RU2381791C2 - Лекарственные формы ризедроната - Google Patents
Лекарственные формы ризедроната Download PDFInfo
- Publication number
- RU2381791C2 RU2381791C2 RU2007136046/15A RU2007136046A RU2381791C2 RU 2381791 C2 RU2381791 C2 RU 2381791C2 RU 2007136046/15 A RU2007136046/15 A RU 2007136046/15A RU 2007136046 A RU2007136046 A RU 2007136046A RU 2381791 C2 RU2381791 C2 RU 2381791C2
- Authority
- RU
- Russia
- Prior art keywords
- risedronate
- oral dosage
- chelating agent
- dosage form
- coating
- Prior art date
Links
- IIDJRNMFWXDHID-UHFFFAOYSA-N Risedronic acid Chemical compound OP(=O)(O)C(P(O)(O)=O)(O)CC1=CC=CN=C1 IIDJRNMFWXDHID-UHFFFAOYSA-N 0.000 title claims abstract description 175
- 229940089617 risedronate Drugs 0.000 title claims abstract description 158
- 239000002552 dosage form Substances 0.000 title description 17
- 239000002738 chelating agent Substances 0.000 claims abstract description 107
- 239000006186 oral dosage form Substances 0.000 claims abstract description 69
- 210000000813 small intestine Anatomy 0.000 claims abstract description 52
- 235000013305 food Nutrition 0.000 claims abstract description 27
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 19
- 241000124008 Mammalia Species 0.000 claims abstract description 16
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 13
- 230000003111 delayed effect Effects 0.000 claims abstract description 11
- 239000000203 mixture Substances 0.000 claims description 63
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 57
- 239000002702 enteric coating Substances 0.000 claims description 48
- 238000009505 enteric coating Methods 0.000 claims description 48
- 238000000034 method Methods 0.000 claims description 36
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 31
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 21
- 150000003839 salts Chemical class 0.000 claims description 18
- 230000036962 time dependent Effects 0.000 claims description 18
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims description 16
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims description 16
- 210000000988 bone and bone Anatomy 0.000 claims description 14
- 241000282414 Homo sapiens Species 0.000 claims description 12
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 12
- 201000010099 disease Diseases 0.000 claims description 11
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 10
- 230000002159 abnormal effect Effects 0.000 claims description 9
- 239000001506 calcium phosphate Substances 0.000 claims description 9
- 235000011010 calcium phosphates Nutrition 0.000 claims description 9
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 8
- 238000005303 weighing Methods 0.000 claims description 8
- 235000015165 citric acid Nutrition 0.000 claims description 7
- 239000003937 drug carrier Substances 0.000 claims description 7
- 230000004060 metabolic process Effects 0.000 claims description 7
- 235000015097 nutrients Nutrition 0.000 claims description 7
- 238000011282 treatment Methods 0.000 claims description 7
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 6
- 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 5
- 208000001132 Osteoporosis Diseases 0.000 claims description 5
- 229910052708 sodium Inorganic materials 0.000 claims description 5
- 208000010191 Osteitis Deformans Diseases 0.000 claims description 4
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims description 4
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 4
- GCLGEJMYGQKIIW-UHFFFAOYSA-H sodium hexametaphosphate Chemical compound [Na]OP1(=O)OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])O1 GCLGEJMYGQKIIW-UHFFFAOYSA-H 0.000 claims description 4
- 235000019982 sodium hexametaphosphate Nutrition 0.000 claims description 4
- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 claims description 4
- 208000037147 Hypercalcaemia Diseases 0.000 claims description 3
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- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 2
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims description 2
- 239000004472 Lysine Substances 0.000 claims description 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 2
