Prototype Gastro-Resistant Soft Gelatin Films and Capsules—Imaging and Performance In Vitro

Abstract

The following study is a continuation of the previous work on preparation of gastro-resistant films by incorporation of cellulose acetate phthalate (CAP) into the soft gelatin film. An extended investigation on the previously described binary Gelatin-CAP and ternary Gelatin-CAP-carrageenan polymer films was performed. The results suggest that the critical feature behind formation of the acid-resistant films is a spinodal decomposition in the film-forming mixture. In the obtained films, upon submersion in an acidic medium, gelatin swells and dissolves, exposing a CAP-based acid-insoluble skeleton, partially coated by a residue of other ingredients. The dissolution-hindering effect appears to be stronger when iota-carrageenan is added to the film-forming mixture. The drug release study performed in enhancer cells confirmed that diclofenac sodium is not released in the acidic medium, however, at pH 6.8 the drug release occurs. The capsules prepared with a simple lab-scale process appear to be resistant to disintegration of the shell structure in acid, although imperfections of the sealing have been noticed.

Special Issue: Advanced Materials in Drug Release and Drug Delivery Systems

“…The next three papers are devoted to the ever-expanding technological approaches in solid oral dosage forms like tablets [ 7 , 8 ] and capsules [ 9 ]. Jamróz et al focus on the deep analysis of the relationship between structure and pharmaceutical characteristics in 3D printed tablets.…”

“…It was shown that this process affected particle size and shape, improved the in vitro bicalutamide release profile, and it evoked changes in the drug crystallinity. The paper by Maciejewski et al [ 9 ] provides data on the gastro resistant soft gelatin films and capsule formulation from binary-gelatin/cellulose acetate phthalate and ternary-gelatin/cellulose acetate phthalate/carrageenan films. They suggest that the discreet kinetically-limited phase separation was the crucial factor affecting the disintegration of the films.…”