AR100977A1 - COMPOSITE FORMULATION FOR ORAL ADMINISTRATION INCLUDING EZETIMIBA AND ROSUVASTATIN, AND A PROCESS FOR PREPARATION - Google Patents
COMPOSITE FORMULATION FOR ORAL ADMINISTRATION INCLUDING EZETIMIBA AND ROSUVASTATIN, AND A PROCESS FOR PREPARATIONInfo
- Publication number
- AR100977A1 AR100977A1 ARP150102016A ARP150102016A AR100977A1 AR 100977 A1 AR100977 A1 AR 100977A1 AR P150102016 A ARP150102016 A AR P150102016A AR P150102016 A ARP150102016 A AR P150102016A AR 100977 A1 AR100977 A1 AR 100977A1
- Authority
- AR
- Argentina
- Prior art keywords
- rosuvastatin
- portion corresponding
- ezetimibe
- composite formulation
- mixture
- Prior art date
Links
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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Una formulación compuesta sólida para la administración oral que incluye: una porción correspondiente a gránulos húmedos de ezetimiba que incluye ezetimiba que se granula por vía húmeda utilizando un granulador de lecho fluido; y una porción correspondiente a una mezcla de rosuvastatina que incluye rosuvastatina o una de sus sales farmacéuticamente aceptables. Reivindicación 5: La formulación compuesta sólida de la reivindicación 1, donde la porción correspondiente a gránulos húmedos de ezetimiba o la porción correspondiente a una mezcla de rosuvastatina comprende además al menos un aditivo farmacéuticamente aceptable seleccionado del grupo constituido por un diluyente, un aglutinante, un desintegrante y un lubricante. Reivindicación 7: La formulación compuesta sólida de la reivindicación 1, donde la porción correspondiente a gránulos húmedos de ezetimiba comprende lactosa, celulosa microcristalina, laurilsulfato de sodio, povidona y croscarmelosa sódica, y la porción correspondiente a una mezcla de rosuvastatina comprende celulosa microcristalina, lactosa, manitol, crospovidona y estearato de magnesio. Reivindicación 8: La formulación compuesta sólida de la reivindicación 1, donde la cantidad de ezetimiba esté comprendida dentro de un rango de aproximadamente 5 mg a aproximadamente 20 mg en una forma farmacéutica unitaria. Reivindicación 9: La formulación compuesta sólida de la reivindicación 1 donde la cantidad de rosuvastatina o una de sus sales farmacéuticamente aceptables está comprendida dentro de un rango de aproximadamente 2.5 mg a aproximadamente 40 mg en una forma farmacéutica unitaria. Reivindicación 10: La formulación compuesta sólida de la reivindicación 1, donde la formulación compuesta está en forma de un pellet, una cápsula, un comprimido de una única capa, un comprimido de dos capas, un comprimido recubierto a presión, polvo o gránulos. Reivindicación 12: Un método de preparación de la formulación compuesta sólida para la administración oral de acuerdo con cualquiera de las reivindicaciones 1 - 11, comprendiendo el método: preparar una porción correspondiente a gránulos húmedos de ezetimiba que comprenda ezetimiba utilizando un granulador de lecho fluido; y formular la porción correspondiente a gránulos húmedos de ezetimiba y una porción correspondiente a una mezcla de rosuvastatina juntas, donde la porción correspondiente a una mezcla de rosuvastatina comprende rosuvastatina o una de sus sales farmacéuticamente aceptables.A solid composite formulation for oral administration that includes: a portion corresponding to wet granules of ezetimibe that includes ezetimibe that is granulated by wet use using a fluid bed granulator; and a portion corresponding to a mixture of rosuvastatin that includes rosuvastatin or a pharmaceutically acceptable salt thereof. Claim 5: The solid composite formulation of claim 1, wherein the portion corresponding to wet granules of ezetimibe or the portion corresponding to a mixture of rosuvastatin further comprises at least one pharmaceutically acceptable additive selected from the group consisting of a diluent, a binder, a disintegrant and a lubricant. Claim 7: The solid composite formulation of claim 1, wherein the portion corresponding to wet granules of ezetimibe comprises lactose, microcrystalline cellulose, sodium