Year: 2017
Author: Shihai Gu, Chunyuan Hou
Communications in Computational Chemistry, Vol. 5 (2017), Iss. 3 : pp. 68–77
Abstract
The prescription of sofosbuvir tablets was screened to select the best prescription proportions. Methods: According to the prescription technology of foreign listed tablets “sovaldi®”, experiments of diluents, disintegrating agents, binders, lubricants and coating process were investigated, including the stability study of self-made samples and reference tablets under the conditions of high temperature, high humidity and illumination. We aimed to screen a reasonable prescription process. Results: Prescription process was ultimately determined including: sofosbuvir 400 mg, mannitol 360 mg, microcrystalline cellulose 360 mg, cross-linked sodium carboxymethyl cellulose 60 mg, magnesium stearate 14 mg, gum arabic 6 mg, opadry film coating powder 36 mg, and chose purified water as a binder. Conclusion: The determined prescription process was stable, and the production process was not harsh, it was suitable for scale-up production. The results of stability study and the dissolution behavior in vitro were similar to those of commercial products, so the prescription is design reasonably.
Journal Article Details
Publisher Name: Global Science Press
Language: English
DOI: https://doi.org/10.4208/cicc.2017.v5.n3.2
Communications in Computational Chemistry, Vol. 5 (2017), Iss. 3 : pp. 68–77
Published online: 2017-01
AMS Subject Headings: Global Science Press
Copyright: COPYRIGHT: © Global Science Press
Pages: 10
Keywords: sofosbuvir tablets stability study prescription technology reference tablet “sovaldi$^® $”.