FORMULATION DEVELOPMENT AND EVALUATION OF BUCCAL DRUG DELIVERY OF DAPOXETINE HYDROCHLORIDE

The current study work is focused on Dapoxetine hydrochloride buccal films. In recent days, buccal drug delivery has aimed at importance in many aspects compared to conventional tablets. The addition of mucoadhesive polymers to the formulation enhances the therapeutic levels of drug. Dapoxetine hydrochloride, a choice of drug used in the therapy of premature ejaculation in men. Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI’s) whose oral bioavailability is 42% due to hepatic first-pass metabolism. To enhance the bio-availability and drug release, Dapoxetine hydrochloride is designed as buccal films. They are prepared by the most commonly used solvent-casting method. Two grades of Hypromellose (E15 and 5cps), polyvinyl alcohol, and polyvinyl pyrrolidine are polymers that are mucoadhesive in nature. Propylene glycol is used as a plasticizer, and also mucoadhesive polymer and methanol as a solvent are used in film preparation. FTIR studies were done, and there is no incompatibility between active pharmaceutical ingredient (API) and excipients. The formulations developed were evaluated for different parameters such as weight uniformity, thickness, folding endurance, surface pH, swelling index, mechanical strength, % moisture absorption, in-vitro drug release, ex-vivo permeation studies, and stability studies. Buccal films of Dapoxetine hydrochloride were formulated as F1 to F8, which consists of different polymers and their combinations. Of all the prepared formulations, F5 (HPMC E15+ HPMC 5cps) shows uniformity of weight (15.79 ± 0.11 mg), thickness (0.98 ± 0.33 mm), folding endurance (302 ± 3.6), surface pH (6.81 ± 0.21), swelling index (33.49 ± 0.80 %), tensile strength (6.974 ± 0.16 kg/mm²), maximum % drug release (89.08 ± 0.06 %) and permeation (91.11 ± 0.85 %). HPMC films are preferred compared to other combinations because they are more elastic, more bioadhesive in the oral cavity. The stability studies were done and described saying there is no prominent changes observed in the optimized F5 formulation.