European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL TABLETS OF NITRAZEPAM

Roshan Kalambe*, Harpreet Kaur Khanuja, Surendra Jain

ABSTRACT

The present study aimed to develop and evaluate fast dissolving oral tablets of Nitrazepam to improve its solubility, disintegration, and patient compliance. Preformulation studies confirmed that Nitrazepam is a white, bitter, crystalline powder with slight solubility in water and 0.1 N HCl, but good solubility in ethanol, methanol, chloroform, phosphate buffer (pH 6.8), and 0.1 N NaOH. The melting point, FTIR spectrum, and loss on drying were consistent with standard specifications, confirming the purity and stability of the drug. Pre-compression studies revealed that the powder blends exhibited fair to acceptable flow properties, with formulations F1, F5, and F6 showing better compressibility. Post-compression evaluation demonstrated that all formulations met pharmacopeial standards for hardness, friability, weight variation, thickness, and drug content. Disintegration studies revealed that formulation F3, containing 20 mg Crospovidone, showed the shortest disintegration time (53±8 seconds), while other formulations showed slower disintegration, particularly those containing Croscarmellose sodium. In-vitro dissolution studies indicated that formulation F3 released 96.65% of drug within 15 minutes, exhibiting rapid and complete release. Kinetic modeling showed that drug release followed Zero Order (r² = 0.9951) and Higuchi kinetics (r² = 0.9888), suggesting a concentration-independent, diffusion-controlled release mechanism. These findings establish formulation F3 as the optimized fast dissolving Nitrazepam tablet, offering rapid onset of action, consistent release, and improved therapeutic effectiveness, thereby enhancing patient compliance.

Keywords: Nitrazepam, Fast dissolving tablets, Preformulation studies, Superdisintegrants, Crospovidone, In-vitro dissolution, Release kinetics, Zero-order kinetics.