The predictive power of biphasic dissolution approach using Class IV model drug

Abstract

This study was aimed to evaluate biphasic dissolution system and its applicability to discriminate between different formulas. Two different tablet formulas of furosemide were prepared using dry compression (F1) and wet granulation (F2). The prepared formulas were evaluated for hardness, friability and disintegration. Thereafter, monophasic and biphasic dissolution systems were used to compare the dissolution profiles of the prepared formulas with a commercially available tablet. The results of the physical properties of the prepared tablets were within acceptable values. Moreover, there were insignificant differences (P>0.05) between generic product and the prepared formulations. The similarity and difference factors were > 58 and <10, respectively. On the other hand, the biphasic dissolution system results showed significant difference regarding dissolution profiles for all items under investigation. In conclusion, biphasic dissolution system could be a viable tool in assessment in-vitro drug performance as a result of its good discriminatory power.

Keywords

• Two phase, dissolution, similarity factor