CN102247368B - Compound acrivastine sustained release tablets, and preparation method thereof - Google Patents
Compound acrivastine sustained release tablets, and preparation method thereof Download PDFInfo
- Publication number
- CN102247368B CN102247368B CN 201110130629 CN201110130629A CN102247368B CN 102247368 B CN102247368 B CN 102247368B CN 201110130629 CN201110130629 CN 201110130629 CN 201110130629 A CN201110130629 A CN 201110130629A CN 102247368 B CN102247368 B CN 102247368B
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- Prior art keywords
- acrivastine
- compound
- sustained release
- parts
- release tablets
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- 229960003792 acrivastine Drugs 0.000 title claims abstract description 44
- PWACSDKDOHSSQD-IUTFFREVSA-N acrivastine Chemical compound C1=CC(C)=CC=C1C(\C=1N=C(\C=C\C(O)=O)C=CC=1)=C/CN1CCCC1 PWACSDKDOHSSQD-IUTFFREVSA-N 0.000 title claims abstract description 44
- 150000001875 compounds Chemical class 0.000 title claims abstract description 33
- 239000007939 sustained release tablet Substances 0.000 title claims abstract description 29
- 238000002360 preparation method Methods 0.000 title claims abstract description 25
- 239000008187 granular material Substances 0.000 claims abstract description 25
- 239000003826 tablet Substances 0.000 claims abstract description 24
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 18
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 claims abstract description 15
- 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 claims abstract description 14
- 239000008101 lactose Substances 0.000 claims abstract description 13
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 12
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 11
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 11
- BALXUFOVQVENIU-KXNXZCPBSA-N pseudoephedrine hydrochloride Chemical compound [H+].[Cl-].CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 BALXUFOVQVENIU-KXNXZCPBSA-N 0.000 claims abstract description 11
- 229960003447 pseudoephedrine hydrochloride Drugs 0.000 claims abstract description 10
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 9
- 239000000203 mixture Substances 0.000 claims abstract description 9
- 239000007779 soft material Substances 0.000 claims abstract description 9
- 239000002994 raw material Substances 0.000 claims abstract description 6
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 6
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 19
- 239000003814 drug Substances 0.000 claims description 15
- 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 claims description 12
- 239000011230 binding agent Substances 0.000 claims description 11
- 238000002156 mixing Methods 0.000 claims description 11
- 229940079593 drug Drugs 0.000 claims description 9
- -1 hydroxypropyl Chemical group 0.000 claims description 8
- 238000005303 weighing Methods 0.000 claims description 7
- 238000004080 punching Methods 0.000 claims description 6
- 238000001514 detection method Methods 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 229960001375 lactose Drugs 0.000 claims description 4
- 238000012856 packing Methods 0.000 claims description 3
- 239000000463 material Substances 0.000 abstract description 10
- SQXPPECBPHSOSQ-GNWPWZHSSA-N (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol;(e)-3-[6-[(e)-1-(4-methylphenyl)-3-pyrrolidin-1-ylprop-1-enyl]pyridin-2-yl]prop-2-enoic acid;hydrochloride Chemical compound Cl.CN[C@@H](C)[C@@H](O)C1=CC=CC=C1.C1=CC(C)=CC=C1C(\C=1N=C(\C=C\C(O)=O)C=CC=1)=C/CN1CCCC1 SQXPPECBPHSOSQ-GNWPWZHSSA-N 0.000 abstract description 4
- 239000000314 lubricant Substances 0.000 abstract description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 3
- 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 abstract 3
- 206010067484 Adverse reaction Diseases 0.000 abstract 1
- 239000000853 adhesive Substances 0.000 abstract 1
- 230000001070 adhesive effect Effects 0.000 abstract 1
- 230000006838 adverse reaction Effects 0.000 abstract 1
- 229910052681 coesite Inorganic materials 0.000 abstract 1
- 229910052906 cristobalite Inorganic materials 0.000 abstract 1
- 229910052682 stishovite Inorganic materials 0.000 abstract 1
- 229910052905 tridymite Inorganic materials 0.000 abstract 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 8
- 230000000694 effects Effects 0.000 description 6
- 238000012216 screening Methods 0.000 description 6
- 239000003795 chemical substances by application Substances 0.000 description 5
- 229910004298 SiO 2 Inorganic materials 0.000 description 3
- 230000001387 anti-histamine Effects 0.000 description 3
- 239000000739 antihistaminic agent Substances 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 238000003825 pressing Methods 0.000 description 3
- 238000010561 standard procedure Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical compound CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 description 2
- 239000003513 alkali Substances 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 238000007599 discharging Methods 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 238000005286 illumination Methods 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 238000005453 pelletization Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- HDLOXDDMKWEDCR-PASALVRNSA-N (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol;(e)-3-[6-[(e)-1-(4-methylphenyl)-3-pyrrolidin-1-ylprop-1-enyl]pyridin-2-yl]prop-2-enoic acid Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1.C1=CC(C)=CC=C1C(\C=1N=C(\C=C\C(O)=O)C=CC=1)=C/CN1CCCC1 HDLOXDDMKWEDCR-PASALVRNSA-N 0.000 description 1
