BR112012002069B8 - processo para a fabricação de um granulado contendo ezetimibe microcristalino - Google Patents
processo para a fabricação de um granulado contendo ezetimibe microcristalinoInfo
- Publication number
- BR112012002069B8 BR112012002069B8 BR112012002069A BR112012002069A BR112012002069B8 BR 112012002069 B8 BR112012002069 B8 BR 112012002069B8 BR 112012002069 A BR112012002069 A BR 112012002069A BR 112012002069 A BR112012002069 A BR 112012002069A BR 112012002069 B8 BR112012002069 B8 BR 112012002069B8
- Authority
- BR
- Brazil
- Prior art keywords
- ezetimibe
- granules
- manufacturing
- present
- granulate
- Prior art date
Links
- 239000008187 granular material Substances 0.000 title abstract 6
- OLNTVTPDXPETLC-XPWALMASSA-N ezetimibe Chemical compound N1([C@@H]([C@H](C1=O)CC[C@H](O)C=1C=CC(F)=CC=1)C=1C=CC(O)=CC=1)C1=CC=C(F)C=C1 OLNTVTPDXPETLC-XPWALMASSA-N 0.000 title abstract 4
- 229960000815 ezetimibe Drugs 0.000 title abstract 4
- 238000000034 method Methods 0.000 title abstract 4
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- 229940124531 pharmaceutical excipient Drugs 0.000 abstract 2
- 239000000725 suspension Substances 0.000 abstract 2
- MOTZDAYCYVMXPC-UHFFFAOYSA-N dodecyl hydrogen sulfate Chemical class CCCCCCCCCCCCOS(O)(=O)=O MOTZDAYCYVMXPC-UHFFFAOYSA-N 0.000 abstract 1
- 238000005469 granulation Methods 0.000 abstract 1
- 230000003179 granulation Effects 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 238000005507 spraying Methods 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K9/14—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
- 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
- A61K31/397—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
- A61K31/40—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
-
- 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
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, 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
- A61K9/2004—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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
processo de granulação e granulados assim preparados. a presente invenção refere-se a um processo para a fabricação de granulado contendo ezetimibe microcristalino, em que a) o ezetimibe é dissolvido; b) o ezetimibe dissolvido é precipitado com água, a qual se necessário contém excipientes farmacêuticos, de preferência derivados de lauril-sulfato; e c) os granulados são formados a partir da suspensão obtida mediante a pulverização da suspensão sobre os excipientes farmacêuticos. um outro aspecto da presente invenção é o granulado obtido pelo presente processo e a composição farmacêutica contendo tal granulado.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
HUP0900468 | 2009-07-28 | ||
HU0900468A HU0900468D0 (en) | 2009-07-28 | 2009-07-28 | Novel granulation process and granulates therefrom |
HU1000044A HU230900B1 (en) | 2010-01-25 | 2010-01-25 | New granulating process and the granulates prepared by this |
HUP1000044 | 2010-01-25 | ||
PCT/HU2010/000022 WO2011012912A2 (en) | 2009-07-28 | 2010-02-24 | New granulating process and thus prepared granulate |
Publications (3)
Publication Number | Publication Date |
---|---|
BR112012002069A2 BR112012002069A2 (pt) | 2016-05-31 |
BR112012002069B1 BR112012002069B1 (pt) | 2020-12-01 |
BR112012002069B8 true BR112012002069B8 (pt) | 2021-05-25 |
Family
ID=89989520
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112012002069A BR112012002069B8 (pt) | 2009-07-28 | 2010-02-24 | processo para a fabricação de um granulado contendo ezetimibe microcristalino |
Country Status (10)
Country | Link |
---|---|
US (1) | US8927021B2 (pt) |
EP (1) | EP2459175B1 (pt) |
BR (1) | BR112012002069B8 (pt) |
EA (1) | EA027578B1 (pt) |
ES (1) | ES2657708T3 (pt) |
HU (1) | HUE038048T2 (pt) |
PL (1) | PL2459175T3 (pt) |
PT (1) | PT2459175T (pt) |
WO (1) | WO2011012912A2 (pt) |
ZA (1) | ZA201200795B (pt) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
HU231036B1 (hu) * | 2013-09-30 | 2019-12-30 | Egis Gyógyszergyár Nyilvánosan Működő Részvénytársaság | Koleszterin bioszintézis gátló hatóanyagot és koleszterin abszorpciót gátló hatóanyagot tartalmazó kombinációs gyógyszerkészítmény |
KR101977785B1 (ko) * | 2014-06-25 | 2019-05-14 | 한미약품 주식회사 | 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 및 그 제조방법 |
EP3243506A1 (en) * | 2016-05-09 | 2017-11-15 | Adamed sp. z o.o. | Pharmaceutical composition |
CZ2016539A3 (cs) * | 2016-09-05 | 2018-03-14 | Zentiva, K.S. | Farmaceutická kompozice obsahující dvě rozdílné účinné látky a způsob její přípravy |
CZ2016538A3 (cs) * | 2016-09-05 | 2018-03-14 | Zentiva, K.S. | Farmaceutická kompozice obsahující dvě rozdílné účinné látky |
GR1010183B (el) * | 2020-12-14 | 2022-03-01 | Elpen Αε Φαρμακευτικη Βιομηχανια, | Στερεες φαρμακοτεχνικες μορφες ατορβαστατινης και εζετιμιμπης |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1817280A1 (en) | 2004-12-03 | 2007-08-15 | Teva Pharmaceutical Industries Ltd. | Ezetimibe polymorphs |
WO2009077573A2 (en) | 2007-12-17 | 2009-06-25 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Suspension comprising non-micronized ezetimibe micro-particles |
-
2010
- 2010-02-24 EA EA201290055A patent/EA027578B1/ru not_active IP Right Cessation
- 2010-02-24 PL PL10715338T patent/PL2459175T3/pl unknown
- 2010-02-24 EP EP10715338.9A patent/EP2459175B1/en active Active
- 2010-02-24 PT PT107153389T patent/PT2459175T/pt unknown
- 2010-02-24 US US13/387,239 patent/US8927021B2/en active Active
- 2010-02-24 BR BR112012002069A patent/BR112012002069B8/pt active IP Right Grant
- 2010-02-24 HU HUE10715338A patent/HUE038048T2/hu unknown
- 2010-02-24 ES ES10715338.9T patent/ES2657708T3/es active Active
- 2010-02-24 WO PCT/HU2010/000022 patent/WO2011012912A2/en active Application Filing
-
2012
- 2012-02-01 ZA ZA2012/00795A patent/ZA201200795B/en unknown
Also Published As
Publication number | Publication date |
---|---|
WO2011012912A3 (en) | 2011-12-08 |
EP2459175A2 (en) | 2012-06-06 |
BR112012002069A2 (pt) | 2016-05-31 |
HUE038048T2 (hu) | 2018-09-28 |
ES2657708T3 (es) | 2018-03-06 |
EA201290055A1 (ru) | 2012-06-29 |
WO2011012912A2 (en) | 2011-02-03 |
EP2459175B1 (en) | 2017-11-01 |
PL2459175T3 (pl) | 2018-04-30 |
ZA201200795B (en) | 2013-05-29 |
US20120164227A1 (en) | 2012-06-28 |
EA027578B1 (ru) | 2017-08-31 |
PT2459175T (pt) | 2018-02-07 |
BR112012002069B1 (pt) | 2020-12-01 |
US8927021B2 (en) | 2015-01-06 |
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B16C | Correction of notification of the grant [chapter 16.3 patent gazette] |
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