BRPI0713785A2 - formas de dosagem sólidas de valsartana, amlodipina e hidroclorotiazida e métodos de fabricação das mesmas - Google Patents
formas de dosagem sólidas de valsartana, amlodipina e hidroclorotiazida e métodos de fabricação das mesmas Download PDFInfo
- Publication number
- BRPI0713785A2 BRPI0713785A2 BRPI0713785-0A BRPI0713785A BRPI0713785A2 BR PI0713785 A2 BRPI0713785 A2 BR PI0713785A2 BR PI0713785 A BRPI0713785 A BR PI0713785A BR PI0713785 A2 BRPI0713785 A2 BR PI0713785A2
- Authority
- BR
- Brazil
- Prior art keywords
- mixed
- valsartan
- amlodipine
- mixing
- sieved
- Prior art date
Links
- 239000007909 solid dosage form Substances 0.000 title claims abstract description 83
- 238000000034 method Methods 0.000 title claims abstract description 50
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 19
- 229940051539 amlodipine and hydrochlorothiazide valsartan Drugs 0.000 title description 10
- 239000004072 C09CA03 - Valsartan Substances 0.000 claims abstract description 116
- 229960004699 valsartan Drugs 0.000 claims abstract description 116
- 229960000528 amlodipine Drugs 0.000 claims abstract description 101
- 239000002552 dosage form Substances 0.000 claims abstract description 91
- 239000002356 single layer Substances 0.000 claims abstract description 82
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 claims abstract 23
- 239000000463 material Substances 0.000 claims description 402
- 238000002156 mixing Methods 0.000 claims description 106
- JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 claims description 104
- 239000007787 solid Substances 0.000 claims description 95
- 238000005469 granulation Methods 0.000 claims description 91
- 230000003179 granulation Effects 0.000 claims description 91
- 229960002003 hydrochlorothiazide Drugs 0.000 claims description 73
- 239000000654 additive Substances 0.000 claims description 50
- 239000007888 film coating Substances 0.000 claims description 32
- 238000009501 film coating Methods 0.000 claims description 32
- 239000000203 mixture Substances 0.000 claims description 28
- 238000003801 milling Methods 0.000 claims description 26
- 239000010410 layer Substances 0.000 claims description 25
- ZPBWCRDSRKPIDG-UHFFFAOYSA-N amlodipine benzenesulfonate Chemical compound OS(=O)(=O)C1=CC=CC=C1.CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl ZPBWCRDSRKPIDG-UHFFFAOYSA-N 0.000 claims description 24
- 239000000314 lubricant Substances 0.000 claims description 19
- 238000012216 screening Methods 0.000 claims description 16
- 238000007873 sieving Methods 0.000 claims description 11
- 239000011230 binding agent Substances 0.000 claims description 7
- 239000003085 diluting agent Substances 0.000 claims description 7
- 239000007884 disintegrant Substances 0.000 claims description 7
- 239000000975 dye Substances 0.000 claims description 7
- -1 glidants Substances 0.000 claims description 7
- 229960004005 amlodipine besylate Drugs 0.000 claims description 6
- 238000002360 preparation method Methods 0.000 claims description 4
- UIYUUEDFAMZISF-FTBISJDPSA-N 6-chloro-1,1-dioxo-3,4-dihydro-2h-1$l^{6},2,4-benzothiadiazine-7-sulfonamide;(2s)-3-methyl-2-[pentanoyl-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic acid Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O.C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NNN=N1 UIYUUEDFAMZISF-FTBISJDPSA-N 0.000 claims description 3
- 206010002383 Angina Pectoris Diseases 0.000 claims description 3
- 206010003210 Arteriosclerosis Diseases 0.000 claims description 3
- 206010007558 Cardiac failure chronic Diseases 0.000 claims description 3
- 206010007559 Cardiac failure congestive Diseases 0.000 claims description 3
