JP2007505108A5 - - Google Patents
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- Publication number
- JP2007505108A5 JP2007505108A5 JP2006526096A JP2006526096A JP2007505108A5 JP 2007505108 A5 JP2007505108 A5 JP 2007505108A5 JP 2006526096 A JP2006526096 A JP 2006526096A JP 2006526096 A JP2006526096 A JP 2006526096A JP 2007505108 A5 JP2007505108 A5 JP 2007505108A5
- Authority
- JP
- Japan
- Prior art keywords
- composition
- weight
- active compound
- hcl
- composition according
- 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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- 239000000203 mixture Substances 0.000 claims 82
- 150000001875 compounds Chemical class 0.000 claims 25
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 20
- 239000011575 calcium Substances 0.000 claims 20
- 229910052791 calcium Inorganic materials 0.000 claims 20
- 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 claims 15
- 239000002245 particle Substances 0.000 claims 13
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 10
- 239000008187 granular material Substances 0.000 claims 10
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 7
- 229920002472 Starch Polymers 0.000 claims 7
- 238000000034 method Methods 0.000 claims 7
- 239000008108 microcrystalline cellulose Substances 0.000 claims 7
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 7
- 239000008107 starch Substances 0.000 claims 7
- 235000019698 starch Nutrition 0.000 claims 7
- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- 239000000546 pharmaceutical excipient Substances 0.000 claims 6
- 239000000843 powder Substances 0.000 claims 6
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims 5
- 229960000913 crospovidone Drugs 0.000 claims 5
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 5
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 5
- 229940069328 povidone Drugs 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- 125000003118 aryl group Chemical group 0.000 claims 4
- 239000011230 binding agent Substances 0.000 claims 4
- 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 claims 4
- 229960003315 cinacalcet Drugs 0.000 claims 4
- 239000003085 diluting agent Substances 0.000 claims 4
- 239000007884 disintegrant Substances 0.000 claims 4
- 238000004090 dissolution Methods 0.000 claims 4
- 238000007922 dissolution test Methods 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- 238000004519 manufacturing process Methods 0.000 claims 4
- -1 methylenedioxy group Chemical group 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- 201000002980 Hyperparathyroidism Diseases 0.000 claims 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 3
- 239000000853 adhesive Substances 0.000 claims 3
- 230000001070 adhesive effect Effects 0.000 claims 3
- 125000002723 alicyclic group Chemical group 0.000 claims 3
- 238000005469 granulation Methods 0.000 claims 3
- 230000003179 granulation Effects 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 239000000463 material Substances 0.000 claims 3
- 239000012748 slip agent Substances 0.000 claims 3
- 208000037147 Hypercalcaemia Diseases 0.000 claims 2
- 125000002777 acetyl group Chemical group [H]C([H])([H])C(*)=O 0.000 claims 2
- 125000003668 acetyloxy group Chemical group [H]C([H])([H])C(=O)O[*] 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 2
- 230000000996 additive effect Effects 0.000 claims 2
- 125000000217 alkyl group Chemical group 0.000 claims 2
- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims 2
- MWKXCSMICWVRGW-UHFFFAOYSA-N calcium;phosphane Chemical compound P.[Ca] MWKXCSMICWVRGW-UHFFFAOYSA-N 0.000 claims 2
- 125000006297 carbonyl amino group Chemical group [H]N([*:2])C([*:1])=O 0.000 claims 2
- 239000001913 cellulose Substances 0.000 claims 2
- 235000010980 cellulose Nutrition 0.000 claims 2
- 229920002678 cellulose Polymers 0.000 claims 2
- 238000009500 colour coating Methods 0.000 claims 2
- 125000004122 cyclic group Chemical group 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 230000000148 hypercalcaemia Effects 0.000 claims 2
- 208000030915 hypercalcemia disease Diseases 0.000 claims 2
- 201000005991 hyperphosphatemia Diseases 0.000 claims 2
- 125000000959 isobutyl group Chemical group [H]C([H])([H])C([H])(C([H])([H])[H])C([H])([H])* 0.000 claims 2
- 125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 claims 2
- 125000000999 tert-butyl group Chemical group [H]C([H])([H])C(*)(C([H])([H])[H])C([H])([H])[H] 0.000 claims 2
- 125000006273 (C1-C3) alkyl group Chemical group 0.000 claims 1
- 101000939517 Homo sapiens Ubiquitin carboxyl-terminal hydrolase 2 Proteins 0.000 claims 1
- 206010020707 Hyperparathyroidism primary Diseases 0.000 claims 1
- 201000000981 Primary Hyperparathyroidism Diseases 0.000 claims 1
- 208000005770 Secondary Hyperparathyroidism Diseases 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 102100029643 Ubiquitin carboxyl-terminal hydrolase 2 Human genes 0.000 claims 1
- 230000002092 calcimimetic effect Effects 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- 125000001070 dihydroindolyl group Chemical group N1(CCC2=CC=CC=C12)* 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 229940057948 magnesium stearate Drugs 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 229940098779 methanesulfonic acid Drugs 0.000 claims 1
