Formulation, Characterization, and Optimization of Captopril Fast-Dissolving Oral Films

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Developing patient-friendly drug delivery systems is crucial for improving medication adherence.
• Fast-dissolving oral films offer an alternative route for drug administration, potentially enhancing absorption.

Purpose of the Study:

• To formulate and optimize a captopril fast-dissolving oral film using pullulan, HPMC, CNF, and glycerine.
• To evaluate the physicochemical properties and in vivo performance of the optimized film.

Main Methods:

• Solvent-casting method was used to prepare films with varying concentrations of pullulan and glycerine.
• Response surface methodology with a central composite design was employed for optimization.
• Physicochemical properties (disintegration, tensile strength, elongation, folding endurance) and dissolution were assessed.
• In vivo pharmacokinetic study compared the optimized film with a conventional sublingual tablet.

Main Results:

• Cellulose nanofiber (CNF) improved compatibility and tensile strength; glycerine enhanced flexibility.
• All formulations exhibited acceptable content uniformity and rapid dissolution (<2 min).
• The optimized formulation (26% pullulan, 74% HPMC, 1% CNF, 5% glycerine) demonstrated superior in vivo performance.
• Compared to sublingual tablets, the optimized film significantly increased AUC (~62%) and Cmax (~52%), and decreased Tmax (~33%).

Conclusions:

• An optimized captopril fast-dissolving oral film was successfully developed.
• The film formulation offers enhanced oral bioavailability and faster absorption.
• This fast-dissolving film represents a promising alternative for captopril delivery.