- 208000007342 Diabetic Nephropathies Diseases 0.000 claims description 3
- 206010019233 Headaches Diseases 0.000 claims description 3
- 206010019280 Heart failures Diseases 0.000 claims description 3
- 206010020772 Hypertension Diseases 0.000 claims description 3
- 208000007177 Left Ventricular Hypertrophy Diseases 0.000 claims description 3
- 208000021642 Muscular disease Diseases 0.000 claims description 3
- 201000009623 Myopathy Diseases 0.000 claims description 3
- 208000018262 Peripheral vascular disease Diseases 0.000 claims description 3
- 208000001647 Renal Insufficiency Diseases 0.000 claims description 3
- 208000006011 Stroke Diseases 0.000 claims description 3
- 230000002378 acidificating effect Effects 0.000 claims description 3
- 208000011775 arteriosclerosis disease Diseases 0.000 claims description 3
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- 231100000869 headache Toxicity 0.000 claims description 3
- 201000006370 kidney failure Diseases 0.000 claims description 3
- 208000010125 myocardial infarction Diseases 0.000 claims description 3
- HTIQEAQVCYTUBX-UHFFFAOYSA-N amlodipine Chemical compound CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl HTIQEAQVCYTUBX-UHFFFAOYSA-N 0.000 abstract description 94
- ACWBQPMHZXGDFX-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=NN1 ACWBQPMHZXGDFX-QFIPXVFZSA-N 0.000 description 94
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- 239000011777 magnesium Substances 0.000 description 5
- 239000004480 active ingredient Substances 0.000 description 4
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 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 2
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- 229940043102 valsartan and amlodipine Drugs 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 238000005550 wet granulation Methods 0.000 description 2
- 125000004182 2-chlorophenyl group Chemical group [H]C1=C([H])C(Cl)=C(*)C([H])=C1[H] 0.000 description 1
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- 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 description 1
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 235000019739 Dicalciumphosphate Nutrition 0.000 description 1
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- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
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- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 1
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- GXGAKHNRMVGRPK-UHFFFAOYSA-N dimagnesium;dioxido-bis[[oxido(oxo)silyl]oxy]silane Chemical compound [Mg+2].[Mg+2].[O-][Si](=O)O[Si]([O-])([O-])O[Si]([O-])=O GXGAKHNRMVGRPK-UHFFFAOYSA-N 0.000 description 1
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- WTFXARWRTYJXII-UHFFFAOYSA-N iron(2+);iron(3+);oxygen(2-) Chemical compound [O-2].[O-2].[O-2].[O-2].[Fe+2].[Fe+3].[Fe+3] WTFXARWRTYJXII-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
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- Diabetes (AREA)
- Neurosurgery (AREA)
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- Hematology (AREA)
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| US60/805,883 | 2006-06-27 | ||
| PCT/US2007/072097 WO2008002905A2 (en) | 2006-06-27 | 2007-06-26 | Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same |
Publications (1)
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| BRPI0713785A2 true BRPI0713785A2 (pt) | 2012-10-30 |
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| JO3239B1 (ar) | 2008-09-22 | 2018-03-08 | Novartis Ag | تركيبات جالينية من مركبات عضوية |
| US20120107397A1 (en) * | 2009-07-03 | 2012-05-03 | Hetero Research Foundation | Pharmaceutical compositions of valsartan |
