Comparative Evaluation of Ropinirole Hydrochloride Orodispersible Films with Marketed Conventional Dosage Forms for Enhanced Patient Compliance and Rapid Onset of Action

Abstract

Ropinirole hydrochloride is a non-ergoline dopamine agonist widely used in the management of Parkinson’s disease; however, its conventional oral dosage forms are associated with delayed onset of action and swallowing difficulties, particularly in geriatric patients. The present study aimed to develop and comparatively evaluate oro-dispersible films (ODFs) of ropinirole hydrochloride to enhance patient compliance and achieve rapid drug release. ODFs were prepared using the solvent casting technique employing polyvinyl alcohol (PVA), pullulan, and their combinations as film-forming polymers. A total of sixteen placebo formulations were initially screened to optimize polymer type and concentration, followed by preparation of nine drug-loaded formulations (F1–F9).
The developed films were evaluated for physicochemical properties, including thickness, tensile strength, folding endurance, surface pH, drug content, transparency, swelling index, and disintegration time. Compatibility studies using FTIR and DSC confirmed the absence of significant drug–excipient interactions. Among all formulations, F9 exhibited optimal performance with uniform thickness (~100 µm), high drug content (95.7%), maximum transparency (95.4%), superior swelling index (~499%), and rapid disintegration (45 seconds). In vitro dissolution studies revealed that F9 achieved approximately 54% drug release within 5 minutes and 98.87% release within 45 minutes, significantly outperforming the marketed immediate-release tablet. Ex vivo permeation studies further demonstrated rapid and efficient drug transport across buccal mucosa.
The findings suggest that the optimized ropinirole ODF provides a promising alternative to conventional dosage forms, offering enhanced dissolution, faster onset of action, and improved patient compliance, particularly for patients with swallowing difficulties.