CO2022000503A2 - Oral solid compositions of immediate release of multiple units, methods and uses of the same - Google Patents

Oral solid compositions of immediate release of multiple units, methods and uses of the same

Info

Publication number
CO2022000503A2
CO2022000503A2 CONC2022/0000503A CO2022000503A CO2022000503A2 CO 2022000503 A2 CO2022000503 A2 CO 2022000503A2 CO 2022000503 A CO2022000503 A CO 2022000503A CO 2022000503 A2 CO2022000503 A2 CO 2022000503A2
Authority
CO
Colombia
Prior art keywords
immediate release
methods
solid compositions
same
oral solid
Prior art date
Application number
CONC2022/0000503A
Other languages
Spanish (es)
Inventor
Ferreira Pereira Ricardo José Camilo
Serra João Pedro Silva
Original Assignee
Tecnimede Soc Tecnico Medicinal Sa
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Tecnimede Soc Tecnico Medicinal Sa filed Critical Tecnimede Soc Tecnico Medicinal Sa
Publication of CO2022000503A2 publication Critical patent/CO2022000503A2/en

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
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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

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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente divulgación se refiere a composiciones sólidas orales estables de liberación inmediata de múltiples unidades que comprenden dosis terapéuticamente eficaces de ezetimiba y rosuvastatina. También se refiere al procedimiento de obtención de dichas composiciones sólidas orales de liberación inmediata de múltiples unidades así como a su uso en el tratamiento de hipercolesterolemia primaria.The present disclosure relates to stable multi-unit immediate release oral solid compositions comprising therapeutically effective doses of ezetimibe and rosuvastatin. It also refers to the process for obtaining said multi-unit immediate-release solid oral compositions as well as their use in the treatment of primary hypercholesterolemia.

CONC2022/0000503A 2019-07-31 2022-01-21 Oral solid compositions of immediate release of multiple units, methods and uses of the same CO2022000503A2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PT11568719 2019-07-31
EP19189932 2019-08-02
PCT/IB2020/057224 WO2021019499A1 (en) 2019-07-31 2020-07-30 Solid oral multiple-unit immediate release compositions, methods and uses thereof

Publications (1)

Publication Number Publication Date
CO2022000503A2 true CO2022000503A2 (en) 2022-01-28

Family

ID=72243172

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2022/0000503A CO2022000503A2 (en) 2019-07-31 2022-01-21 Oral solid compositions of immediate release of multiple units, methods and uses of the same

Country Status (3)

Country Link
BR (1) BR112022001783A2 (en)
CO (1) CO2022000503A2 (en)
WO (1) WO2021019499A1 (en)

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2648897B2 (en) 1991-07-01 1997-09-03 塩野義製薬株式会社 Pyrimidine derivatives
US5631365A (en) 1993-09-21 1997-05-20 Schering Corporation Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
WO2006134604A1 (en) 2005-06-15 2006-12-21 Hetero Drugs Limited Combination composition of cholesterol absorption inhibitor and 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitor
WO2009024889A2 (en) 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
WO2013066279A1 (en) 2011-10-13 2013-05-10 Mahmut Bilgic Solid dosage forms comprising ezetimibe
PT2844233T (en) 2012-05-01 2020-06-25 Althera Life Sciences Llc Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
MX2012014970A (en) 2012-12-18 2013-08-27 Hetlabs Mexico S A De C V Pharmaceutical compositions comprising ezetimibe and novel amorphous rosuvastatin calcium.
HU231036B1 (en) 2013-09-30 2019-12-30 Egis Gyógyszergyár Nyilvánosan Működő Részvénytársaság Pharmaceutical composition comprising a cholesterol biosynthesis inhibitor and a cholesterol absorption inhibitor
CN103585157B (en) 2013-11-13 2016-02-03 武汉武药科技有限公司 A kind of double-layer tablet containing Ezetimibe and Rosuvastatin and preparation method thereof
KR20150065323A (en) 2013-12-05 2015-06-15 주식회사 네비팜 A Pharmaceutical Composition comprising Rosuvastatin and Ezetimibe
TWI586380B (en) 2013-12-18 2017-06-11 夢製藥公司 Pharmaceutical combination preparation comprising a hmg-coa reductase inhibitor and a cholesterol absorption inhibitor
KR20150079373A (en) 2013-12-30 2015-07-08 한미약품 주식회사 Composite formulation for oral administration comprising ezetimibe and rosuvastatin
KR101977785B1 (en) 2014-06-25 2019-05-14 한미약품 주식회사 Composite formulation for oral administration comprising ezetimibe and rosuvastatin and a process for the preparation thereof
KR101834559B1 (en) 2015-02-27 2018-03-06 한미약품 주식회사 Solid composite formulation for oral administration comprising ezetimibe and rosuvastatin
EP3243506A1 (en) 2016-05-09 2017-11-15 Adamed sp. z o.o. Pharmaceutical composition
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
CN107028906A (en) 2017-06-21 2017-08-11 江苏福瑞生物医药有限公司 A kind of composite tablet containing Ezetimibe and Rosuvastatin and preparation method thereof

Also Published As

Publication number Publication date
BR112022001783A2 (en) 2022-03-22
WO2021019499A1 (en) 2021-02-04

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