ABSTRACT:
Recent developments in mouth dissolving/disintegrating tablets have brought convenience in dosing to elderly and children who have trouble in swallowing tablets. The objective of the present study was to prepare the mouth disintegrating tablet of clonazepam (antiepileptic). As precision of dosing and patient's compliance become important prerequisite for a long term antiepileptic treatment, there is a need to develop a formulation for this drug which overcomes problems such as difficulty in swallowing, inconvenience in administration while travelling and patient's acceptability. Hence, the present investigation was undertaken with a view to develop a fast disintegrating tablet of clonazepam which offers a new range of product having desired characteristics and intended benefits. The drug is poorly water soluble therefore to enhance the solubility and release of drug, solid dispersion of drug and PVP K30 was prepared by solvent evaporation method. Different combinations of superdisintegrants such as crosscarmellose sodium, sodium starch glycolate, crospovidone were used. Directly compressible mannitol, and aspartame were used to enhance the mouth feel and taste. Lactose was used as diluents. The tablets were prepared by direct compression technique on rotary tablet machine. The tablets were evaluated for hardness, friability, weight variation, wetting time, dispersion time and uniformity of content. Optimized formulations were evaluated by in vitro dissolution test. All the tablets had hardness 3-3.5 kg/cm2 and friability of all formulations was less than 1, weight variation and drug content were within official limit. Amongst all formulations, formulation F10 prepared by drug:PVPK30 (1:4:)ratio and combination of 5% w/w crosscarmellose sodium and 5% w/w of sodium starch glycolate showed least dispersion time of 8s and faster dissolution.