Montelukast sodium, is an antileukotriene agent for asthma and allergic rhinitis, is a BCS II drug with high
permeability and low solubility. This study aims to formulate and assess montelukast sodium tablets using
press coating. Tablets were prepared with montelukast sodium as the core in three formulations (CF1, CF2,
CF3) by varying diluent (PROSOLV SMCC HD 90) and super disintegrant (AC-Di-Sol) concentrations.
Before compression, powder flow characteristics like Repose angle, Bulk density(BD), Tapped density
(TD), Hausner’s ratio (HR), and Carr’s compressibility index (CI) were assessed for CF1 to CF3, followed
by optimization. Coating material was created with nine combinations (POF1 to POF9) using gum karaya
as a binder and Avicel pH 101 as diluent. Tablets from all batches were analyzed for weight variation, drug
content uniformity, hardness, friability, and in vitro disintegration time. POF4 (gum karaya and Avicel
pH101 in a 93:40 ratio) had a lag time of 4.5 hours before drug release, making it the optimized formulation.
POF4 underwent FTIR, SEM, DSC, and P-XRD studies, showing no reaction between the drug and
excipients. Thus, gum karaya is deemed suitable for the development of montelukast sodium tablets. The
study successfully developed and evaluated montelukast sodium tablets with desired properties for potential
use.
Keywords: Montelukast Sodium, Press coated tablets, Gum karaya, In-vitro disintegration time, lag
time, characterization studies
Publication date: 01/05/2026
https://www.ijbpas.com/pdf/2026/May/MS_IJBPAS_2026_10130.pdf
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https://doi.org/10.31032/IJBPAS/2026/15.5.10130
