JP2010539196A - エタノールの影響に対して耐性を有する非オピオイド薬のpH依存性制御放出医薬組成物 - Google Patents
エタノールの影響に対して耐性を有する非オピオイド薬のpH依存性制御放出医薬組成物 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
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- A61P9/00—Drugs for disorders of the cardiovascular system
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Abstract
Description
本発明は、活性化合物の放出に際してエタノールの影響に対する感受性が減少したオピオイド薬でない薬物のpH依存性制御放出医薬組成物に関する。
US2003/0118641A1は、抽出可能なオピオイドを含む経口医薬形態の乱用の可能性を減らす方法を記載している。この方法では、常用の家庭用溶媒、例えばイソプロピルアルコール、ウォッカ、白ワイン酢、湯または過酸化物、希釈アルコール中0.01HClを用いることによる活性化合物抽出に対する耐性が特に得られるはずである。活性化合物にマトリックス形成ポリマーおよびイオン交換体、例えば、スチレン−ジビニルベンゼンポリマーを微粉化形態で配合することが提案されている。イオン交換体は、活性化合物抽出に対する増大した耐性の機能に極めて重要である。マトリックス形成ポリマーは、明らかに医薬コアの構造付与剤としての働きをする。可能な物質の膨大なリストは、マトリックス形成ポリマーに対して特異的であり、なかでも、ポリメタクリレートも含む。好適なマトリックス形成剤は、C1−C6ヒドロキシアルキル−セルロースである。
pH依存性制御放出医薬組成物とは、薬学的に許容されるフィルム形成ポリマー、および場合によって他の薬学的に許容される賦形剤と配合された薬剤成分を含む医薬組成物を意味し、この医薬組成物は、薬剤成分のpH依存性制御放出を示す。
pH依存性制御放出医薬組成物は、オピオイドを除く少なくとも1つの医薬活性成分を含むコアを含む。1以上のオピオイドを含む医薬組成物(オピオイド作動薬)は、明らかに本発明から除外される。
1.障害、状態、身体的損害もしくは病的症状を、治療、軽減、予防または診断するため;
2.身体の調子、状態、もしくは機能、または精神状態を明らかにするため;
3.ヒトもしくは動物の身体によって産生される活性物質または体液を置換するため;
4.病原体、寄生生物もしくは外因性物質を回避、排除または無害化するため、あるいは
5.身体の調子、状態、もしくは機能、または精神状態に影響を及ぼすために、
用いることを目的としている。
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、ゾテピンである。
薬剤成分のpH依存性制御放出とは、約pH1〜約pH7の範囲で約1pH刻みの様々なpH値で緩衝されたUSP媒体に対して、in−vitro溶解試験で医薬組成物がさらされる場合、ある時間間隔でこの媒体中に放出または溶解する薬剤成分の量が、様々なpH値を有する媒体中で有意に異なることを意味する。
コーティング層はさらに、ポリマー混合物の乾燥質量基準で計算して、110〜250、好ましくは140〜220質量%の無孔性不活性滑剤を含むことができる。
エタノール耐性医薬製剤は、エタノールの存在下で有意に影響を受けない放出動態を有する製剤である。エタノール耐性は、近い将来、重要な登録条件になり得る。特にペレット上の従来型医薬コーティングは、アルコールに対して十分耐性でない。意外にも、不溶性および可溶性フィルム形成物質を併せ持つコーティングは、アルコールに対してより高い耐性を提供する。
本発明は、経口投与用制御放出医薬品形態に由来する。この種類の医薬品形態は、通常、腸を通過する間に、活性化合物をより多くまたはより長く持続放出させることを目的とする。医薬品形態の適切な製剤を用いることによって、血液レベルでの活性化合物濃度の初期増加後、血液レベルをできるだけ長く、治療的に最適な範囲に維持できるように試みる。特に、毒性効果を有する可能性がある過度に高い活性化合物の血中濃度レベルは、回避すべきである。
