JP5755382B2 - 口腔内崩壊錠 - Google Patents
口腔内崩壊錠 Download PDFInfo
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- JP5755382B2 JP5755382B2 JP2015004937A JP2015004937A JP5755382B2 JP 5755382 B2 JP5755382 B2 JP 5755382B2 JP 2015004937 A JP2015004937 A JP 2015004937A JP 2015004937 A JP2015004937 A JP 2015004937A JP 5755382 B2 JP5755382 B2 JP 5755382B2
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- orally disintegrating
- candesartan cilexetil
- disintegrating tablet
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- 239000006191 orally-disintegrating tablet Substances 0.000 title claims description 15
- 239000003826 tablet Substances 0.000 claims description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- GHOSNRCGJFBJIB-UHFFFAOYSA-N Candesartan cilexetil Chemical compound C=12N(CC=3C=CC(=CC=3)C=3C(=CC=CC=3)C3=NNN=N3)C(OCC)=NC2=CC=CC=1C(=O)OC(C)OC(=O)OC1CCCCC1 GHOSNRCGJFBJIB-UHFFFAOYSA-N 0.000 claims description 16
- 229960004349 candesartan cilexetil Drugs 0.000 claims description 16
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 8
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims description 8
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 8
- 229950008138 carmellose Drugs 0.000 claims description 8
- 239000007884 disintegrant Substances 0.000 claims description 6
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 5
- 229920000881 Modified starch Polymers 0.000 claims description 5
- 239000011575 calcium Substances 0.000 claims description 5
- 229910052791 calcium Inorganic materials 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 3
- 229920002472 Starch Polymers 0.000 claims description 3
- 238000000748 compression moulding Methods 0.000 claims description 3
- 229960000913 crospovidone Drugs 0.000 claims description 3
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 3
- 239000011734 sodium Substances 0.000 claims description 3
- 229910052708 sodium Inorganic materials 0.000 claims description 3
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- 235000019698 starch Nutrition 0.000 claims description 3
- 229940032147 starch Drugs 0.000 claims description 3
- 239000000047 product Substances 0.000 description 22
- 238000000034 method Methods 0.000 description 8
- 239000000203 mixture Substances 0.000 description 8
- 239000003795 chemical substances by application Substances 0.000 description 6
- 239000011230 binding agent Substances 0.000 description 5
- 238000003860 storage Methods 0.000 description 5
- 238000010438 heat treatment Methods 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 229920002261 Corn starch Polymers 0.000 description 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 3
- 150000001720 carbohydrates Chemical class 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 239000008120 corn starch Substances 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 3
- 239000008101 lactose Substances 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 239000000546 pharmaceutical excipient Substances 0.000 description 3
- 239000004014 plasticizer Substances 0.000 description 3
- 238000010298 pulverizing process Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000001069 triethyl citrate Substances 0.000 description 3
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 3
- 235000013769 triethyl citrate Nutrition 0.000 description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- ZFOZVQLOBQUTQQ-UHFFFAOYSA-N Tributyl citrate Chemical compound CCCCOC(=O)CC(O)(C(=O)OCCCC)CC(=O)OCCCC ZFOZVQLOBQUTQQ-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
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- 239000013078 crystal Substances 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 2
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 description 1
- VVQNAFBGAWCMLU-UHFFFAOYSA-N 1h-benzimidazole-4-carboxylic acid Chemical compound OC(=O)C1=CC=CC2=C1N=CN2 VVQNAFBGAWCMLU-UHFFFAOYSA-N 0.000 description 1
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- 239000005541 ACE inhibitor Substances 0.000 description 1
- MQIUGAXCHLFZKX-UHFFFAOYSA-N Di-n-octyl phthalate Natural products CCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCC MQIUGAXCHLFZKX-UHFFFAOYSA-N 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 244000294411 Mirabilis expansa Species 0.000 description 1
