JP2008231110A - ヒドロコドン放出制御製剤 - Google Patents
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Abstract
【解決手段】a)製薬上許容しうるマトリックスの中に、放出制御物質と組み合わしたヒドロコドンまたは製薬上許容しうるその塩の鎮痛有効量を含むか、またはb)複数の不活性な製薬上許容しうるビーズ上にヒドロコドンまたは製薬上許容しうるその塩の鎮痛有効量をコートし、更に放出制御物質でオーバーコートしたものを含み、ヒト患者への投与後に0.55〜約0.85のC24/Cmax比を有し、かつ、ヒト患者への投与後に少なくとも約24時間治療効果を有する、前記固体経口放出制御製剤である。
【選択図】なし
Description
本発明の特定の実施形態の目的は、疼痛対処の有効性およびその質を実質的に改善する1日1回投与に適する生体利用性のあるヒドロコドン製剤を提供することである。
特定の好ましい実施形態においては、本発明の製剤は投与後少なくとも約24時間治療効果を与える。
特定の実施形態においては、上記したインビボのパラメーターの何れかまたは全ては、1人のヒト患者またはヒト患者集団への製剤の定常的投与後に達成される。
「USPパドル法またはバスケット法」という用語は、例えば米国薬局方XXII(1990)(参照して本明細書に組み込まれる)に記載されているパドル法およびバスケット法である。
「pH非依存性」という用語は、本発明の目的のためには、pHに実質的に影響を受けない特性(即ち溶解性)を有するものとして定義される。
「放出制御」という用語は、本発明の目的のためには、約12時間かそれより長時間の期間に渡り、治療効果範囲内であるが毒性濃度より低く血中(例えば血漿中)濃度を維持するような速度での薬剤(例えばヒドロコドン)の放出として定義される。
「C24」という用語は、本明細書においては、投与後24時間における血漿中濃度である。
「W50」という用語は、本明細書においては、血漿中濃度が最高濃度の50%以上である持続時間である。
「半透過性壁部」という用語は、本発明の目的のためには、使用環境、例えば胃腸管における水性または生物学的液体のような外部液体の通過に対しては透過性であるが、薬剤に対しては非透過性であることを意味する。
「患者集団」という用語は、少なくとも2人の患者または被験者の平均薬物動態パラメーターに考察(または請求項)が関わる場合を意味する。
本発明の目的のためには、本明細書に開示した放出制御製剤および即時放出製剤は用量比例的である。このような製剤においては、薬物動態パラメーター(例えばAUCおよびCmax)は異なる用量強度間で直線的に増大する。従って、特定用量の薬物動態パラメーターは、異なる用量の同じ製剤型のパラメーターから推定することができる。
「定常状態」という用語は、系に到達する薬剤の量と、系を離れる薬剤の量とがほぼ同じであることを意味する。即ち、「定常状態」においては、血流への吸収を介して薬剤が患者の系に利用される速度とほぼ同じ速度で、薬剤が患者の身体から排除されている。
本発明の放出制御性経口製剤は、好ましくは約0.5mg〜約1250mgのヒドロコドンまたは等量の製薬上許容しうるその塩を含む。より好ましくは、該製剤は約5〜約60mg(例えば30mg)のヒドロコドンまたはその塩を含有する。ヒドロコドンの製薬上許容しうる塩の適当なものとしては重酒石酸ヒドロコドン、重酒石酸ヒドロコドン水和物、塩酸ヒドロコドン、p−トルエンスルホン酸ヒドロコドン、リン酸ヒドロコドン、ヒドロコドンチオセミカルバゾン、硫酸ヒドロコドン、トリフルオロ酢酸ヒドロコドン、ヒドロコドンヘミ5水和物、ペンタフルオロプロピオン酸ヒドロコドン、ヒドロコドンp−ニトロフェニルヒドラゾン、ヒドロコドンo−メチルオキシム、ヒドロコドンセミカルバゾン、臭化水素酸ヒドロコドン、ムチン酸ヒドロコドン、オレイン酸ヒドロコドン、2塩基性リン酸ヒドロコドン、1塩基性リン酸ヒドロコドン、ヒドロコドンの無機塩、ヒドロコドンの有機塩、酢酸ヒドロコドン3水和物、ビス(ヘプタフルオロ酪酸)ヒドロコドン、ビス(メチルカルバミン酸)ヒドロコドン、ビス(ペンタフルオロプロピオン酸)ヒドロコドン、ビス(ピリジンカルボン酸)ヒドロコドン、ビス(トリフルオロ酢酸)ヒドロコドン、ヒドロコドンクロロ水和物、硫酸ヒドロコドン5水和物が挙げられる。好ましくはヒドロコドンは重酒石酸塩として存在する。