in−vivo効果の予測可能性のためではなく、本発明は、客観的に理解できる測定基準としてin−vitro状態に基づく。厳しい試験条件として、USP Method 1(バスケット)に準拠したin−vitro条件(100rpm、40%(v/v)エタノールを添加および添加しない媒体中、pH6.8(欧州薬局方(EP))に緩衝)を選択することができる。
・USP Method 1(バスケット)に準拠した条件下(100rpm pH6.8で緩衝(欧州薬局方))、医薬活性成分が40%(v/v)エタノールを添加しない場合の、20%未満の程度まで放出される場合、40%(v/v)エタノールを添加した放出速度における差は、40%(v/v)エタノールを含まない対応する放出値の±15%を超えない。例えば、医薬活性成分が40%(v/v)エタノールを添加しない場合の18%の程度まで放出される条件下で、40%(v/v)エタノールを添加した放出速度は、40%(v/v)エタノールを含まない放出値と±15%を超えて異ならず、このことは、3〜33%の範囲であることを意味する。
放出される活性化合物の量(%)の測定は、例えば、各活性化合物に好適な波長でのオンラインUV分光法によって行うことができる。この方法は、当業者に周知である。
本発明は、
pH依存性制御放出医薬組成物であって、
オピオイドを除く少なくとも1つの医薬活性成分を含み、医薬組成物の放出を制御する少なくとも1つのコーティング層でコーティングされたコアを含み、
コーティング層は、
i)ポリマー混合物の乾燥質量に対して、40〜95、好ましくは50〜80質量%の少なくとも1つの水不溶性で、本質的に中性のビニルポリマーもしくはコポリマー、および
ii)ポリマー混合物の乾燥質量に対して、5〜60、好ましくは20〜50質量%の少なくとも1つのアニオン性ポリマーもしくはコポリマーであって、pH4.0未満の緩衝媒体中に不溶性であり、少なくともpH7.0〜pH8.0の範囲で可溶性であるアニオン性ポリマーもしくはコポリマー
のポリマー混合物を含み、
このコーティング層が、ポリマー混合物の乾燥質量に基づいて計算して、110〜250、好ましくは140〜220質量%の無孔性不活性滑剤をさらに含み、このコーティングが、コアの質量に基づいて計算して、少なくとも60質量%の量で存在することを特徴とする、pH依存性制御放出医薬組成物に関する。
それ自体公知の方法で、活性成分含有コアまたはペレットコアは、ビニル(コ)ポリマーのコーティングのベースを形成する。ペレット化は、活性成分を含まない球(ノンパレイユ)または無コアペレット上で実施でき、ペレットコアを生成させることができる。まず、コアを有するか、または有さない丸い活性成分含有基質を生成させる。流動床方法を用いることによって、液体をプラセボペレットまたは他の好適な担体材料に適用することができ、溶媒または懸濁剤が蒸発する。製造方法にしたがって、乾燥工程を追加することができる。スプレー工程およびその後の乾燥を、意図する量の医薬活性成分が完全に適用されるまで、数回繰り返してもよい。
− Voigt, R.(1984):Lehrbuch der pharmazeutischen Technologie [Textbook of Pharmaceutical Technology]; Verlag Chemie Weinheim − Beerfield Beach/Florida − Basle.
− Sucker, H., Fuchs, P., Speiser, P.:Pharmazeutische Technologie [Pharmaceutical Technology], George Thieme Verlag Stuttgart(1991)、特に、chapters 15 and 16, pp. 626 −642.
− Gennaro, A., R.(Editor), Remington’s Pharmaceutical Sciences, Mack Publishing Co., Easton Pennsylvania(1985), Chapter 88, pp. 1567−1573.
− List, P. H.(1982):Arzneiformenlehre [Pharmaceutical Form Theory], Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart.を参照。
コアを、少なくとも1つ、好ましくは1以上、好ましくは唯一の、医薬組成物の放出を制御するコーティング層でコーティングする。コーティング層は、エタノール含有水性媒体に対する放出特性の耐性効果を付与する。医薬組成物の放出を制御するコーティング層は、コアを取り囲んでいるので、外側コーティング層とも呼ばれる。
制御放出医薬組成物は、好ましくは、全平均直径が100〜2000、好ましくは300〜1000μmである被覆ペレットの形態で存在し得る。
制御放出医薬組成物は、好ましくは、被覆ミニ錠剤の形態で存在することができ、この場合、ミニ錠剤は1〜3mmの平均直径を有する。
水不溶性で本質的に中性のビニルポリマーまたはコポリマーは、1〜14のpH範囲全体にわたって水不溶性であり、水中で膨潤可能なだけであるポリマーまたはコポリマーを意味すると理解される。
好適な水不溶性ポリマーは、ポリ酢酸ビニルポリマー種のもの、もしくはこれから誘導されるコポリマーである。
水不溶性(メタ)アクリルコポリマーのうち、中性または本質的に中性のメタクリレートコポリマーが本発明に好適である。
中性または本質的に中性のメタクリレートコポリマーは、少なくとも95質量%を越える程度まで、特に少なくとも98質量%の程度まで、好ましくは少なくとも99質量%の程度まで、特に少なくとも99質量%の程度まで、さらに好ましくは100質量%の程度までの、中性基、特にC1−C4アルキル基を有する(メタ)アクリレートモノマーからなる。
本発明の意味での水溶性アニオン性ポリマーとは、好適な緩衝媒体中、好ましくはUSPもしくは欧州薬局方標準に準拠した緩衝媒体中に、pH5.0未満では不溶性であり、少なくともpH7.0〜pH8.0の範囲、好ましくはpH6.0〜8.0の範囲で可溶性であり、最も好ましくは、5.5〜8.0の範囲で可溶性であるポリマーである。pH7.0〜pH8.0の範囲で、好適な緩衝水性媒体中に可溶性であるほとんどのポリマーは、純水または脱塩水中に可溶性でない。
アニオン性セルロース誘導体は、天然のセルロース鎖ベースであり、アニオン性化合物で化学的に修飾されている。このポリマーは、部分的または全体的に、好ましくはアルカリイオンを用いて中和してもよい。アニオン性セルロース誘導体の例は、セルロースアセテートフタレート(CAP)、ヒドロキシプロピルメチルセルロースフタレート(HPMCP)、カルボキシメチルセルロース(CMC)、ヒドロキシルプロピルメチルセルロースアセテートスクシネート(HPMCAS)またはセルロースアセテートスクシネート(CAS)である。
好適な水溶性アニオン性(メタ)アクリレートコポリマーは、25〜95、好ましくは40〜95、特に60〜40質量%の、アクリル酸もしくはメタクリル酸のフリーラジカル重合したC1〜C4−アルキルエステル、および75〜5、好ましくは60〜5、特に40〜60質量%の、アニオン基を有する(メタ)アクリレートモノマーのフリーラジカル重合単位から構成される。
20〜34質量%のメタクリル酸および/またはアクリル酸、
20〜69質量%のメチルアクリレートおよび
0〜40質量%エチルアクリレートおよび/または必要に応じて、
0〜10質量%のビニル共重合可能なさらなるモノマー
から構成されるコポリマーである。ただし、ISO11357−2、サブセクション3.3.3に準拠したこのコポリマーのガラス転移温度は、60℃以下であるとする。この(メタ)アクリレートコポリマーは、その良好な破断時伸び特性のために、ペレットを圧縮して錠剤にするために特に好適である。
20〜33質量%のメタクリル酸および/またはアクリル酸、
5〜30質量%のメチルアクリレートおよび
20〜40質量%エチルアクリレートおよび
10〜30質量%を超えるブチルメタクリレートおよび必要に応じて
0〜10質量%のビニル共重合可能なさらなるモノマー(ここで、モノマーの割合は、合計して100質量%になる)から構成されるコポリマーである。
ただし、ISO11357−2、サブセクション3.3.3(融点Tmg)に準拠したこのコポリマーのガラス転移温度は、55〜70℃であるとする。この種のコポリマーは、その良好な機械的特性のために、ペレットを圧縮して錠剤にするために特に好適である。
20〜33、好ましくは25〜32、特に好ましくは、28〜31質量%のメタクリル酸もしくはアクリル酸(メタクリル酸が好ましい)、
5〜30、好ましくは10〜28、特に好ましくは、15〜25質量%のメチルアクリレート、
20〜40、好ましくは25〜35、特に好ましくは、18〜22質量%エチルアクリレート、および
10〜30、好ましくは15〜25、特に好ましくは、18〜22質量%のブチルメタクリレートのフリーラジカル重合単位から構成され、
ここで、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、特に好ましくは、60〜65℃であるように選択される。
