Enhancement of Fingolimod Content Uniformity as a Low-Dose Drug with Narrow Therapeutic Index Using Liquisolid Technique

Abstract

Acceptable content uniformity is one of the major challenges in industrial pharmacy especially in low-dose drugs with narrow therapeutic index. Several methods have been proposed for solving this problem. Liquisolid technique is a new promising method that mainly has been used for enhancing solubility rate of drugs. It seems that this method could be able to obtain better distribution of drug and then content uniformity. The purpose of this investigation was to improve content uniformity of fingolimod hydrochloride, which is a low-dose drug with narrow therapeutic index, using liquisolid technique. In this study, liquisolid formulations were prepared using PG as nonvolatile solvent and also absolute ethanol as a volatile solvent. The analysis carried out using HPLC method and content uniformity test was done according to the USP guideline. The results showed that content uniformity was improved in liquisolid method in comparison with classic method. Better distribution was obtained using combination of nonvolatile and volatile solvents. It seemed that liquisolid method could be used as a promising technique for obtaining acceptable content uniformity in low-dose drugs with narrow therapeutic index such as fingolimod hydrochloride.