CN101822646A - 一种盐酸非索非那定口腔崩解片及其制备方法 - Google Patents
一种盐酸非索非那定口腔崩解片及其制备方法 Download PDFInfo
- Publication number
- CN101822646A CN101822646A CN200910079332A CN200910079332A CN101822646A CN 101822646 A CN101822646 A CN 101822646A CN 200910079332 A CN200910079332 A CN 200910079332A CN 200910079332 A CN200910079332 A CN 200910079332A CN 101822646 A CN101822646 A CN 101822646A
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- CN
- China
- Prior art keywords
- compound
- fexofenadine hydrochloride
- correctives
- disintegrating agent
- sheet
- 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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- RRJFVPUCXDGFJB-UHFFFAOYSA-N Fexofenadine hydrochloride Chemical compound Cl.C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RRJFVPUCXDGFJB-UHFFFAOYSA-N 0.000 title claims abstract description 53
- 229960000354 fexofenadine hydrochloride Drugs 0.000 title claims abstract description 53
- 239000006191 orally-disintegrating tablet Substances 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title claims description 35
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 56
- 239000000945 filler Substances 0.000 claims abstract description 14
- 239000000314 lubricant Substances 0.000 claims abstract description 13
- 150000001875 compounds Chemical class 0.000 claims description 55
- 239000000203 mixture Substances 0.000 claims description 18
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 14
- 239000008187 granular material Substances 0.000 claims description 14
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 14
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 14
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 14
- 238000003756 stirring Methods 0.000 claims description 14
- 239000007779 soft material Substances 0.000 claims description 5
- -1 add correctives Substances 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 3
- 239000011734 sodium Substances 0.000 claims description 3
- 229910052708 sodium Inorganic materials 0.000 claims description 3
- 229920001817 Agar Polymers 0.000 claims description 2
- 229920000881 Modified starch Polymers 0.000 claims description 2
- 229920002472 Starch Polymers 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- 239000008272 agar Substances 0.000 claims description 2
- 150000001413 amino acids Chemical class 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 2
- 238000004132 cross linking Methods 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical class 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 claims description 2
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 2
- 238000012545 processing Methods 0.000 claims description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- 235000019698 starch Nutrition 0.000 claims description 2
- 210000000214 mouth Anatomy 0.000 abstract description 35
- 238000004090 dissolution Methods 0.000 abstract description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 9
- 235000019658 bitter taste Nutrition 0.000 abstract description 6
- 239000002131 composite material Substances 0.000 abstract description 6
- 239000000796 flavoring agent Substances 0.000 abstract description 6
- 235000013355 food flavoring agent Nutrition 0.000 abstract 2
- 239000003826 tablet Substances 0.000 description 40
- 238000000034 method Methods 0.000 description 31
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 16
- 238000002474 experimental method Methods 0.000 description 13
- 108010011485 Aspartame Proteins 0.000 description 12
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 12
- 239000000605 aspartame Substances 0.000 description 12
- 235000010357 aspartame Nutrition 0.000 description 12
- 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 12
- 229960003438 aspartame Drugs 0.000 description 12
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 12
- 229950005770 hyprolose Drugs 0.000 description 12
- 239000002671 adjuvant Substances 0.000 description 11
- 235000019219 chocolate Nutrition 0.000 description 11
- 238000005516 engineering process Methods 0.000 description 11
- 238000009472 formulation Methods 0.000 description 10
- 239000002245 particle Substances 0.000 description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 9
- 239000000546 pharmaceutical excipient Substances 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
- 229930195725 Mannitol Natural products 0.000 description 8
- 238000011161 development Methods 0.000 description 8
- 235000019359 magnesium stearate Nutrition 0.000 description 8
- 239000000594 mannitol Substances 0.000 description 8
- 235000010355 mannitol Nutrition 0.000 description 8
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 229960000935 dehydrated alcohol Drugs 0.000 description 5
- 239000012738 dissolution medium Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 229960003592 fexofenadine Drugs 0.000 description 5
- RWTNPBWLLIMQHL-UHFFFAOYSA-N fexofenadine Chemical compound C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RWTNPBWLLIMQHL-UHFFFAOYSA-N 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 108010010803 Gelatin Proteins 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 4
- 235000019634 flavors Nutrition 0.000 description 4
- 239000008273 gelatin Substances 0.000 description 4
- 229920000159 gelatin Polymers 0.000 description 4
- 235000019322 gelatine Nutrition 0.000 description 4
- 235000011852 gelatine desserts Nutrition 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 208000003251 Pruritus Diseases 0.000 description 3
- 239000011230 binding agent Substances 0.000 description 3
- 238000005469 granulation Methods 0.000 description 3
