JPWO2017002796A1 - 易服用性固形製剤の製造方法及び易服用性固形製剤 - Google Patents
易服用性固形製剤の製造方法及び易服用性固形製剤 Download PDFInfo
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- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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Abstract
Description
臼内面、上杵下端面及び下杵上端面に、水に触れると滑り性を示すゲル化剤を含むコーティング剤から成る粉体のみを直接に適用した後、核用成形材料を充填して一体圧縮成形することを含む、圧縮成形された核を該コーティング剤で被覆して成る易服用性固形製剤の乾式製造方法。
[態様2]
ゲル化剤が少なくとも1種の水溶性高分子を含む、態様1記載の製造方法。
[態様3]
水溶性高分子がカルボキシメチルセルロースナトリウム、アルギン酸ナトリウム、カラギーナン、キサンタンガム及びゼラチンから成る群から選択される、態様2に記載の製造方法。
[態様4]
水溶性高分子がカルボキシメチルセルロースナトリウムである、態様3に記載の製造方法。
[態様5]
コーティング剤がさらに滑沢剤を含む態様1〜4のいずれか一項に記載の製造方法。
[態様6]
滑沢剤がステアリン酸カルシウム、ステアリン酸マグネシウム及びショ糖脂肪酸エステルから成る群から選択される、態様5に記載の製造方法。
[態様7]
請求項1〜6に記載の製造方法で製造される易服用性固形製剤。
[態様8]
カルボキシメチルセルロースナトリウムを含む、固形製剤被覆用粉体組成物。
以下の実施例及び比較例で得た各錠剤について、以下の方法によって、硬度、滑りやすさを以下の条件・方法で測定した。
3: 滑りやすく飲み込みやすい
2: わずかに滑りやすいが飲み込みにくい
1: 滑りづらく飲み込みにくい
乳糖 (FlowLac90、メグレジャパン株式会社) 18g、ヒドロキシプロピルセルロース (HPC-SSL-SFP、日本曹達株式会社) 2gを混合し、混合物を得た。得られた混合物を、予め臼および上下杵表面にステアリン酸カルシウム(太平化学産業株式会社)を少量塗布し、打錠圧縮力8kNにおいて打錠した以外は、実施例1と同様に打錠し、直径8.0mm、隅角平錠、重量250mgの錠剤を得た。
乳糖 (FlowLac90、メグレジャパン株式会社) 17.9g、ヒドロキシプロピルセルロース (HPC-SSL-SFP、日本曹達株式会社) 2.0g、ステアリン酸カルシウム(太平化学産業株式会社)0.1gを混合し、混合物を得た。得られた混合物を、打錠圧縮力6kNにおいて打錠した以外は、実施例1と同様に打錠し、直径8.0mm、R6.5錠、重量200mgの錠剤を得た。
Claims (8)
- 臼内面、上杵下端面及び下杵上端面に、水に触れると滑り性を示すゲル化剤を含むコーティング剤から成る粉体のみを直接に適用した後、核用成形材料を充填して一体圧縮成形することを含む、圧縮成形された核を該コーティング剤で被覆して成る易服用性固形製剤の乾式製造方法。
- ゲル化剤が少なくとも1種の水溶性高分子を含む、請求項1記載の製造方法。
- 水溶性高分子がカルボキシメチルセルロースナトリウム、アルギン酸ナトリウム、カラギーナン、キサンタンガム及びゼラチンから成る群から選択される、請求項2に記載の製造方法。
- 水溶性高分子がカルボキシメチルセルロースナトリウムである、請求項3に記載の製造方法。
- コーティング剤がさらに滑沢剤を含む請求項1〜4のいずれか一項に記載の製造方法。
- 滑沢剤がステアリン酸カルシウム、ステアリン酸マグネシウム及びショ糖脂肪酸エステルから成る群から選択される、請求項5に記載の製造方法。
- 請求項1〜6に記載の製造方法で製造される易服用性固形製剤。
- カルボキシメチルセルロースナトリウムを含む、固形製剤被覆用粉体組成物。
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JP2015129529 | 2015-06-29 | ||
JP2015129529 | 2015-06-29 | ||
PCT/JP2016/069112 WO2017002796A1 (ja) | 2015-06-29 | 2016-06-28 | 易服用性固形製剤の製造方法及び易服用性固形製剤 |
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JPWO2017002796A1 true JPWO2017002796A1 (ja) | 2018-05-24 |
JP6749903B2 JP6749903B2 (ja) | 2020-09-02 |
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US (1) | US10959915B2 (ja) |
EP (1) | EP3315114B1 (ja) |
JP (1) | JP6749903B2 (ja) |
KR (1) | KR20180021377A (ja) |
CN (1) | CN107708648B (ja) |
TW (1) | TWI716415B (ja) |
WO (1) | WO2017002796A1 (ja) |
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JPH09104621A (ja) * | 1995-10-06 | 1997-04-22 | Bentoretsupu Sante Kk | ゲル化剤、滑沢化剤、滑沢剤を被覆した薬剤 |
EP1222917A4 (en) | 1999-10-13 | 2007-01-17 | Kyowa Hakko Kogyo Kk | BY COMPRESSING MOLDED PRODUCT AND METHOD FOR THE PRODUCTION THEREOF |
CN100342846C (zh) * | 1999-10-13 | 2007-10-17 | 协和发酵工业株式会社 | 压缩成形品及其制备方法 |
ES2402753T3 (es) * | 2008-02-06 | 2013-05-08 | University Of East Anglia | Composición y método para ayudar a la deglución |
CN103813807B (zh) * | 2011-09-30 | 2017-02-08 | 持田制药株式会社 | 易服用性固体制剂 |
AU2012318239B2 (en) * | 2011-11-01 | 2015-07-09 | Celgene Corporation | Methods for treating cancers using oral formulations of cytidine analogs |
JP6042610B2 (ja) * | 2011-12-27 | 2016-12-14 | 三栄源エフ・エフ・アイ株式会社 | タンパク質含有飲食品用ゲル化剤 |
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EP3315114B1 (en) | 2020-08-12 |
KR20180021377A (ko) | 2018-03-02 |
US20180168934A1 (en) | 2018-06-21 |
CN107708648A (zh) | 2018-02-16 |
TW201709901A (zh) | 2017-03-16 |
US10959915B2 (en) | 2021-03-30 |
TWI716415B (zh) | 2021-01-21 |
EP3315114A4 (en) | 2019-02-27 |
WO2017002796A1 (ja) | 2017-01-05 |
EP3315114A1 (en) | 2018-05-02 |
JP6749903B2 (ja) | 2020-09-02 |
CN107708648B (zh) | 2021-01-01 |
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