MX2021012728A - Combinación de dosis fija de antihipertensivo y reductor de colesterol y método de fabricación. - Google Patents
Combinación de dosis fija de antihipertensivo y reductor de colesterol y método de fabricación.Info
- Publication number
- MX2021012728A MX2021012728A MX2021012728A MX2021012728A MX2021012728A MX 2021012728 A MX2021012728 A MX 2021012728A MX 2021012728 A MX2021012728 A MX 2021012728A MX 2021012728 A MX2021012728 A MX 2021012728A MX 2021012728 A MX2021012728 A MX 2021012728A
- Authority
- MX
- Mexico
- Prior art keywords
- dose combination
- cholesterol
- fixed
- hypertensive
- lowering
- Prior art date
Links
- 229940000425 combination drug Drugs 0.000 title abstract 4
- 230000003276 anti-hypertensive effect Effects 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 230000003627 anti-cholesterol Effects 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 abstract 6
- 239000013543 active substance Substances 0.000 abstract 4
- 239000002552 dosage form Substances 0.000 abstract 2
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 abstract 1
- 229960001138 acetylsalicylic acid Drugs 0.000 abstract 1
- 239000003529 anticholesteremic agent Substances 0.000 abstract 1
- 229940127226 anticholesterol agent Drugs 0.000 abstract 1
- 230000002526 effect on cardiovascular system Effects 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 238000005469 granulation Methods 0.000 abstract 1
- 230000003179 granulation Effects 0.000 abstract 1
- 239000003112 inhibitor Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/401—Proline; Derivatives thereof, e.g. captopril
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
Se divulga un método de fabricación de una forma farmacéutica combinada de dosis fija cardiovascular que incluye un agente activo antihipertensivo, un agente activo reductor del colesterol y, opcionalmente, una aspirina o un inhibidor de plaquetas con revestimiento entérico. La combinación de dosis fija se prepara con al menos dos soluciones de granulación que están desprovistas de ácido cítrico y mejoran la solubilidad acuosa del agente reductor del colesterol en la combinación de dosis fija. Los agentes activos en la forma farmacéutica resultante, que está desprovista de ácido cítrico, tienen la misma concentración y los mismos perfiles de liberación que los mismos agentes activos preparados en una formulación simple.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US2019/027936 WO2020214163A1 (en) | 2019-04-17 | 2019-04-17 | Anti-hypertensive and cholesterol-lowering fixed-dose combination and method of manufacture |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2021012728A true MX2021012728A (es) | 2022-01-24 |
Family
ID=72833469
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2021012728A MX2021012728A (es) | 2019-04-17 | 2019-04-17 | Combinación de dosis fija de antihipertensivo y reductor de colesterol y método de fabricación. |
Country Status (10)
Country | Link |
---|---|
US (1) | US11737988B2 (es) |
EP (1) | EP3955912A4 (es) |
AU (1) | AU2019441241B2 (es) |
CA (2) | CA3235781A1 (es) |
EA (1) | EA202192854A1 (es) |
IL (1) | IL287299B1 (es) |
JO (1) | JOP20210280A1 (es) |
MX (1) | MX2021012728A (es) |
WO (1) | WO2020214163A1 (es) |
ZA (1) | ZA202107873B (es) |
Family Cites Families (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5157025A (en) * | 1991-04-01 | 1992-10-20 | E. R. Squibb & Sons, Inc. | Method for lowering serum cholesterol employing a phosphorus containing ace inhibitor alone or in combination with a cholesterol lowering drug |
