JP2012533584A - 加熱溶融押出成型した制御放出性投与剤型 - Google Patents
加熱溶融押出成型した制御放出性投与剤型 Download PDFInfo
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Abstract
Description
− 医薬投与剤型のコアが、加熱溶融押出成型により引き起こされた、投与剤型の長手方向の伸長に対して実質的に直角である形態学的方向性を有し、かつ/または
− 薬理学的に活性な成分の、前側および向かい合う後側を通しての放出が、周縁を通しての放出よりも速い。
− 医薬投与剤型のコアが、加熱溶融押出成型により引き起こされた、投与剤型の長手方向の伸長に対して実質的に直角である形態学的方向性を有し、かつ/または
− 薬理学的に活性な成分(A)の、前側および向かい合う後側を通しての面積当たりの放出が、周縁を通しての放出よりも速い。
D1:c>a≧b;c>a>b;
D2:c>1.5a;c>2a;c>2.5a;c>3a;
D3:a2>a1≒a3;a2>1.1a1≒1.1a3;a2>1.2a1≒1.2a3;a2>1.3a1≒1.3a3;
D4:b2≧b1≒b3;b2≧1.1b1≒1.1b3;b2≧1.2b1≒1.2b3;b2≧1.3b1≒1.3b3;
D5:b2≦b1≒b3;b2≦0.9b1≒0.9b3;b2≦0.8b1≒0.8b3;b2≦0.7b1≒0.7b3;および/または
D6:c2>c1≒c3;c2>1.1c1≒1.1c3;c2>1.2c1≒1.2c3;c2>1.3c1≒1.3c3
である。
S≧A・W2/3、
式中、Aは、少なくとも4.5である、すなわち、S≧4.5・W2/3である。
投与剤型中に最初に含有させる薬理学的に活性な成分(A)の総重量に対して、
0.5時間後に少なくとも5重量%、
1時間後に少なくとも10重量%、
3時間後に少なくとも20重量%、
6時間後に少なくとも35重量%、および
12時間後に少なくとも55重量%。
− 少なくとも0.2・106g/モルの重量平均分子量(Mw)または粘度平均分子量(Mη)を有するポリアルキレンオキシドを、
− ポリエチレン、ポリプロピレン、ポリ塩化ビニル、ポリカーボネート、ポリスチレン、ポリアクリル酸、ポリ(ヒドロキシ脂肪酸)、ポリカプロラクトン、ポリビニルアルコール、ポリエステルアミド、ポリエチレンコハク酸、ポリラクトン、ポリグリコリド、ポリウレタン、ポリビニルピロリドン、ポリアミド、ポリラクチド、ポリラクチド/グリコリド、ポリラクトン、ポリグリコリド、ポリオルトエステル、ポリ酸無水物、ポリエチレングリコールとポリブチレンテレフタレートとのブロックポリマー、ポリ酸無水物、ポリアセタール、セルロースエステル、セルロースエーテル、およびそれらのコポリマーからなる群から選択される少なくとも1つのさらなるポリマーであって、好ましくはまた、少なくとも0.2・106g/モルの重量平均分子量(Mw)または粘度平均分子量(Mη)も有するが必ずしもそうとは限らないポリマー
と組み合わせて含む。セルロースエステルおよびセルロースエーテル、例えば、メチルセルロース、エチルセルロース、ヒドロキシメチルセルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース等が特に好ましい。
i)構成成分(A)、構成成分(C)、場合により、構成成分(B)および/もしくは構成成分(D)を混合するステップと、
ii)押出成型機中で、得られた混合物を少なくとも構成成分(C)の軟化点まで加熱し、こうして加熱した混合物を、力を加えることによって、押出成型機の出口のオリフィスを通して押出成型するステップと、
iii)まだ柔軟な押出成型品を小分けし、前記小分け押出成型品から医薬投与剤型を形成するステップ、または
iv)冷却もしくは場合により再加熱した小分け押出成型品から、医薬投与剤型を形成するステップと
を含む。
(a)
− 薬理学的に活性な成分(A)、および
− ポリマー(C)
を含む塊を、楕円形の金型を通して加熱溶融押出成型し、それによって、楕円形の横断面を有する押出成型品を得るステップと、
(b)前記押出成型品を、楕円形の形状の2つの対向する切断表面を有する切片に(好ましくは、押出成型方向に対して実質的に直角の平面で)切断するステップと、
(c)前記切片を、上部パンチおよび下部パンチを含む打錠ツール中に、楕円形の形状の対向する表面が前記上部および下部のパンチそれぞれに面するように置くステップと、
(d)切片から投与剤型をプレス成型するステップと、
(e)場合により、フィルムコーティングを塗布するステップと
を含む。
− 偶発的な誤用(例えば、意図的でない誤用)、