アニオン性(メタ)アクリレートコポリマーを、それ自体公知の方法で、モノマーのフリーラジカル重合によって製造することができる(例えば、EP0704207A2およびEP0704208A2参照)。本発明のコポリマーは、それ自体既知の方法で、好ましくはアニオン性乳化剤の存在下、水性相中のフリーラジカル乳化重合によって、例えば、DE−C2135073に記載されている方法によって製造することができる。
アニオン性ポリマーを、塩基によって部分的または完全に中和することができる。好適な塩基は、EP0088951A2もしくはWO2004/096185またはその派生文献に明記されているものである。特に:水酸化ナトリウム溶液、水酸化カリウム溶液(KOH)、水酸化アンモニウムまたは有機塩基、例えば、トリエタノールアミン、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またはアンモニアあるいは生理学的に許容されるアミン、例えばトリエタノールアミンまたはトリス(ヒドロキシメチル)アミノメタンである。さらに好適なカチオン性有機塩基は、塩基性アミノ酸ヒスチジン、アルギニンおよび/またはリシンである。
本発明の制御放出医薬組成物は、例えば、圧縮錠、カプセル、サシェ、発泡錠または再構成可能な粉末の形態で、多粒子医薬品形態に含められたペレットの形態を有することができる。
本発明の制御放出医薬組成物は、サブコートおよび/またはトップコートでさらにコーティングすることができる。
本発明の制御放出医薬組成物は、それ自体既知の方法で、薬学的に慣例的な方法、例えば直接圧縮、乾燥、湿潤もしくは焼結顆粒の圧縮とそれに続く丸み付け、湿式もしくは乾式造粒または直接ペレット化によるか、あるいは粉末(粉末層化)を、活性成分を含まないビーズもしくは中性コア(ノンパレイユ)または活性成分を含有する粒子上に結合させること、およびスプレー方法でポリマーコーティングを適用することによるか、または流動床造粒によって製造することができる。
コアは、医薬活性成分に加えて、賦形剤もしくは慣用の添加剤をそれぞれ当業者に既知の方法でさらに含んでもよい。
顔料がさらに存在する場合、これらは好ましくはトップコートに添加される。コーティング剤に不適合な顔料を、特に、例えば撹拌することによって、例えば、(メタ)アクリレートコポリマーの乾燥質量に対して20〜400質量%の通常使用される量で分散液に直接添加すると、分散液の不安定化、凝固、不均一の兆候または同様の望ましくない効果をもたらし得るものである。さらに、使用される顔料は、もちろん、無毒で、医薬目的に好適である。これに関しては、例えば:Deutsche Forschungsgemeinschaft, Farbstoffe fuer Lebensmittel, Harald, Boldt Verlag KG, Boppard(1978); Deutsche Lebensmittelrundschau 74, No. 4, p. 156(1978); Arzneimittelfarbstoffverordnung AmFarbV of 25.08.1980を参照されたい。
さらなる添加剤は、可塑剤であってもよい。可塑剤は、コーティング層に有利に添加することができる。通常の量は、例えば、層コーティング層の(メタ)アクリレートコポリマー基準で、0〜50、好ましくは5〜20質量%である。
本発明のpH依存性制御放出医薬組成物を用いて、エタノール含有飲料の同時もしくは連続摂取(誤用)により、経口摂取後に含まれる医薬活性成分の放出が向上される危険性を低下させることができる。
モデル医薬品
メトプロロールスクシネートをモデル医薬品として使用して研究を行った。微粉化タルクを賦形剤として使用した。
被覆ペレットを USP 28−NF23, General Chapter <711>, Dissolutionに準拠して試験した。
装置:USPタイプ1(バスケット)
RPM:100/分
温度:37.5+0.5℃
溶解体積:900ml
採取体積:ピペットを用い、媒体を補充することなく、10mlを手作業で抜き取った。
溶解媒体1:
リン酸塩緩衝塩溶液pH6.8(欧州薬局方=EP)
溶解媒体2:
リン酸塩緩衝塩溶液pH6.8、EP(30%v/vアルコールを含む)−0.9gのKH2PO4、1.8gのK2HPO4、7.65gのNaClと630mlの脱塩水および270mlのアルコール。
リン酸塩緩衝塩溶液pH6.8、EP(40%v/vアルコールを含む)−0.9gのKH2PO4、1.8gのK2HPO4、7.65gのNaClと540mlの脱塩水および360mlのアルコール。
EUDRAGIT(登録商標)NEは、30質量%のエチルアクリレートおよび70質量%のメチルメタクリレートのフリーラジカル重合単位から構成されるコポリマーである。
コア:
500のノンパレイユシード(600ミクロン)に、水性ポリビニルピロリドン溶液を結合剤として使用して、従来型コーティングパン中で942gのメトプロロールスクシネートをロードした。
EUDRAGIT(登録商標)分散液を、穏やかに撹拌しながら、好適な容器中に充填するか、または混合する。滑剤および様々なポリマーを、高剪断力を加えながら、水中に溶解または分散させる。
