Vishal Sapra*, Kumar Guarve, Sandeep Kumar, Priyanka Kriplani
Abstract:
In the present paper, controlled release formulation of mebeverine hydrochloride was developed with an objective to achieve colon specific drug delivery with reduced frequency of dosing, to minimize gastric side effects and thus to increase patient compliance. The study includes a microbially triggered colon targeted controlled porosity osmotic pump, which was prepared in the form of a tablet containing drug and other excipients, spray coated with cellulose acetate solutions with varying amount of guar gum as pore former, the amount and nature of plasticizing agents. The coated core tablet was then further coated with enteric layer to protect the device from acidic environment of stomach. The effect of various formulation variables namely the level of solubility modifier in core, level of hydrophilic and hydrophobic plasticizers in semipermeable membrane, level of pore former in semipermeable membrane, concentration of cellulose acetate in semipermeable membrane coating layer have been studied. The drug release from the developed formulations was found inversely proportional to the level of solubility modulating agent in core compartment, hydrophobic plasticizers in semipermeable membrane and concentration of cellulose acetate in semipermeable membrane. As the proportion of guar gum was increased in coating solution, decrease in release rate of drug in small intestine and increase in release rate in colon was observed. The present results confirmed that the membrane controlling factors responsible for the drug release were the amount of pore former, the amount and nature plasticizers in the membrane.