Development of direct compression entecavir 0.5 mg-loaded tablet exhibiting enhanced content uniformity

Title
Development of direct compression entecavir 0.5 mg-loaded tablet exhibiting enhanced content uniformity
Author(s)
김종오아비드 유사프[아비드 유사프]지준필[지준필]황승림[황승림]맹한주[맹한주]박영준[박영준]최한곤[최한곤]조관형[조관형]용철순
Keywords
CHRONIC HEPATITIS-B; COLLOIDAL SILICON DIOXIDE; LAMIVUDINE; INFECTION
Issue Date
201411
Publisher
ELSEVIER SCIENCE BV
Citation
POWDER TECHNOLOGY, v.267, pp.302 - 308
Abstract
The aim of the present research was to develop direct compression entecavir 0.5 mg-loaded tablet (DCET) providing enhanced content uniformity. Various compositions and preblending methods were tested at labscale, and the optimum composition and method were applied to pilot-scale production for further confirmation of the entire process.The content uniformity, physical properties and dissolution behavior of the final film-coated DCET were compared to the commercial product. In lab-scale preparation, the method involving preblending, micronization of API (d(0.5) = 5.13 mu m), addition of a larger quantity of colloidal silicon dioxide (1%) and sieving through smaller pores (300 mu m) yielded an excellent acceptance value (AV) in the content uniformity criteria compared to a control method and composition (AV 1.0 vs. 9.8). In pilot-scale production, the film-coated DCET provided better content uniformity than the commercial product (AV 13 vs. 3.8). Furthermore, both products exhibited similar dissolution profiles in various media. Thus, direct compression entecavir 0.5 mg-loaded tablet developed in this study would be a promising dosage form with excellent content uniformity that may be bioequivalent to the commercial product. (C) 2014 Elsevier B.V. All rights reserved.
URI
http://hdl.handle.net/YU.REPOSITORY/30497http://dx.doi.org/10.1016/j.powtec.2014.07.041
ISSN
0032-5910
Appears in Collections:
약학대학 > 약학부 > Articles
Files in This Item:
There are no files associated with this item.
Export
RIS (EndNote)
XLS (Excel)
XML


qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

BROWSE