剤は、通常は親油性を有し、かつ通常はスプレー懸濁液に添加される。これは、膜形成の間のコアの凝集を阻止する。タルク、ステアリン酸Mg又はステアリン酸Ca、粉砕された珪酸、カオリン又は3〜8のHLB−値を有する非イオン乳化剤が有利に使用される。本発明のコーティング剤及び結合剤中の離型剤の慣用量は、コポリマーに対して0.5〜100質量%である。
コーティング剤と非相容性である顔料とは、殊に、それが(メタ)アクリレート−コポリマー分散液に直接添加される場合に、例えば乾燥質量に対して20〜400質量%の慣用量での(メタ)アクリレート−コポリマーの撹拌混入によって、分散液の脱安定化、凝固、解乳化現象又は類似の不所望の作用効果をもたらすような顔料である。更に、使用される顔料は勿論無毒性であり、薬剤学的目的のために好適である。これに関しては、Deutche Forshungsgemeinschaft,Farbstoffe fuer Lebensmittel,Harald Boldt Verlag KG,Boppard(1978) ;Deutche Lebensmittelrundschau 74,Nr.4.S.156(1978); Arzneimittelfarbstoffverordnung AmFarbV vom 25.08.1980を参照されたし。
更なる添加物質は、可塑剤であることもできる。慣用量は0〜50、有利には2〜20、殊に5〜10質量%である。
生じる層又は膜のスプレー可能性及びフレキシビリティを改良するために、通常は、乳化剤が使用される。乳化剤の使用は、例えば当該層又は膜の全質量に対して0.1〜50質量%の濃度で行うことができる。
慣用の医薬品は、参考文献、例えばRoten Liste又はMerck Indexから知ることができる。
1.病気、苦痛、身体障害又は病的苦訴を快癒し、緩和し、予防し又は検知するため、
2.身体の容態、状態、機能又は精神的状態を検知するため、
3.人体又は動物体から生じる作用物質又は体液を置換するため、
4.病原体、寄生生物又は異物を防御し、除去し又は無害にするため、又は
5.身体の容態、状態又は機能又は精神的状態に影響するため。
この薬物学的活性物質は、下記の1種以上の作用物質群に属する:例えばACE−抑制剤、アドレナリン作動薬、副腎皮質ステロイド、挫創治療剤、アルドース−レダクターゼ−抑制剤、アルドステロン−拮抗薬、α−グルコシダーゼ抑制剤、α1−拮抗薬、アルコール乱用に対する薬剤、アミノ酸、殺アメーバ剤、同化作用剤、中枢神経興奮剤、麻酔剤−添加剤、麻酔剤(非吸入性)、麻酔剤(局所)、鎮痛剤、アンドロゲン、狭心症治療剤、拮抗薬、抗アレルギー剤、PDE−抑制剤の様な抗アレルギー剤、喘息治療用抗アレルギー剤、他の抗アレルギー剤(例えばロイコトリエン拮抗薬)、抗貧血剤、抗アンドロゲン、不安解消剤、抗関節炎剤、抗不整脈剤、抗細動脈硬化症薬、抗生物質、抗コリン作動薬、抗痙攣剤、抗抑圧剤、抗糖尿病剤、抗下痢剤、抗利尿剤、解毒薬、抗嘔吐剤、抗癲癇剤、抗フィブリン溶解剤、抗癲癇剤、抗寄生虫剤、抗ヒスタミン剤、抗低緊張症剤、抗過緊張症剤、抗高血圧症剤、抗低血圧症剤、抗血液凝固剤、抗糸状菌剤、抗エストロゲン、抗エストロゲン(非−ステロイド)、抗パーキンソン病剤、抗炎症剤、抗細胞増殖作用物質、抗原虫作用物質、抗リューマチ剤、抗住血吸虫剤、鎮痙剤、抗血栓剤、抗百日咳剤、食欲抑制剤、細動脈硬化症剤、静細菌剤、βレセプター遮断剤、血管拡張剤、カルボアンヒドラーゼー抑制剤、化学療法剤、胆汁分泌剤、コリン作動薬、コリンエステラーゼ−抑制剤、大腸潰瘍の治療剤、シクロオキシゲナーゼ抑制剤、利尿薬、外寄生虫剤、催吐剤、酵素、酵素阻害剤、フィブリン溶解剤、静真菌剤、痛風薬、緑内障治療薬、グルココルチコイド、グルココルチコステロイド、止血剤、強心配糖体、ヒスタミンH2−拮抗薬、ホルモン及びそれらの抑制物質、免疫治療剤、強心薬、静コクチジウム剤、緩下剤、脂質低下剤、胃−腸治療剤、マラリア治療薬、片頭痛薬、抗微生物剤、クローン病の処置剤、転位抑制剤、片頭痛薬、ミネラル物質製剤、運動機能上昇作用物質、筋肉弛緩剤、神経鎮静剤、骨多孔症治療作用物質、耳鼻科用薬、パーキンソン病薬、植物薬剤、プロトンポンプ抑制剤、プロスタグランジン、初期前立腺肥大症治療用の作用物質、かゆみ症治療用作用物質、疥癬症作用物質、精神病薬、ラジカル捕捉剤、レニン−拮抗薬、甲状腺治療薬、脂漏症治療用作用物質、鎮痙剤、α−及びβ−交感神経類似薬、テナトプラゾール、血小板凝固抑制剤、チロシンキナーゼ抑制剤、トランキライザー、潰瘍治療剤、尿石症治療剤、静ウィルス剤、ビタミン、サイトカイン、静細胞剤。
