JP2013136537A - 錠剤及びその製造方法 - Google Patents
錠剤及びその製造方法 Download PDFInfo
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- JP2013136537A JP2013136537A JP2011288330A JP2011288330A JP2013136537A JP 2013136537 A JP2013136537 A JP 2013136537A JP 2011288330 A JP2011288330 A JP 2011288330A JP 2011288330 A JP2011288330 A JP 2011288330A JP 2013136537 A JP2013136537 A JP 2013136537A
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- Prior art keywords
- tablet
- acetaminophen
- starch
- particles
- coating
- Prior art date
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Abstract
【解決手段】(A)アセトアミノフェン含有被覆粒子と、(B)糖アルコール及びデンプンを含有する粒子径150〜600μmの造粒粒子とを含む錠剤。
【選択図】なし
Description
[1].(A)アセトアミノフェン含有被覆粒子と、(B)糖アルコール及びデンプンを含有する粒子径150〜600μmの造粒粒子とを含む錠剤。
[2].(B)成分中の糖アルコール:デンプンの配合質量比が、98:2〜50:50である[1]記載の錠剤。
[3].さらに、(C)香料及び/又は甘味料を含有することを特徴とする[1]又は[2]記載の錠剤。
[4].口腔内崩壊錠である[1]〜[3]のいずれかに記載の錠剤。
[5].(A)アセトアミノフェン含有被覆粒子と、(B)糖アルコール及びデンプンを含有する粒子径150〜600μmの造粒粒子とを混合し、この混合物を打錠する錠剤の製造方法。
本発明の錠剤は、(A)アセトアミノフェン含有被覆粒子と、(B)糖アルコール及びデンプンを含有する粒子径150〜600μmの造粒粒子とを含むものである。
(A)アセトアミノフェン含有被覆粒子はアセトアミノフェンが被覆されていれば特に問題はないが、水不溶性のコーティング剤で被覆されることが好ましい。なお、「水不溶性」とは、水10000mLに対する溶解する量が1gまたは1mL未満であることを示す。コーティング膜を形成するコーティング剤には、水不溶性のコーティング成分を含み、さらに可塑剤及び制酸剤を配合することができる。
(B)粒子を配合することで、(A)アセトアミノフェン含有被覆粒子の打錠時の破壊を抑制できる。糖アルコールだけだと口中崩壊性が低下し、デンプンのみだと、硬度を保つために高い打錠圧を要し、(A)アセトアミノフェン含有被覆粒子が破壊されやすくなり、結果として苦味マスキング効果が劣る。
苦味不快な味を呈するアセトアミノフェン(タイコヘルスケアジャパン(株)製)を使用した。まず、コーティング液の総固形分濃度を20質量%に調整する量の精製水に、エチルセルロース水分散液、トリアセチン及び合成ヒドロタルサイトを、固形分量で4:1:4の割合で所定量加え、よく攪拌しコーティング液を得た。次いで、流動層造粒機マルチプレックスMP−01ワースター使用(パウレック社製)を用い、アセトアミノフェン粒子800gを入れ、これに給気温度65℃、排気温度25〜40℃になる風量にて上記で調製したコーティング液を固形分総量が160gとなるよう噴霧した。これを給気温度80℃で40分間乾燥し、マスキング粒子を得た。平均粒径は200〜250μmであった。
D−マンニトール3240gとトウモロコシデンプン360gとを混ぜ、スパイラフローSFC−5型(フロイント社製)に入れ、吸気温度90℃、排気温度36〜45℃で、ヒドロキシルプロピルセルロース6%水溶液2400g噴霧し造粒した。次いで、得られた顆粒を篩い、所望の粒径の粒子を得た。
上記調製例2と同様の方法で、量を調整することにより、D−マンニトール:トウモロコシデンプン=80:20の粒子を得た。
上記調製例で得られた粒子を用いて、表3〜5に示す組成の各成分を十分混合し、混合物に、ステアリン酸マグネシウム(目開き500μmの篩を用いて篩過したもの)を投入し、軽く混合して打錠用顆粒とした。臼杵はφ11.0mm、スミ角平杵を用いて、12本立てで回転盤回転数を30rpmとし、ロータリー式打錠機により表中に記載の打錠圧で打錠して、アセトアミノフェンの含有量が100mg/錠、質量450mg、11mmの円形錠を得た。なお、比較例3は成形ができなかった。
