Formulation of mebeverine hydrochloride MR pellets in capsules and comparative characterization against colofac MR capsules

Abstract

The aim and objective of the present study is to develop Mebeverine Hydrochloride MR pellets in the form of capsule. Pellets
with coating for Modified Release have a lower risk of dose dumping than coated tablets. Modified Release capsules of
Mebeverine HCl were formulated by using the solid drug layering (SDL) process by dusting the Drug Excipients mixture on
inert MCC pellets by using Povidone K-30 + IPA solution as binder. The drug layered pellets were coated by using the
Eudragit S-100, PEG 6000 and Talc dispersed in purified water in order to modify the drug release. The coated pellets are
filled in capsules and these capsules were evaluated for assay, weight variation, content uniformity, lock length, moisture
content and in-vitro dissolution tests and all within the specification limit. There is no physicochemical interaction between
drug and excipient which was proven by compatibility study results which was carried out for 4 weeks at Accelerated
stability (AS) condition. The optimized batch F7 is kept under AS conditions (40°C/75%RH) and the product is monitored
and analyzed for assay, moisture content, content uniformity, in-vitro dissolution study and all the parameters were well
within the specification limit. The release rate was compared with the Reference product “Colofac MR” (Abbot
Pharmaceuticals Ltd) and F1 & F2 values were within the limit. And it is pharmaceutically equivalent to that of the reference.