- 230000003179 granulation Effects 0.000 description 3
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 3
- 235000017557 sodium bicarbonate Nutrition 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- 235000019640 taste Nutrition 0.000 description 3
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 description 2
- 208000035285 Allergic Seasonal Rhinitis Diseases 0.000 description 2
- 241000282414 Homo sapiens Species 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 206010048908 Seasonal allergy Diseases 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 235000010358 acesulfame potassium Nutrition 0.000 description 2
- 229960004998 acesulfame potassium Drugs 0.000 description 2
- 239000000619 acesulfame-K Substances 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 208000024376 chronic urticaria Diseases 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000011978 dissolution method Methods 0.000 description 2
- 229960004756 ethanol Drugs 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 230000000704 physical effect Effects 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-L Phosphate ion(2-) Chemical compound OP([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-L 0.000 description 1
- 208000036071 Rhinorrhea Diseases 0.000 description 1
- 206010039101 Rhinorrhoea Diseases 0.000 description 1
- 206010052568 Urticaria chronic Diseases 0.000 description 1
- 238000007605 air drying Methods 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 208000024754 bloodshot eye Diseases 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 208000030949 chronic idiopathic urticaria Diseases 0.000 description 1
- 206010072757 chronic spontaneous urticaria Diseases 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000012395 formulation development Methods 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 229960001855 mannitol Drugs 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
- 239000011812 mixed powder Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 210000002200 mouth mucosa Anatomy 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 201000005111 ocular hyperemia Diseases 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 210000003254 palate Anatomy 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 201000005404 rubella Diseases 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 210000004916 vomit Anatomy 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Abstract
Description
Claims (7)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN2009100793322A CN101822646B (zh) | 2009-03-06 | 2009-03-06 | 一种盐酸非索非那定口腔崩解片及其制备方法 |
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CN2009100793322A CN101822646B (zh) | 2009-03-06 | 2009-03-06 | 一种盐酸非索非那定口腔崩解片及其制备方法 |
Publications (2)
Publication Number | Publication Date |
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CN101822646A true CN101822646A (zh) | 2010-09-08 |
CN101822646B CN101822646B (zh) | 2013-04-17 |
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CN2009100793322A Active CN101822646B (zh) | 2009-03-06 | 2009-03-06 | 一种盐酸非索非那定口腔崩解片及其制备方法 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102512389A (zh) * | 2011-12-27 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | 非索非那定盐酸盐口腔崩解药物组合物 |
CN105456327A (zh) * | 2015-12-29 | 2016-04-06 | 刘书玲 | 一种治疗精神病的中药组合物及其制剂 |
CN106137989A (zh) * | 2016-07-20 | 2016-11-23 | 南通雅本化学有限公司 | 一种基于盐酸非索非那定的药物组合物 |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB202212656D0 (en) * | 2022-08-31 | 2022-10-12 | Novumgen Ltd | An orodispersible tablet of fecofenadine and it process of preparation |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6723348B2 (en) * | 2001-11-16 | 2004-04-20 | Ethypharm | Orodispersible tablets containing fexofenadine |
CN101103980A (zh) * | 2006-07-14 | 2008-01-16 | 海南盛科生命科学研究院 | 一种非索非那定的药用组合物 |
-
2009
- 2009-03-06 CN CN2009100793322A patent/CN101822646B/zh active Active
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102512389A (zh) * | 2011-12-27 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | 非索非那定盐酸盐口腔崩解药物组合物 |
CN102512389B (zh) * | 2011-12-27 | 2013-08-21 | 天津市嵩锐医药科技有限公司 | 非索非那定盐酸盐口腔崩解药物组合物 |
CN105456327A (zh) * | 2015-12-29 | 2016-04-06 | 刘书玲 | 一种治疗精神病的中药组合物及其制剂 |
CN106137989A (zh) * | 2016-07-20 | 2016-11-23 | 南通雅本化学有限公司 | 一种基于盐酸非索非那定的药物组合物 |
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CN101822646B (zh) | 2013-04-17 |
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Addressee: Bencao Tianyuan Pharmaceutical Research Inst., Beijing Document name: Notification to Pay the Fees |
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Inventor after: Gu Qun Inventor after: Jin Zhigang Inventor after: Sun Xuewei Inventor after: Wang Dong Inventor after: Xu Chunxia Inventor after: Wei Junling Inventor before: Gu Qun Inventor before: Jin Zhigang Inventor before: Sun Xuewei Inventor before: Wang Dong Inventor before: Xu Chunxia |
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Effective date of registration: 20170616 Address after: 100072 Beijing City, Fengtai District Linghai Jincheng Garden 4 Building 5 unit 802 Patentee after: Wei Junling Address before: 100039 Beijing city Fengtai District indigo plant Village No. 795 Patentee before: Bencao Tianyuan Pharmaceutical Research Inst., Beijing |
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Effective date of registration: 20180917 Address after: 123000 fluorine chemical park, Fumeng County, Liaoning (Fuxin) Patentee after: Fuxin Long Rui Pharmaceutical Co., Ltd. Address before: 100072 unit 5, unit 4, Jincheng garden, Linghai, Fengtai District, Beijing 802 Patentee before: Wei Junling |