A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/22 (2006.01) A61K 47/38 (2006.01)
Patent
CA 2744142
An improved excipient comprising substantially homogeneous particles of a compressible, high functionality granular microcrystalline cellulose based excipient is provided. The improved excipient comprises microcrystalline cellulose and a binder, and optionally a disintegrant, and is formed by spraying a homogeneous slurry of the components. The excipient provides enhanced flowability/good flow properties, excellent/high compactibility, and increased API loading and blendability as compared to the individual components, and as compared to conventional excipients formed from the same materials. The improved excipient has strong intraparticle bonding bridges between the components, resulting in a unique structural morphology including significant open structures or hollow pores. The presence of these pores provides a surface roughness that is the ideal environment for improved blending with an API.
La présente invention concerne un excipient amélioré à base de cellulose microcristalline granulaire compressible à haute fonctionnalité sous forme de particules sensiblement homogènes. Cet excipient comprend de la cellulose microcristalline, un liant et éventuellement un délitant, et est formé en pulvérisant une suspension homogène des composants. Il offre des propriétés de fluidité/écoulement améliorées, une compressibilité excellente/élevée ainsi quune charge en API et une aptitude au mélange accrues, comparé aux composants individuels et aux excipients classiques formés à partir des mêmes matériaux. Lexcipient amélioré comporte de solides ponts de liaison intraparticules entre les composants, qui se traduisent par une morphologie structurale unique comprenant des structures sensiblement ouvertes ou des pores creux. La présence de ces pores génère une rugosité de surface qui constitue l'environnement idéal pour un mélange amélioré avec un API.
Deorkar Nandu
Farina James
Miinea Liliana
Randive Sameer
Avantor Performance Materials Inc.
Osler Hoskin & Harcourt Llp
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