US7374779B2 (en) | 1999-02-26 | 2008-05-20 | Lipocine, Inc. | Pharmaceutical formulations and systems for improved absorption and multistage release of active agents |
US6576256B2 (en) | 2001-08-28 | 2003-06-10 | The Brigham And Women's Hospital, Inc. | Treatment of patients at elevated cardiovascular risk with a combination of a cholesterol-lowering agent, an inhibitor of the renin-angiotensin system, and aspirin |
US6669955B2 (en) | 2001-08-28 | 2003-12-30 | Longwood Pharmaceutical Research, Inc. | Combination dosage form containing individual dosage units of a cholesterol-lowering agent, an inhibitor of the renin-angiotensin system, and aspirin |
CA2483099A1 (en) * | 2002-05-03 | 2003-11-13 | Hexal Ag | Stable pharmaceutical formulation for a combination of a statin and an ace inhibitor |
BRPI0412557A (pt) * | 2003-07-28 | 2006-09-19 | Reddys Lab Inc Dr | forma de dosagem farmacêutica de eventos cardiovasculares |
US7838552B2 (en) | 2004-06-04 | 2010-11-23 | Forest Laboratories Holdings Limited | Compositions comprising nebivolol |
WO2006085128A1 (en) * | 2005-02-09 | 2006-08-17 | Wockhardt Limited | Cardiovascular therapeutic combinations |
US20100310607A1 (en) | 2005-04-08 | 2010-12-09 | Abbott Laboratories | Pharmaceutical formulations |
CN101590232A (zh) | 2008-05-29 | 2009-12-02 | 北京奥萨医药研究中心有限公司 | 血管紧张素转化酶抑制剂、他汀类降脂药和烟酸的药物组合物及其用途 |
CN101632673B (zh) | 2008-07-24 | 2011-08-10 | 鲁南制药集团股份有限公司 | 含有氯沙坦、吡格列酮和瑞舒伐他汀的药物组合物及其新用途 |
CA2754134C (en) * | 2009-02-11 | 2018-09-18 | Cadila Pharmaceuticals Ltd. | Stable pharmaceutical composition for atherosclerosis |
EP2405747A4 (en) | 2009-03-13 | 2013-01-16 | Nucitec Sa De Cv | COMPOSITIONS AND METHODS FOR TREATMENT AND PREVENTION OF CARDIOVASCULAR DISEASES |
EP2424509A4 (en) | 2009-04-30 | 2012-11-07 | Reddys Lab Ltd Dr | MEDICINAL COMBINATION FORMULATIONS WITH DETERMINED DOSAGE |
KR101771766B1 (ko) | 2013-12-30 | 2017-08-28 | 알보젠코리아 주식회사 | 안지오텐신-Ⅱ 수용체 차단제 및 HMG-CoA 환원효소 저해제를 포함하는 약제학적 복합제제 |
US11622939B2 (en) * | 2017-11-23 | 2023-04-11 | Zhejiang Hisun Pharmaceutical Co., Ltd. | HS-25 tablet and preparation method therefor |
-
2019
- 2019-04-17 US US16/620,431 patent/US11737988B2/en active Active
- 2019-04-17 JO JOP/2021/0280A patent/JOP20210280A1/ar unknown
- 2019-04-17 WO PCT/US2019/027936 patent/WO2020214163A1/en unknown
- 2019-04-17 EA EA202192854A patent/EA202192854A1/ru unknown
- 2019-04-17 AU AU2019441241A patent/AU2019441241B2/en active Active
- 2019-04-17 CA CA3235781A patent/CA3235781A1/en active Pending
- 2019-04-17 EP EP19924674.5A patent/EP3955912A4/en active Pending
- 2019-04-17 IL IL287299A patent/IL287299B1/en unknown
- 2019-04-17 CA CA3136797A patent/CA3136797C/en active Active
- 2019-04-17 MX MX2021012728A patent/MX2021012728A/es unknown
-
2021
- 2021-10-15 ZA ZA2021/07873A patent/ZA202107873B/en unknown
Also Published As
Publication number | Publication date |
---|---|
CA3136797C (en) | 2024-05-28 |
JOP20210280A1 (ar) | 2023-01-30 |
ZA202107873B (en) | 2022-06-29 |
IL287299A (en) | 2022-07-01 |
AU2019441241A1 (en) | 2021-11-18 |
WO2020214163A1 (en) | 2020-10-22 |
US20200330391A1 (en) | 2020-10-22 |
IL287299B1 (en) | 2024-06-01 |
AU2019441241B2 (en) | 2023-11-23 |
US11737988B2 (en) | 2023-08-29 |
EA202192854A1 (ru) | 2022-01-28 |
CA3235781A1 (en) | 2020-10-22 |
CA3136797A1 (en) | 2020-10-22 |
EP3955912A4 (en) | 2022-12-14 |
EP3955912A1 (en) | 2022-02-23 |
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