好適な作用物質の例は、次のものである:アカルボース、アセチルサリチル酸、アバカビル、アセクロフェナク、アクラルビシン、アシクロビア、アクチノマイシン、アダリムマブ、アデフォビル、アデフォビルジピボキシル、アデノシルメチオニン、アドレナリン及びアドレナリン誘導体、アガルシダーゼアルファ、アガルシダーゼベータ、アレムツズマブ、アルフゾシン、アルモトリプタン、アロプリノール、アルモトリプタン、アロセトロン、アルファセプト、アルプラゾラム、アルプロスタジル、アマンタジン、アンブロキソール、アミスルプリド、アムロジピン、アモキシシリン、5−アミノサリチル酸、アミトリプチリン、アムロジピン、アモキシシリン、アムプレナビル、アナグレリド、アナキンラ、アナストロゾール、アンドロゲン及びアンドロゲン誘導体、アポモルフィン、アリピプラゾール、三酸化ヒ素、アルテメテル、アテノロール、アトルバスタチン、アトシバン、アザチオプリン、アゼライン酸、バルビツール酸誘導体、バルサラジド、バシリキシマブ、ベクラペルミン、ベクロメタゾン、ベミパリン、ベナゼプリル、ベンゾジアゼピン、ベラプロスト、ベタヒスチン、ベキサロテン、ベザフィブレート、ビカルタミド、ビマトプロスト、クエン酸ビスマス、ビスマスサブサリチレート、ボセンタン、ボツリヌムトキシン、ブリモニジン、ブリンゾラミド、ブロマセパム、ブロモクリプチン、ブデソニド、ブジピン、ブフェキサマック、ブメタニド、ブプレノフィン、ブプロピオン、ブチジン、カルシトニン、カルシウムアンタゴニスト、炭酸カルシウム、カルシウムドベシレート、カルシウム塩、カマゼパム、カンデサルタン、カペシタビン、カプトプリル、カルバマゼピン、カリフェナシン、カルヴェジロール、カスポフンギン、セファクロル、セファドロキシル、セファレキシン、セファロスポリン、セフジトレン、セフプロジル、セフロキシム、セレコキシブ、セペシタビン、セリバスタチム、セチリジン、セトロレリクス、セツキシマブ、ケノデオキシコール酸、クロロジアゼポキシド、コリオゴナドトロピン、シクロスポリン、シドフォビル、シラザプリル、シメチジン、シプロフロキサシン、シスプラチン、クラドリビン、クラリトロマイシン、クラブラン酸、クリンダマイシン、クロバザム、クロブチノール、クロナゼパム、クロニジン、クロピドグレル、コデイン、カフェイン、コレスチラミン、クロモグリシン酸、コトリモキサゾール、クマリン及びクマリン誘導体、システアミン、システイン、シタラビン、シクロホスファミド、シプロテロン、シタラビン、ダクリズマブ、ダルフォプリスチン、ダナパロイド、ダピプラゾール、ダルベポエチン、デフェプリプロン、デスフェリキサミン、デシプラミン、デシルジン、デスロアラタジン、デスモプレッシン、デソゲストレル、デソニド、デキシブプロフェン、デキシケトプロフェン、ジダノシン、ジソプロキシル、ジアゼパム及びジアゼパム誘導体、ジダノシン、ジヒドララジン、ジルチアゼム、ジメンヒドリナート、ジメチルスルホキシド、ジメチコン、ジピボキシル、ジピリダルノイル、ドラセトロン、ドムペリドン及びドムペリドン誘導体、ドネプジル、ドパミン、ドキサゾシン、ドキソルビジン、ドキシルアミン、ジクロフェナク、ジバルプロエクス、ドロナビノール、ドロスピレノン、ドロトレコギンアルファ、ジュロキセチン、ジュタステリド、エバスチン、エコナゾール、エファビレンツ、エレトリパン、エミダスチン、エムトリシタビン、エナラプリル、エンセプール、エンタカポン、エンフルビルチド、エフェドリン、エピネフリン、エプレレノン、エポエチン及びエポエチン誘導体、エプロサルタン、エプチフィバチド、エルタペネム、エソメプラゾール、エストロゲン及びエストロゲン誘導体、エタネルセプト、エテンザミド、エチノエストラジオール、エトフェナメート、エトフィブレート、エトフィリン、エトノゲストレル、エトポシド、エトリコキシブ、エキセメスタン、エゼチミブ、ファムシクロヴィル、ファモチジン、ファロペナンダロキセート、フェロジピン、フェノフィブレート、フェノフィブリン酸、フェノルドパミン、フェンタニル、フェンチコナゾール、フェキソフェナジン、フィナステリド、フルコナゾール、フルダラビン、フルナリジン、フルオロウラシル、フルオキセチン、フルラゼパム、フルルビプロフェン、フルピルチン、フルタミド、フルバスタチン、フォリトロピン、フォミビルセン、フォンダパリヌックス、フォルモテロール、フォスフォミシン、フォシノプリル、フロバトリプタン、フロセミド、フシジン酸、ガバペンチン、ガドベネート、ガランタミン、ガロパミル、ガンシクロビル、ガニレリックス、ガブチロキサシン、ゲフィチニブ、ゲムフィブロジル、ゲモパトリレート、ゲンタマイシン、ゲピロン、ゲスタゲン及びゲスタゲン誘導体、ギンクゴ、グラチラメール、グリベンクラミド、グリメプリド、グリピジド、グルカゴン、グルシトール及びグルシトール誘導体、グルコサミン及びグルコサミン誘導体、グリコシド抗生物質、グルタチオン、グリセロール及びグリセロール誘導体、ハイポタラムスホルモン、ゴセレリン、グラニセトロン、グレパフロキサシン、ギラーゼ抑制剤、グアネチジン、ギラーゼ抑制剤、ヘミン、ハロファントリン、ハロペリドール、経口抗糖尿病薬としての尿素誘導体、ヘパリン及びヘパリン誘導体、強心配糖体、ヒアルロン酸、ヒドララジン、ヒドロクロロチアジド及びヒドロクロロチアジド誘導体、ヒドロキソメプラゾール、ヒドロキシジン、イブリツモマブ、イブプロフェン、イダルビシン、イフリキシマブ、イフォスファミド、イロプロスト、イマチニブ、イミダプリル、イミグルセラーゼ、イミプラミン、イミキモド、イミダプリル、インドメタシン、インドラミン、インフリキシマブ、インスリン、インスリングラルギン、インターフェロン、イルベサルタン、イリノテカン、イソコナゾール、イソプレナリン、イソルビド−モノニトレート、イソルビド−ジニトレート、イトラコナゾール、イバブラジン、ヨード及びヨード誘導体、オトギリソウ、カリウム塩、ケトコナゾール、ケトプロフェン、ケトチフェン、ラシジピン、ラミブジン、ラモトリギン、ランソプラゾール、ラロニダーゼ、ラタノプロスト、レフルノミド、レミノプラゾール、レピルジン、レルカニジピン、レテプリニム、レトロゾール、レバセチルメタドール、レベチラセタム、レボセトリジン、レボドーパ、レボドロプロピシン、レボフロキサシン、レボメタドン、リコフェロン、リネゾリド、リピナビル、リポン酸及びリポン酸誘導体、リシノプリル、リスリド、ロフェプラミン、ロドキサミド、ロメフロキサシン、ロムスチン、ロペラミド、ロピナビル、ロラタジン、ロルノキシカム、ロサルタン、ロバスタチン、ルメファントリン、ルトロピン、マグネシウム塩、マクロリド抗生物質、マンガフォジピル、マプロチリン、メベダゾール、メベベリン、メクロジン、メフェナミン酸、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、メソプレストール、メスキシミド、メタミゾール、メタキソロン、メトフェルミン、メタドン、メトトレキセート、メチル−(5−アミノ−4−オキソペンタノェート)、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、メチルプレドニソロン、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、ミグルスタド、ミルナシプラン、ミノシクリン、ミノキシジル、ミソプロストール、ミトマイシン、ミゾラスチン、モダフィニル、モエキシプリル、モルシドミン、モンテルカスト、モロクトコグ、モルフィナン、モルフィン及びモルフィン誘導体、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、ニセタミド、ニフェジピン、ニフルミン酸、ニルタミド、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、ニザチジン、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、オクトトリド、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、オマパトリレート、オメプラゾール、オモコナゾール、オンダンセトロン、オルリステート、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、オキシカルバセピン、オキシブチン、オキシコドン、オキシコナゾール、オキシブチミン、オキシコドン、オキシメタゾリン、パリビズマブ、パラノセトロン、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、Peg−インターフェロン、ペグフィルグラストリム、ペンシクロビル、経口ペニシリン、ペンタゾシ、ペンチフィリン、ペントキシフィリン、ペプチド抗生物質、ペルインドプリル、ペルフェナジン、ペチジン、植物エキス、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、ピタバスタチン、ポサコナゾール、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、ケチアピン、キナプリル、キナプリレート、キヌプリスチン、ラベプラゾール、ラミプリル、ラニチジン、ラロキシフェン、ラノラジン、ラパマイシン、ラスブリカーゼ、レボキセチン、レパクリニド、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、リファムピシン、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、リバスチグミン、リサトリプタン、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、ロチゴチン、ロキサチジン、ロキシトロマイシン、ルスコゲニン、ロスバスタチン、ルトシド及びルトシド誘導体、サバジラ、サルブタモール、サリチレート、サルメトロール、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、セルタリン、セベラメル、シブトラミン、シルデナフィル、珪酸塩、シンバスタチン、シロリムス、シトステリン、ソタロール、スパグルミン酸、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、スクラルフェート、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、スルタマイシリン、スルチアム、スマトリプタン、スクサメトニウムクロリド、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、タムスロシン、タソネルミン、タザロテン、テガフール、テガセロド、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、テルリプレッシン、テルタトロール、テストステロン及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、チアムフェニコール、チオテーパ、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、トロフィバン、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、トルペリソン、トルテロジン、トピラメート、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、トレポスチニル、トリアムシノロン及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、チロスリシン、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、バルプロイン酸、バルサルタン、バンコマイシン、バルデナフィル、ベクロニウムクロリド、ベンラファキシン、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、ビクイジル、ビタミンD及びビタミンDの誘導体、ボリコナゾール、バルファリン、キサンチノールニコチネート、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、ゾテピン及び類似物。
本発明による薬剤形は、作用物質に関連している、作用物質の投薬を促進する物質と共に配合されているペプチド−又はタンパク質−作用物質に対して特に好適である。好適な製剤は、例えばWO2005/007139から公知である。