放出制御製剤は、場合によりヒドロコドンと共にマトリクスに配合される、または薬剤を含む基剤上に徐放性コーティングとして適用される放出制御物質を含有してよい(「基剤」という用語はビーズ、ペレット、球体、錠剤、錠剤コア部等を含む)。放出制御物質は所望により疎水性でも親水性でもよい。本発明の経口製剤は例えば顆粒、球体、ペレットまたは他の多粒子系製剤として提供してよい。長時間に渡り所望の量のオピオイドを提供するのに有効な量の多粒子をカプセル内に入れるか、他の適当な経口固体剤型内に配合してよく、例えば圧縮成型して錠剤としてよい。一方、本発明の経口製剤は、放出制御コーティングにより被覆された錠剤コアとして、または薬剤と放出制御物質とのマトリクス、更に場合により他の製薬上望ましい成分(例えば希釈剤、バインダー、着色料、潤滑剤等)を含む錠剤として調製してよい。また本発明の放出制御製剤はビーズ製剤または浸透圧製剤として調製してもよい。
本発明の特定の好ましい実施形態において、放出制御製剤は、以下に記載する放出制御物質を含有するマトリクス(例えばマトリクス錠剤)を介して達成される。放出制御マトリクスを含有する剤型は、好ましい範囲内のオピオイドのインビトロ溶解速度を示し、pH依存性またはpH非依存性の態様でオピオイドを放出する。放出制御マトリクス内に含有させるのに適する物質はマトリクスを形成するために使用する方法により異なる。該経口製剤は親水性または疎水性の放出制御物質少なくとも1種を1〜80重量%で含有してよい。
別の適当な放出制御マトリクスは、アルキルセルロース(特にエチルセルロース)、C12〜C36脂肪族アルコールおよび場合によりポリアルキレングリコールを含む。
(a)上記した疎水性および/または親水性物質少なくとも1種(例えば水溶性ヒドロキシアルキルセルロース)をヒドロコドンと共に含有する顆粒を形成すること;
(b)疎水性および/または親水性物質少なくとも1種を含有する顆粒を、C12〜C36脂肪族アルコール少なくとも1種と混合すること、および、
(c)場合により顆粒を圧縮成型すること、
により行なってよい。
また本発明のマトリクスは溶融ペレット化を介して調製してもよい。このような状況において、微細分割されたオピオイドをバインダー(これも粒状形態である)および他の任意の不活性成分と共に混合し、その後混合物を、例えば高剪断回転ミキサー中で混合物を機械的に処理してペレット(顆粒、球体)とすることにより、ペレット化する。その後、そのペレット(顆粒、球体)を通篩して所望の粒径のペレットを得る。バインダー物質は好ましくは粒状であり、約40℃より高い融点を有する。適当なバインダー物質の例としては、水添ひまし油、水添植物油、他の水添脂肪、脂肪アルコール、脂肪酸エステル、脂肪酸グリセリド等が挙げられる。
更に別の実施形態において、押出し物は米国特許第4,957,681号(Klimeschら)(参照して本明細書に組み込まれる)に記載の通りに錠剤に成型することができる。
本発明の経口製剤を製剤するために使用してよい製薬上許容しうる担体および賦形剤の特定の例は、Handbook of Pharmaceutical Excipients,American Pharmaceutical Association(1986)(参照して本明細書に組み込まれる)に記載されている。
本発明の球体は、前述したマトリクス製剤または後述する直径0.1mm〜2.5mm、特に0.5mm〜2mmを有するビーズ製剤を含む。