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- 235000014655 lactic acid Nutrition 0.000 claims description 2
- 235000018977 lysine Nutrition 0.000 claims description 2
- 239000001630 malic acid Substances 0.000 claims description 2
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 30
- 239000004480 active ingredient Substances 0.000 description 27
- 239000007891 compressed tablet Substances 0.000 description 27
- 239000008213 purified water Substances 0.000 description 22
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 21
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- 239000000969 carrier Substances 0.000 description 19
- 239000008199 coating composition Substances 0.000 description 18
- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 description 17
- 239000000454 talc Substances 0.000 description 17
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- 229920003138 Eudragit® L 30 D-55 Polymers 0.000 description 16
- 235000019166 vitamin D Nutrition 0.000 description 16
- 239000011710 vitamin D Substances 0.000 description 16
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 15
- 235000019359 magnesium stearate Nutrition 0.000 description 15
- 229960000759 risedronic acid Drugs 0.000 description 15
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- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 15
- 235000013769 triethyl citrate Nutrition 0.000 description 15
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- KEAYESYHFKHZAL-UHFFFAOYSA-N Sodium Chemical class [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 0.000 description 11
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 description 11
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Landscapes
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| Application Number | Priority Date | Filing Date | Title |
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| US11/106,816 US7645459B2 (en) | 2004-05-24 | 2005-04-15 | Dosage forms of bisphosphonates |
| US11/106,816 | 2005-04-15 |
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| RU2007136046A RU2007136046A (ru) | 2009-05-20 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2591082C2 (ru) * | 2011-06-23 | 2016-07-10 | Байер Нью Зиленд Лимитед | Антипаразитарная композиция, содержащая макроциклический лактон и левамизол, и способ лечения паразитарной инфестации |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US7563460B2 (en) * | 2004-02-26 | 2009-07-21 | Med Five, Inc. | Enteric coated oral pharmaceutical to erode kidney stones |
| US7645459B2 (en) | 2004-05-24 | 2010-01-12 | The Procter & Gamble Company | Dosage forms of bisphosphonates |
| US20080287400A1 (en) * | 2004-05-24 | 2008-11-20 | Richard John Dansereau | Low Dosage Forms Of Risedronate Or Its Salts |
| US20080286359A1 (en) * | 2004-05-24 | 2008-11-20 | Richard John Dansereau | Low Dosage Forms Of Risedronate Or Its Salts |
| US7645460B2 (en) * | 2004-05-24 | 2010-01-12 | The Procter & Gamble Company | Dosage forms of risedronate |
| US20060134190A1 (en) * | 2004-12-16 | 2006-06-22 | Banner Pharmacaps Inc. | Formulations of bisphosphonate drugs with improved bioavailability |
| US8158153B2 (en) * | 2005-03-17 | 2012-04-17 | Alkermes Pharma Ireland Limited | Nanoparticulate bisphosphonate compositions |
| GB2430156A (en) * | 2005-09-16 | 2007-03-21 | Selamine Ltd | Bisphosphonate formulation |
| US7473684B2 (en) * | 2005-09-16 | 2009-01-06 | Selamine Limited | Bisphosphonate formulation |
| US7201929B1 (en) * | 2005-12-30 | 2007-04-10 | Alan James Group, Llc. | Aspirin formulation for cardiovascular health |
| US7202229B1 (en) * | 2005-12-30 | 2007-04-10 | Alan James Group, Llc. | Aspirin formulation for cardiovascular health |
| GB0616794D0 (en) | 2006-08-24 | 2006-10-04 | Arrow Int Ltd | Solid dosage form |
| GB0624087D0 (en) * | 2006-12-01 | 2007-01-10 | Selamine Ltd | Ramipril combination salt |
| GB0624084D0 (en) * | 2006-12-01 | 2007-01-10 | Selamine Ltd | Ramipril amino acid salts |
| JP5290198B2 (ja) * | 2006-12-20 | 2013-09-18 | ミラン ファーマシューティカルズ ユーエルシー | ホットメルト顆粒化潤滑剤を含んでなる医薬組成物 |
| AU2014201170B2 (en) * | 2006-12-20 | 2015-09-24 | Mylan Pharmaceuticals Ulc | Pharmaceutical composition comprising a hot-melt granulated lubricant |