アバレリックス、アンギオテンシンII、アニジュラフンギン、アンチド、アルギプレッシン、アザリン及びアザリンB、ボンベシン−拮抗薬、ブラディキニン、ブセレリン、セトロレリックス、シクロスポリンA、デスモプレッシン、デチレリックス、エンケファリンス(Lue−、Met−)ガニレリックス、ゴナドレリン、ゴセレリン、成長ホルモン−分泌促進剤、ミカフンギン、ナファレリン、ロイプロリド、ロイプロレリン、オクトレオチド、オルニチド、オキシトシン、ラモレリックス、セクレチン、ソマトトロピン、テルリプレッシン、テトラコサクチド、テベレリックス、トリプトレリン、チロリベリン、チロトロピン又はバソプレッシン。
カルシトニン、コルチコトロピン、エンドルフィン、上皮成長因子、グルカゴン、インスリン、ノボリン、上皮小体ホルモン、リラキシン、プロ−ソマトスタチン又はサーモンセクレチン。
インターフェロン(α、β、γ)、インターロイキン(IL1、IL2)、ソマトトロピン、エリスロポイエチン、腫瘍壊死因子(TNFα、β)、リラキシン、エンドルフィン、ドルナーゼアルファ、卵胞刺激ホルモン(FSH)、ヒトコリオンゴナドトロピン(HCG)、ヒト成長ホルモン放出因子(hGRF)、黄体分泌ホルモン(LH)又は上皮増殖因子。
本発明による薬剤形は、作用物質に関連している、作用物質の投薬を促進する物質と共に配合されている核酸−作用物質のために特別好適である。好適な製剤は、例えばWO2006/061069から公知である。
A) リシンを用いる部分中和の作用効果
USP28<711>パドル−法(=装置2)によるテオフィリン−ペレットの放出試験
方法:
1.放出装置の容器に、0.1M−HCl(pH 1.2)各360mlを充填し、水浴の温度を37±0.5℃に調節する。
2.羽根攪拌機を、100Upmの回転速度でスイッチを入れる。
3.装置の各容器中にペレット1gを加える。ペレット−表面上に気泡が存在しないように注意する。
4.120分後にリン酸塩−緩衝液(37℃に熱処理された)140mlを添加して、500mlの最終量中で所望のpH−値:pH5.5;5.6;5.7;5;8又は7.0を生じさせる。
5.100%の作用物質放出の時点の測定(271nmでの光度測定、回転法)。
EUDRAGIT L30D55(アクリル酸エチル50質量%とメタクリル酸50質量%とからのコポリマーを含有している30%分散液)を有するペレットコーティングをリシンで部分中和する。Firma Klinge Pharmaからの粒子寸法0.7〜1.0mmを有するテオフィリンペレット100g上に、次の処方を有するポリマー分散液(メタクリル酸50質量%とアクリル酸エチル50質量%とからのメタクリレートコポリマー)の乾燥物質30%をコーティングする。全乾燥物質−適用量は、バッチ量に対して35.7質量%である。
スプレーノズル 0.6mm
スプレー速度 26g/min/kg
スプレー圧 1.0バール
微小気候 0.6バール
供給空気流 20m3
供給空気温度 33−39℃
生成物温度 26−29℃
装置中での仕上げ乾燥時間 40℃で10分
スプレー時間 1.5〜2時間
室温(RT)で一晩乾燥。
EUDRAGIT(R)L30D55を有するペレットコーティングを、NaOHで部分中和した。Firma Klinge Pharmaからの粒子寸法0.7〜1.0mmを有するテオフィリンペレット100g上に、次の処方を有するポリマー分散液(メタクリル酸50質量%とアクリル酸エチル50質量%とからのメタクリレートコポリマー)の乾燥物質30%でコーティングする。全乾燥物質−適用量は、バッチ量に対して33.11質量%である。
スプレーノズル 0.6mm
スプレー速度 27g/min/kg
スプレー圧 1.0バール
微小気候 0.6バール
供給空気流 20m3
供給空気温度 33−40℃
生成物温度 26−30℃
装置中での仕上げ乾燥時間 40℃で10分
スプレー時間 1〜1.5時間
室温Tで一晩乾燥。
部分中和されていないEUDRAGIT L30D55を有するペレットコーティング。
スプレーノズル 0.5mm
スプレー速度 1〜2g/min
スプレー圧 0.8バール
供給空気 0.7バール
供給空気温度 35〜37℃
生成物温度 32〜33℃
装置中での仕上げ乾燥時間 40℃で10分
スプレー時間 約2〜3時間
室温Tで一晩乾燥。
コーティングの製造
