CN104721164B - A kind of cinacalcet hydrochloride Film coated tablets composition - Google Patents
A kind of cinacalcet hydrochloride Film coated tablets composition Download PDFInfo
- Publication number
- CN104721164B CN104721164B CN201510132899.7A CN201510132899A CN104721164B CN 104721164 B CN104721164 B CN 104721164B CN 201510132899 A CN201510132899 A CN 201510132899A CN 104721164 B CN104721164 B CN 104721164B
- Authority
- CN
- China
- Prior art keywords
- cinacalcet hydrochloride
- film
- coated tablets
- film coated
- weight ratio
- 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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Links
- 229960000478 cinacalcet hydrochloride Drugs 0.000 title claims abstract description 47
- QANQWUQOEJZMLL-PKLMIRHRSA-N cinacalcet hydrochloride Chemical compound Cl.N([C@H](C)C=1C2=CC=CC=C2C=CC=1)CCCC1=CC=CC(C(F)(F)F)=C1 QANQWUQOEJZMLL-PKLMIRHRSA-N 0.000 title claims abstract description 47
- 239000007941 film coated tablet Substances 0.000 title claims abstract description 28
- 239000000203 mixture Substances 0.000 title claims abstract description 21
- 239000007888 film coating Substances 0.000 claims abstract description 34
- 238000009501 film coating Methods 0.000 claims abstract description 34
- 238000004090 dissolution Methods 0.000 claims abstract description 26
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 22
- 229960000540 polacrilin potassium Drugs 0.000 claims abstract description 12
- WVWZXTJUCNEUAE-UHFFFAOYSA-M potassium;1,2-bis(ethenyl)benzene;2-methylprop-2-enoate Chemical compound [K+].CC(=C)C([O-])=O.C=CC1=CC=CC=C1C=C WVWZXTJUCNEUAE-UHFFFAOYSA-M 0.000 claims abstract description 11
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 11
- 239000010410 layer Substances 0.000 claims description 39
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- 239000003795 chemical substances by application Substances 0.000 claims description 15
- 238000002156 mixing Methods 0.000 claims description 14
- 239000008213 purified water Substances 0.000 claims description 14
- 210000002784 stomach Anatomy 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 abstract description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 238000000034 method Methods 0.000 description 8
- 239000003826 tablet Substances 0.000 description 8
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- 239000012467 final product Substances 0.000 description 6
- 102000003982 Parathyroid hormone Human genes 0.000 description 4
- 108090000445 Parathyroid hormone Proteins 0.000 description 4
- 239000000199 parathyroid hormone Substances 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 3
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 description 3
- VDHAWDNDOKGFTD-MRXNPFEDSA-N cinacalcet Chemical compound N([C@H](C)C=1C2=CC=CC=C2C=CC=1)CCCC1=CC=CC(C(F)(F)F)=C1 VDHAWDNDOKGFTD-MRXNPFEDSA-N 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000008363 phosphate buffer Substances 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 229960003315 cinacalcet Drugs 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 2
- 230000000968 intestinal effect Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- CPKOXUVSOOKUDA-UHFFFAOYSA-N 1-bromo-5-fluoro-2-iodo-4-methylbenzene Chemical compound CC1=CC(I)=C(Br)C=C1F CPKOXUVSOOKUDA-UHFFFAOYSA-N 0.000 description 1
- 125000001637 1-naphthyl group Chemical group [H]C1=C([H])C([H])=C2C(*)=C([H])C([H])=C([H])C2=C1[H] 0.000 description 1
- -1 3- (trifluoromethyl) phenyl Chemical group 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 208000005156 Dehydration Diseases 0.000 description 1
- 206010012289 Dementia Diseases 0.000 description 1
- 241000790917 Dioxys <bee> Species 0.000 description 1
- 201000002980 Hyperparathyroidism Diseases 0.000 description 1
- 206010054949 Metaplasia Diseases 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 208000000821 Parathyroid Neoplasms Diseases 0.000 description 1
- 235000008331 Pinus X rigitaeda Nutrition 0.000 description 1
- 235000011613 Pinus brutia Nutrition 0.000 description 1
- 241000018646 Pinus brutia Species 0.000 description 1
- 229910003978 SiClx Inorganic materials 0.000 description 1
- 206010041349 Somnolence Diseases 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 229960002919 dronedarone hydrochloride Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 230000031891 intestinal absorption Effects 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
- 230000015689 metaplastic ossification Effects 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 201000003913 parathyroid carcinoma Diseases 0.000 description 1
- 208000017954 parathyroid gland carcinoma Diseases 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 150000003016 phosphoric acids Chemical class 0.000 description 1
- 108010048734 sclerotin Proteins 0.000 description 1
- 229940116949 sensipar Drugs 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
