Chronomodulated Therapy for the Treatment of Type II Diabetics by Using a GlucosidaseI Inhibitor

Miglitol is an Anti-diabetic having a place with the class of α-glucosidase inhibitors, it has ability to bring down the postprandial glucose level in type-II diabetic patients. The present work was aimed to prepare miglitol pulsincaps to reduce the dose frequency and increase the patient compliance. Arrangement of pulsicapsules is associated with the four distinct stages: First stage involved preparation of immediate release granules and optimization of immediate release granules which were prepared by using crospovidone as superdisintegtrant in different conc. (MCM1-MCM6) by wet granulation method and granules were evaluated for the flow properties, drug content and in-vitro dissolution. Based on the results MCM5 was optimized to prepare the pulsincaps. In the second stage insoluble bodies of the capsules was prepared by treating with the formaldehyde solution. Third step was preparation of hydrogel plugs with 6 hr. lag time and the final stage was assembling of pulsincaps with three pulses of immediate release granules (MCM5) which were separated by two hydrogel plugs. The prearranged pulsincaps were assessed for in vitro drug release in three distinctive dissolution media. From the results CDC8 was optimized based on the predetermined lag time and drug release. Stability studies led at 40±2˚C/75±5% RH showed no note worthy changes inferring that an effective pulsatile drug delivery system of Miglitol was designed.