Optimization and Assessment of Three Generation Solid Dispersion for Enhancement of Solubility and Dissolution for Montelukast Sodium.

Objective: To enhance the solubility of Montelukast sodium using three generation polymers by solid dispersion method.

Material And Method: Montelukast sodium with selected generation of carriers were used for phase solubility and to optimize the stoichiometric ratio for the preparation of SD with MS. Various characterization techniques (FTIR, DSC and XRD) have been used to evaluate the MS-SD formulations with selected hydrophilic carriers. Dissolution and stability study were also investigated.

Result And Discussion: The two best-selected formulations (MS-PVP & MS-HPMC SD) have shown the highest dissolution profile as compared to pure drug, physical mixture and commercially available marketed product (Montel-10, Cipla). The FTIR, DSC and XRD results of these SD formulations have shown interaction between drug and polymers, decrease in enthalpy compared to the drug and amorphous behaviour respectively. Finally, MS-PVP & MS-HPMC SD formulations have shown good stability for one-month period under accelerated storage condition.

Conclusion: The study showed increase in solubility of Montelukast sodium with second generation polymers (PVP & HPMC) in comparison to pure drug as well as marketed formulation.