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Practical approach to prepare solid dispersion drug product using spherical silicate.

Abstract：

:The purpose of this study is to establish a novel approach for preparing a solid dispersion drug product using spherical silicate by a Wurster-type fluidized bed granulator. The spherical silicate used in this study has porous structure and ideal particle size for loading by a Wurster-type fluidized bed granulator. As model drugs, ibuprofen (IBU), indomethacin (IMC), and phenytoin (PNT) were used and the proposed approach was applied to prepare amorphous drug. All drugs could be loaded on the spherical silicate in an amorphous state. On the other hand, spray drying of spherical silicate suspended in IBU solution was conducted to prepare amorphous product of IBU as a reference; however, complete amorphization was not achieved. Dissolution profiles of each drug after loading on spherical silicate by a Wurster-type fluidized bed granulator were evaluated, and dramatic improvement of dissolution was observed compared with those of crystalline drug. In the proposed approach, specific surface area and particle size of spherical silicate were determined as a key factors to contribute to high yield of amorphous product.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Nagane K,Kimura S,Ukai K,Ogawa N,Yamamoto H

doi

10.1016/j.ijpharm.2014.08.016

subject

Has Abstract

pub_date

2014-11-20 00:00:00

pages

364-71

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(14)00582-1

journal_volume

475

pub_type

杂志文章

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