Journal of International Research in Medical and Pharmaceutical Sciences

Background: Mucoadhesive buccal patches are being investigated as alternatives to conventional oral dosage forms for drugs affected by hepatic first-pass metabolism.

Objective: This study aimed to formulate and evaluate clomipramine hydrochloride buccal patches using hydroxypropyl methylcellulose (HPMC E15) and Carbopol 940.

Methods: Six formulations (F1–F6) containing 15 mg of clomipramine hydrochloride were prepared by solvent casting with varying polymer proportions and glycerin as a plasticiser. The patches were characterised for physical appearance, weight uniformity, thickness, folding endurance, surface pH, drug content, flatness, swelling, moisture uptake and loss, and in vitro drug release in phosphate buffer (pH 6.8). Release kinetics, surface morphology, and short-term stability were also assessed.

Results: The optimised formulation, F3, contained 750 mg of HPMC E15 and 250 mg of Carbopol 940. It showed a surface pH of 6.52, folding endurance exceeding 300 folds, drug content of 98.26%, and a swelling index of 537.13%. Cumulative drug release reached 82.52% after 6 hours. Among the kinetic models examined, the Higuchi model provided the best fit (R² = 0.9894). Following 30 days of room-temperature storage, no visible changes in appearance were reported, and drug content was 97.52%.

Conclusion: F3 demonstrated favourable formulation characteristics and sustained in vitro release over the study period. Further permeation and in vivo studies are required to establish buccal absorption and therapeutic performance.