BR112012002069B8 - processo para a fabricação de um granulado contendo ezetimibe microcristalino - Google Patents

processo para a fabricação de um granulado contendo ezetimibe microcristalino

Info

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
Application number
BR112012002069A
Other languages
English (en)
Other versions
BR112012002069A2 (pt
BR112012002069B1 (pt
Inventor
Újfalussy György
Leventiszné Huszár Magdolna
Agyagos Mónika
Tonka-Nagy Péter
Tölgyesi Zoltán
Zsigmond Zsolt
Original Assignee
Egis Gyogyszergyar Nyilvanosan Muekodo Reszvenytarsasag
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
Priority claimed from HU0900468A external-priority patent/HU0900468D0/hu
Priority claimed from HU1000044A external-priority patent/HU230900B1/hu
Application filed by Egis Gyogyszergyar Nyilvanosan Muekodo Reszvenytarsasag filed Critical Egis Gyogyszergyar Nyilvanosan Muekodo Reszvenytarsasag
Publication of BR112012002069A2 publication Critical patent/BR112012002069A2/pt
Publication of BR112012002069B1 publication Critical patent/BR112012002069B1/pt
Publication of BR112012002069B8 publication Critical patent/BR112012002069B8/pt

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
    • A61K9/14—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

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.
BR112012002069A 2009-07-28 2010-02-24 processo para a fabricação de um granulado contendo ezetimibe microcristalino BR112012002069B8 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
HUP0900468 2009-07-24
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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
BR112012002069A2 (pt) 2016-05-31
EP2459175A2 (en) 2012-06-06
WO2011012912A2 (en) 2011-02-03
US8927021B2 (en) 2015-01-06
PL2459175T3 (pl) 2018-04-30
EA027578B1 (ru) 2017-08-31
EA201290055A1 (ru) 2012-06-29
EP2459175B1 (en) 2017-11-01
WO2011012912A3 (en) 2011-12-08
ZA201200795B (en) 2013-05-29
PT2459175T (pt) 2018-02-07
ES2657708T3 (es) 2018-03-06
BR112012002069B1 (pt) 2020-12-01
US20120164227A1 (en) 2012-06-28
HUE038048T2 (hu) 2018-09-28

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
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B09A Decision: intention to grant [chapter 9.1 patent gazette]
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B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/02/2010 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF