Introduction: This study aimed to evaluate and compare the formulation characteristics of four commercially available clonazepam fast-dissolving tablet (FDT) brands in the Indian market and to assess their anxiolytic efficacy using behavioral animal models. Methods: Twenty tablets from each brand were analyzed for weight variation, friability, hardness, and disintegration time in accordance with pharmacopeial standards. Behavioral effects were evaluated in mice subjected to sleep deprivation-induced anxiety using the actophotometer, elevated zero maze, and light/dark box tests. Results: Among the tested brands, Zapiz showed the least weight variation (−0.38% to +0.28%) and the fastest disintegration (24 sec). Lonazep exhibited the lowest friability (0.657%), while Petril had the highest hardness (7.1 kg/cm²). In behavioral tests, all clonazepam FDTs significantly (p < 0.001) reduced anxiety-like behaviors compared with the sleep-deprived group. Zapiz consistently showed superior anxiolytic efficacy, reflected in improved locomotor activity, increased exploration of open quadrants in the elevated zero maze, and greater time spent in the light compartment. Discussion: While all brands met pharmacopeial standards, differences in formulation influenced disintegration and clinical potential. Zapiz demonstrated the most favorable balance of mechanical strength and rapid action, aligning with its superior anxiolytic effects in animal models. These findings emphasize the role of excipient selection and formulation design in optimizing FDT performance. Conclusion: Zapiz emerged as the best-performing brand, offering both pharmaceutical quality and significant anxiolytic benefits. Optimizing FDT formulations with novel superdisintegrants and validating findings through pharmacokinetic and clinical studies may further enhance therapeutic outcomes in anxiety management.
Gupta et al. (Wed,) studied this question.