JP5253235B2 - 腸溶性カプセル - Google Patents
腸溶性カプセル Download PDFInfo
- Publication number
- JP5253235B2 JP5253235B2 JP2009048494A JP2009048494A JP5253235B2 JP 5253235 B2 JP5253235 B2 JP 5253235B2 JP 2009048494 A JP2009048494 A JP 2009048494A JP 2009048494 A JP2009048494 A JP 2009048494A JP 5253235 B2 JP5253235 B2 JP 5253235B2
- Authority
- JP
- Japan
- Prior art keywords
- capsule
- weight
- enteric
- parts
- gellan gum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Description
(I-1)ヒドロキシプロピルメチルセルロース(HPMC)、ヒドロキシプロピルセルロース(HPC)、およびジェランガムを含有するフィルムからなる腸溶性カプセルであって、HPMCとHPCの総量100重量部あたりHPMCの割合が45重量部より多く80重量部より少なく、またHPCの割合が55重量部より少なく20重量部より多く、且つHPMCとHPCの総量100重量部に対するジェランガムの割合が0より多く11重量部より少ないことを特徴とする腸溶性カプセル。
(I-2)HPMCとHPCの総量100重量部あたりHPMCの割合が50〜75重量部、HPCの割合が50〜25重量部であり、且つHPMCとHPCの総量100重量部に対するジェランガムの割合が0.5〜10重量部であることを特徴とする(I-1)記載の腸溶性カプセル。
(I-3)上記ジェランガムが脱アシル型ジェランガムまたは脱アシル型ジェランガムとネイティブ型ジェランガムとの混合物である(I-1)または(I-2)記載の腸溶性カプセル。
(I-4)上記フィルムが、さらにゲル化補助剤を含有するものである、(I-1)乃至(I-3)のいずれかに記載する腸溶性カプセル。
(I-5)ゲル化補助剤が、水溶性のカルシウム塩である(I-4)に記載する腸溶性カプセル。
(I-6)ゲル化補助剤が、乳酸カルシウム、酢酸カルシウム、パントテン酸カルシウム、塩化カルシウム、臭化カルシウム、および硝酸カルシウムからなる群から選択される少なくとも1種の水溶性カルシウム塩である(I-4)に記載する腸溶性カプセル。
(I-7)上記フィルムが、さらに腸溶性基剤を含有するものである、(I-1)乃至(I-6)のいずれかに記載する腸溶性カプセル。
(I-8)腸溶性基剤が、アルギン酸の水溶性塩、カルボキシメチルセルロースの水溶性塩、LMペクチン、およびHMペクチンからなる群から選択される少なくとも1種である(I-7)に記載する腸溶性カプセル。
(II-1)HPMC、HPC、およびジェランガムを含むカプセル調製液であって、HPMCとHPCの総量100重量部あたりHPMCの割合が45重量部より多く80重量部より少なく、またHPCの割合が55重量部より少なく20重量部より多く、且つHPMCとHPCの総量100重量部に対するジェランガムの割合が0より多く11重量部より少ないカプセル調製液に、カプセル成型用ピンを浸漬して引き上げ、当該成型用ピンに付着した上記カプセル調製液を乾燥固化し、これを成型ピンから脱離回収する工程を有する、(I-1)乃至(I-3)のいずれかに記載する腸溶性カプセルの調製方法。
(II-2)カプセル調製液が、HPMCとHPCの総量100重量部あたりHPMCの割合が50〜75重量部、HPCの割合が50〜25重量部であり、且つHPMCとHPCの総量100重量部に対するジェランガムの割合が0.5〜10重量部であることを特徴とする(II-1)記載の調製方法。
(II-3)上記ジェランガムが脱アシル型ジェランガムまたは脱アシル型ジェランガムとネイティブ型ジェランガムとの混合物である(II-1)または(II-2)記載の調製方法。
