JP6558530B2 - アリピプラゾール医薬品製剤 - Google Patents
アリピプラゾール医薬品製剤 Download PDFInfo
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- JP6558530B2 JP6558530B2 JP2015096895A JP2015096895A JP6558530B2 JP 6558530 B2 JP6558530 B2 JP 6558530B2 JP 2015096895 A JP2015096895 A JP 2015096895A JP 2015096895 A JP2015096895 A JP 2015096895A JP 6558530 B2 JP6558530 B2 JP 6558530B2
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- Prior art keywords
- aripiprazole
- present
- silicic acid
- tablet
- pharmaceutical preparation
- 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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- 229960004372 aripiprazole Drugs 0.000 title claims description 27
- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 title claims description 26
- 239000008194 pharmaceutical composition Substances 0.000 title description 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 20
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims description 17
- 235000012239 silicon dioxide Nutrition 0.000 claims description 17
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 10
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 10
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 10
- 239000003826 tablet Substances 0.000 description 21
- 238000004220 aggregation Methods 0.000 description 12
- 230000002776 aggregation Effects 0.000 description 12
- 239000008186 active pharmaceutical agent Substances 0.000 description 11
- 229940088679 drug related substance Drugs 0.000 description 11
- 238000004090 dissolution Methods 0.000 description 10
- 238000002360 preparation method Methods 0.000 description 9
- 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 8
- 238000000034 method Methods 0.000 description 8
- 229920002678 cellulose Polymers 0.000 description 7
- 235000010980 cellulose Nutrition 0.000 description 7
- 239000008187 granular material Substances 0.000 description 7
- 210000000214 mouth Anatomy 0.000 description 7
- 239000001913 cellulose Substances 0.000 description 6
- 230000000052 comparative effect Effects 0.000 description 6
- 238000007922 dissolution test Methods 0.000 description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- 239000006191 orally-disintegrating tablet Substances 0.000 description 6
- 229920002261 Corn starch Polymers 0.000 description 5
- 239000004480 active ingredient Substances 0.000 description 5
- 239000011230 binding agent Substances 0.000 description 5
- 239000008120 corn starch Substances 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 239000000378 calcium silicate Substances 0.000 description 4
- 229910052918 calcium silicate Inorganic materials 0.000 description 4
- 239000002270 dispersing agent Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000005469 granulation Methods 0.000 description 4
- 230000003179 granulation Effects 0.000 description 4
- 235000010355 mannitol Nutrition 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- QZAYGJVTTNCVMB-UHFFFAOYSA-N serotonin Chemical compound C1=C(O)C=C2C(CCN)=CNC2=C1 QZAYGJVTTNCVMB-UHFFFAOYSA-N 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- 108010011485 Aspartame Proteins 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 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
- 229920002472 Starch Polymers 0.000 description 3
- 239000000605 aspartame Substances 0.000 description 3
- 235000010357 aspartame Nutrition 0.000 description 3
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 3
- 229960003438 aspartame Drugs 0.000 description 3
- 239000007884 disintegrant Substances 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 239000008101 lactose Substances 0.000 description 3
- 235000019359 magnesium stearate Nutrition 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- -1 silicate compound Chemical class 0.000 description 3
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 238000000748 compression moulding Methods 0.000 description 2
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 229940076279 serotonin Drugs 0.000 description 2
- 235000010413 sodium alginate Nutrition 0.000 description 2
- 239000000661 sodium alginate Substances 0.000 description 2
- 229940005550 sodium alginate Drugs 0.000 description 2
- 239000007944 soluble tablet Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- 235000000346 sugar Nutrition 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- 102000049773 5-HT2A Serotonin Receptor Human genes 0.000 description 1
- 108010072564 5-HT2A Serotonin Receptor Proteins 0.000 description 1
- 102100022738 5-hydroxytryptamine receptor 1A Human genes 0.000 description 1
- 101710138638 5-hydroxytryptamine receptor 1A Proteins 0.000 description 1
- 244000215068 Acacia senegal Species 0.000 description 1
- UMSGKTJDUHERQW-UHFFFAOYSA-N Brotizolam Chemical compound C1=2C=C(Br)SC=2N2C(C)=NN=C2CN=C1C1=CC=CC=C1Cl UMSGKTJDUHERQW-UHFFFAOYSA-N 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 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
