Abstract
The aim of this research is to prepare orodispersible tablets of Meclizine Hydrochloride (MHCl). MHCl is used to treat or prevent nausea, vomiting, and dizziness. Wet granulation method was used to prepare the orodispersible tablets of MHCl using different super disintegrant; crospovidone (CP), sodium starch glycolate (SSG), croscarmellose sodium (CCS), and microcrystalline cellulose (MCC) at different concentrations. Camphor and ammonium carbonate were also incorporated in preparation as subliming agents. Co processing of super disintegrant with MCC is a new approach to increase disintegration rate which we tried. The prepared tablets were evaluated for weight variation, content uniformity, hardness, disintegration time, and friability of tablets. All the formulations showed low weight variation with in-vitro disintegration time less than 71 s. The drug content of all the formulations was within the acceptable limits. Crospovidone shows the shortest disintegration time among super disintegrants while use of subliming agent produced friable tablets. Although use of combination of super disintegrant with MCC decreases disintegration time, the use of co processed super disintegrant (10%CP with 20% MCC) provides the optimum properties of orodispersible tablets (F11). Stability study of selected formula showed no significant changes in tablet properties. Key words: Meclizine hydrochloride, wet granulation method, subliming agent, orodispersible tablet, co process.
Highlights
The disadvantages of conventional solid oral dosage forms is the necessity of water to enhance swallowing the dosage forms specially for certain groups of patients as geriatrics, pediatrics, and unconscious patients and during travelling (Venkatal et al, 2009)
The definition of orodispersible tablet in European Pharmacopoeia as “A tablet that to be placed in the mouth where it disperses rapidly before swallowing in less than three minutes” (Kamal et al, 2010)
The (ODT) technology has been recently approved by United States Pharmacopoeia (USP), Centre for Drug Evaluation and Research (CDER)
Summary
The disadvantages of conventional solid oral dosage forms is the necessity of water to enhance swallowing the dosage forms specially for certain groups of patients as geriatrics, pediatrics, and unconscious patients and during travelling (Venkatal et al, 2009). The definition of orodispersible tablet in European Pharmacopoeia as “A tablet that to be placed in the mouth where it disperses rapidly before swallowing in less than three minutes” (Kamal et al, 2010). The (ODT) technology has been recently approved by United States Pharmacopoeia (USP), Centre for Drug Evaluation and Research (CDER). United States Food and Drug Administration (FDA) defined orally disintegrating tablet as “A solid dosage form containing medicinal substance or active ingredient which disintegrates rapidly usually within a matter of seconds when placed upon the tongue” (Bhupendra et al, 2010).
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