| US9061076B2 (en) | 2007-05-25 | 2015-06-23 | North Carolina State University | Viral nanoparticle cell-targeted delivery platform |
| US8345282B2 (en) * | 2007-08-03 | 2013-01-01 | Kyocera Document Solutions Inc. | Image forming system and image forming apparatus |
| WO2009018834A1 (en) * | 2007-08-06 | 2009-02-12 | Pharmathen S.A. | Pharmaceutical composition containing bisphosphonate and method for the preparation thereof |
| US20090215729A1 (en) * | 2008-02-19 | 2009-08-27 | Johnson Erin M | Microparticle compositions to modify cancer promoting cells |
| JP2011529902A (ja) * | 2008-07-31 | 2011-12-15 | 味の素株式会社 | リセドロネートまたはその塩の低投与量形態 |
| CN102215823A (zh) * | 2008-11-20 | 2011-10-12 | 安万托特性材料股份有限公司 | 直接可压制的基于高功能性颗粒磷酸氢钙的共处理的赋形剂 |
| US8628812B2 (en) * | 2008-12-30 | 2014-01-14 | Pepsico, Inc. | Preservative system for acidic beverages based on sequestrants |
| TR200900878A2 (tr) * | 2009-02-05 | 2010-08-23 | Bi̇lgi̇ç Mahmut | Tek bir dozaj formunda kombine edilen farmasötik formülasyonlar |
| TWI480286B (zh) * | 2009-02-25 | 2015-04-11 | Merrion Res Iii Ltd | 雙膦酸鹽類組合物及藥物遞送 |
| US8980868B2 (en) | 2009-07-31 | 2015-03-17 | Thar Pharmaceuticals, Inc. | Oral forms of a phosphonic acid derivative |
| HUE034784T2 (en) | 2009-07-31 | 2018-02-28 | Gruenenthal Gmbh | Crystallization process and bioavailability |
| US20160016982A1 (en) | 2009-07-31 | 2016-01-21 | Thar Pharmaceuticals, Inc. | Crystallization method and bioavailability |
| US9169279B2 (en) | 2009-07-31 | 2015-10-27 | Thar Pharmaceuticals, Inc. | Crystallization method and bioavailability |
| SG10201406846XA (en) | 2009-10-26 | 2014-12-30 | Warner Chilcott Co Llc | Bisphosphonate compounds for treating bone metabolism disorders |
| FR2954320B1 (fr) | 2009-12-17 | 2012-06-15 | Cll Pharma | Composition pharmaceutique orale suprabiodisponible contenant un acide biphosphonique ou un de ses sels |
| WO2011120033A1 (en) | 2010-03-26 | 2011-09-29 | Merrion Research Iii Limited | Pharmaceutical compositions of selective factor xa inhibitors for oral administration |
| FR2967576B1 (fr) * | 2010-11-18 | 2013-07-12 | Advicenne Pharma | Composition pharmaceutique comprenant du sel precurseur du cycle de krebs, en particulier du sel de citrate, et son utilisation comme medicament |
| WO2012071517A2 (en) | 2010-11-24 | 2012-05-31 | Thar Pharmaceuticals, Inc. | Novel crystalline forms |
| KR20120105738A (ko) * | 2011-03-16 | 2012-09-26 | 현대약품 주식회사 | 장용코팅된 경구용 제제 |
| CN102885759A (zh) * | 2011-07-20 | 2013-01-23 | 杭州赛利药物研究所有限公司 | 利塞膦酸钠延释制剂及其制备方法 |
| KR101324425B1 (ko) * | 2011-07-22 | 2013-11-01 | 동아에스티 주식회사 | 증가된 비스포스포네이트의 생체이용률을 가지는 경구투여 약제 |
| EP2830599B1 (en) | 2012-03-29 | 2018-08-15 | Therabiome, Llc | Gastrointestinal site-specific oral vaccination formulations active on the ileum and appendix |
| US9844559B2 (en) | 2012-05-14 | 2017-12-19 | Antecip Bioventures Ii Llc | Neridronic acid for treating bone marrow lesions |
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| US7645459B2 (en) | 2010-01-12 |
| IL268462A (en) | 2019-09-26 |
| KR20110002887A (ko) | 2011-01-10 |
| MA29681B1 (fr) | 2008-08-01 |
| NO20075834L (no) | 2007-11-14 |
| KR20070111551A (ko) | 2007-11-21 |
| KR101280138B1 (ko) | 2013-06-28 |
| SMAP200700047A (it) | 2007-11-21 |
| AU2005330654A1 (en) | 2006-10-26 |
| MX2007012821A (es) | 2007-11-20 |
| CN101166519A (zh) | 2008-04-23 |
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| US20100086593A1 (en) | 2010-04-08 |
| EP1868584A1 (en) | 2007-12-26 |
| CA2675652A1 (en) | 2006-10-26 |
| JP4788765B2 (ja) | 2011-10-05 |
| IL186339A0 (en) | 2008-01-20 |
| CA2602188A1 (en) | 2006-10-26 |
| US8246989B2 (en) | 2012-08-21 |
| JP2008535912A (ja) | 2008-09-04 |
| CN104027323A (zh) | 2014-09-10 |
| US20050260262A1 (en) | 2005-11-24 |
| KR101070205B1 (ko) | 2011-10-06 |
| US8535718B2 (en) | 2013-09-17 |
| WO2006112889A1 (en) | 2006-10-26 |
| US20130012478A1 (en) | 2013-01-10 |
| RU2007136046A (ru) | 2009-05-20 |
| AU2005330654B2 (en) | 2011-06-23 |
| SMP200700047B (it) | 2007-11-21 |
| CA2602188C (en) | 2009-10-13 |
| US20130331361A1 (en) | 2013-12-12 |
| BRPI0520082A2 (pt) | 2009-04-14 |
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