0.1mol/L hydrochloric acid solutions | PH4.5 phosphate buffers | PH6.8 phosphate buffers | |
Embodiment 1 | 98.1% | 92.0% | 77.3% |
Embodiment 2 | 99.5% | 95.4% | 75.6% |
Embodiment 3 | 98.7% | 92.8% | 72.3% |
Embodiment 4 | 99.9% | 99.2% | 98.9% |
Embodiment 5 | 100.0% | 99.4% | 98.4% |
Embodiment 6 | 99.2% | 99.7% | 98.5% |
Commercialized product | 99.5% | 88.1% | 25.0% |
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510132899.7A CN104721164B (en) | 2015-03-25 | 2015-03-25 | A kind of cinacalcet hydrochloride Film coated tablets composition |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510132899.7A CN104721164B (en) | 2015-03-25 | 2015-03-25 | A kind of cinacalcet hydrochloride Film coated tablets composition |
Publications (2)
Publication Number | Publication Date |
---|---|
CN104721164A CN104721164A (en) | 2015-06-24 |
CN104721164B true CN104721164B (en) | 2017-07-07 |
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CN201510132899.7A Active CN104721164B (en) | 2015-03-25 | 2015-03-25 | A kind of cinacalcet hydrochloride Film coated tablets composition |
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CN (1) | CN104721164B (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105213346B (en) * | 2015-11-02 | 2019-03-26 | 北京泰德制药股份有限公司 | A kind of pharmaceutical composition and preparation method thereof containing cinacalcet hydrochloride |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1946382A (en) * | 2003-09-12 | 2007-04-11 | 安姆根有限公司 | Rapid dissolution formulation of a calcium receptor-active compound |
WO2008064202A2 (en) * | 2006-11-20 | 2008-05-29 | Dr. Reddy's Labortories, Ltd. | Modified-release formulations of calcium receptor-active compounds |
CN102552258A (en) * | 2012-02-24 | 2012-07-11 | 北京协和药厂 | Pharmaceutical composition containing repaglinide and preparation method of same |
CN103933005A (en) * | 2014-05-15 | 2014-07-23 | 严白双 | Pantoprazole sodium-containing enteric-coated tablet and preparation method thereof |
WO2014207691A1 (en) * | 2013-06-26 | 2014-12-31 | Jubilant Life Sciences Limited | Disintegrant free composition of cinacalcet |
-
2015
- 2015-03-25 CN CN201510132899.7A patent/CN104721164B/en active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1946382A (en) * | 2003-09-12 | 2007-04-11 | 安姆根有限公司 | Rapid dissolution formulation of a calcium receptor-active compound |
WO2008064202A2 (en) * | 2006-11-20 | 2008-05-29 | Dr. Reddy's Labortories, Ltd. | Modified-release formulations of calcium receptor-active compounds |
CN102552258A (en) * | 2012-02-24 | 2012-07-11 | 北京协和药厂 | Pharmaceutical composition containing repaglinide and preparation method of same |
WO2014207691A1 (en) * | 2013-06-26 | 2014-12-31 | Jubilant Life Sciences Limited | Disintegrant free composition of cinacalcet |
CN103933005A (en) * | 2014-05-15 | 2014-07-23 | 严白双 | Pantoprazole sodium-containing enteric-coated tablet and preparation method thereof |
Also Published As
Publication number | Publication date |
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CN104721164A (en) | 2015-06-24 |
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C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant | ||
CP02 | Change in the address of a patent holder |
Address after: 051500 Haixing Road, Zhaoxian County Industrial Park, Shijiazhuang, Hebei Patentee after: HEBEI RENHE YIKANG PHARMACEUTICAL Co.,Ltd. Address before: 053411 Hengshui City, Hebei, Wuyi County, Qing Liang store town Patentee before: HEBEI RENHE YIKANG PHARMACEUTICAL Co.,Ltd. |
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CP02 | Change in the address of a patent holder | ||
TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20211129 Address after: 050000 2 / F, Hongchang science and Technology Park, 238 Changjiang Avenue, high tech Zone, Shijiazhuang City, Hebei Province Patentee after: Renhe Yikang Group Co.,Ltd. Address before: 051500 Haixing Road, Zhaoxian County Industrial Park, Shijiazhuang, Hebei Patentee before: HEBEI RENHE YIKANG PHARMACEUTICAL Co.,Ltd. |
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CP02 | Change in the address of a patent holder | ||
CP02 | Change in the address of a patent holder |
Address after: 051530 No. 7, Haixing Road, industrial park, xinzhaidian Town, Zhao county, Shijiazhuang City, Hebei Province Patentee after: Renhe Yikang Group Co.,Ltd. Address before: 050000 2 / F, Hongchang science and Technology Park, 238 Changjiang Avenue, high tech Zone, Shijiazhuang City, Hebei Province Patentee before: Renhe Yikang Group Co.,Ltd. |
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PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A combination of cinacalcet hydrochloride film coated tablets Granted publication date: 20170707 Pledgee: Cangzhou Bank Co.,Ltd. Xinji sub branch Pledgor: Renhe Yikang Group Co.,Ltd. Registration number: Y2024980034736 |