Design and In Vitro Characterization of Novel Pulsatile Delivery System of Biguanide Antidiabetic Drug

Aim: This work shows the development of pulsatile capsular pellets of metformin hydrochloride and its characterisation. Material and Methods: The novel drug delivery system consisted of hydroxy propyl cellulose Type H. It has a lag time modifier and Eudragit L-100 and Eudragit S-100 in different concentrations as pH-dependent release modifier in the gastrointestinal tract. The pellets were subjected to in vitro release studies using USP dissolution apparatus type-II in distilled water, phosphate buffer of pH 6.8, and 0.1 N HCl and methanol. Ultraviolet (UV), infrared (IR), high-performance liquid chromatography (HPLC), and mass spectroscopy were performed for active pharmaceutical ingredients and formulations. Result: The study was characterized by the complete release of the drug in pulses after a well-defined lag time of 6 h (+/- 0.20) (period of no drug release) for the treatment of type II diabetes mellitus. Conclusion: The stability studies on the selected formulation of Metformin were found to be stable, with shelf life of 1.94 years. Hence it may be concluded that the newly formulated pulsatile drug delivery systems of Metformin Hydrochloride, when ingested at the bed time in the night, produce effective control of the increased blood glucose level after intake of meals by allowing the drug to release after a lag time of 6 h (after meals).