JP2013249283A - フィルム製剤 - Google Patents
フィルム製剤 Download PDFInfo
- Publication number
- JP2013249283A JP2013249283A JP2012125965A JP2012125965A JP2013249283A JP 2013249283 A JP2013249283 A JP 2013249283A JP 2012125965 A JP2012125965 A JP 2012125965A JP 2012125965 A JP2012125965 A JP 2012125965A JP 2013249283 A JP2013249283 A JP 2013249283A
- Authority
- JP
- Japan
- Prior art keywords
- film
- film preparation
- surfactant
- polyoxyalkylene
- pharmaceutically acceptable
- 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.)
- Granted
Links
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 4
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Abstract
【解決手段】 配合する難溶性成分の溶解性を向上させ、かつ患者の服用性が向上したフィルム製剤を開示する。本発明のフィルム製剤は、難溶性成分、界面活性剤およびフィルム形成材料を含有し、該界面活性剤が、ポリオキシアルキレン糖脂肪酸エステル、ポリオキシアルキレンアルキルエーテルおよびポリオキシアルキレンエーテルからなる群から選択される少なくとも1種の化合物であり、そして該フィルム形成材料が、アルギン酸およびその薬学的に許容し得る塩、ヒアルロン酸およびその薬学的に許容し得る塩、プルラン、ペクチン、デキストラン、ゼラチン、ならびにコンドロイチン硫酸およびその薬学的に許容し得る塩からなる群から選択される少なくとも1種の天然多糖類である。
【選択図】 なし
Description
該界面活性剤が、ポリオキシアルキレン糖脂肪酸エステル、ポリオキシアルキレンアルキルエーテルおよびポリオキシアルキレンエーテルからなる群から選択される少なくとも1種の化合物であり、そして該フィルム形成材料が、アルギン酸およびその薬学的に許容し得る塩、ヒアルロン酸およびその薬学的に許容し得る塩、プルラン、ペクチン、デキストラン、ゼラチン、ならびにコンドロイチン硫酸およびその薬学的に許容し得る塩からなる群から選択される少なくとも1種の天然多糖類である、フィルム製剤である。
粘度300cps(1%水溶液)のアルギン酸ナトリウム(ナカライテスク株式会社製)粉末をイオン交換水に溶解させ、1.5%の濃度に調製した。この水溶液に、界面活性剤として、モノオレイン酸ポリオキシエチレンソルビタン(日光ケミカルズ株式会社製TO−10MV)をその濃度が0.5%となるように添加し、均一に攪拌することにより、基剤水溶液を得た。
粘度300cps(1%水溶液)のアルギン酸ナトリウム(ナカライテスク株式会社製)粉末をイオン交換水に溶解させ、1.5%の濃度に調製した。この水溶液に、界面活性剤として、モノステアリン酸ポリオキシエチレンソルビタン(日光ケミカルズ株式会社製TS−10MV)をその濃度を0.15%となるように添加し、均一に攪拌することにより、基剤水溶液を得た。
粘度300cps(1%水溶液)のアルギン酸ナトリウム(ナカライテスク株式会社製)粉末をイオン交換水に溶解させ、1.5%の濃度に調製した。この水溶液に、界面活性剤として、ポリオキシエチレンラウリルエーテル(日光ケミカルズ株式会社製BL−4.2)をその濃度を0.5%となるように添加し、均一に攪拌することにより、基剤水溶液を得た。
300cpsのアルギン酸ナトリウム(ナカライテスク株式会社製)粉末をイオン交換水に溶解させ、1.5%の濃度に調製した。この水溶液に、界面活性剤を添加することなく、基剤水溶液を得た。
粘度300cps(1%水溶液)のアルギン酸ナトリウム(ナカライテスク株式会社製)粉末をイオン交換水に溶解させ、1.5%の濃度に調製した。この水溶液に、界面活性剤として、モノステアリン酸ソルビタン(日光ケミカルズ株式会社製SS−10MV)を添加し、その濃度を0.5%となるように調製し、均一に攪拌することにより、基剤水溶液を得た。
実施例1〜3ならびに比較例1および2で作製したフィルム1枚を予め37℃に加温したプラスチックシャーレのそれぞれの上に置き、10mLの生理食塩水を37℃にて添加し、シェーキングインキュベーターにて300rpmで振盪した。
実施例4〜10については、アルギン酸ナトリウム粉末の代わりに表1に記載の各フィルム形成材料を用い、かつモノオレイン酸ポリオキシエチレンソルビタンの代わりに表1に記載の各界面活性剤を用いて基剤水溶液を調製し、そしてミコナゾールの代わりに表1に記載の各難溶性成分を所定含有量となるように添加かつ分散させたこと以外は実施例1と同様にして、それぞれ表1に示すフィルムを作製した。
実施例4〜10ならびに比較例3〜9で作製したフィルム各1枚を予め37℃に加温したプラスチックシャーレのそれぞれの上に置き、10mLの生理食塩水を37℃にて添加し、シェーキングインキュベーターにて300rpmで振盪した。
Claims (7)
- 難溶性成分、界面活性剤およびフィルム形成材料を含有するフィルム製剤であって、
該界面活性剤が、ポリオキシアルキレン糖脂肪酸エステル、ポリオキシアルキレンアルキルエーテルおよびポリオキシアルキレンエーテルからなる群から選択される少なくとも1種の化合物であり、そして該フィルム形成材料が、アルギン酸およびその薬学的に許容し得る塩、ヒアルロン酸およびその薬学的に許容し得る塩、プルラン、ペクチン、デキストラン、ゼラチン、ならびにコンドロイチン硫酸およびその薬学的に許容し得る塩からなる群から選択される少なくとも1種の天然多糖類である、フィルム製剤。 - 前記フィルム形成材料が、フィルム製剤に対し、70質量%から95質量%の割合で含有されている、請求項1に記載のフィルム製剤。
- 前記難溶性成分が、抗真菌薬、植物抽出物、コエンザイムQ10、フィトステロール、リポ酸、テルペン類、フラボノイド、およびフェノール類からなる群から選択される少なくとも1種の薬学成分である、請求項1または2に記載のフィルム製剤。
- 前記界面活性剤がポリオキシアルキレン糖脂肪酸エステルである、請求項1から3のいずれか一項に記載のフィルム製剤。
- 前記ポリオキシアルキレン糖脂肪酸エステルが、ポリオキシエチレンソルビタン脂肪酸エステルである、請求項4に記載のフィルム製剤。
- 口腔内適用のために用いられる、請求項1から5のいずれか一項に記載のフィルム製剤。
- 皮膚外用のために用いられる、請求項1から5のいずれか一項に記載のフィルム製剤。
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WO2018199303A1 (ja) * | 2017-04-28 | 2018-11-01 | 持田製薬株式会社 | ミコナゾール及び/又は硝酸ミコナゾールを含むシート製剤 |
JP2018203618A (ja) * | 2017-05-30 | 2018-12-27 | 日清ファルマ株式会社 | コエンザイムq10フィルム製剤 |
JP2021083826A (ja) * | 2019-11-29 | 2021-06-03 | Nissha株式会社 | 可食性フィルムの製造方法、フィルム製剤及び可食性フィルム |
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JP2021083826A (ja) * | 2019-11-29 | 2021-06-03 | Nissha株式会社 | 可食性フィルムの製造方法、フィルム製剤及び可食性フィルム |
US12059019B2 (en) | 2019-11-29 | 2024-08-13 | Nissha Co., Ltd. | Method of producing edible film, film formulation, and edible film |
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