− 娯楽目的の誤用、および
− 常習的な薬物の誤用
を回避するのに適切である。
測定寸法5*15mmおよび7*18mmを有する、楕円形の形状の押出成型の金型を検討した。
粉末ブレンドを調製した。ここで、組成を、以下の表に示す。
a)押出成型
押出成型を、Leistritz(登録商標)PH27micro二軸スクリュー式押出成型機上で、処理量を3.5kg/時間に低下させて実施した。個々の加熱帯域の温度を、30℃〜135℃の値に調節した。
切断を、円形の押出成型品については、Schlicht(登録商標)CC250切断機を使用して、および楕円形の形状の押出成型品については、パン用スライサーを手動で使用して行った。手作業の切断の結果、これらに限定されないが、はるかにより多くの表面の欠陥を含めて、押出成型品の極めて劣った品質を得た。
錠剤の形成を、Korsch(登録商標)EK0上で、7*17mmのH9フォーマットについて実施した。その他の錠剤は全て、Kilian(登録商標)S250上で成形した。
a)寸法
寸法を、手動ノギスを使用して測定した。
破砕に対する抵抗力を、平ブラケットを有するSotax(登録商標)HT100上で測定した。錠剤の方向性は縦であった。
溶解を、Ph Eur.2.9.3(非特許文献31)に従って、シンカーを有するパドル装置中の擬似腸液(900ml、pH6.6、KH2PO4+NaOH)中、回転スピード50rpm、37℃で測定した。それぞれの試料について、6回測定した(n=6)。放出を、UV分光法により271nmでモニターした。
a)押出成型−例1
押出成型は、いずれの予想外の課題も伴うことなく、可能であった。ぴったり同一の押出成型機の設定を使用したので、目覚しい観察結果を得ることができる。
押出成型は、いずれの予想外の課題も伴うことなく、可能であった。ぴったり同一の押出成型機の設定を使用したので、目覚しい観察結果を得ることができる。
図6:7*17mmの楕円形の錠剤に成形した例1の溶解プロファイル、平均、n=3
図7:7*17mmのH9形状の錠剤に成形した例1の溶解プロファイル、平均、n=3
図8:9*21mmの楕円形の錠剤に成形した例2の溶解プロファイル、平均、n=3
図9:9*21mmのH0形状の錠剤に成形した例2の溶解プロファイル、平均、n=3
図10:8.6*22.6mmのH1形状の錠剤に成形した例2の溶解プロファイル、平均、n=3
図11:例1の溶解:円形の押出成型品からのH9フォーマットと、楕円形の押出成型品からの楕円形フォーマットとの比較、平均、n=3
図12:例2の溶解:円形の押出成型品からのH0フォーマットと、楕円形の押出成型品からの楕円形フォーマットとの比較、平均、n=3
粉末ブレンドを調製した。ここで、組成を、以下の表に示す。
Claims (14)
- ポリマー(C)を含むマトリックス中に包埋させた薬理学的に活性な成分(A)の制御放出を示す、加熱溶融押出成型した医薬投与剤型であって、前記投与剤型が、長手方向の伸長、長手方向の伸長に対して直角の、横方向の伸長、前側、向かい合う後側、および前記前側と後側との間の周縁を含む楕円形の形状を有し、
− 医薬投与剤型のコアが、加熱溶融押出成型により引き起こされた、投与剤型の長手方向の伸長に対して実質的に直角である形態学的方向性を有し、かつ/または
− 薬理学的に活性な成分(A)の、前側および向かい合う後側を通しての面積当たりの放出が、周縁を通しての放出よりも速い
投与剤型。 - 加熱溶融押出成型により引き起こされた形態学的方向性が、投与剤型の横方向の伸長に対して実質的に直角である、請求項1に記載の投与剤型。
- 一体型のコアを含む、請求項1または2のいずれか一つに記載の投与剤型。
- 薬理学的に活性な成分(A)が、オピオイドである、請求項1〜3のいずれか一つに記載の投与剤型。
- ポリマー(C)が、少なくとも200,000g/モルの重量平均分子量を有するポリアルキレンオキシドである、請求項1〜4のいずれか一つに記載の投与剤型。
- ポリマー(C)の含有量が、投与剤型の総重量に対して少なくとも30重量%である、請求項1〜5のいずれか一つに記載の投与剤型。
- 長手方向の伸長と横方向の伸長の相対的な長さの比が、少なくとも1.1:1である、請求項1〜6のいずれか一つに記載の投与剤型。
- フィルムコーティングを含む、請求項1〜8のいずれか一つに記載の投与剤型。
- 人工胃液中のin vitroの条件下では、薬理学的に活性な成分(A)を以下の放出プロファイル:
投与剤型中に最初に含有させる薬理学的に活性な成分(A)の総重量に対して、
0.5時間後に少なくとも5重量%、
1時間後に少なくとも10重量%、
3時間後に少なくとも20重量%、
