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
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- 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) | EP2821067B1 (enExample) |
| JP (3) | JP5026077B2 (enExample) |
| KR (1) | KR101332058B1 (enExample) |
| CN (1) | CN1946382B (enExample) |
| AR (1) | AR045637A1 (enExample) |
| AU (1) | AU2004279318C1 (enExample) |
| BR (2) | BRPI0414254B8 (enExample) |
| CA (1) | CA2536487C (enExample) |
| CY (5) | CY1119609T1 (enExample) |
| DE (1) | DE19164145T1 (enExample) |
| DK (6) | DK3260117T3 (enExample) |
| EA (1) | EA013425B1 (enExample) |
| ES (7) | ES2655435T3 (enExample) |
| HR (1) | HRP20130114T4 (enExample) |
| HU (5) | HUE044822T2 (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) | PL3395338T3 (enExample) |
| PT (6) | PT3395338T (enExample) |
| SG (1) | SG146608A1 (enExample) |
| SI (6) | SI3395340T1 (enExample) |
| TR (4) | TR201910447T4 (enExample) |
| TW (1) | TWI344363B (enExample) |
| WO (1) | WO2005034928A1 (enExample) |
| ZA (1) | ZA200602710B (enExample) |
Families Citing this family (64)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7829595B2 (en) | 2003-09-12 | 2010-11-09 | Amgen Inc. | Rapid dissolution formulation of a calcium receptor-active compound |
| PL2489659T3 (pl) | 2004-06-24 | 2018-06-29 | Vertex Pharma | Modulatory transporterów posiadających kasetę wiążącą atp |
| ES2332016T3 (es) * | 2005-05-16 | 2010-01-22 | Teva Pharmaceutical Industries Ltd. | Procedimiento para la preparacion de hidrocloruro de cinacalcet. |
| EP1883618B1 (en) * | 2005-05-23 | 2009-10-14 | Teva Pharmaceutical Industries Ltd. | Processes for preparing cinacalcet hydrochloride crystal form i |
| JP2008507567A (ja) * | 2005-05-23 | 2008-03-13 | 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 | 非晶性シナカルセト塩酸塩及びその調製 |
| CN101184489B (zh) | 2005-05-26 | 2011-01-19 | 大日本住友制药株式会社 | 药物组合物 |
| ES2400693T3 (es) * | 2005-09-02 | 2013-04-11 | Amgen Inc. | Regulación del equilibrio de fluido intestinal usando calcimiméticos |
| US7563930B2 (en) * | 2005-11-22 | 2009-07-21 | Teva Pharmaceutical Industries Ltd | Crystal forms of Cinacalcet HCI and processes for their preparation |
| PT1993360T (pt) | 2005-12-28 | 2017-05-25 | Vertex Pharma | Formas sólidas de n-[2,4-bis(1,1-dimetiletil)-5-hidroxifenil]-1,4-di-hidro-4-oxoquinolina-3-carboxamida |
| SI1993559T1 (sl) | 2006-02-03 | 2017-01-31 | Opko Renal, Llc | Zdravljenje nezadostnosti in pomanjkanja vitamina D s 25-hidroksivitaminon D2 in 25-hidroksivitaminom D3 |
| CA2645494C (en) * | 2006-03-23 | 2016-01-12 | Amgen Inc. | Methods and compositions for making and using polymorphs of cinacalcet |
| TW200811082A (en) * | 2006-04-27 | 2008-03-01 | Teva Pharma | Process for the preparation of cinacalcet base |
| WO2007127445A2 (en) * | 2006-04-27 | 2007-11-08 | Teva Pharmaceutical Industries Ltd. | Process for the preparation of cinacalcet base |
| DK3357496T3 (da) | 2006-06-21 | 2020-05-11 | Opko Ireland Global Holdings Ltd | Terapi ved brug af vitamin d-repletteringsmiddel og vitamin d-hormonsubstitutionsmiddel |
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| TWI573802B (zh) | 2007-03-06 | 2017-03-11 | 安美基公司 | 變異之活動素受體多肽及其用途 |
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| PT2148661E (pt) | 2007-04-25 | 2013-03-06 | Proventiv Therapeutics Llc | Composições orais de libertação controlada compreendendo um composto de vitamina d e veículo ceroso |
| CA2691196C (en) * | 2007-06-21 | 2016-05-24 | Amgen Inc. | Methods of synthesizing cinacalcet and salts thereof |
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| US12458635B2 (en) | 2008-08-13 | 2025-11-04 | Vertex Pharmaceuticals Incorporated | Pharmaceutical composition and administrations thereof |
| US20100256184A1 (en) * | 2008-08-13 | 2010-10-07 | Vertex Pharmaceuticals Incorporated | Pharmaceutical composition and administrations thereof |
| US20100074949A1 (en) * | 2008-08-13 | 2010-03-25 | William Rowe | Pharmaceutical composition and administration thereof |
| EP2334284B1 (de) * | 2008-09-25 | 2012-08-08 | Ratiopharm GmbH | Kompaktiertes cinacalcet |
| WO2010086129A1 (en) | 2009-01-27 | 2010-08-05 | Rathiopharm Gmbh | Inclusion complex comprising cinacalcet and cyclodextrin |
| EP3330255B1 (en) | 2009-03-20 | 2020-12-09 | Vertex Pharmaceuticals Incorporated | Process for making modulators of cystic fibrosis transmembrane conductance regulator |
| WO2010136035A2 (en) | 2009-05-27 | 2010-12-02 | Leo Pharma A/S | Novel calcium sensing receptor modulating compounds and pharmaceutical use thereof |
| EP2435404A1 (en) | 2009-05-27 | 2012-04-04 | Leo Pharma A/S | Novel calcium sensing receptor modulating compounds and pharmaceutical use thereof |
| EP2314286A1 (de) | 2009-10-21 | 2011-04-27 | Ratiopharm GmbH | Schmelzgranuliertes Cinacalcet |
| US11672809B2 (en) | 2010-03-29 | 2023-06-13 | Eirgen Pharma Ltd. | Methods and compositions for reducing parathyroid levels |
| WO2012021629A2 (en) | 2010-08-11 | 2012-02-16 | Philadelphia Health & Education Corporation | Novel d3 dopamine receptor agonists to treat dyskinesia in parkinson's disease |
| RS60203B1 (sr) * | 2010-11-23 | 2020-06-30 | Amgen Inc | Pedijatrijska formulacija |
| CN103228629A (zh) | 2010-11-26 | 2013-07-31 | 利奥制药有限公司 | 作为CaSR活性化合物的被取代的环戊基-氮杂苯类 |
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| RU2013128973A (ru) | 2010-11-26 | 2015-01-10 | Лео Фарма А/С | Соединения, активные в отношении кальций-чувствительных рецепторов |
| JP6145112B2 (ja) | 2011-12-19 | 2017-06-07 | アムジエン・インコーポレーテツド | 単独でのまたは化学療法と組み合わされた変異アクチビン受容体ポリペプチド、およびその使用 |
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