Preparation And Characterization of ORO-Dispersible Montlukast Sodium Tablet using Neem leaf powder

The study aimed to develop and characterize orodispersible tablets (ODTs) of Montelukast sodium using neem leaf powder (Azadirachta indica) as a natural excipient. Orodispersible tablets offer an advantage for patients with swallowing
difficulties by rapidly disintegrating in the oral cavity, eliminating the need for water. The tablets were formulated using the direct compression method, incorporating neem leaf powder as a multifunctional excipient to enhance drug release and provide additional therapeutic benefits. Nine formulations (F1–F9) were developed by varying the concentrations of neem leaf powder and croscarmellose sodium as a superdisintegrant. The prepared ODTs were evaluated for physical properties, including hardness, weight variation, thickness, and disintegration time. The disintegration time ranged between 22 and 31 seconds, confirming rapid disintegration suitable for orodispersible formulations. Dissolution studies were conducted in 0.1 N HCl to
assess drug release profiles. The results indicated that all formulations exhibited efficient drug release, with the percentage of Montelukast sodium released at 30 minutes ranging from 93% to 99%. Among the formulations, batch F4 demonstrated superior performance, showing the highest dissolution rate (99% at 30 min) and the shortest disintegration time (22 sec), making it the optimal formulation. Neem leaf powder contributed to the rapid disintegration and improved dissolution properties,
suggesting its potential as a natural excipient in ODT formulations. The findings highlight the feasibility of utilizing neem leaf powder in pharmaceutical applications, enhancing drug bioavailability while offering additional therapeutic properties. This study provides valuable insights into the development of herbal-based excipients in modern drug delivery systems, aligning with the increasing interest in natural and patient-friendly formulations. Future research may explore the long-term stability of
these formulations and the broader applicability of neem in pharmaceutical dosage forms.