Formulation Development and Evaluation of Mouth Dissolving Tablets of Cilnidipine

Abstract

Orodispersible tablets (ODT) are tablets that dissolve quickly or disintegrate in the oral cavity without the need for water. In this study, orodispersible tablets containing Cilnidipine (an antihypertensive agent) were formulated by direct compression method to improve the safety and efficacy of the drug molecules and achieve better patient compliance. Cilnidipine is an antihypertensive drug and acts as a calcium channel blocker. The aim of this study was to develop orally dispersible Cilnidipine tablets with increased dissolution rate using sodium starch glycolate and croscarmellose sodium as super disintegrant and microcrystalline cellulose as binders. Mannitol has a better effect in the mouth, although it is used as a binding agent, and sodium saccharin is used as a flavoring. The tablets that were developed underwent a thorough assessment across several parameters, including thickness, disintegration time, hardness, friability, wetting time, and in vitro dissolution time. All parameters were evaluated and found within limits. Among the Cilnidipine formulations developed, batch F4 disintegrated in 18.36 seconds. Nearly 90% of the drug is released from all formulations within 18 minutes. Based on the shortest disintegration time, lot F4 (consisting of 6.66% sodium starch glycolate, 5% croscarmellose sodium and 25% microcrystalline cellulose) was considered an optimized lot for Cilnidipine ODT.