500gの医薬品層状ペレットを適切な条件下、すなわち、適切には、コア1kgあたり20g/分のコーティング懸濁液の噴霧速度、適切には25〜30℃の床温度で、流動床装置中、様々なコーティング懸濁液でコーティングした。ペレットのポストコーティングを、40℃で、トレイ上、少なくとも2時間オーブン中で乾燥した。
500gのメトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30D(30%w/wのレベル)で、200%w/wのタルクをコーティング懸濁液中滑剤として使用して、コーティングした。コーティングを、流動床プロセッサーにおいて通常の方法パラメータを使用して適用した。
被覆ペレットは、30%v/vのレベルのアルコールでも耐性を示さず、40%のエタノールに対して耐性でないと予想されるので、本発明のポリマーの組み合わせを適用しなかった。
EUDRAGIT(登録商標)NE30D/ヒドロキシプロピルメチルセルロース(95:5)/滑剤:タルク(200%w/wのポリマー)/165%w/wのコーティング/コア
500gのコア用コーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、ヒドロキシプロピルメチルセルロース(HPMC)(5cps)をEUDRAGIT(登録商標)NE30Dと組み合わせたものでコーティングした。EUDRAGIT(登録商標)NE30Dのヒドロキシプロピルメチルセルロースに対する比は、9.5:0.5であり、200%w/wのタルクは滑剤であった。コーティングを、流動床プロセッサーにおいて通常の方法パラメータを使用して適用した。
被覆ペレットは、30%v/vのレベルのアルコールでも耐性を示さず、したがって40%のエタノールに対しても耐性を示さないと予想され、本発明のポリマーの組み合わせを適用しなかった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、1:9/滑剤:タルク(200%w/wのポリマー)/165%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(1:9比)で、200%w/wのタルクをコーティング懸濁液中滑剤として使用して、コーティングした。コーティングを、流動床プロセッサーにおいて通常の方法パラメータを用いて適用した。
被覆ペレットは、30%v/vのレベルのアルコールでも耐性を示さず、40%のエタノールに対して耐性でないと予想されるので、本発明のポリマーの組み合わせを適用しなかった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、7:3/滑剤:タルク(100%w/wのポリマー)/110%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(7:3比)で、100%w/wのタルクをコーティング懸濁液中滑剤として使用して、コーティングした。流動床プロセッサーにおいて通常の方法パラメータを使用して、コーティングを適用した。
被覆ペレットは、40%v/vレベルのアルコール中で耐性を示さず、したがって、無孔性不活性滑剤のレベルが非常に低かった。
EUDRAGIT7(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、7:3/滑剤:グリセリルモノステアレート(GMS)(50%w/wのポリマー)/94%w/wコーティング/コア
500gのコアについての94%w/wコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(7:3比)で、50%w/wのグリセリルモノステアレートをコーティング懸濁液中滑剤として使用して、コーティングしたと仮定した。コーティングは、流動床プロセッサーにおいて通常の方法パラメータを用いて適用されることを意図していた。
EUDRAGIT(登録商標)NE30DおよびEUDRAGIT(登録商標)FS30Dとの組み合わせとコーティング懸濁液中滑剤としての50%w/wのGMSを用いた、医薬品をロードしたペレットのコーティングは、ノズルが詰まるので、実際には実行可能ではなかった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、6:4/滑剤:タルク(200%w/wのポリマー)/165%w/wコーティング/コア
500gのコアについての165%w/wコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(6:4比)で、200%w/wのタルクをコーティング懸濁液中滑剤として使用して、コーティングした。流動床プロセッサーにおいて通常の方法パラメータを使用して、コーティングを適用した。
30%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
40%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、7:3/滑剤:タルク(200%w/wのポリマー)/165%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(7:3比)で、200%w/wのタルクをコーティング懸濁液中滑剤として使用して、コーティングした。流動床プロセッサーにおいて通常の方法パラメータを使用して、コーティングを適用した。
