JP6634706B2 - 口腔内付着フィルム製剤 - Google Patents
口腔内付着フィルム製剤 Download PDFInfo
- Publication number
- JP6634706B2 JP6634706B2 JP2015111919A JP2015111919A JP6634706B2 JP 6634706 B2 JP6634706 B2 JP 6634706B2 JP 2015111919 A JP2015111919 A JP 2015111919A JP 2015111919 A JP2015111919 A JP 2015111919A JP 6634706 B2 JP6634706 B2 JP 6634706B2
- Authority
- JP
- Japan
- Prior art keywords
- film
- oral
- adhesive film
- mass
- carboxyvinyl polymer
- 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
(1)カルボキシビニルポリマー並びにトラガントガム、キサンタンガム、ジェランガム、カラギーナン及びアルギン酸ナトリウムから選ばれる少なくとも1種を含有することを特徴とする口腔内付着フィルム製剤、
(2)α化デンプンを含有することを特徴とする前記(1)に記載の口腔内付着フィルム製剤、
(3)口腔内で溶解する消耗性フィルムである前記(1)又は(2)に記載の口腔内付着フィルム製剤である。
適量の加温した水に、表1−1の処方の増粘剤を秤量、溶解し、均一な溶液とした。先の溶液にフィルム基剤及び可塑剤を均一に分散させ、溶液を冷却し、溶解した。別に、不溶性基剤を秤量、アルコール95に溶解し、均一な溶液を得た。この溶液を先の溶液と混和し、乳化機(超高速マルチ攪拌システムロボミックス:PRIMIX社製)を用いて乳化、脱泡してフィルム溶液を得た。フィルム溶液をPETフィルム上に展延し、室温で12時間乾燥させてフィルムを形成した。このフィルムをPETフィルムから剥がしたのちφ9.5mmに打ち抜き、消耗性フィルム製剤を得た。
表1−1〜表1−3の処方で実施例1と同様にしてフィルム製剤を得た(表1−1〜表1−3中の%は、質量%を意味する)。
[方法]
実施例1〜6及び比較例1〜11で得られたフィルム製剤それぞれを、唾液を拭き取らずに口腔内(内頬)に付着した。付着直後のフィルム製剤の付着力をパネル3名にて評価した。
結果を表2に示した。
[結果]
表2より、カルボキシビニルポリマー及びトラガントガムをそれぞれ単独で用いた比較例1、2では唾液存在下での付着力が低いことが確認された。また、カルボキシビニルポリマーにフィルム基剤として汎用される他の増粘剤を組み合わせた比較例3〜11では、カルボキシビニルポリマー単独の場合と比較して付着力は大きく変化しなかった。これに対して、カルボキシビニルポリマーにトラガントガム、キサンタンガム、ジェランガム、カラギーナン、アルギン酸ナトリウムを組み合わせた実施例1〜6では唾液存在下での口腔内付着力が向上することが確認された。さらに実施例2より、α化デンプンを加えることで付着力がより向上することが明らかになった。
以上により、カルボキシビニルポリマー並びにトラガントガム、キサンタンガム、ジェランガム、カラギーナン及びアルギン酸ナトリウムから選ばれる少なくとも1種を配合することにより、患部の唾液を拭き取ることなく口腔内粘膜への貼付性が十分改善された口腔内付着フィルム製剤を得られることがわかった。
Claims (2)
- カルボキシビニルポリマー並びにトラガントガム、キサンタンガム、ジェランガム、カラギーナン及びアルギン酸ナトリウムから選ばれる少なくとも1種、並びにα化デンプンを含有することを特徴とする口腔内付着フィルム製剤。
- 口腔内で溶解する消耗性フィルムである請求項1に記載の口腔内付着フィルム製剤。
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