MX336607B - Formas novedosas de dosificacion de liberacion modificada de inhibidor de xantina oxidorreductasa o inhibidores de xantina oxidasa. - Google Patents

Formas novedosas de dosificacion de liberacion modificada de inhibidor de xantina oxidorreductasa o inhibidores de xantina oxidasa.

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Publication number
MX336607B
MX336607B MX2012014836A MX2012014836A MX336607B MX 336607 B MX336607 B MX 336607B MX 2012014836 A MX2012014836 A MX 2012014836A MX 2012014836 A MX2012014836 A MX 2012014836A MX 336607 B MX336607 B MX 336607B
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MX
Mexico
Prior art keywords
xanthine
dosage forms
release dosage
modified release
oxidase inhibitors
Prior art date
Application number
MX2012014836A
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English (en)
Other versions
MX2012014836A (es
Inventor
Rajneesh Taneja
Majid Vakilynejad
Vijay Gupte
Original Assignee
Takeda Pharmaceuticals Usa Inc
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Application filed by Takeda Pharmaceuticals Usa Inc filed Critical Takeda Pharmaceuticals Usa Inc
Publication of MX2012014836A publication Critical patent/MX2012014836A/es
Publication of MX336607B publication Critical patent/MX336607B/es

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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
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    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
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    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
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    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
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    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Abstract

La presente invención se refiere a una composición farmacéutica de libración modificada que comprende gránulos de febuxostat de liberación inmediata en una cantidad que fluctúa de aproximadamente 20% hasta aproximadamente 40% (p/p) del peso de la composición total y los gránulos de febuxostat de libración retardada que tienen una solubilidad en niveles de pH mayores o iguales a 6.8 en una cantidad que fluctúa de aproximadamente 60% hasta aproximadamente 80% f(p/p) del peso total, en donde los gránulos de liberación inmediata, comprende: (a) un núcleo inerte en una cantidad que fluctúa de aproximadamente 50% hasta aproximadamente 55% (p/p) del peso del gránulo de libración inmediata, y (b) una capa de libración inmediata que encapsula el núcleo inerte que comprende una mezcla de febuxostat e hidroxipropil metilcelulosa en una cantidad que fluctúa de aproximadamente 45% hasta aproximadamente 50% (p/p) del peso del gránulo de libración inmediata, en donde la proporción de febuxostat a hidroxipropil metilcelulosa fluctúa de aproximadamente 1.5 hasta aproximadamente 3; y en donde los gránulos de liberación retardada comprenden (a) un núcleo inerte en una cantidad que fluctúa aproximadamente 40.5% hasta aproximadamente 43% (p/p) del peso de gránulo de liberación retardada, (b) una capa de liberación inmediata que encapsula el núcleo inerte que comprende una mezcla de febuxostat e hidroxipropil metilcelulosa en una cantidad que fluctúa de aproximadamente 35% hasta aproximadamente 40$ (p/p) del peso del gránulo de liberación retardada, en donde la proporción de fubuxostat a hidroxipropil metilcelulosa fluctúa de aproximadamente 1.5 hasta aproximadamente 3, (c) una capa de polímero entérico de liberación retardada que encapsula la capa de liberación inmediata lque comprende un polímero entérico de liberación retardada en una cantidad que fluctúa de aproximadamente 17% hasta aproximadamente 20% (p/p) del gránulo de liberación retardada, el polímero entérico de liberación retardada que comprenden una mezcla del copolímero de ácido metacrílico tipo A y el copolímero de ácido metacrílico tipo B en una proporción que fluctúa de aproximadamente 0.1 hasta aproximadamente 0.5, y (d) un plastificante en una cantidad que fluctúa de aproximadamente 1% hasta aproximadamente 3% (p/p) del peso del gránulo de libración retardada-controlada, en donde el plastificante comprende citrato de trietilo.
MX2012014836A 2010-06-16 2011-06-15 Formas novedosas de dosificacion de liberacion modificada de inhibidor de xantina oxidorreductasa o inhibidores de xantina oxidasa. MX336607B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US35516410P 2010-06-16 2010-06-16
PCT/US2011/040418 WO2011159745A1 (en) 2010-06-16 2011-06-15 Novel modified release dosage forms of xanthine oxidoreductase inhibitor or xanthine oxidase inhibitors

Publications (2)

Publication Number Publication Date
MX2012014836A MX2012014836A (es) 2013-05-01
MX336607B true MX336607B (es) 2016-01-25

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MX2012014836A MX336607B (es) 2010-06-16 2011-06-15 Formas novedosas de dosificacion de liberacion modificada de inhibidor de xantina oxidorreductasa o inhibidores de xantina oxidasa.
MX2016002326A MX361138B (es) 2010-06-16 2011-06-15 Formas novedosas de dosificacion de liberacion modificada de inhibidor de xantina oxidorreductasa o inhibidores de xantina oxidasa.

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Country Status (25)

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US (2) US9248119B2 (es)
EP (1) EP2582812B1 (es)
JP (2) JP5865904B2 (es)
KR (1) KR101872189B1 (es)
CN (1) CN103210084B (es)
AU (2) AU2011268445B9 (es)
BR (1) BR112012032033A2 (es)
CA (1) CA2801930A1 (es)
CL (1) CL2012003548A1 (es)
CO (1) CO6650415A2 (es)
EC (1) ECSP13012394A (es)
ES (1) ES2669184T3 (es)
HK (1) HK1187371A1 (es)
IL (2) IL223455B (es)
JO (1) JO3450B1 (es)
MX (2) MX336607B (es)
MY (1) MY167126A (es)
NZ (1) NZ604646A (es)
PE (2) PE20130574A1 (es)
RU (1) RU2602188C2 (es)
SG (1) SG186301A1 (es)
TW (1) TW201202249A (es)
UA (1) UA112632C2 (es)
WO (1) WO2011159745A1 (es)
ZA (1) ZA201209386B (es)

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CN102958521A (zh) * 2010-06-25 2013-03-06 帝人制药株式会社 缓释性高血压和肾功能不全治疗剂
NZ605562A (en) * 2010-07-09 2013-11-29 Teijin Pharma Ltd Deuterated benzylbenzene derivatives and methods of use
WO2012153313A1 (en) * 2011-05-11 2012-11-15 Ranbaxy Laboratories Limited Pharmaceutical composition of febuxostat
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EP2808018B1 (en) * 2012-01-27 2018-03-14 Teijin Pharma Limited Therapeutic agent for diabetes
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CN102973530B (zh) * 2012-12-14 2016-08-03 贵州信邦制药股份有限公司 一种非布索坦双层肠溶片剂及其制备方法
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CN105579037A (zh) * 2013-05-31 2016-05-11 武田制药美国有限公司 用黄嘌呤氧化酶抑制剂治疗的方法和含黄嘌呤氧化酶抑制剂的组合物
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