パネラー7人が錠剤1錠を口に含み、舌と上顎でシアーをかけて溶解した際に感じた苦味の強さを、下記5段階で評価し平均値を算出した。
<評価点>
5:苦味を感じない
4:苦味をやや感じる
3:苦味を少し感じる
2:苦味をかなり感じる
1:苦味を非常に感じる
結果を、上記で得られた平均値に基づき、下記基準で示す。
<基準>
◎:4.5以上
○:4以上4.5未満
△:3以上4未満
×:3未満
日本薬局方パドル法に準拠する溶出試験を行った。口腔内における唾液での溶出性の代替として唾液のpHを想定したpH6.8の緩衝液を用いて行った。溶出率(%)とは1サンプルに含まれる成分量を100%とした場合、それに対する溶出した成分量の割合を示す。(A)の被覆粒子の被覆が破壊されていると、薬物の溶出率が高くなり、苦味が出るため、苦味評価の指標となる。
結果を、上記で得られた30分後の溶出率(%)から、下記基準で示す。
<基準>
◎:35%未満
○:35%以上45%未満
△:45%以上60%未満
×:60%以上
なお、この評価において、30分後の溶出率が60%未満であれば、上記苦味マスキング試験の評価点3以上である。実施例の結果から、苦味マスキングの結果と、口中の溶出率の結果には相関性がみられた。
パネラー7人が錠剤1錠を口に含み、舌と上顎でシアーをかけて溶解した際の崩壊性を下記3段階で評価した。評価基準:錠剤が崩壊すれば許容できる。
<基準>
○:容易に崩壊する
△:崩壊する
×:崩壊しづらい
実施例で得られた錠剤は、口腔内の唾液のみで、舌と上顎によるシアーや咀嚼により口腔内で錠剤を崩壊でき、口腔内崩壊錠として適していた。
アセトアミノフェン含有顆粒720g、マンニトール造粒品1914g、スクラロース、ピーチフレーバー、メントール/トウモロコシデンプン粉砕品を十分混合し、滑沢剤のステアリン酸マグネシウムを目開き500μmの篩を用いて篩過した後所定量投入し、軽く混合して打錠用顆粒とする。臼杵はφ11.0mm、スミ角平杵を用いて、12本立てで回転盤回転数を30rpmとしロータリー式打錠機によりアセトアミノフェンの含有量が100mg/錠になるように単層錠を作製し、粉全量を打錠し終わった際の盤・杵の様子を観察する。
結果を下記基準で示す(目視で粉の付着がみられなければ杵付着はしていないと判断した)。
<基準>
○:粉の付着が見られない
×:粉の付着が見られる
Claims (5)
- (A)アセトアミノフェン含有被覆粒子と、(B)糖アルコール及びデンプンを含有する粒子径150〜600μmの造粒粒子とを含む錠剤。
- (B)成分中の糖アルコール:デンプンの配合質量比が、98:2〜50:50である請求項1記載の錠剤。
- さらに、(C)香料及び/又は甘味料を含有することを特徴とする請求項1又は2記載の錠剤。
- 口腔内崩壊錠である請求項1〜3のいずれか1項記載の錠剤。
- (A)アセトアミノフェン含有被覆粒子と、(B)糖アルコール及びデンプンを含有する粒子径150〜600μmの造粒粒子とを混合し、この混合物を打錠する錠剤の製造方法。
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JP2016520100A (ja) * | 2013-11-13 | 2016-07-11 | ▲財▼▲団▼法人国防教育研究基金会National Defense Education And Research Foundation | 肝臓に対する副作用がない、新しいアセトアミノフェン複合組成 |
JP2018158928A (ja) * | 2018-05-25 | 2018-10-11 | ▲財▼▲団▼法人国防教育研究基金会National Defense Education And Research Foundation | 肝臓に対する副作用がない、新しいアセトアミノフェン複合組成 |
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JP2018158928A (ja) * | 2018-05-25 | 2018-10-11 | ▲財▼▲団▼法人国防教育研究基金会National Defense Education And Research Foundation | 肝臓に対する副作用がない、新しいアセトアミノフェン複合組成 |
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