Hydroxypropyl cellulose-based orally disintegrating films of promethazine HCL for the treatment of motion sickness

Abstract

Purpose: To prepare and characterize orally disintegrating films (ODFs) of promethazine hydrochloride (HCl) for prompt treatment of motion sickness. Methods: Films were prepared by solvent casting method using hydroxypropyl cellulose (HPC) as film former and glycerin as plasticizer along with a saliva stimulating and sweetening agent. Nine different film formulations were prepared and evaluated for their characteristics including thickness, disintegration time, tensile strength and drug release behavior. Results: The prepared films were transparent and slightly sticky in nature with thickness that ranged from 0.22 mm to 0.29 mm and tensile strength of 0.56 N/cm² to 2.49 N/cm². The disintegration time of film formulations ranged from 26.3 to 52.7 s and a majority of formulations released approx. 80 % of the drug within 10 min with a non-Fickian diffusion pattern. Conclusion: The study concludes that the orally disintegrating films of promethazine HCl can be prepared using HPC as film former.