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-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
- 229920000084 Gum arabic Polymers 0.000 description 1
- ILRKKHJEINIICQ-OOFFSTKBSA-N Monoammonium glycyrrhizinate Chemical compound N.O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O ILRKKHJEINIICQ-OOFFSTKBSA-N 0.000 description 1
- 229920001218 Pullulan Polymers 0.000 description 1
- 239000004373 Pullulan Substances 0.000 description 1
- 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 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000000205 acacia gum Substances 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 239000012752 auxiliary agent Substances 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
- 235000019658 bitter taste Nutrition 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 229960003051 brotizolam Drugs 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 1
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 229940105329 carboxymethylcellulose Drugs 0.000 description 1
- 229940084030 carboxymethylcellulose calcium Drugs 0.000 description 1
- 208000015114 central nervous system disease Diseases 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000000306 component Substances 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 235000019700 dicalcium phosphate Nutrition 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 229960003638 dopamine Drugs 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 239000001341 hydroxy propyl starch Substances 0.000 description 1
- 235000013828 hydroxypropyl starch Nutrition 0.000 description 1
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- VRVKOZSIJXBAJG-TYYBGVCCSA-M monosodium fumarate Chemical compound [Na+].OC(=O)\C=C\C([O-])=O VRVKOZSIJXBAJG-TYYBGVCCSA-M 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229920001592 potato starch Polymers 0.000 description 1
- 208000020016 psychiatric disease Diseases 0.000 description 1
- 235000019423 pullulan Nutrition 0.000 description 1
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
- 229960004172 pyridoxine hydrochloride Drugs 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
- 239000000018 receptor agonist Substances 0.000 description 1
- 229940044601 receptor agonist Drugs 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 201000000980 schizophrenia Diseases 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 150000004760 silicates Chemical class 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- 229940100445 wheat starch Drugs 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Description
(1)アリピプラゾールと、軽質無水ケイ酸と、ヒドロキシプロピルセルロースとを含有する錠剤であることを特徴とするアリピプラゾール医薬品製剤。
(2)錠剤が口腔内速崩壊錠である(1)に記載のアリピプラゾール医薬品製剤。
下記表1の処方に従い、以下のようにして口腔内速崩壊錠を製造した。アリピプラゾール、D−マンニトール、トウモロコシデンプンを転動流動層装置に投入し,混合した。さらに、混合物を流動させながら、ヒドロキシプロピルセルロース液をスプレーし、湿式造粒した。この湿顆粒を、給気温度を80℃にて乾燥を行った。この乾燥顆粒を、30メッシュ篩を用いて篩過後、軽質無水ケイ酸を加え混合し、さらにD−マンニトール、結晶セルロース、トウモロコシデンプン及びアスパルテームを加え混合し、その後ステアリン酸マグネシウムを加え混合した。得られた打錠用顆粒をロータリー打錠機により打錠成型し、錠剤とした。
実施例1と同様に下記処方の口腔内速崩壊錠を得た。
溶出試験
実施例及び比較例で製造した口腔内崩壊錠の溶出試験を行った。
錠剤1個をとり,試験液に溶出試験第1液900mlを用い、試験液の温度を37℃とし、パドル法の50rpmで実施した。また、凝集の有無を目視で観察した。
崩壊試験
実施例および比較例で製造した口腔内崩壊錠の口腔内での崩壊時間を試験した。
下記表1の処方に従い、下記のようにして口腔内速崩壊錠を製造した。アリピプラゾール、D−マンニトール、トウモロコシデンプンを撹拌混合造粒装置に投入し、撹拌混合した。さらに混合物を撹拌しながら、ヒドロキシプロピルセルロース水溶液を加え、湿式造粒した。この湿顆粒を、送風低温恒温器を用い温度80℃にて乾燥した。この乾燥顆粒を、30メッシュ篩を用いて篩過後、軽質無水ケイ酸を加え混合し、さらにD−マンニトール、結晶セルロース、トウモロコシデンプン及びアスパルテームを加え混合し、その後ステアリン酸マグネシウムを加え混合した。得られた打錠用顆粒をロータリー打錠機により打錠成型し、錠剤とした。
実施例2と同様に下記処方の口腔内速崩壊錠を得た。
溶出試験
実施例及び比較例で製造した口腔内崩壊錠を40℃75%RHの無包装条件下で2週間保存し、溶出試験を行った。錠剤1個をとり,試験液にpH4.0の薄めたMcIlvaine緩衝液900mlを用い、試験液の温度を37℃とし、パドル法の50rpmで実施した。
Claims (1)
- アリピプラゾールと、軽質無水ケイ酸と、ヒドロキシプロピルセルロースとを含有する錠剤であって、錠剤が口腔内速崩壊錠であることを特徴とするアリピプラゾール医薬品製剤。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2015096895A JP6558530B2 (ja) | 2015-04-20 | 2015-04-20 | アリピプラゾール医薬品製剤 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2015096895A JP6558530B2 (ja) | 2015-04-20 | 2015-04-20 | アリピプラゾール医薬品製剤 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2016204346A JP2016204346A (ja) | 2016-12-08 |
JP2016204346A5 JP2016204346A5 (ja) | 2019-02-21 |
JP6558530B2 true JP6558530B2 (ja) | 2019-08-14 |
Family
ID=57488796
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2015096895A Active JP6558530B2 (ja) | 2015-04-20 | 2015-04-20 | アリピプラゾール医薬品製剤 |
Country Status (1)
Country | Link |
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JP (1) | JP6558530B2 (ja) |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BR0117147A (pt) * | 2001-10-09 | 2006-05-09 | Bristol Myers Squibb Co | preparado de dosagem oral de desintegração instantánea |
JP5201837B2 (ja) * | 2007-01-01 | 2013-06-05 | 東亜薬品株式会社 | 口腔内速崩壊錠 |
US20110053942A1 (en) * | 2008-02-13 | 2011-03-03 | Dainippon Sumitomo Pharma Co., Ltd. | Orally disintegrating tablets |
JP2013203690A (ja) * | 2012-03-28 | 2013-10-07 | Fujifilm Corp | 口腔内崩壊錠及びその製造方法 |
JP2014114243A (ja) * | 2012-12-11 | 2014-06-26 | Ohara Yakuhin Kogyo Kk | 安定な固形製剤の製造方法 |
-
2015
- 2015-04-20 JP JP2015096895A patent/JP6558530B2/ja active Active
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