(II-4)上記カプセル調製液が、さらにゲル化補助剤を含有するものである、(II-1)乃至(II-3)のいずれかに記載する調製方法。
(II-5)ゲル化補助剤が、水溶性のカルシウム塩である(II-4)に記載する調製方法。
(II-6)ゲル化補助剤が、乳酸カルシウム、酢酸カルシウム、パントテン酸カルシウム、塩化カルシウム、臭化カルシウム、および硝酸カルシウムからなる群から選択される少なくとも1種の水溶性カルシウム塩である(II-4)に記載する調製方法。
(II-7)上記カプセル調製液が、さらに腸溶性基剤を含有するものである、(II-1)乃至(II-6)のいずれかに記載する調製方法。
(II-8)腸溶性基剤が、アルギン酸の水溶性塩、カルボキシメチルセルロースの水溶性塩、LMペクチン、およびHMペクチンからなる群から選択される少なくとも1種である(II-7)に記載する調製方法。
(III-1)(I-1)乃至(I-8)のいずれかに記載する腸溶性カプセルに内容物が充填されてなる腸溶性カプセル製剤。
(III-2)内容物が食品または経口医薬品である(III-1)に記載する腸溶性カプセル製剤。
本発明の腸溶性カプセルは、ヒドロキシプロピルメチルセルロース(以下、単に「HPMC」ともいう)、ヒドロキシプロピルセルロース(以下、単に「HPC」ともいう)、およびジェランガムを後述する特定の割合で含有するカプセル皮膜(カプセルフィルム)からなり、胃環境で溶解せず、腸環境で溶解する特性、すなわち腸溶性を有することを特徴とする。
<第1液>
塩化ナトリウム2.0gに塩酸7.0mLおよび水を加えて溶かし1000mLに調整したもの(pHは約1.2)。
0.2mol/Lのリン酸二水素カリウム試液250mLに、0.2mol/Lの水酸化ナトリウム試液118mLおよび水を加えて溶かし1000mLに調整したもの(pHは約6.8)。
非置換構造単位:162.14
置換構造単位:約180(置換度1.19)、約210(置換度2.37)
重合体:約13,000(n=約70)〜約200,000(n=約1000)。
(2)カプセル調製液(浸漬液)からカプセル成型用ピンを引き上げて、当該ピンの外表面に付着したカプセル調製液をゲル化する工程(ゲル化工程(成型工程))、
(3)カプセル成型用ピンの外表面に被覆形成されたゲル化カプセルフィルム(ゲル化皮膜)を乾燥する工程(乾燥固化工程)、
(4)乾燥したカプセルフィルム(皮膜)をカプセル成型用ピンから脱離する工程(脱離工程)。
斯くして調製される硬質カプセルのボディ部とキャップ部は、前述する内容物をボディ部に充填したのち、該ボディ部にキャップ部を被覆して両者を嵌合させることによりボディ部とキャップ部を接合させることによって硬質カプセル剤として提供することができる。
硬質カプセルの原料としてヒドロキシプロピルメチルセルロース(HPMC)、ヒドロキシプロピルセルロース(HPC)、ジェランガム、ゲル化補助剤(乳酸カルシウム)、腸溶性基剤(アルギン酸ナトリウム)を用いて、表1〜5に記載する処方からなるカプセル調製液を調製した。
(1)カプセル成型性
下記の観点から、カプセル成型性を評価した。
(a)カプセル調製液の液ダレの有無
上記のカプセル調製に際して使用したカプセル調製液(50〜55℃)について、カプセル成型ピンを浸漬し引き上げたときの液ダレの有無を観察した。
(b)カプセル皮膜の亀裂の有無
各カプセル調製液(50〜55℃)にカプセル成型ピンを浸漬し引き上げ、次いでカプセル成型ピンの表面に形成された皮膜を27℃で乾燥固化させたときに、皮膜に亀裂が生じるか否かを観察した。
上記方法で成型できた硬質カプセル(成型可:○)について、耐酸性と腸溶性の有無を評価した。
(a)耐酸性試験(第15改正日本薬局方崩壊試験法第1液(pH1.2)による試験)
試験器の6本のガラス管にそれぞれに試料1個ずつを入れ、試験液に崩壊試験第1液を用いて、37±2℃で試験器を作動させた。120分後試験器を試験液から引き上げ、試料の崩壊の様子を観察した。腸溶性カプセルが壊れた場合、又は腸溶性皮膜が開口、破損した場合、崩壊したものとした(耐酸性なし)。試験を行ったすべての試料(6個)が崩壊しない場合、適合とした(耐酸性あり)。なお、1個又は2個が崩壊した場合は、更に12個の試料について試験を行い、計18個の試料のうち16個以上の試料が崩壊しない場合に、適合とした(耐酸性あり)。