本発明の特定の実施形態において、本発明の経口固体放出制御製剤は複数のコーティングされた物質、例えば不活性の製薬上許容しうるビーズ、例えばヌパリエル(nu pariel)18/20ビーズを含む。疎水性物質の水性分散液を用いてビーズをコーティングすることによりヒドロコドンの放出制御を達成できる。特定の実施形態においては、複数の得られた安定化固体放出制御ビーズは、摂取後、環境の液体、例えば胃液または溶解液に接触した際に、有効な放出制御用量を与えるのに十分な量でゼラチンカプセル内に入れてよい。
本発明の放出制御製剤は、浸透圧製剤としても調製してよい。浸透圧製剤は好ましくは薬剤層およびデリバリー層またはプッシュ層を含む二層コア部を包含し、ここで二層コア部は、場合により少なくとも1つの通路を配置した半透過性壁部により包囲される。特定の実施形態において、二層コア部はヒドロコドンまたはその塩を有する薬剤層および置換(displacement)層またはプッシュ層を含む。特定の実施形態においては、薬剤層は少なくとも1つの重合体ヒドロゲルを含んでもよい。重合体ヒドロゲルは約500〜約6,000,000の平均分子量を有してよい。重合体ヒドロゲルの例としては、限定ではなく、nが3〜7,500であり、かつ式(C6H12O5)n・H2Oを有するマルトデキストリン重合体であって、その数平均分子量500〜1,250,000を有するもの;ポリ(アルキレンオキシド)、例えばポリ(エチレンオキシド)およびポリ(プロピレンオキシド)であって、重量分子量50,000〜750,000のもの、より詳細には、ポリ(エチレンオキシド)であって、少なくとも1種の重量平均分子量が100,000、200,000、300,000または400,000のもの;カルボキシアルキルセルロースアルカリ、ただしアルカリはナトリウムまたはカリウムであり、アルキルはメチル、エチル、プロピルまたはブチルであり、重量平均分子量が10,000〜175,000のもの;および、エチレン−アクリル酸、例えばメタクリル酸とエタクリル酸の共重合体であって、数平均分子量が10,000〜500,000のものが挙げられる。
本発明の製剤は場合により、放出制御のために、または製剤の保護のために適する1種以上のコーティングを適用してよい。1つの実施形態において、該コーティングは、例えば胃腸内の液体に曝露された場合にpH依存性またはpH非依存性の放出をもたらすように提供される。pH非依存性のコーティングが望まれる場合は、コーティングは環境の液体、例えばGI管のpHの変化にかかわらず、最適放出を達成するように設計される。他の好ましい実施形態は、患者に対して少なくとも約12時間、好ましくは24時間まで鎮痛作用を与えることが可能な吸収特性が得られるように、胃腸(GI)管の所望の領域、例えば胃または小腸においてオピオイドを放出するpH依存性コーティングを包含する。GI管の所望の1箇所の領域、例えば胃において用量の一部を放出し、その用量の残りはGI管の別の領域、例えば小腸で放出するような組成物を製剤することも可能である。
特定の実施形態において、放出制御製剤を得るためには、例えばアルキルセルロースまたはアクリル重合体の水性分散液の十分な量で、オピオイド鎮痛剤を含有する基剤を、約2〜約50%、例えば約2〜約25%の重量増加となるように、オーバーコーティングすることが必要となる。オーバーコーティングは、治療活性剤の物理的性質および所望の放出速度、水性分散液中の可塑剤の存在およびその配合方法等により多少変動する場合がある。
アルキルセルロースなどのセルロース系の物質および重合体は、本発明の基剤、例えばビーズ、錠剤等をコーティングするのに十分に適する放出制御物質である。単なる例示であるが、1つの好ましいアルキルセルロース系重合体はエチルセルロースであるが、当業者の知るとおり他のセルロースおよび/またはアルキルセルロース重合体も単独または組み合わせて、本発明の疎水性コーティングの全体または部分として容易に使用される。
本発明の別の好ましい実施形態において、放出制御コーティングを含む放出制御物質は製薬上許容しうるアクリル重合体、例えば、限定でなく、アクリル酸およびメタクリル酸の共重合体、メチルメタクリレート共重合体、エトキシエチルメタクリレート、シアノエチルメタクリレート、ポリ(アクリル酸)、ポリ(メタクリル酸)、メタクリル酸アルキルアミド共重合体、ポリ(メチルメタクリレート)、ポリメタクリレート、ポリ(メチルメタクリレート)共重合体、ポリアクリルアミド、アミノアルキルメタクリレート共重合体、ポリ(無水メタクリル酸)、および、グリシジルメタクリレート共重合体である。
