NGHIÊN CỨU BÀO CHẾ PHIM DIPHENHYDRAMIN HYDROCLORID 12,5mg RÃ NHANH TẠI KHOANG MIỆNG BẰNG PHƯƠNG PHÁP ĐỔ KHUÔN DUNG MÔI

Abstract

Objectives: To prepare 12.5mg diphenhydramine hydrochloride (DPH) oral   fast-disintegrating   films   (OFDF)   using   the   solvent   casting    method. Methods: This was an in vitro experimental study design. DPH films were prepared by the solvent casting method. The effects of solvent, film-forming polymer, film size, and plasticizer on film characteristics were investigated. The films were evaluated for quality attributes, dissolution, and physicochemical properties using Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and X-ray diffraction (XRD). Results: The selected formulation containing HPMC E15, PEG 400, and glycerine produced transparent, smooth films with a folding endurance of > 350 folds, a thickness of approximately 100μm, and a disintegration time of less than 30s. The DPH content met the acceptance criteria, with more than 70% of the drug released after 5 min and nearly complete release after 15 min. FTIR, DSC, and XRD analyses suggested that DPH was predominantly present in an amorphous state without significant interactions with the excipients. Conclusion: A 12.5mg DPH oral fast-disintegrating film was successfully prepared using the solvent casting method.