- 229920006395 saturated elastomer Polymers 0.000 claims 1
- 238000005029 sieve analysis Methods 0.000 claims 1
- 239000000377 silicon dioxide Substances 0.000 claims 1
- 235000012239 silicon dioxide Nutrition 0.000 claims 1
- 229940032147 starch Drugs 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 235000012222 talc Nutrition 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 229940033134 talc Drugs 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US50221903P | 2003-09-12 | 2003-09-12 | |
| US60/502,219 | 2003-09-12 | ||
| PCT/US2004/026732 WO2005034928A1 (en) | 2003-09-12 | 2004-09-10 | Rapid dissolution formulation of a calcium receptor-active compound |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012110758A Division JP5849015B2 (ja) | 2003-09-12 | 2012-05-14 | カルシウム受容体−活性化合物の急速溶解処方 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2007505108A JP2007505108A (ja) | 2007-03-08 |
| JP2007505108A5 true JP2007505108A5 (enExample) | 2007-10-18 |
| JP5026077B2 JP5026077B2 (ja) | 2012-09-12 |
Family
ID=34434844
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2006526096A Expired - Lifetime JP5026077B2 (ja) | 2003-09-12 | 2004-09-10 | カルシウム受容体−活性化合物の急速溶解処方 |
| JP2012110758A Expired - Lifetime JP5849015B2 (ja) | 2003-09-12 | 2012-05-14 | カルシウム受容体−活性化合物の急速溶解処方 |
| JP2014165378A Expired - Lifetime JP5940120B2 (ja) | 2003-09-12 | 2014-08-15 | カルシウム受容体−活性化合物の急速溶解処方 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012110758A Expired - Lifetime JP5849015B2 (ja) | 2003-09-12 | 2012-05-14 | カルシウム受容体−活性化合物の急速溶解処方 |
| JP2014165378A Expired - Lifetime JP5940120B2 (ja) | 2003-09-12 | 2014-08-15 | カルシウム受容体−活性化合物の急速溶解処方 |
Country Status (30)
| Country | Link |
|---|---|
| US (7) | US7829595B2 (enExample) |
| EP (8) | EP3395340B8 (enExample) |
| JP (3) | JP5026077B2 (enExample) |
| KR (1) | KR101332058B1 (enExample) |
| CN (1) | CN1946382B (enExample) |
| AR (1) | AR045637A1 (enExample) |
| AU (1) | AU2004279318C1 (enExample) |
| BR (2) | BR122018013029B1 (enExample) |
| CA (1) | CA2536487C (enExample) |
| CY (5) | CY1119609T1 (enExample) |
| DE (1) | DE19164145T1 (enExample) |
| DK (6) | DK1663182T4 (enExample) |
| EA (1) | EA013425B1 (enExample) |
| ES (7) | ES2401769T5 (enExample) |
| HR (1) | HRP20130114T4 (enExample) |
| HU (5) | HUE035596T2 (enExample) |
| IL (1) | IL173737A (enExample) |
| IS (1) | IS3027B (enExample) |
| MX (1) | MXPA06002616A (enExample) |
| MY (1) | MY142046A (enExample) |
| NO (1) | NO335739B1 (enExample) |
| NZ (1) | NZ545498A (enExample) |
| PL (6) | PL3395339T3 (enExample) |
| PT (6) | PT2821067T (enExample) |
| SG (1) | SG146608A1 (enExample) |
| SI (6) | SI3395338T1 (enExample) |
| TR (4) | TR201910447T4 (enExample) |
| TW (1) | TWI344363B (enExample) |
| WO (1) | WO2005034928A1 (enExample) |
| ZA (1) | ZA200602710B (enExample) |
Families Citing this family (64)
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| ES2401769T5 (es) | 2003-09-12 | 2020-07-01 | Amgen Inc | Formulación de disolución rápida de cinacalcet HCl |
| CN101891680B (zh) | 2004-06-24 | 2014-10-29 | 沃泰克斯药物股份有限公司 | Atp-结合弹夹转运蛋白的调控剂 |
| US7250533B2 (en) * | 2005-05-16 | 2007-07-31 | Teva Pharmaceutical Industries Ltd | Process for preparing Cinacalcet hydrochloride |
| CA2605764A1 (en) * | 2005-05-23 | 2006-11-30 | Teva Pharmaceutical Industries Ltd. | Amorphous cinacalcet hydrochloride and preparation thereof |
| WO2006127932A2 (en) * | 2005-05-23 | 2006-11-30 | Teva Pharmaceutical Industries Ltd. | Purification of cinacalcet |
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| AU2006285080B2 (en) * | 2005-09-02 | 2012-05-03 | Amgen Inc. | Methods of modulating intestinal fluid balance |
| US7563930B2 (en) * | 2005-11-22 | 2009-07-21 | Teva Pharmaceutical Industries Ltd | Crystal forms of Cinacalcet HCI and processes for their preparation |
| DK3219705T3 (da) | 2005-12-28 | 2020-04-14 | Vertex Pharma | Farmaceutiske sammensætninger af den amorfe form af n-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinolin-3-carboxamid |
| CA2882048C (en) | 2006-02-03 | 2020-03-24 | Opko Renal, Llc | Treating vitamin d insufficiency and deficiency with 25-hydroxyvitamin d2 and 25-hydroxyvitamin d3 |
| US8415501B2 (en) * | 2006-03-23 | 2013-04-09 | Amgen, Inc. | Methods and compositions for making and using polymorphs of cinacalcet |
| JP5027214B2 (ja) * | 2006-04-27 | 2012-09-19 | テバ ファーマシューティカル インダストリーズ リミティド | シナカルセット塩基の調製法 |
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| US12458635B2 (en) | 2008-08-13 | 2025-11-04 | Vertex Pharmaceuticals Incorporated | Pharmaceutical composition and administrations thereof |
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| CN103037902A (zh) | 2010-03-29 | 2013-04-10 | 赛特克罗公司 | 用于降低甲状旁腺水平的方法和组合物 |
| CN103347517B (zh) | 2010-08-11 | 2018-10-02 | 德雷克塞尔大学 | 治疗帕金森病中运动障碍的d3多巴胺受体激动剂 |
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| BR112014015003A2 (pt) * | 2011-12-19 | 2019-09-24 | Amgen Inc | composição farmacêutica, método para tratar um cancer e método para reduzir o tamanho de uma massa tumoral |
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