Design, Development and Characterization of Flash release wafers containing Levocetrizine hydrochloride and Montelukast sodium

Abstract

The main objective of the current research investigation was to develop and characterize flash release wafers containing Levocetrizine hydrochloride and Montelukast sodium. The formulation of flash release wafers was done by the solvent casting method. HPMC E5 LV, HPMC E50 LV, HPMC Lab grade polymer and plasticizer like glycerol, di-butyl phthalate were screened for wafers formation. Amongst them, HPMC lab-grade as polymer basis and glycerol as plasticizer showed good smooth wafers, acceptable thickness, clear and easy to peel off from the Petri plate. There was no interaction found between drug-drug and drug-excipients by FT-IR spectral analysis and shown that the ingredients used for the formulation of wafers were highly compatible. Then the optimized flash release wafers were evaluated for main parameters like disintegration time, drug content, surface pH, thickness and percentage drug release. Batch ML-7 was found to be optimized formulation of wafers which showed the satisfactory acceptable results of drug content 99.56±1.03of Levocetrizine hydrochloride and 98.92±2.33 of Montelukast sodium, least disintegration time of about 15±0.68 seconds, surface pH was 6.78± 0.010 and percentage drug release of Levocetrizine hydrochloride and Montelukast sodium was 96% and 97.5% at 5th minute. Hence it was found that the optimized formulation ML-7 showed much faster drug release than the oral marketed immediate-release tablet formulation in a 5th minute. This depicted that the formulation containing a lower concentration of polymer and a higher concentration of superdisintegrates showed a positive effect on disintegration time and drug release.