6時間後に少なくとも35重量%、および
12時間後に少なくとも55重量%。
に従って放出する、請求項1〜8のいずれか一つに記載の投与剤型 - ポリマー(C)を含むマトリックス中に包埋させた薬理学的に活性な成分(A)の制御放出を示す、加熱溶融押出成型した医薬投与剤型を製造するための方法あって、前記投与剤型が、少なくとも300Nの破壊強度を示し、長手方向の伸長、長手方向の伸長に対して直角の、横方向の伸長、前側、向かい合う後側、および前記前側と後側との間の周縁を含む楕円形の形状をし、前記方法が、
(a)
− 薬理学的に活性な成分(A)、および
− ポリマー(C)
を含む塊を、
楕円形の金型を通して加熱溶融押出成型し、それによって、楕円形の横断面を有する押出成型品を得るステップと、
(b)前記押出成型品を、楕円形の形状の2つの対向する切断表面を有する切片に切断するステップと、
(c)前記切片を、上部パンチおよび下部パンチを含む打錠ツール中に、楕円形の形状の対向する表面が前記上部および下部のパンチそれぞれに面するように置くステップと、
(d)切片から投与剤型をプレス成型するステップと、
(e)場合により、フィルムコーティングを塗布するステップと
を含む方法。 - 請求項1〜9に記載のいずれか一つに記載の投与剤型を製造するためのものである、請求項10に記載の方法。
- ステップ(a)を、w型二軸スクリュー式押出成型機により実施する、請求項10または11のいずれか一つに記載の方法。
- ステップ(b)で得られた切片の総表面の少なくとも50%が、2つの対向する切断表面により形成される、請求項10〜12に記載のいずれか一つに記載の方法。
- 請求項10〜13に記載のいずれか一つに記載の方法により得ることができる、加熱溶融押出成型した医薬投与剤型。
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WO2006076191A2 (en) * | 2005-01-10 | 2006-07-20 | Elc Management Llc | Discontinuous surface coating for particles |
DE102005005449A1 (de) * | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
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CL2011002968A1 (es) | 2012-05-18 |
BR112012001547A2 (pt) | 2016-03-08 |
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ZA201109445B (en) | 2012-08-29 |
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CA2765971C (en) | 2017-08-22 |
KR101738369B1 (ko) | 2017-05-22 |
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JP5667183B2 (ja) | 2015-02-12 |
NZ596667A (en) | 2013-09-27 |
ES2534908T3 (es) | 2015-04-30 |
CO6470796A2 (es) | 2012-06-29 |
EP2456427B1 (en) | 2015-03-04 |
CA2765971A1 (en) | 2011-01-27 |
PL2456427T3 (pl) | 2015-07-31 |
CN102573805A (zh) | 2012-07-11 |
ECSP12011597A (es) | 2012-02-29 |
AU2010275753B2 (en) | 2014-08-21 |
EP2456427A1 (en) | 2012-05-30 |
MX2012000317A (es) | 2012-02-08 |
AR077493A1 (es) | 2011-08-31 |
HK1167811A1 (en) | 2012-12-14 |
RU2012106163A (ru) | 2013-08-27 |
US20110038930A1 (en) | 2011-02-17 |
RU2547555C2 (ru) | 2015-04-10 |
IL216526A0 (en) | 2012-02-29 |
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