Formulation and Evaluation of Stable Montelukast Sodium Sublingual Tablet by Using Lyophilization Technique

The aim of present work research work was formulation and evaluation of stable montelukast sodium sublingual tablet. Since The thermal stress testing study of Monte in solutions at 65°C showed that it is highly stable in NaOH solution, while it degrades rapidly in both acidic and H₂O₂ solutions. Hence lyophilization technology was adopted to increase the stability of montelukast sodium. Before lyophilization three trials were carried out to optimize the process parameters in which Trial 2 was considered as optimized process. The Lyophilization was carried out in nine different batches by varying the total cycle time, freezing and holding time, primary drying and secondary drying time by maintaining the quantities of all the active pharmaceutical ingredients constant and selection of cryoprotectant ratio. An optimized lyophilization cycle of 56 hours has been achieved. The optimized lyophilized product was subjected to Tablet compression. In this process the batch-9 formulation was considered as an optimized Formulation for compression with the process. All the in-vitro evaluation parameters complies the limits as per the specification. Stability studies were conducted and from the result it was concluded that the optimized formulation was found to be stable. Finally, it is concluded that the lyophilization is a suitable technique to increase the stability and bioavailability of Montelukast sodium.