| CA2775962C (en) | 2009-09-30 | 2017-09-05 | Boehringer Ingelheim International Gmbh | Processes for preparing of glucopyranosyl-substituted benzyl-benzene derivatives |
| US10610489B2 (en) * | 2009-10-02 | 2020-04-07 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof |
| CN102091069A (zh) * | 2009-12-11 | 2011-06-15 | 浙江华海药业股份有限公司 | 缬沙坦和氨氯地平的复方制剂及其制备方法 |
| CN101897675B (zh) * | 2010-02-10 | 2012-11-21 | 温士顿医药股份有限公司 | 含有凡尔沙坦或其药学上可接受的盐的固体剂型口服医药组成物 |
| CN101829111B (zh) * | 2010-05-23 | 2014-12-17 | 浙江华海药业股份有限公司 | 含有缬沙坦的固体制剂及其制备方法 |
| CN102716132B (zh) * | 2011-03-29 | 2015-09-30 | 石药集团中奇制药技术（石家庄）有限公司 | 复方氨氯地平/缬沙坦/氢氯噻嗪片及其制备方法 |
| EP2797580A2 (en) * | 2011-12-26 | 2014-11-05 | Novartis AG | Tablets and dry-coated agents |
| US9192617B2 (en) | 2012-03-20 | 2015-11-24 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, methods for treating and uses thereof |
| CN102614190A (zh) * | 2012-04-17 | 2012-08-01 | 北京哈三联科技股份有限公司 | 含有缬沙坦、氨氯地平和氢氯噻嗪的片剂及其制备方法 |
| JP6018420B2 (ja) * | 2012-06-05 | 2016-11-02 | ニプロ株式会社 | アンジオテンシンｉｉ受容体拮抗薬およびサイアザイド系利尿薬を含む医薬組成物 |
| MX358211B (es) | 2012-07-23 | 2018-08-10 | Landsteiner Scient S A De C V | Una composición farmacéutica de liberación comprendiendo hidroclorotiazida, losartán y basilato de amlodipino. |
| CN103655580B (zh) * | 2012-08-28 | 2017-12-01 | 海南中济医药科技有限公司 | 一种含有缬沙坦、苯磺酸氨氯地平和氢氯噻嗪的药物组合物及其制备方法 |
| WO2014058047A1 (ja) * | 2012-10-12 | 2014-04-17 | 味の素株式会社 | カルシウム拮抗薬／アンジオテンシンｉｉ受容体拮抗薬含有医薬製剤の製造方法 |
| CN102846625A (zh) * | 2012-10-18 | 2013-01-02 | 海口华仕联医药科技有限公司 | 一种稳定的缬沙坦、氨氯地平和氢氯噻嗪的药物组合及其制备方法 |
| CA2812519A1 (en) | 2013-04-05 | 2014-10-05 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, methods for treating and uses thereof |
| ES2702174T3 (es) | 2013-04-05 | 2019-02-27 | Boehringer Ingelheim Int | Usos terapéuticos de empagliflozina |
| US11813275B2 (en) | 2013-04-05 | 2023-11-14 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition, methods for treating and uses thereof |
| HK1213818A1 (zh) | 2013-04-05 | 2016-07-15 | 勃林格殷格翰国际有限公司 | 依帕列净的治疗用途 |
| JP2016520564A (ja) | 2013-04-18 | 2016-07-14 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 医薬組成物、治療方法及びその使用 |
| CZ2013783A3 (cs) | 2013-10-08 | 2015-04-15 | Zentiva, K. S | Stabilní farmaceutická kompozice obsahující amlodipin a valsartan |
| CN105106962A (zh) * | 2015-08-29 | 2015-12-02 | 西安力邦肇新生物科技有限公司 | 一种复方降压制剂及其应用 |
| US20200316029A1 (en) * | 2016-05-30 | 2020-10-08 | Boehringer Ingelheim International Gmbh | Fixed dose combination of telmisartan, hydrochlorothiazide and amlodipine |
| MX2019005435A (es) | 2016-11-10 | 2019-07-10 | Boehringer Ingelheim Int | Composicion farmaceutica, metodos para tratamiento y sus usos. |
| AU2017400276B2 (en) | 2017-02-27 | 2024-01-11 | Idorsia Pharmaceuticals Ltd | Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases |
| US11382866B2 (en) * | 2017-07-06 | 2022-07-12 | Mankind Pharma Ltd. | Fixed dose pharmaceutical composition of valsartan and sacubitril |
| ES3035734T3 (en) | 2017-11-30 | 2025-09-08 | Idorsia Pharmaceuticals Ltd | Combination of a 4-pyrimidinesulfamide derivative with an sglt-2 inhibitor for the treatment of endothelin related diseases |
| WO2022132067A1 (en) * | 2020-12-18 | 2022-06-23 | Santa Farma Ilac Sanayii A.S. | Stable bilayer tablet compositions |
| CN113171352A (zh) * | 2021-04-15 | 2021-07-27 | 海南锦瑞制药有限公司 | 一种沙坦类降压复方制剂的制备方法 |
| GR1010320B (el) * | 2021-08-04 | 2022-10-11 | Win Medica Φαρμακευτικη Ανωνυμη Εταιρεια, | Στερεες φαρμακοτεχνικες μορφες ιρβεσαρτανης, υδροχλωροθειαζιδης και αμλοδιπινης |
