FORMULATION AND CHARACTERIZATION OF FAST DISSOLVING WAFERS OF AN ANTIDEPRESSANT DRUG USING NATURAL POLYMERS
Dharnidhar Pandey*, Sunil Shah, B. K. Dubey, Deepak Kumar Basedia and Prabhat Kumar Jain
ABSTRACT
The aim of this study was to formulate and evaluate fast-dissolving oral wafers of Amitriptyline, a commonly
prescribed antidepressant, to improve patient compliance, particularly for those who have difficulty swallowing
tablets or capsules. A total of nine formulations (F1 to F9) were developed using various excipients, and their
properties such as weight, thickness, tensile strength, folding endurance, disintegration time, drug content, and
dissolution profiles were systematically evaluated. The results showed that all formulations exhibited good
mechanical strength and flexibility, with formulation F6 showing the best performance. F6 demonstrated the
shortest disintegration time (48±4 sec) and the highest cumulative drug release (98.85%) within 10 minutes,
indicating its suitability for fast drug release. The drug content of all formulations was found to be within the
acceptable range, with F6 exhibiting the highest content of 99.65±0.36%. Stability studies on the optimized
formulation (F6) confirmed that the wafer maintained its physical appearance, disintegration time, and dissolution
profile even after 90 days of storage. The study suggests that fast-dissolving amitriptyline wafers, particularly
formulation F6, are a promising alternative for improving the therapeutic efficacy and patient compliance of
amitriptyline therapy.
Keywords: Amitriptyline, fast-dissolving wafers, drug delivery, formulation, disintegration time, drug release, patient compliance, stability, dissolution profile, folding endurance.
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