Abstract :
Pellets were witnessed as one of the promising modified drug delivery systems widely employed now-a-days in the
management of various diseases. Mebeverine hydrochloride pellets were coated by suspension layer technique using fluidized
bed processor (FBP). This method applied found to be effective to coat the drug uniformly onto the non-pareil (NP) seeds. In
this study, three coatings viz., binder (PVP K30), barrier (EC 5 cps) and sustained release (EC 3 cps and HPMC 10 cps) were
applied. At each stage of coating, optimized formulation was found out for next subsequent coating and they were F4, B1 and
S3. F4 is a formulation with binder solution 2.5% w/v concentration showed 90% coating efficiency with less processing
problems and less lump formation. To this formulation barrier coating was given with EC 5 cps. Barrier pellets coated with
rate retarding polymers EC 3 cps and HPMC 10 cps. Out of three formulations S3 formulation exhibited 90.39% drug release
at 16th hr which matched with the 90.69% release of marketed formulation. Similarity (f2) and dissimilarity (f1) factors for S3
were 83.5 and 6.2 respectively. This revealed the S3 is in vitro bioequivalent with marketed formulation. These pellets were
evaluated further for micromeritic properties, SEM and dissolution rate test studies. The micrometrics of S3 revealed good
flow ability for packing and filling into capsules (Compressibility index, angle of repose and hausner’s ratio were 24.29%,
26.04° and 1.009 respectively). The formulation was extended for stability studies at different conditions. The stability data
produced evidenced the formulation was intact during storage.
Key words: pellets, suspension layering technique, rate retarding polymers.
Keyword :
pellets, suspension layering technique, rate retarding polymers.