Design and Characterization of Quick Dissolving Film for Simultaneous Delivery of Montelukast Sodium and Levocetirizine Dihydrochloride

摘要

The main objective of the present investigation was to develop fast dissolving films of montelukast sodium and levocetirizine dihydrochloride using sodium starch glycolate as disintegrating agent to achieve better drug bio-availability and patient's compliance. This combination is the most effective in the management of allergic rhinitis and asthma. The results of preformulation study indicated that drug and excipients are compatible with each other with its purest forms. The solvent casting method was used to prepare different batches of films. The prepared fast dissolving films were evaluated for physical appearance, weight uniformity, uniformity of thickness, folding endurance, surface pH, tensile strength, moisture content, disintegration time, % drug content, in-vitro dissolution studies. From the study it was found that F8 has showed maximum release of 94.40±0.48% for montelukast sodium and 95.66±0.24% for levocetirizinedihydrochloride within 225sec. Based on the results such as drug content, disintegrating time and drug release it was concluded that fast dissolving films are suitable for oral administration of montelukast sodium and levocetirizine dihydrochloride.