Background: Design and evaluation of sustained release microspheres incorporated
in orally disintegrating tablet for glimepiride and comparison with conventional tablet.
Method: Glimepiride (GLP) was encapsulated with different amount of ethyl cellulose
polymer by an emulsion solvent evaporation technique. Optimization was done using
32 randomized full factorial design. The physicochemical properties of the formulation like
particle Size, morphology, drug loading and encapsulation efficiency and yeild were evaluated
using Scanning electron microscopy SEM), Differential scanning calorimetry(DSC) and
X ray diffraction. A pharmacokinetic study was conducted on male wistar rats for bioequivalance
testing. A single blind study was conducted for taste masking test and disintegration time in
Result: DSC study showed that there was no interaction between drug and polymer in GLP microspheres.
Particle size and drug release were dependent on stirring speed and polymer concentration respectively. The
drug release mechanism of optimized formulation can be explained with first order model which describes the
concentration dependent drug release. Microspheres obtained showed good flow properties with entrapment
efficiency of 80-100%.
Conclusion: It can be concluded that GLP microspheres ODT is potential delivery system for GLP as the
controlled release of drug from GLP microspheres provides for higher plasma drug content and improved
bioavailability which was more than conventional tablet.