lauryl sulfate, povidone and croscarmellose sodium, and the portion corresponding to a mixture of rosuvastatin comprises microcrystalline cellulose, lactose , mannitol, crospovidone and magnesium stearate. Claim 8: The solid composite formulation of claim 1, wherein the amount of ezetimibe is within a range of about 5 mg to about 20 mg in a unit dosage form. Claim 9: The solid compound formulation of claim 1 wherein the amount of rosuvastatin or a pharmaceutically acceptable salt thereof is within a range of about 2.5 mg to about 40 mg in a unit dosage form. Claim 10: The solid composite formulation of claim 1, wherein the composite formulation is in the form of a pellet, a capsule, a single layer tablet, a two layer tablet, a pressure coated tablet, powder or granules. Claim 12: A method of preparing the solid composite formulation for oral administration according to any one of claims 1-11, the method comprising: preparing a portion corresponding to wet granules of ezetimibe comprising ezetimibe using a fluid bed granulator; and formulating the portion corresponding to wet granules of ezetimibe and a portion corresponding to a mixture of rosuvastatin together, wherein the portion corresponding to a mixture of rosuvastatin comprises rosuvastatin or a pharmaceutically acceptable salt thereof.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020140078388A KR101977785B1 (en) | 2014-06-25 | 2014-06-25 | Composite formulation for oral administration comprising ezetimibe and rosuvastatin and a process for the preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR100977A1 true AR100977A1 (en) | 2016-11-16 |
Family
ID=54938391
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP150102016A AR100977A1 (en) | 2014-06-25 | 2015-06-24 | COMPOSITE FORMULATION FOR ORAL ADMINISTRATION INCLUDING EZETIMIBA AND ROSUVASTATIN, AND A PROCESS FOR PREPARATION |
Country Status (10)
| Country | Link |
|---|---|
| KR (1) | KR101977785B1 (en) |
| AR (1) | AR100977A1 (en) |
| BR (1) | BR112016030111A2 (en) |
| CL (1) | CL2016003283A1 (en) |
| EC (1) | ECSP16096477A (en) |
| JO (1) | JOP20150154B1 (en) |
| SG (2) | SG11201610748RA (en) |
| TW (1) | TWI700100B (en) |
| UY (1) | UY36190A (en) |
| WO (1) | WO2015199356A1 (en) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ2016538A3 (en) | 2016-09-05 | 2018-03-14 | Zentiva, K.S. | A pharmaceutical composition comprising two different active ingredients |
| CZ2016539A3 (en) * | 2016-09-05 | 2018-03-14 | Zentiva, K.S. | A pharmaceutical composition comprising two different active substances and a method of its preparation |
| KR102206535B1 (en) * | 2016-11-29 | 2021-01-22 | 한미약품 주식회사 | Oral composite tablet comprising ezetimibe and rosuvastatin |
| EP3437636A1 (en) * | 2017-08-02 | 2019-02-06 | Adamed sp. z o.o. | Pharmaceutical composition comprising ezetimibe |
| KR102500643B1 (en) * | 2019-04-18 | 2023-02-16 | 한미약품 주식회사 | Pharmaceutical combination preparation comprising ezetimibe and losartan |
| KR20200137243A (en) | 2019-05-29 | 2020-12-09 | 콜마파마(주) | Process for preparation of pharmaceutical combination containing ezetimibe and rosuvastatin |
| BR112022001783A2 (en) | 2019-07-31 | 2022-03-22 | Tecnimede Soc Tecnico Medicinal Sa | Immediate release multi-unit solid oral compositions, their methods and uses. |
| BR112023003323A2 (en) * | 2020-08-25 | 2023-03-21 | Daewoong Pharmaceutical Co Ltd | PHARMACEUTICAL COMPOSITION IN SINGLE DOSAGE FORM |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100907144B1 (en) * | 2007-09-05 | 2009-07-09 | 박재섭 | The golf club using moving ball |
| WO2009024889A2 (en) * | 2007-08-21 | 2009-02-26 | Ranbaxy Laboratories Limited | Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe |
| WO2011019326A2 (en) * | 2009-07-02 | 2011-02-17 | Mahmut Bilgic | Solubility and stability enchancing pharmaceutical formulation |
| HUE038048T2 (en) * | 2009-07-28 | 2018-09-28 | Egyt Gyogyszervegyeszeti Gyar | New granulating process and thus prepared granulate |
| EP2468258A1 (en) * | 2010-12-22 | 2012-06-27 | LEK Pharmaceuticals d.d. | Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient |
