Abstract

DEVELOPMENT AND EVALUATION OF A NOVEL PELLETS BASED TABLET SYSTEM OF PANTOPRAZOLE

*Jayesh Kapadiya

ABSTRACT

Objective: Peptic ulcer refers to the ulceration in the gastric environment. Pantoprazole is the class of drug that is used in the ulcer treatment. For better patient compliance and to deliver drug safely pellets containing dosage form are now in demand. Multiple unit pellet system (MUPS) is such a dosage form to deliver drug locally and faster in action. Experimental work: Delayed release formulation was designed to trial and error method in which various trials are taken and optimization of coating agent and cushioning agent was being carried out. Pantoprazole pellets were prepared by extrusion-spheronization method. Pantoprazole belongs to the class of proton pump inhibitors that required gastric protection. Cellulose acetate phthalate was used for enteric coating of pellets. Enteric coated pellets were then compressed along with cushioning agent (MCC PH 101) and evaluated for their acid resistance and % drug release. A 32 factorial design was used for optimization by taking concentration of coating solution (X1) and concentration of MCC PH 101 as independent variables and the % drug release at 6 hr (Y1) as dependent variables. Result: The moderate concentration of coating solution and MCC PH 101 provides desired acid resistance and release of pantoprazole. Batch F9 was considered optimum because it has maximum acid resistance and desired drug release. Conclusion: Gastro-resistant MUPS dosage form has been successfully developed for pantoprazole using 8 % concentration of Cellulose acetate phthalate (as a coating agent) and 75 % concentration of MCC PH 101 (as a cushioning agent).

Keywords: Gastro-resistant, Delayed release, Multiple unit pellet system, Cellulose acetate phthalate, MCC PH 101.