コーティングが疎水性放出制御物質の水性分散液を含む本発明の実施形態において、疎水性物質の水性分散液中に有効量の可塑剤を含有させることは放出制御コーティングの物理的特性を更に改善する。例えば、エチルセルロースは比較的高いガラス転移温度を有し、通常のコーティング条件下では可撓性膜を形成しないため、放出制御コーティングを含有するエチルセルロースコーティングには、これをコーティング材料として使用する前に、可塑剤を配合することが好ましい。一般的にはコーティング溶液中に含有される可塑剤の量は膜形成物質の濃度に基づき、最も頻繁には膜形成物質の約1〜約50重量%である。しかしながら、可塑剤の濃度は特定のコーティング溶液および適用方法を用いて慎重に実験を行なった後に適切に決定されるのみである。
本発明の放出制御製剤からの治療活性剤の放出は、1種以上の放出調節剤の添加により、またはコーティングを通過する1個以上の通路を設けることにより、更に影響を受けさせる、即ち、所望の速度に調節されることが可能である。水溶性物質に対する疎水性放出制御物質の比率は、種々の要因の中でも、必要な放出速度および選択された物質の溶解度特性により決定される。
また本発明の放出制御コーティングは、澱粉およびガム類のような腐食促進剤を含有できる。
実施例1
ヒドロコドン徐放性錠剤を以下の表1Aに記載する処方で製造した。
表1A
――――――――――――――――――――――――――――――――――――
成分 量/単位(mg) 量/バッチ(グラム)
重酒石酸ヒドロコドン 30.0 150.0
噴霧乾燥乳糖 90.0 450.0
ポビドン 8.0 40.0
オイドラギットRS30D(固体) 30.0 150.0
トリアセチン 6.0 30.0
ステアリルアルコール 50.0 250.0
タルク 4.0 20.0
ステアリン酸マグネシウム 2.0 10.0
オパドライレッドYS1-15597-A 10.0 50.0
精製水 * *
総量 230.0 1150.0
――――――――――――――――――――――――――――――――――――
*製造時に使用し、製品中には残留水分としてのみ残存。
1.造粒:オイドラギット/トリアセチン分散液を、流動床造粒装置を用いて酒石酸ヒドロコドン、噴霧乾燥乳糖およびポビドン上に噴霧する。
2.ミリング:顆粒を排出し、ミルを通過させる。
3.ワクシング:ステアリルアルコールを溶融させ、ミキサーを用いてミリングされた顆粒に添加する。放冷する。
4.ミリング:冷却した顆粒をミルに通す。
5.潤滑化:ミキサーを用いてタルクおよびステアリン酸マグネシウムで顆粒を潤滑化する。
6.圧縮:錠剤プレス機を用いて顆粒を圧縮成型して錠剤とする。
7.フィルムコーティング:錠剤に水性のフィルムコーティングを適用する。
1.装置:USPI型(バスケット)。100rpm。
2.溶媒:最初の55分間は700mlSGF、その後リン酸塩緩衝液pH7.5で900mlとする。
3.サンプリング時間:1、2、4、8および12時間。
4.分析法:高速液体クロマトグラフィー
溶解性パラメーターを以下の表1Bに示す。
表1B
――――――――――――
時間(時) 溶解度%
1 25.5
2 31.7
4 41.5
8 54.7
12 65.0
――――――――――――
ヒドロコドン徐放性錠剤を以下の表2Aに示す処方で製造した。
表2A
――――――――――――――――――――――――――――――――――――
成分 量/単位(mg) 量/バッチ(グラム)
重酒石酸ヒドロコドン 15.0 187.5
オイドラギットRSPO 78.0 975.0
ステアリルアルコール 27.0 337.5
総量 120.0 1500.0
――――――――――――――――――――――――――――――――――――
