Design of Experiment Assisted Formulation and Development of Multiparticulate Systems Based Sustained Release Tablets of Glibenclamide

Abstract

Background: Tablets or capsules being the conventional dosage forms can be modified for providing the desired therapeutic effect to the patients. The network of matrix in the tablet allows the drug release to be slowed down considerably.
Objective: The prime objective of the study was to formulate sustained release Glibenclamide matrix tablets by compressing pellets prepared using wax material and pore-forming agent.
Methods: Tablets were formulated by compressing optimized pellets. Pellets were prepared using hot melt extrusion method and optimized using 32 full factorial design. The independent variables were the amount of wax material (cetostearyl alcohol) (X1) and
pore-forming agent (HPMC K 100M) (X2) while the dependent variables selected were entrapment efficiency, aspect ratio, Q2, Q12 and Q20. Prepared optimized pellets were mixed with suitable excipients and compressed as a matrix tablet and characterized for
quality parameters and drug release kinetics.
Results: All the formulations (pellets) showed retarded drug release as the concentration of the polymer was increased. Optimized formulation of pellets showed about 95 % drug release within 24 hr. The results of release kinetics studies of the optimized formulation
suggested that formulation followed Korsmeyer-Peppas release model suggesting the diffusion dominant release mechanism while all the other parameters were in accordance with pharmacopoeial limits.
Conclusion: A 32 full factorial design was successfully employed to optimize pellets with desired characteristics. Optimized pellets were successfully compressed in the form of a sustained release matrix tablet of Glibenclamide.