Formulation and Evaluation of Montelukast Sodium Lozenges

Montelukast Sodium are formulated as lozenges to provide slow release medicament for the management of chronic asthma and allergic rhinitis. The benefits of prepared lozenges showed increase in bioavailability, reduction in gastric irritation, bypassing of first metabolism and increase in onset of action.The molded lozenges can provide an attractive alternative formulation in allergic conditions.  The lozenges are prepared using sucrose, liquid glucose, Hydroxy propyl methyl cellulose K4M (HPMC K4M). Sodium Saccharine along with flavors are used to mask the bitter taste of drug. All the formulations prepared are subjected to various physicochemical parameters like weight variation, hardness, thickness, friability, content uniformity, and moisture content etc. The prepared formulations have a hardness of 8-11 kg/cm2, non-gritty and pleasant mouth feel. Some selected formulations are also tested for drug excipient interactions subjecting to IR Spectral analysis, In vitro release rate studies showed that the drug release for lozenges was maximum in formulation F6 (99.3±0.52%) at 30 minutes.