1.ミリング:ミルにステアリルアルコールフレークを通す。
2.ブレンディング:重酒石酸ヒドロコドン、オイドラギットおよびミリングされたステアリルアルコールを混合する。
3.ブレンドした材料を連続してツインスクリュー押出機に供給し、得られたストランドをコンベアー上に回収する。
4.冷却:コンベアー上でストランドを放冷する。
5.ペレット化:冷却したストランドをペレタイザーによりペレット化する。
6.スクリーニング:ペレットをスクリーニングにかけ、所望の分篩部分を回収する。
1.装置:USP I型(バスケット)。100rpm。
2.溶媒:最初の1時間は700ml SGF、その後リン酸塩緩衝液pH7.5で900mlとする。
3.サンプリング時間:1、2、4、8および12時間。
4.分析法:高速液体クロマトグラフィー。
溶解性パラメーターを以下の表2Bに示す。
表2B
――――――――――――――
時間(時) 溶解度%
SGF/SIF
1 19.5
2 26.3
4 38.2
8 54.0
12 63.8
――――――――――――――
ヒドロコドン徐放性浸透圧錠剤を以下の表3Aに示す処方で製造する。
表3A
――――――――――――――――――――――――
成分 比率
薬剤層 薬剤層の比率
重酒石酸ヒドロコドン 25.4
ポリエチレンオキシド 70.1
ポビドン 4
ステアリン酸マグネシウム 0.5
置換層 置換層の比率
ポリエチレンオキシド 68.57
塩化ナトリウム 26
ヒドロキシプロピルメチルセルロース 4.5
酸化鉄 0.6
ステアリン酸マグネシウム 0.25
BHT 0.08
半透過性壁部 半透過性壁部の比率
セルロースアセテート 95
ポリエチレングリコール 5
――――――――――――――――――――――――
必要量の重酒石酸ヒドロコドン、平均分子量200,000のポリ(エチレンオキシド)およびポリ(ビニルピロリドン)を遊星型ミキサーボウルに添加し、混合する。次に変性無水エチルアルコールをゆっくり混合物に添加し、その間混合を15分継続することにより湿性顆粒を得る。次に、新しく調製した湿性顆粒を20メッシュスクリーンに通し、室温で乾燥し、16メッシュスクリーンに通す。次に顆粒を遊星型ミキサーに移し、必要量のステアリン酸マグネシウムと混合して潤滑化する。
次に重酒石酸ヒドロコドン薬剤組成物およびプッシュ組成物をキリアン(Kilian)(登録商標)タブレットプレスにより二層錠剤に圧縮成型する。先ず、重酒石酸ヒドロコドン組成物をダイキャビティーに添加し、予備圧縮し、次に、プッシュ組成物を添加し、層を加圧して二層構造物とする。
本発明の他の多くの変形は当業者の容易に知るものであり、本発明添付の請求項の範囲内に包含される。
Claims (3)
- ヒト患者への24時間おきの投与に適する固体経口放出制御製剤であって、a)製薬上許容しうるマトリックスの中に、放出制御物質と組み合わしたヒドロコドンまたは製薬上許容しうるその塩の鎮痛有効量を含むか、またはb)複数の不活性な製薬上許容しうるビーズ上にヒドロコドンまたは製薬上許容しうるその塩の鎮痛有効量をコートし、更に放出制御物質でオーバーコートしたものを含み、
ヒト患者への投与後に0.55〜約0.85のC24/Cmax比を有し、かつ、ヒト患者への投与後に少なくとも約24時間治療効果を有する、前記固体経口放出制御製剤。 - 放出制御コーティングでコートされた錠剤の形態である、請求項1に記載の固体経口放出制御製剤。
- (a)(i)ヒドロコドンまたは製薬上許容しうるその塩の鎮痛有効量を含む薬剤層と、(ii)オスモポリマーを含む置換層と、を含む二層コア部;および
(b)該ヒドロコドンまたは製薬上許容しうるその塩の放出のための通路を配置した、二層コア部を包囲する半透過性壁部、
を含有する徐放性経口製剤であって、
該製剤は、ヒト患者への投与後に0.55〜約0.85のC24/Cmax比を有し、かつ、ヒト患者への経口投与後に少なくとも約24時間の治療効果を有する、前記徐放性経口製剤。
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