Montelukast Sodium

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.

A specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Ebastine (EBA) and Montelukast Sodium (MONTE) in Combined dosage forms. The analysis was carried out using Phenomenex  C18, column (250 mm × 4.6 mm id, 5 µm particle size) with Mobile phase consisting of  Methanol : Phosphate buffer (65:35 v/v) pH 5.0+0.05 was  pumped at a flow rate was 1.0 ml/ min and  Quantification was achieved with photodiode array (PDA) detection at 261 nm over the concentration range of 10 - 50 µg/mL for ebastine & Montelukast Sodium  with mean recovery of 100.32 ± 0.85 % and 100.15 ± 0.94 % for Ebastine and Montelukast Sodium, respectively. These methods were found to be simple, sensitive, accurate, precise and economical and applicable for the simultaneous determination of Ebastine & Montelukast Sodium in combined dosage form.