JP2020103185A - 密封容器入り発泡性経口錠剤 - Google Patents
密封容器入り発泡性経口錠剤 Download PDFInfo
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- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
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Abstract
Description
(A) 酒石酸及びその塩から選ばれる1種以上 0.1質量%以上22質量%以下
(B) クエン酸、アスコルビン酸及びそれらの塩から選ばれる1種以上
(C) 炭酸塩から選ばれる1種以上 14質量%以上30質量%以下
成分(A)は酒石酸及びその塩から選ばれる1種以上である。成分(A)が酒石酸塩である場合、塩としてはアルカリ金属塩が好ましく、なかでもナトリウム塩、カリウム塩から選ばれる1種以上が好ましく、更にはナトリウム塩が好ましい。
成分(B)は、クエン酸、アスコルビン酸及びそれらの塩から選ばれる1種以上である。成分(B)がクエン酸塩又はアスコルビン酸塩である場合、服用時の良好な味を実現する観点から、塩としてはアルカリ金属塩が好ましく、なかでもナトリウム塩、カリウム塩から選ばれる1種以上が好ましく、更にはナトリウム塩が好ましい。成分(B)としては、いずれかを単独で又は2種以上を組み合わせて用いることができ、口中での優れた発泡速度を実現する観点、容器の膨れを抑制する観点、及び開封後の吸湿を抑制する観点から、クエン酸又はその塩と、アスコルビン酸又はその塩とを組み合わせて用いることが好ましい。
成分(C)は、炭酸塩から選ばれる1種以上である。炭酸塩としては、例えば、炭酸ナトリウム、炭酸水素ナトリウム、炭酸カリウム、炭酸水素カリウム、炭酸アンモニウム、セスキ炭酸ナトリウム等が挙げられる。これらは単独で又は2種以上を組み合わせて用いることができる。なかでも、口中での優れた発泡速度を実現する観点から、好ましくは炭酸ナトリウム、炭酸水素ナトリウム、炭酸カリウムから選ばれる1種以上であり、より好ましくは炭酸水素ナトリウムである。
本発明の発泡性経口錠剤を製造するには、成分(A)〜(C)のほか必要に応じて添加される添加剤を混合し、その混合物を原料粉末として直接打錠成形機で圧縮して成形しても、乾式造粒法、湿式造粒法等を用いて造粒してから、造粒物を打錠成形機で圧縮して成形してもよい。打錠成形機としてはロータリー式打錠機や単発式打錠機等通常使用されるものを用いることができる。打錠時の圧縮成型圧は、成型物の硬度維持の点から、10〜30MPa程度が好ましい。また、錠剤硬度は、運搬や保存等に耐え得る硬度であることが好ましく、具体的には10N〜200N程度が好ましい。
(A) 酒石酸及びその塩から選ばれる1種以上 0.1質量%以上22質量%以下
(B) クエン酸及びその塩から選ばれる1種以上
(C) 炭酸塩から選ばれる1種以上 14質量%以上30質量%以下
(A) 酒石酸及びその塩から選ばれる1種以上 0.1質量%以上22質量%以下
(B1) クエン酸及びその塩から選ばれる1種以上
(B2) アスコルビン酸及びその塩から選ばれる1種以上
(C) 炭酸塩から選ばれる1種以上 14質量%以上30質量%以下
(A) 酒石酸及びその塩から選ばれる1種以上 0.1質量%以上22質量%以下
(B) クエン酸、アスコルビン酸及びそれらの塩から選ばれる1種以上
(C) 炭酸塩から選ばれる1種以上 14質量%以上30質量%以下
(A) 酒石酸及びその塩から選ばれる1種以上 0.1質量%以上22質量%以下
(B) クエン酸及びその塩から選ばれる1種以上
(C) 炭酸塩から選ばれる1種以上 14質量%以上30質量%以下
(A) 酒石酸及びその塩から選ばれる1種以上 0.1質量%以上22質量%以下
(B1) クエン酸及びその塩から選ばれる1種以上
(B2) アスコルビン酸及びその塩から選ばれる1種以上
(C) 炭酸塩から選ばれる1種以上 14質量%以上30質量%以下
恒温槽中に水で満たした状態の100mLメスシリンダーを逆さに立てる。そのメスシリンダーの中に各錠剤2錠ずつ入れ溶解させる。その際に1分あたりにメスシリンダー内にたまる泡量を発泡量とし、発泡性の指標とした。数値が高いほど、発泡性に優れることを表す。
25℃75%の恒温槽内に各錠剤を入れ、24時間後の外観上の変化を確認し、下記基準に従って評価した。
4:ほとんど変化がない
3:ごくわずかに変化がみられる
2:わずかに変化が見られる
1:錠剤が発泡により変形している
各錠剤をアルミピロー(60mm×60mm)に入れて密封後、60℃の恒温槽で1週間時間保存した。保存前後のピローの体積をアルキメデス法によって測定し、保存前後のピローの体積変化量を計算した。数値が低いほど、膨れが抑制できていることを示す。
3名のパネラーにより、タブレット1錠を口に入れた際の発泡感について、下記基準に従って評価した。評価結果は、3名の協議により決定した。基準を4段階に分け、服用時に心地良い発泡感をかなり強く感じつ実施例5を評価基準の4とし、服用時に心地良い発泡感をあまり感じない比較例15を1として評価した。
4:心地良い発泡感をかなり強く感じる
3:心地良い発泡感を強く感じる
2:心地良い発泡感をやや感じる
1:心地良い発泡感をあまり感じない
マルチトール:アマルティMR-50(三菱商事フードテック(株))
酒石酸:L-酒石酸(扶桑化学工業(株))
クエン酸:クエン酸フソウ(無水)(扶桑化学工業(株))
アスコルビン酸:ビタミンC TypeS(扶桑化学工業(株))
重曹:重曹(食添C)(東ソー(株))
ステアリン酸カルシウム:ステアリン酸カルシウム(太平化学(株))
粉末セルロース:KC-フロックW-400G(日本製紙(株))
二酸化ケイ素:カープレックス FPS-500(EVONIK社)
アスパルテーム:PALSWEETDIET(味の素(株))
Claims (4)
- 下記成分(A)〜(C)を含有し、成分(B)の酸基のモル数の成分(A)の酸基のモル数に対する比(HB)/(HA)が、成分(B)がクエン酸又はその塩のみからなるか、アスコルビン酸又はその塩のみからなる場合には0.1以上4.0以下、成分(B)がクエン酸又はその塩とアスコルビン酸又はその塩との組合せからなる場合には0.05以上5.5以下であり、かつ成分(A)及び(B)の酸基の合計モル数の成分(C)のモル数に対する比[(HA)+(HB)]/(C)が0.7以上1.35以下である、密封容器入り発泡性経口錠剤。
(A) 酒石酸及びその塩から選ばれる1種以上 0.1質量%以上22質量%以下
(B) クエン酸、アスコルビン酸及びそれらの塩から選ばれる1種以上
(C) 炭酸塩から選ばれる1種以上 14質量%以上30質量%以下 - 成分(B)がクエン酸又はその塩とアスコルビン酸又はその塩からなるものである請求項1に記載の密封容器入り発泡性経口錠剤。
- チュアブル錠である請求項1又は2に記載の密封容器入り発泡性経口錠剤。
- 更に糖アルコールを含有する、請求項1〜3のいずれか1項に記載の密封容器入り発泡錠剤。
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JP2018246294A JP2020103185A (ja) | 2018-12-27 | 2018-12-27 | 密封容器入り発泡性経口錠剤 |
KR1020217019509A KR20210095663A (ko) | 2018-12-27 | 2019-12-24 | 밀봉 용기에 들어있는 발포성 경구 정제 |
TW108147393A TW202038919A (zh) | 2018-12-27 | 2019-12-24 | 密封容器裝之發泡性經口錠劑 |
PCT/JP2019/050523 WO2020138036A1 (ja) | 2018-12-27 | 2019-12-24 | 密封容器入り発泡性経口錠剤 |
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Citations (5)
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JPS61207322A (ja) * | 1985-03-11 | 1986-09-13 | Sunstar Inc | アスコルビン酸含有発泡性固形組成物 |
WO1999027901A1 (fr) * | 1997-12-03 | 1999-06-10 | Kao Corporation | Preparation solide pour l'hygiene buccale |
JP2001008666A (ja) * | 1999-06-30 | 2001-01-16 | Otsuka Pharmaceut Co Ltd | オリゴ糖補給組成物 |
JP2017036232A (ja) * | 2015-08-10 | 2017-02-16 | 花王株式会社 | 固形状組成物 |
JP2018083763A (ja) * | 2016-11-21 | 2018-05-31 | 花王株式会社 | 口腔内発泡製剤及びその製造法 |
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GB8724763D0 (en) * | 1987-10-22 | 1987-11-25 | Aps Research Ltd | Sustained-release formulations |
JP2818892B2 (ja) * | 1989-10-02 | 1998-10-30 | 大塚製薬 株式会社 | 発泡製剤 |
JPH04327526A (ja) * | 1991-04-26 | 1992-11-17 | Lion Corp | 経口用固形製剤 |
WO1997004754A1 (de) * | 1995-07-31 | 1997-02-13 | Gerhard Gergely | Kautablette mit brausewirkung |
JPH09291039A (ja) * | 1995-12-26 | 1997-11-11 | Suntory Ltd | プロシアニジンを有効成分とする抗肥満剤 |
US6077539A (en) * | 1996-11-12 | 2000-06-20 | Pozen, Inc. | Treatment of migraine headache |
JP4475693B2 (ja) * | 1998-08-28 | 2010-06-09 | 大鵬薬品工業株式会社 | アセトアミノフェン含有発泡組成物 |
JP3809132B2 (ja) | 2002-06-14 | 2006-08-16 | 花王株式会社 | キャンディ |
JP5779961B2 (ja) * | 2011-04-26 | 2015-09-16 | ユーハ味覚糖株式会社 | 発泡性食品及びその製造方法 |
US20130280176A1 (en) * | 2012-04-18 | 2013-10-24 | Mallinckrodt Llc | Immediate Release Pharmaceutical Compositions with Abuse Deterrent Properties |
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Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS61207322A (ja) * | 1985-03-11 | 1986-09-13 | Sunstar Inc | アスコルビン酸含有発泡性固形組成物 |
WO1999027901A1 (fr) * | 1997-12-03 | 1999-06-10 | Kao Corporation | Preparation solide pour l'hygiene buccale |
JP2001008666A (ja) * | 1999-06-30 | 2001-01-16 | Otsuka Pharmaceut Co Ltd | オリゴ糖補給組成物 |
JP2017036232A (ja) * | 2015-08-10 | 2017-02-16 | 花王株式会社 | 固形状組成物 |
JP2018083763A (ja) * | 2016-11-21 | 2018-05-31 | 花王株式会社 | 口腔内発泡製剤及びその製造法 |
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