全てのコーティングのための出発物質として、Fa.Klinge Pharmからのテオフィリン含有率94.13%を有するテオフィリン−ペレット(710〜1250μm)を使用した。
標準EUDRAGIT(R)L30D−55製剤:
テオフィリンペレット(710〜850μm)100g上に、Huettlin Mycrolab中で、水性スプレー懸濁液を用いて 乾燥物質15.0%をスプレーする。
EUDRAGIT(R)L30D−55を含有し、リシンで15%部分中和された製剤:
テオフィリンペレット(710〜850μm)100g上に、Huettlin Mycrolab中で、水性スプレー懸濁液を用いて乾燥物質15.0%をスプレーする。懸濁液の組成:EUDRAGIT(R)L30D−55 66.7g、リシン2.5g、クエン酸トリエチル2.0g、グリセリンモノステアレート1.5g、ポリソルベート80 0.6g。USPNo.2(パドル)による0.1NHCl中2時間及び引き続くリン酸塩緩衝液(pH5.8)の後のこのペレットの作用物質放出又は残留作用物質含分は、次の通りである:
EUDRAGIT(R)L30D−55及び1層分離層としてのHPMCを有している製剤:
A.)HPMC(Methocel E5)10.0gを脱塩水132.9g中に溶かす。テオフィリンペレット(710〜850μm)100g上に、Huettlin Mycrolab中でスプレー適用を実施する。
EUDRAGIT(R)L30D−55及び3層の分離層としてのHPMC/カプリン酸/HPMCを有している製剤:
B)HPMC(Methocel E5)5.0gを脱塩水66.4g中に溶かし、テオフィリンペレット(710〜850μm)100g上に、Huettlin Mycrolab中でスプレーする。
C)カプリン酸5.0gを無水エタノール61.7g中に溶かし、B)からのペレット100.0g上に同様にHuttlin Mycrolab中でスプレーする。
D)HPMC(Methocel E5)5.0gを脱塩水66.4g中に溶かし、C)のペレット100g上に改めてスプレーする。
リシン15%で部分中和されたEUDRAGIT(R)L30D−55を有し、かつ1層の分離層としてのHPMCを有している製剤:
A)HPMC(Methocel E5 Premium)10.0gを脱塩水132.9g中に溶かし、引き続きテオフィリンペレット(710〜850μm)100g上にHuettlin Mycrolab中でスプレーする。
リシン15%で部分中和されたEUDRAGIT(R)L30D−55及び3層の分離層としてのHPMC/カプリン酸/HPMCを有する製剤:
B)HPMC(Methocel E5 Premium)5.0gを脱塩水66.4g中に溶かし、引き続きテオフィリンペレット(710〜1250μm)100g上にHuettlin Mycrolab中でスプレーする。
C)カプリン酸5.0gを無水エタノール61.7g中に溶かし、B)からのペレット100.0g上に、同様にHuettlin Mycrolab中でスプレーする。
D)HPMC(Methocel E5 Premium)5.0gを脱塩水66.4g中に溶かし、C)からのペレット100g上に改めてスプレーする。
例B1〜B6からのペレット各250mgを、USPNo.2(パドル)に従い、0.1N−HCl700ml中で2時間撹拌し、引き続きNa3PO4−溶液でpH5.8に調節する。約10ペレットの試料採取を、120分後(再緩衝の前)、140分後、145分後又は150分後に(リン酸塩緩衝液pH5.8)行う。
++ = 薄いEUDRAGIT(R)L30D−55層(5〜約20μm)
+++= 厚いEUDRAGIT(R)L30D−55層(20〜約45μm)。
Claims (27)
- 胃液抵抗性で腸液可溶性の(メタ)アクリレート−コポリマーからなるコーティング層で包囲されている作用物質含有コアを含有し、この際、コアとコーティング層との間に膜形成性の水溶性ポリマーを含有している分離層が存在する薬剤形において、この分離層は、少なくとも3層に設計されており、この際、撥水性物質を有している1つの層と、その上ならびにその下にそれぞれ、膜形成性の水溶性ポリマーを有している1つの層が存在していることを特徴とする、薬剤形。
- 膜形成性の水溶性ポリマーには、非イオン性セルロース誘導体、多糖類、ゼラチン、ポリエチレングリコール及び/又はポリビニルピロリドンが包含されることを特徴とする、請求項1に記載の薬剤形。