- ZOPQOWMEWBFVAR-PXRPMCEGSA-N 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid;(1s,2s)-2-(methylamino)-1-phenylpropan-1-ol Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1.C1CN(CCOCC(=O)O)CCN1C(C=1C=CC(Cl)=CC=1)C1=CC=CC=C1 ZOPQOWMEWBFVAR-PXRPMCEGSA-N 0.000 description 1
- 208000035285 Allergic Seasonal Rhinitis Diseases 0.000 description 1
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 description 1
- 102000000543 Histamine Receptors Human genes 0.000 description 1
- 108010002059 Histamine Receptors Proteins 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 208000036284 Rhinitis seasonal Diseases 0.000 description 1
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 description 1
- 229940042500 acrivastine / pseudoephedrine Drugs 0.000 description 1
- 229940086148 acrivastine 8 mg Drugs 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 201000010105 allergic rhinitis Diseases 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 239000002269 analeptic agent Substances 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 230000002804 anti-anaphylactic effect Effects 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 229940056152 cetirizine / pseudoephedrine Drugs 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 229960002179 ephedrine Drugs 0.000 description 1
- ZQBWEJQBVWJHRY-PXRPMCEGSA-N ethyl 4-(8-chloro-5,6-dihydrobenzo[1,2]cyclohepta[2,4-b]pyridin-11-ylidene)piperidine-1-carboxylate;(1s,2s)-2-(methylamino)-1-phenylpropan-1-ol Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1.C1CN(C(=O)OCC)CCC1=C1C2=NC=CC=C2CCC2=CC(Cl)=CC=C21 ZQBWEJQBVWJHRY-PXRPMCEGSA-N 0.000 description 1
- 229940042366 fexofenadine / pseudoephedrine Drugs 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 229940033996 loratadine / pseudoephedrine Drugs 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 238000006303 photolysis reaction Methods 0.000 description 1
- 230000015843 photosynthesis, light reaction Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 229940035056 pseudoephedrine hydrochloride 120 mg Drugs 0.000 description 1
- 150000003233 pyrroles Chemical group 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 208000017022 seasonal allergic rhinitis Diseases 0.000 description 1
- 229940115174 semprex-d Drugs 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
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CN 201110130629 CN102247368B (en) | 2011-05-19 | 2011-05-19 | Compound acrivastine sustained release tablets, and preparation method thereof |
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CN 201110130629 CN102247368B (en) | 2011-05-19 | 2011-05-19 | Compound acrivastine sustained release tablets, and preparation method thereof |
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CN102247368A CN102247368A (en) | 2011-11-23 |
CN102247368B true CN102247368B (en) | 2013-05-29 |
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Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
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PL2474545T3 (en) | 2005-12-13 | 2017-04-28 | Incyte Holdings Corporation | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
AR081315A1 (en) | 2010-03-10 | 2012-08-08 | Incyte Corp | HETEROCICLIC DERIVATIVES OF PIPERIDIN AND PIRIMIDIN -4-IL-AZETIDINA, A CRYSTALLINE FORM OF THE SALT OF ACETONITRILADIPICO ACID OF A PYRIMIDINIC DERIVATIVE, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND USE OF THE SAME THINGS WITH THE TREATMENT OF INJECTION , T |
AR086983A1 (en) | 2011-06-20 | 2014-02-05 | Incyte Corp | DERIVATIVES OF AZETIDINIL FENIL, PIRIDIL OR PIRAZINIL CARBOXAMIDA AS JAK INHIBITORS |
PL2919766T3 (en) | 2012-11-15 | 2021-10-04 | Incyte Holdings Corporation | Sustained-release dosage forms of ruxolitinib |
MX2016001639A (en) | 2013-08-07 | 2016-10-07 | Incyte Corp | Sustained release dosage forms for a jak1 inhibitor. |
CN108125924B (en) * | 2018-03-16 | 2021-02-09 | 重庆华邦制药有限公司 | Alvastigmine capsule and preparation method thereof |
US11833155B2 (en) | 2020-06-03 | 2023-12-05 | Incyte Corporation | Combination therapy for treatment of myeloproliferative neoplasms |
Family Cites Families (6)
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AU675557B2 (en) * | 1993-06-14 | 1997-02-06 | Janssen Pharmaceutica N.V. | Extended release, film-coated tablet of astemizole and pseudoephedrine |
US20020106408A1 (en) * | 2000-12-01 | 2002-08-08 | Johnatan Bacon | Prolamin-based sustained-release compositions and delayed-onset compositions |
JP2010180238A (en) * | 2001-11-22 | 2010-08-19 | Daiichi Sankyo Healthcare Co Ltd | Composition for rhinitis |
CN1535686A (en) * | 2003-04-09 | 2004-10-13 | 北京德众万全药物技术开发有限公司 | Slowly-released preparation containing loratadine and pseudoephedrine sulfate and its preparation method |
JP2009007332A (en) * | 2007-05-25 | 2009-01-15 | Daiichi Sankyo Healthcare Co Ltd | Pharmaceutical composition containing azelastines and ephedorines |
US20120100221A1 (en) * | 2009-06-02 | 2012-04-26 | Ranbaxy Laboratories Limited | Pharmaceutical compositions containing a combination of an antihistamine and a decongestant |
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Denomination of invention: Compound acrivastine sustained release tablets, and preparation method thereof Effective date of registration: 20160906 Granted publication date: 20130529 Pledgee: Agricultural Bank of China Limited by Share Ltd. Linquan county subbranch Pledgor: ANHUI YONGSHENGTANG PHARMACEUTICAL Co.,Ltd. Registration number: 2016340000050 |
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