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| US6057344A (en) * | 1991-11-26 | 2000-05-02 | Sepracor, Inc. | Methods for treating hypertension, and angina using optically pure (-) amlodipine |
| EP0795327A1 (en) * | 1996-03-13 | 1997-09-17 | Pfizer Inc. | Use of Amlodipine for the treatment and prophylaxis of congestive cardiac failure of non-ischaemic origin |
| RU2188636C2 (ru) * | 1998-03-26 | 2002-09-10 | Др. Редди'С Лабораторис Лтд. | Стабильный фармацевтический препарат, содержащий амлодипина безилат и атенолол |
| AU2002226365A1 (en) * | 2000-12-01 | 2002-06-11 | Novartis Ag | Combinations of an angiotensin receptor antagonist and an anti-hypertensive drug or a statin, for the treatment of sexual dysfunction |
| US20030152622A1 (en) * | 2001-10-25 | 2003-08-14 | Jenny Louie-Helm | Formulation of an erodible, gastric retentive oral diuretic |
| ES2445041T3 (es) * | 2002-01-16 | 2014-02-27 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Método para la preparación de telmisartán amorfo |
| US6869970B2 (en) | 2002-02-04 | 2005-03-22 | Novartis Ag | Crystalline salt forms of valsartan |
| AUPS236902A0 (en) * | 2002-05-16 | 2002-06-13 | Northern Sydney Area Health Service | Composition and method for treating hypertension |
| EG24716A (en) * | 2002-05-17 | 2010-06-07 | Novartis Ag | Combination of organic compounds |
| KR100580168B1 (ko) | 2003-03-21 | 2006-05-16 | 삼성전자주식회사 | 다중 홈 에이전트 제어장치 및 방법 |
| WO2005070463A2 (en) | 2004-01-12 | 2005-08-04 | Sepracor, Inc. | Compositions comprising (s)-amlodipine malate and an angiotensin receptor blocker and methods of their use |
| AU2005245027B2 (en) | 2004-05-21 | 2011-05-19 | Accu-Break Technologies, Inc. | Pharmaceutical tablets having a separation mark positioned on the side of said tablets |
| EP1814527B2 (en) * | 2004-11-05 | 2020-11-18 | Boehringer Ingelheim International GmbH | Bilayer tablet comprising telmisartan and amlodipine |
| CN100389830C (zh) * | 2005-05-08 | 2008-05-28 | 广州市施柏医药科技有限公司 | 一种治疗高血压的药物组合物 |
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- 2007-06-26 BR BRPI0713785-0A patent/BRPI0713785A2/pt not_active IP Right Cessation
- 2007-06-26 KR KR1020087031581A patent/KR20090021191A/ko not_active Ceased
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- 2007-06-26 MX MX2008016532A patent/MX2008016532A/es not_active Application Discontinuation
- 2007-06-26 JP JP2009518503A patent/JP2009542709A/ja active Pending
- 2007-06-26 TW TW096123057A patent/TW200808379A/zh unknown
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| CL2007001870A1 (es) | 2008-06-13 |
| ECSP088987A (es) | 2009-01-30 |
| KR20090021191A (ko) | 2009-02-27 |
| WO2008002905A3 (en) | 2008-12-11 |
| US8475839B2 (en) | 2013-07-02 |
| NZ573295A (en) | 2012-01-12 |
| CA2654986A1 (en) | 2008-01-03 |
| WO2008002905A2 (en) | 2008-01-03 |
| PE20120542A1 (es) | 2012-05-14 |
| PE20080991A1 (es) | 2008-09-05 |
| AR061627A1 (es) | 2008-09-10 |
| IL195797A0 (en) | 2009-09-01 |
| AU2007265138A1 (en) | 2008-01-03 |
| HK1133818A1 (en) | 2010-04-09 |
| EP2037893A2 (en) | 2009-03-25 |
| CN101478956A (zh) | 2009-07-08 |
| NO20090314L (no) | 2009-01-26 |
| JP2009542709A (ja) | 2009-12-03 |
| CN101478956B (zh) | 2013-03-20 |
| RU2009102273A (ru) | 2010-08-10 |
| RU2449786C2 (ru) | 2012-05-10 |
| ZA200810053B (en) | 2009-11-25 |
| MA30529B1 (fr) | 2009-06-01 |
| TW200808379A (en) | 2008-02-16 |
| TNSN08538A1 (en) | 2010-04-14 |
| US20120164218A1 (en) | 2012-06-28 |
| US20100003321A1 (en) | 2010-01-07 |
| MX2008016532A (es) | 2009-01-19 |
| CN103169711A (zh) | 2013-06-26 |
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Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2312 DE 28-04-2015 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. |