- 非イオン性セルロース誘導体が、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース又はカルボキシメチルセルロースナトリウムである、及び/又は多糖類が、澱粉、アミロース、アルギン酸塩、ペクチン又はキサンタンであることを特徴とする、請求項2記載の薬剤形。
- 膜形成性の水溶性ポリマーは、1%溶液(質量/質量)に対する粘度1〜20mPa・sを有するヒドロキシプロピルメチルセルロースであることを特徴とする、請求項2または3に記載の薬剤形。
- 膜形成性の水溶性ポリマーの層は、作用物質含有コアの質量に対してそれぞれ1〜50質量%に達していることを特徴とする、請求項1から4までのいずれか1項に記載の薬剤形。
- 撥水性物質は、C8〜C24−脂肪アルコール、C8〜C24−脂肪アルコールと有機酸とのエステル、C8〜C24−脂肪酸、C8〜C24−脂肪酸とアルコール又はポリアルコールとのエステルであることを特徴とする、請求項1から5までのいずれか1項に記載の薬剤形。
- C8〜C24−脂肪酸が、ステアリン酸又はカプリン酸であり、及び/又はC8〜C24−脂肪酸とアルコール又はポリアルコールとのエステルが、グリセロールモノステアレート又はグリセロールジステアレートであることを特徴とする、請求項6記載の薬剤形。
- 撥水性物質の層は、作用物質含有コアの質量に対して0.1〜25質量%に達していることを特徴とする、請求項1から7までのいずれか1項に記載の薬剤形。
- 膜形成性の水溶性ポリマーは、20℃での脱塩水中の溶解度が少なくとも50g/lであることを特徴とする、請求項1から8までのいずれか1項に記載の薬剤形。
- 撥水性物質は、20℃でのアセトン中の溶解度が少なくとも50g/lであることを特徴とする、請求項1から8までのいずれか1項に記載の薬剤形。
- 胃液抵抗性で腸液可溶性のポリマーコーティングは、アクリル酸又はメタクリル酸のC1〜C4−アルキルエステル25〜95質量%とアニオン基を有する(メタ)アクリレート−モノマー5〜75質量%とのラジカル重合単位から成っているアニオン性(メタ)アクリレート−コポリマーであることを特徴とする、請求項1から10までのいずれか1項に記載の薬剤形。
- アニオン性(メタ)アクリレート−コポリマーは、メタクリル酸40〜60質量%とメタクリル酸メチル60〜40質量%又はアクリル酸エチル60〜40質量%とのラジカル重合単位から成っていることを特徴とする、請求項1から11までのいずれか1項に記載の薬剤形。
- コーティングのアニオン性(メタ)アクリレート−コポリマーは、全て又は部分的に塩基によって、全体として部分中和されていることを特徴とする、請求項1から12までのいずれか1項に記載の薬剤形。
- (メタ)アクリレート−コポリマーのアニオン基は、全体として0.1〜25%が中和されていることを特徴とする、請求項13に記載の薬剤形。
- 塩基として、150を上回る分子量を有するカチオン性有機塩基又はリシンを含有していることを特徴とする、請求項13又は14に記載の薬剤形。
- 塩基として、ヒスチジン、アルギニン、ポリ−ヒスチジン、ポリ−アルギニン、ポリ−リシン、リン脂質、リボヌクレオシド又はデオキシリボヌクレオシド、カチオン界面活性助剤又は乳化剤からの塩基を含有していることを特徴とする、請求項15に記載の薬剤形。
- リン脂質が、ホスファチジルコリンであることを特徴とする、請求項16記載の薬剤形。
- アルギニン又はリシンとアルギニンを部分中和剤として含有していることを特徴とする、請求項16又は17に記載の薬剤形。
- ポリマーコーティングは、リシン及び/又はアルギニンを、ポリマーに対して5〜25質量%の可塑剤と組み合わせて含有していることを特徴とする、請求項16から18までのいずれか1項に記載の薬剤形。
- ポリマーコーティングは、リシン及び/又はアルギニンを、ポリマーに対して10〜30質量%の濃度で含有していることを特徴とする、請求項16から19までのいずれか1項に記載の薬剤形。
- コアは、1の作用物質、及びこの作用物質に関連して、作用物質の放出を促進する物質を含有していることを特徴とする、請求項1から20までのいずれか1項に記載の薬剤形。