- 235000015429 Mirabilis expansa Nutrition 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000002333 angiotensin II receptor antagonist Substances 0.000 description 1
- 229940126317 angiotensin II receptor antagonist Drugs 0.000 description 1
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 1
- ZFMQKOWCDKKBIF-UHFFFAOYSA-N bis(3,5-difluorophenyl)phosphane Chemical compound FC1=CC(F)=CC(PC=2C=C(F)C=C(F)C=2)=C1 ZFMQKOWCDKKBIF-UHFFFAOYSA-N 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 239000003168 generic drug Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 239000001087 glyceryl triacetate Substances 0.000 description 1
- 235000013773 glyceryl triacetate Nutrition 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000004898 kneading Methods 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 235000013536 miso Nutrition 0.000 description 1
- 239000004570 mortar (masonry) Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229920001592 potato starch Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
後述の特許文献1によると、カンデサルタンシレキセチルを包含するベンズイミダゾール−7−カルボン酸またはその誘導体は、固体単独の静置状態では、温度、湿度等に対して安定であるが、製剤化工程における粉砕、混合、撹拌、乾燥、加熱、圧縮などによる衝撃、摩擦、加熱、加圧等により結晶に歪みが生じ、保存時には経時的に含量低下をきたすこと、しかし低融点油脂状物質を配合しておくと、製剤化後の保存時も経時的な分解を抑制できることが記載されている。
また、カンデサルタンシレキセチルは水に対して難溶性であるため、一定の粒子径以下(例えば、平均粒子径で約4μm以下)に粉砕し溶解性を改善することが必須であり、さらに二次凝集塊のない均一分散や微粉末化することにより体内での吸収を容易にすることが必要となる。しかし、カンデサルタンシレキセチルは、上述のとおり、製剤化時の圧力、衝撃、摩擦、加熱等の影響によって保存安定性が低下するため、結晶を微粉末化する際の粉砕によっても主薬の経時的な含量低下をきたす可能性がある。
(1)カンデサルタンシレキセチルを含有する錠剤であって、錠剤全重量に対して水を2〜10重量%及び崩壊剤を0.1〜10重量%含有させた口腔内崩壊錠。
(2)崩壊剤がカルメロース、カルメロースカルシウム、カルボキシメチルスターチナトリウム、クロスポビドン、低置換度ヒドロキシプロピルセルロース及び部分アルファー化デンプンから選択された少なくとも一種である(1)に記載の口腔内崩壊錠。
(3)口腔内崩壊錠が、圧縮成形の工程を含む製造方法によって製造されたものである(1)又は2に記載の口腔内崩壊錠。
(2)乳糖552.0g、トウモロコシデンプン120.0g及びカルメロースカルシウム24.0gを流動層造粒機(パウレック社製:MP−01型)に投入し、流動化させ、(1)で得た湿式粉砕薬液を噴霧して造粒した。薬液噴霧終了後、引き続き流動層乾燥機にて造粒物中の水の含有率が2.0重量%になるまで乾燥した後、24メッシュ篩で整粒した。得られた整粒品の一部である129.0gにステアリン酸マグネシウム1.0gを加え、ポリエチレン製の袋にて混合した。次いで、この混合物をロータリー式打錠機(菊水製作所製:VIRGO型)を用いて打錠圧力8kNで直径7mmに圧縮成型し下記組成の口腔内崩壊錠剤を得た。なお、造粒物中の水の含有率は、赤外水分計を用いて測定した。
[成分] [1錠当たりの重量(mg)]
カンデサルタンシレキセチル 2.0
乳糖 92.0
トウモロコシデンプン 20.0
カルメロースカルシウム 4.0
ヒドロキシプロピルセルロース 5.0
クエン酸トリエチル 1.0
(上記添加剤の全体で水2.5mg分を保水)
ステアリン酸マグネシウム 1.0
実施例1と同様の操作を行い、造粒物中の水の含有率が1.6重量%の整粒品を得た。得られた整粒品を用いて、以下実施例1と同様に操作し錠剤を得た。
実施例及び比較例の錠剤をそれぞれ硝子瓶に入れ、密栓後、温度60℃の条件下に保存した。保存開始から7日および14日経過後、各錠剤中の分解物を高速液体クロマトグラフィーにより測定した。その結果から、それぞれ総分解物量(面積百分率)を算出し、結果を表1に示した。
Claims (3)
- カンデサルタンシレキセチルを含有する錠剤であって、錠剤全重量に対して水を2〜10重量%及び崩壊剤を0.1〜10重量%含有させた口腔内崩壊錠。
- 崩壊剤がカルメロース、カルメロースカルシウム、カルボキシメチルスターチナトリウム、クロスポビドン、低置換度ヒドロキシプロピルセルロース及び部分アルファー化デンプンから選択された少なくとも一種である請求項1に記載の口腔内崩壊錠。
- 口腔内崩壊錠が、圧縮成形の工程を含む製造方法によって製造されたものである請求項1又は2に記載の口腔内崩壊錠。
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JP2015004937A JP5755382B2 (ja) | 2011-11-10 | 2015-01-14 | 口腔内崩壊錠 |
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JP2011246022 | 2011-11-10 | ||
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US20190060325A1 (en) | 2016-04-08 | 2019-02-28 | Shionogi & Co., Ltd. | Stabilized solid dosage form |
JP7029875B1 (ja) | 2020-05-15 | 2022-03-04 | 塩野義製薬株式会社 | 不純物の生成を抑制した医薬組成物 |
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TW580397B (en) * | 1997-05-27 | 2004-03-21 | Takeda Chemical Industries Ltd | Solid preparation |
MX2007008212A (es) * | 2005-01-06 | 2007-08-16 | Elan Pharma Int Ltd | Formulaciones de candesartan en nanoparticulas. |
CN101669940A (zh) * | 2008-09-08 | 2010-03-17 | 北京瑞伊人科技发展有限公司 | 坎地沙坦酯/氢氯噻嗪胶囊及其制备方法 |
JP5756651B2 (ja) * | 2011-02-24 | 2015-07-29 | エルメッド エーザイ株式会社 | カンデサルタンシレキセチルを安定化した組成物及びその製造方法 |
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2012
- 2012-11-07 JP JP2012245349A patent/JP5680607B2/ja active Active
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- 2015-01-14 JP JP2015004937A patent/JP5755382B2/ja active Active
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Publication number | Publication date |
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JP5680607B2 (ja) | 2015-03-04 |
JP2013121951A (ja) | 2013-06-20 |
JP2015063570A (ja) | 2015-04-09 |
JP2015145434A (ja) | 2015-08-13 |
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