DEVELOPMENT AND EVALUATION OF ORODISPERSIBLE TABLETS OF MECLIZINE HYDROCHLORIDE

In the present study, an attempt has been made to formulate and evaluate orodispersible tablets of meclizine hydrochloride by using direct compression via employing different excipients in different ratio including: superdisintegrants {sodium starch glycolate (SSG), crosscarmellose sodium (CCS), crosspovidone (CP), and microcrystalline cellulose (MCC)} which were used alone and in combination, solid dispersion of MHCl in microcrystalline cellulose, diluents: lactose, granulated lactose, and mannitol, along with lubricant and glidants. The prepared formulas were evaluated for pre and post compression parameters including bulk density, tapped density, Carr’s index, angle of repose, weight variation, thickness, friability, hardness, in vitro disintegration and dispersion time, wetting time, and water absorption ratio. The formulas containing granulated lactose (as diluent) showed good flow properties. Increasing concentration of three superdisintegrants (CP, SSG, and CCS) was accompanied with an increase in disintegration time (DT) while the disintegration time was decreased with an increase in concentration of MCC. Depending on the obtained results, formula 11 (F11) which contains 4% W/W CP, 10% W/W MCC was selected as an optimum formula and evaluated for further studies including in vitro drug release, content uniformity, drug assay by HPLC technique, drug-excipient compatibility, and accelerated stability tests. The assay studies of the chosen formula F11 was confirmed the uniformity of the drug dose within the dosage form. It released 80% of its content within 6.28 min. No drug-excipient interaction was observed and no significant change in the tablet properties was appeared after the period of stability tests.