- 作用物質は、ペプチド、タンパク質、核酸又は多糖類又は記載物質群の誘導体であることを特徴とする、請求項21に記載の薬剤形。
- 作用物質に関連して、作用物質の放出を促進する物質は、浸透促進剤及び/又は粘着性ポリマー及び/又は消化器官中で生じる酵素による作用物質の酵素分解を抑制する物質又はエフラックス−ポンプ−インヒビター(Pgp−インヒビター)であることを特徴とする、請求項21又は22に記載の薬剤形。
- 多粒子薬剤形、ペレット含有錠剤、ミニ錠剤、カプセル、小袋、沸騰錠剤又は乾燥ジュースの形で存在していることを特徴とする、請求項1から23までのいずれか1項に記載の薬剤形。
- 製剤学的に慣用の方法によって、請求項1から24までのいずれか1項に記載の薬剤形を製造する方法。
- 直接圧縮、乾燥顆粒、湿潤顆粒又は焼結顆粒の圧縮、押出し及び引き続く丸み付け、湿式又は乾式造粒又は直接ペレット化を用いるか又は粉末の結合(粉末成層)によって、懸濁液又は溶液を作用物質不含の球又は中性コア(ノンパレイル)又は作用物質含有粒子上に吹き付けることによって、及びスプレー法でのポリマーコーティングの適用を用いるか又は渦動床造粒によって薬剤形を製造することを特徴とする、請求項25記載の方法。
- タンパク質、ペプチド、核酸又は多糖類である作用物質又はその誘導体の薬剤形の製剤のための、請求項1から24までのいずれか1項に記載の3層の分離層を有する薬剤形の使用。
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DE102004036437A1 (de) | 2004-07-27 | 2006-03-23 | Röhm GmbH & Co. KG | Multipartikuläre Arzneiform für wenig lösliche Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform |
DE102004059792A1 (de) * | 2004-12-10 | 2006-06-14 | Röhm GmbH & Co. KG | Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Nukleinsäure-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform |
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BRPI0715247B8 (pt) | 2022-07-05 |
BRPI0715247A2 (pt) | 2012-12-25 |
PL2046304T3 (pl) | 2014-03-31 |
CN101484149A (zh) | 2009-07-15 |
IL195223A (en) | 2015-07-30 |
SI2046304T1 (sl) | 2014-02-28 |
BRPI0715247B1 (pt) | 2020-05-19 |
EP2046304A1 (de) | 2009-04-15 |
MX2009000964A (es) | 2009-02-04 |
ES2441953T3 (es) | 2014-02-07 |
CA2659026A1 (en) | 2008-01-31 |
CA2659026C (en) | 2014-05-13 |
DE102006035549A1 (de) | 2008-01-31 |
WO2008012115A1 (de) | 2008-01-31 |
US20080026051A1 (en) | 2008-01-31 |
EP2046304B1 (de) | 2013-10-09 |
KR101390079B1 (ko) | 2014-05-19 |
KR20090038438A (ko) | 2009-04-20 |
JP2009544639A (ja) | 2009-12-17 |
US7871643B2 (en) | 2011-01-18 |
CN101484149B (zh) | 2015-12-02 |
IL195223A0 (en) | 2009-08-03 |
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