ABSTRACT:
Methotrexate is an ideal candidate for incorporation in a controlled release device to diminish its adverse effect after oral administration. Beads were prepared by using chitosan as a polymer and Tripolyphosphate as a gelling agent. In this investigation, 32 full factorial design was used to investigate the joint influence of two variables: the concentration of Tripolyphosphate (X1) and concentration of Span 80 (X2) on the drug content (DC) and time for 50% drug dissolution (t50). A statistical model with significant terms is derived to predict DC and t50. The DC value and t50 value for the nine batches showed the response ranges from a 30.61 to 58.56 % and 120 to 300 min, respectively. The beads of best batch (CH1) were found comparatively smooth, spherical in shape and free flowing. The size analysis study revealed that the beads mean particle sizes ranging from 500 to1000. The results of similarity factor, f2, confirmed that the release of drug from prepared formulation was similar to that of desired drug release profile. The results of multiple linear regression analysis concluded that for obtaining controlled drug release with high drug content, the beads should be prepared using relatively lower levels of Tripolyphosphate and Span 80.