(b)腸溶性試験(第14改正日本薬局方崩壊試験法第2液(pH6.8)による試験)
試験器の6本のガラス管にそれぞれに試料1個ずつを入れ、試験液に崩壊試験第2液を用い、補助盤を入れ、37±2℃で試験器を作動させた。60分後、試料の崩壊の様子を観察した。試料の残留物がガラス管内に認められないか、又は認められても皮膜若しくは海綿状の物質であるか、または軟質の物質若しくは泥状の物質がわずかのとき、試料は崩壊したものとした。試験を行ったすべての試料(6個)が崩壊した場合、適合とし(腸溶性あり)、そうでない場合を不適合とした(腸溶性なし)。
Claims (9)
- ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロース、およびジェランガムを含有するフィルムからなる腸溶性カプセルであって、ヒドロキシプロピルメチルセルロースとヒドロキシプロピルセルロースの総量100重量部あたりヒドロキシプロピルメチルセルロースの割合が45重量部より多く80重量部より少なく、またヒドロキシプロピルセルロースの割合が55重量部より少なく20重量部より多く、且つヒドロキシプロピルメチルセルロースとヒドロキシプロピルセルロースの総量100重量部に対するジェランガムの割合が0より多く11重量部より少ないことを特徴とする腸溶性カプセル。
- 上記ジェランガムが脱アシル型ジェランガムまたは脱アシル型ジェランガムとネイティブ型ジェランガムとの混合物である請求項1記載の腸溶性カプセル。
- 上記フィルムが、さらにゲル化補助剤を含有するものである、請求項1または2に記載する腸溶性カプセル。
- 上記フィルムが、さらに腸溶性基剤を含有するものである、請求項1乃至3のいずれかに記載する腸溶性カプセル。
- ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロース、およびジェランガムを含むカプセル調製液であって、ヒドロキシプロピルメチルセルロースとヒドロキシプロピルセルロースの総量100重量部あたりヒドロキシプロピルメチルセルロースの割合が45重量部より多く80重量部より少なく、またヒドロキシプロピルセルロースの割合が55重量部より少なく20重量部より多く、且つヒドロキシプロピルメチルセルロースとヒドロキシプロピルセルロースの総量100重量部に対するジェランガムの割合が0より多く11重量部より少ないカプセル調製液に、カプセル成型用ピンを浸漬して引き上げ、当該成型用ピンに付着した上記カプセル調製液を乾燥固化し、これを成型ピンから脱離回収する工程を有する、請求項1乃至4のいずれかに記載する腸溶性カプセルの調製方法。
- 上記カプセル調製液が、さらにゲル化補助剤を含有するものである、請求項5に記載する調製方法。
- 上記カプセル調製液が、さらに腸溶性基剤を含有するものである、請求項5または6に記載する調製方法。
- 請求項1乃至4のいずれかに記載する腸溶性カプセルに内容物が充填されてなる腸溶性カプセル製剤。
- 内容物が食品または経口医薬品である請求項8に記載する腸溶性カプセル製剤。
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EP3181125A4 (en) * | 2014-07-31 | 2018-01-17 | Capsugel Belgium NV | Capsule formulation |
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JPS61218516A (ja) * | 1985-03-25 | 1986-09-29 | Ichimaru Fuarukosu Kk | 徐放性マイクロカプセルの製造法 |
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