| MX365046B (en) * | 2012-05-01 | 2019-05-17 | Althera Life Sciencies Llc | Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases. |
-
2014
- 2014-06-25 KR KR1020140078388A patent/KR101977785B1/en active IP Right Grant
-
2015
- 2015-06-09 WO PCT/KR2015/005779 patent/WO2015199356A1/en active Application Filing
- 2015-06-09 SG SG11201610748RA patent/SG11201610748RA/en unknown
- 2015-06-09 SG SG10201811586YA patent/SG10201811586YA/en unknown
- 2015-06-09 BR BR112016030111A patent/BR112016030111A2/en not_active Application Discontinuation
- 2015-06-16 TW TW104119406A patent/TWI700100B/en active
- 2015-06-24 JO JOP/2015/0154A patent/JOP20150154B1/en active
- 2015-06-24 AR ARP150102016A patent/AR100977A1/en not_active Application Discontinuation
- 2015-06-24 UY UY0001036190A patent/UY36190A/en not_active Application Discontinuation
-
2016
- 2016-12-21 CL CL2016003283A patent/CL2016003283A1/en unknown
- 2016-12-23 EC ECIEPI201696477A patent/ECSP16096477A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| TW201625223A (en) | 2016-07-16 |
| KR20160000762A (en) | 2016-01-05 |
| ECSP16096477A (en) | 2017-01-31 |
| CL2016003283A1 (en) | 2017-07-28 |
| BR112016030111A2 (en) | 2017-08-22 |
| WO2015199356A1 (en) | 2015-12-30 |
| TWI700100B (en) | 2020-08-01 |
| JOP20150154B1 (en) | 2021-08-17 |
| KR101977785B1 (en) | 2019-05-14 |
| UY36190A (en) | 2015-10-30 |
| SG11201610748RA (en) | 2017-01-27 |
| SG10201811586YA (en) | 2019-02-27 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AR100977A1 (en) | COMPOSITE FORMULATION FOR ORAL ADMINISTRATION INCLUDING EZETIMIBA AND ROSUVASTATIN, AND A PROCESS FOR PREPARATION | |
| PH12019500395A1 (en) | Amino-pyrrolopyrimidinone compounds and methods of use thereof | |
| PH12018501390A1 (en) | Tetrahydropyranyl amino-pyrrolopyrimidinone and methods of use thereof | |
| FI3265084T3 (en) | Pharmaceutical formulations of bruton's tyrosine kinase inhibtor | |
| UY27995A1 (en) | NEW SOLID PHARMACEUTICAL FORMULATIONS THAT INCLUDE TELMARTISAN AND ITS PREPARATION | |
| RS54329B1 (en) | Pharmaceutical compositions comprising rifaximin, processes for their preparation and their use in the treatment of vaginal infections | |
| RU2015110699A (en) | PHARMACEUTICAL ANTIRETROVIRAL COMPOSITION | |
| MX2022015606A (en) | Immediate-release tablets containing a drug and processes for forming the tablets. | |
| NZ628993A (en) | Pharmaceutical formulations comprising ccr3 antagonists | |
| JP2015510916A5 (en) | ||
| RU2019138248A (en) | PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION, CONTAINING ENZALUTAMIDE | |
| PH12015501945B1 (en) | Formulations of organic compounds | |
| JP2017523149A5 (en) | ||
| HRP20201155T1 (en) | Method for preparing pharmaceutical composition comprising quinoline derivative or salt thereof | |
| ECSP16005208A (en) | STABLE ANTI-TUBERCULOSIS PHARMACEUTICAL COMPOSITION IN A FORM OF A COATED TABLET INCLUDING ISONIAZID GRANULES AND RIFAPENTINE GRANULES AND THEIR PREPARATION PROCESS | |
| AU2016231883B2 (en) | Pharmaceutical compositions of dimethyl fumarate | |
| EA033291B1 (en) | Dosage unit comprising ramipril and bisoprolol hemifumarate, process for the preparation thereof and method of treating hypertension | |
| PE20160245A1 (en) | STABLE ANTI-TUBERCULOSIS PHARMACEUTICAL COMPOSITION IN A FORM OF A DISPERSABLE TABLET INCLUDING ISONIAZID GRANULES AND RIFAPENTINE GRANULES AND THEIR PREPARATION PROCESS | |
| MY190027A (en) | P38 map kinase inhibiting indanyl urea compounds | |
| RU2013107724A (en) | PHARMACEUTICAL COMPOSITIONS OF MONTELUKAST AND LEVOCETIRISINE | |
| MX2019005005A (en) | Extended release tablet comprising a weight-loss drug. | |
| PH12016502540A1 (en) | Pharmaceutical dosage forms | |
| HRP20210969T1 (en) | Pharmaceutical composition comprising darunavir and method for the preparation thereof | |
| EA202090842A1 (en) | DEFERIPRONE DELAYED RELEASE TABLETS AND METHODS OF THEIR USE | |
| RU2013118917A (en) | MEDICINAL FORM CONTAINING DESLORATADINE AND METHOD FOR PRODUCING IT |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |