TY - JOUR
T1 - Research and Development the Prescription of Sofosbuvir Tablets
AU - Gu , Shihai
AU - Hou , Chunyuan
JO - Communications in Computational Chemistry
VL - 3
SP - 68
EP - 77
PY - 2018
DA - 2018/10
SN - 5
DO - http://doi.org/10.4208/cicc.2017.v5.n3.2 
UR - https://global-sci.org/intro/article_detail/cicc/12745.html
KW - sofosbuvir tablets, stability study, prescription technology, reference tablet “sovaldi$^® $”.
AB - <p style="text-align: justify;">The prescription of sofosbuvir tablets was screened to select the best
prescription proportions. Methods: According to the prescription technology of foreign
listed tablets “sovaldi<sup>®</sup>”, 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.</p>