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.
Highlights
Gastro-resistant formulations are an example of the most common type of modified drug release systems
Gastro-resistant soft gelatin capsules can prove their usefulness in oral administration of drugs of irritating or acid-labile nature, often displaying at the same time enhanced bioavailability in a liquid form, which can be considered an advantage to coated tablets [2]
The structures revealed with scanning electron microscopy (SEM) suggest that the phase separation proceeds with a spinodal decomposition mechanism, which is spontaneously initiated, and kinetically limited by increase in the viscosity of gelatin during the gelling process when the temperature drops at the casting stage
Summary
Gastro-resistant formulations are an example of the most common type of modified drug release systems. Gastro-resistant forms of drug administration allow to: (1) (2) (3). Gastro-resistant soft gelatin capsules can prove their usefulness in oral administration of drugs of irritating or acid-labile nature, often displaying at the same time enhanced bioavailability in a liquid form, which can be considered an advantage to coated tablets [2]. The most obvious examples of the substances that need to be formulated in gastro-resistant dosage forms are non-steroidal anti-inflammatory drugs (NSAIDs), which are irritating to gastric mucosa. Due to the liquid fill, modification of the drug release rate from soft capsules can be achieved only by modification of the capsule shell to make it resistant to acidic pH
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