JP2008037804A - 用時調製が可能なゼリー状医薬品 - Google Patents
用時調製が可能なゼリー状医薬品 Download PDFInfo
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Abstract
【解決手段】冷水に可溶なペクチン、アルギン酸ナトリウム、カラギーナン、キサンタンガム、ローカストビーンガム、グアガム、タラガムのいずれか1種以上を使用することにより、用時調製が可能なゼリー状医薬品を提供する。
【選択図】図1
Description
用時調製のゼリー剤は以下のように調製した。なお、薬物としては苦みが強いことが知られているアセトアミノフェンを使用した。
アセトアミノフェン0.3g、ペクチン0.15g、粉末還元麦芽糖水アメ1.798g、クエン酸0.008g、フマル酸0.004g、第二リン酸カルシウム0.032g及びアスパルテーム0.008gを粉末の状態で良く混合したものをカップ容器に入れた。
アセトアミノフェン0.3g、キサンタンガム0.3g、タラガム0.1g、粉末還元麦芽糖水アメ1.3g、溶性デンプン1.3g、アスパルテーム0.2g及びアセスルファムカリウム0.032gを粉末の状態で良く混合したものをカップ容器に入れた。
アセトアミノフェン0.3g、キサンタンガム0.3g、グアガム0.1g、粉末還元麦芽糖水アメ1.3g、溶性デンプン1.3g、アスパルテーム0.2g及びアセスルファムカリウム0.032gを粉末の状態で良く混合したものをカップ容器に入れた。
アセトアミノフェン0.3g、カンテン0.1g、粉末還元麦芽糖水アメ2g、アスパルテーム0.2g及びアセスルファムカリウム0.032gを粉末の状態で良く混合したものをカップ容器に入れた。
アセトアミノフェン0.3g、ゼラチン0.2g、粉末還元麦芽糖水アメ1g、アスパルテーム0.2g及びアセスルファムカリウム0.032gを粉末の状態で良く混合したものをカップ容器に入れた。
本発明により得られた用時調製ゼリー剤が徐放性の機能を有することを明らかにするため、薬物として抗てんかん薬であるバルプロ酸ナトリウムの徐放性顆粒を選定し、実施例に倣い、ゼリー化した。これについて溶出試験を実施した。溶出試験の実施にあたっては、医療用医薬品 品質再評価に伴う品質情報集(オレンジブック)に公的溶出試験法として掲載されている、バルプロ酸ナトリウム徐放性顆粒の溶出試験法に準じて実施し、溶出試験結果の妥当性を評価した。
図1に示すように、用時調製ゼリー剤と徐放性顆粒製剤の溶出試験結果はほぼ同じであり、両製剤ともオレンジブックに記載されている溶出規格(溶出3時間後 溶出率15〜45%、溶出6時間後 溶出率35〜65%、溶出24時間後 溶出率75%以上)を満たしていた。このことから、本発明の用時調製ゼリー剤は、徐放性を有することが確認出来た。
Claims (8)
- 医薬品としての有効性を有する薬物を含有し、使用時に温湯や加熱による溶解操作を経ず、また、冷却の操作も必要としない、加水のみで短時間にゼリー状となる粉末。
- 熱や水に不安定な薬物を含むことを特徴とする請求項1に記載の粉末。
- 徐放性又は腸溶性のいずれかの放出制御機能を備えた薬物を含むことを特徴とする請求項1又は2に記載の粉末。
- 冷水に可溶なゲル化剤を含むことを特徴とする請求項1〜3のいずれか1項に記載の粉末。
- ゲル化剤として、ペクチン、アルギン酸ナトリウム、カラギーナン、キサンタンガム、ローカストビーンガム、グアガム、タラガムのいずれか1種以上を含むことを特徴とする請求項1〜4のいずれか1項に記載の粉末。
- 用時調製時における水に対するゲル化剤の濃度が0.5〜10%であること、を特徴とする請求項1〜5のいずれか1項に記載の粉末。
- 加水のみで5〜240秒という短時間にゼリー状となること、を特徴とする請求項1〜6のいずれか1項に記載の粉末。
- 請求項1〜7のいずれか1項に記載の粉末にpH調整剤及び甘味料から選択される添加剤を混合し、製造してなること、を特徴とする顆粒又は錠剤。
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2009278968A (ja) * | 2008-04-22 | 2009-12-03 | Sanei Gen Ffi Inc | 液状食品用ゲル化剤及びゲル状食品の製造方法 |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH01502668A (ja) * | 1987-03-13 | 1989-09-14 | ベンツオン ファルマ エイ/エス | 活性物質含有粒子からなる経口組成物 |
WO1993004670A1 (en) * | 1991-08-30 | 1993-03-18 | Showa Yakuhin Kako Co., Ltd. | Dry gel composition |
JPH11322624A (ja) * | 1998-05-06 | 1999-11-24 | Ina Food Ind Co Ltd | 用時調製漢方・生薬製剤 |
JP2000103730A (ja) * | 1998-07-31 | 2000-04-11 | Otsuka Pharmaceut Co Ltd | 服用感が改善された医薬組成物 |
JP2003034632A (ja) * | 2001-05-16 | 2003-02-07 | Otsuka Pharmaceut Co Ltd | 徐放性医薬組成物 |
JP2003104912A (ja) * | 2001-09-28 | 2003-04-09 | Wakoudou Kk | 服薬補助食品 |
JP2004097114A (ja) * | 2002-09-10 | 2004-04-02 | Ohkura Pharmaceutical Co Ltd | ゼリー乾燥物 |
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2006
- 2006-08-07 JP JP2006214863A patent/JP5414966B2/ja active Active
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH01502668A (ja) * | 1987-03-13 | 1989-09-14 | ベンツオン ファルマ エイ/エス | 活性物質含有粒子からなる経口組成物 |
WO1993004670A1 (en) * | 1991-08-30 | 1993-03-18 | Showa Yakuhin Kako Co., Ltd. | Dry gel composition |
JPH11322624A (ja) * | 1998-05-06 | 1999-11-24 | Ina Food Ind Co Ltd | 用時調製漢方・生薬製剤 |
JP2000103730A (ja) * | 1998-07-31 | 2000-04-11 | Otsuka Pharmaceut Co Ltd | 服用感が改善された医薬組成物 |
JP2003034632A (ja) * | 2001-05-16 | 2003-02-07 | Otsuka Pharmaceut Co Ltd | 徐放性医薬組成物 |
JP2003104912A (ja) * | 2001-09-28 | 2003-04-09 | Wakoudou Kk | 服薬補助食品 |
JP2004097114A (ja) * | 2002-09-10 | 2004-04-02 | Ohkura Pharmaceutical Co Ltd | ゼリー乾燥物 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2009278968A (ja) * | 2008-04-22 | 2009-12-03 | Sanei Gen Ffi Inc | 液状食品用ゲル化剤及びゲル状食品の製造方法 |
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