Preparation of Diphenhydramine Hydrochloride Mucoadhesive Oral Film and the Evaluation of its Pharmaceutics characteristics

Background & Objective: In recent years, mucoadhesive drug delivery systems has shown interested for prolonging the residence time of the dosage form and for providing a controlled rate of drug release. Mucoadhesive buccal films can enhance drug bioavailability by absorption through buccal mucosa and bypassing the first pass metabolism for improved therapeutic effect.. In addition, buccal films have advantages such as providing a convenient accessibility, painless method of drug delivery, and improved patient compliance. Buccal tablets allow drinking, eating, and speaking without any major discomfort.   Materials & Methods: Buccal films of diphenhydramine were prepared by solvent casting technique using Hydroxyl Propyl Methyl Cellulose (HPMC) 6000cps, Sodium Carboxymethyl Cellulose (NaCMC), and Poly Vinyl Alcohol (PVA). Prepared films were evaluated for weight, thickness, swelling index, drug content uniformity, tensile strength, and in vitro release studies. Results: The thickness of the films were between 0.13 and 0.25 mm. Their weight were in range of 0.98 and 1.26. F1 (containing 875mg HPMC and 125mg PVA), F5 (made of HPMC 50 mg and PVA 950mg), and F6 (containing 800mg PVA) showed success in the primary tests. No bubble or shrinkage was observed in them. F1, F5, and F6 released 97.8%, 96.7%, and 97.6% of the drug, respectively during five hours, two hours, and 40 minutes.   Conclusion: F6, which contained 800mg PVA, released 97.6% of the drug in 40 minutes. This film has proper pharmaceutic characteristics to be used.