30%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
40%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
アルコール耐性配合物のpH依存性および様々なpHのアルコール性溶解媒体中でのこれらの耐性を示す。
・被覆ペレットはpH依存性であることが立証されている。
・被覆ペレットはpH依存性であることが立証されている。
・被覆ペレットはpH依存性であることが立証されている。
・被覆ペレットはpH依存性であることが立証されている。
・被覆ペレットはpH依存性であることが立証されている。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、7:3/滑剤:タルク(150%w/wのポリマー)/138%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(7:3比)で、150%w/wのタルクをコーティング懸濁液中滑剤として使用して、コーティングした。コーティングを、流動床プロセッサーにおいて通常の方法パラメータを使用して、適用した。
30%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値を、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
40%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、8:2/滑剤:タルク(200%w/wのポリマー)/165%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(8:2比)で、200%w/wのタルクを滑剤として使用してコーティングした。コーティングを、流動床プロセッサーにおいて通常の方法パラメータを使用して、適用した。
リン酸塩緩衝塩溶液pH6.8、EPおよび30%v/vアルコールを含む対応するアルコール性媒体中での比較放出特性。
30%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値を、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
40%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)L30D−55、9:1/滑剤:タルク(200%w/wのポリマー)/165%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)L30D55との混合物(9:1比)で、200%w/wのタルクを滑剤として使用して、コーティングした。流動床プロセッサーにおいて通常の方法パラメータを使用して、コーティングを適用した。
リン酸塩緩衝塩溶液pH6.8、EPおよび40%v/vアルコールを含む対応するアルコール性媒体中での比較放出特性。
40%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)L30D−55、9:1/滑剤:タルク(125%w/wのポリマー)/124%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)L30D55との混合物(9:1比)で、125%w/wのタルクを滑剤として使用してコーティイングした。流動床プロセッサーにおいて通常の方法パラメータを使用して、コーティングを適用した。
リン酸塩緩衝塩溶液pH6.8、EPおよび40%v/vアルコールを含む対応するアルコール性媒体中での比較放出特性。
40%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
EUDRAGIT(登録商標)NE30D/EUDRAGIT(登録商標)FS30D、7:3/滑剤:二酸化チタン(200%w/wのポリマー)/165%w/wコーティング/コア
500gのコアについてのコーティング懸濁液配合の詳細
メトプロロールスクシネートペレットを、EUDRAGIT(登録商標)NE30DとEUDRAGIT(登録商標)FS30Dとの混合物(7:3比)で、200%w/wの二酸化チタンをコーティング懸濁液中滑剤として使用して、コーティングした。流動床プロセッサーにおいて通常の方法パラメータを使用して、コーティングを適用した。
リン酸塩緩衝塩溶液pH6.8、EPおよび40%v/vアルコールを含む対応するアルコール性媒体中での比較放出特性。
40%v/vヒドロ−アルコール性溶解媒体中で試験した被覆ペレットの放出特性値は、アルコールを含まない溶解媒体中で試験した被覆ペレットの放出特性と比較した場合、全ての時点で耐性であった。
Claims (16)
- pH依存性制御放出医薬組成物であって、
オピオイドを除く少なくとも1つの医薬活性成分を含むコアを含み、
前記コアは、医薬組成物の放出を制御する少なくとも1つのコーティング層によってコーティングされ、
前記コーティング層は、
