Development of Orally Disintegrating Films HPMC-Based Containing Captopril: Mechanical, Optical and Physicochemical Studies

Abstract

Orally disintegrating films (ODFs) comprising hydroxypropyl methylcellulose (HPMC) E6 (2%, 2.5%, and 3%) and plasticizers (glycerin [Gly], propylene glycol [PP], or polyethylene glycol [PEG]) containing CPT were prepared by the solvent casting method and characterized. The design of experiments (DoE) was used considering the amount of film-forming agent (HPMC) and the nature of the plasticizers as independent variables and thickness, mechanical properties, disintegration time, and dissolution efficiency as dependent variables. The best formulation was selected based on the desirability function (fD). Color analysis was performed using CIE-Lab coordinates. The films had a pH less than 4 and were thus suitable for maximum stability of CPT. The amount of HPMC E6 and the nature of the plasticizer play a critical role in the physical, mechanical, and physicochemical properties of the films. Principal component analysis and hierarchical cluster analysis revealed a more defined distinction of the ODFs according to their chromatic characteristics. ODFs prepared with Gly and PEG 400 were translucent, whereas the other films were transparent. DoE successfully facilitated the interpretation of the experimental data and allowed the identification of optimal values of the factors for maximum yield. The maximum value obtained for fD was 0.8520, corresponding to 2.0 - 2.5% of the polymer (HPMC E6), and PP as plasticizer. The best-fitting kinetics model for CPT release from the ODFs was the Korsmeyer–Peppas model. The results showed that orally disintegrating films can be a promising alternative for oral administration of captopril.