i)ポリマー混合物の乾燥質量に対して40〜95質量%の少なくとも1つの水不溶性で本質的に中性のビニルポリマーもしくはコポリマー、および
ii)ポリマー混合物の乾燥質量に対して5〜60質量%の少なくとも1つの、pH4.0未満の緩衝媒体中に不溶性であり、少なくともpH7.0〜pH8.0の範囲で可溶性であるアニオン性ポリマーもしくはコポリマー
のポリマー混合物を含むpH依存性制御放出医薬組成物において、
前記コーティング層が、ポリマー混合物の乾燥質量基準で計算して、110〜250質量%の無孔性不活性滑剤をさらに含み、前記コーティング層が、コアの質量基準で計算して、少なくとも60質量%の量で存在することを特徴とする、pH依存性制御放出医薬組成物。 - 無孔性不活性滑剤が、層状シリカ成分、顔料またはステアレート化合物であることを特徴とする、請求項1に記載の制御放出医薬組成物。
- 不活性滑剤がタルクであることを特徴とする、請求項2に記載の制御放出医薬組成物。
- 不活性滑剤が、ステアリン酸カルシウムまたはステアリン酸マグネシウムであることを特徴とする、請求項2に記載の制御放出医薬組成物。
- 水不溶性で本質的に中性のビニルポリマーもしくはコポリマーが、95〜100質量%のアクリル酸もしくはメタクリル酸のC1〜C4−アルキルエステルおよび5質量%未満のアクリル酸またはメタクリル酸のフリーラジカル重合単位から構成されるコポリマーであることを特徴とする、請求項1から4までのいずれか1項に記載の制御放出医薬組成物。
- 水不溶性で、本質的に中性のポリマーが、ポリ酢酸ビニルタイプのポリマーもしくはコポリマーであることを特徴とする、請求項1から4までのいずれか1項に記載の制御放出医薬組成物。
- 水溶性アニオン性ポリマーが、25〜95質量%のアクリル酸もしくはメタクリル酸のC1〜C4−アルキルエステルおよび5〜75質量%のアニオン基を有する(メタ)アクリレートモノマーのフリーラジカル重合単位から構成される(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6までのいずれか1項に記載の制御放出医薬組成物。
- USP(パドル、100rpm、pH6.8に緩衝)に準拠したin−vitro条件下、40%(v/v)のエタノールを添加した媒体および添加しない媒体中、次の特性:
・医薬活性成分が、40%(v/v)のエタノールを添加しないと20%未満の程度まで放出される場合、40%(v/v)のエタノール添加した場合の放出速度の差が、40%(v/v)のエタノールを含まない対応する放出値の±15%以下であること、
・医薬活性成分が、40%(v/v)のエタノールを添加しないと20〜80%の程度まで放出される場合、40%(v/v)のエタノールを添加した放出速度における差が、40%(v/v)のエタノールを含まない対応する放出値の±30%以下であること、
を有することを特徴とする、請求項1から7までのいずれか1項に記載の制御放出医薬組成物。 - 医薬活性成分がメトプロロールまたはメトプロロールの薬学的に許容される塩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項に記載の制御放出医薬組成物。
- 多粒子医薬品形態中に含まれるペレットの形態、例えば、圧縮錠、カプセル、サシェ、発泡錠または再構成可能な粉末の形態であることを特徴とする、請求項1から9までのいずれか1項に記載の制御放出医薬組成物。
- サブコートおよび/またはトップコートを備えていることを特徴とする、請求項1から10までのいずれか1項に記載の制御放出医薬組成物。
- 全平均直径が100〜3000μmの範囲である被覆ペレットまたはミニ錠剤の形態で存在することを特徴とする、請求項1に記載の制御放出医薬組成物。
- 被覆ペレットが、100〜700μmの範囲の全平均直径を有することを特徴とする、請求項1に記載の制御放出医薬組成物。
- 被覆ペレットまたはミニ錠剤が、1400〜3000μmの範囲の全平均直径を有することを特徴とする、請求項1に記載の制御放出医薬組成物。
- 直接圧縮、乾燥、湿潤もしくは焼結顆粒の圧縮と、それに続く丸み付け、湿式もしくは乾式造粒または直接ペレット化または粉末の活性成分を含まないビーズもしくは中性コア(ノンパレイユ)もしくは活性成分含有粒子上への結合(粉末層化)およびポリマーコーティングの噴霧方法での適用または流動床造粒によって既知の方法で請求項1から14までのいずれか1項に記載の制御放出医薬組成物を製造するための方法。
- エタノール含有飲料の同時もしくは連続摂取によって、経口摂取後に、含まれる医薬活性成分の放出が向上もしくは減少する危険性を低下させるための、請求項1から14までのいずれか1項に記載の制御放出医薬組成物の使用。
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R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
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LAPS | Cancellation because of no payment of annual fees |