María Adolfina Ruiz Martínez

Development of gastro-resistant tablets for the protection and intestinal delivery of Lactobacillus fermentum CECT 5716

Different studies have attributed health benefits to Lactobacillus fermentum CECT 5716. However, the main problem associated with probiotics, is their low resistance to environmental and technological factors. Actually, probiotics are marketed as capsules or sachets, but few probiotic tablets exist. The aim of this study was to design tablets made out of functional polymers (formula 1: methocel K-15-sodium alginate; formula 2: Eudragit(®) L-100-sodium alginate; formula 3: cellulose acetate phthalate) that improve the stability and survival of probiotics. Rigid tablets were produced through direct compression with a bacterial content of 10(9)CFU/tablet (9logCFU). Tablets were shown to improve the survival of cells when exposed to an acidic medium as compared to free cells. Eudragit(®) L-100-sodium alginate was found to be the most suitable excipient for the protection of probiotic within gastric conditions, resulting in the survival of 10(9)CFU (9logCFU) after 2h of incubation. Finally, these tablets were found to be stable over 6 months when stored at 4°C. No significant differences were reported between the number of cells at time cero and after 6 months of storage at 4°C (p>0.05). In conclusion, direct compression using Eudragit(®) L-100-sodium alginate seems to be a suitable to produce probiotics tablets and could confer protection during passage trough stomach and storage.

Evaluation of Viability of Lactobacillus fermentum CECT 5716 in Gelatin and Gastroresistant Capsules

Different studies have attributed health benefits to Lactobacillus fermentum CECT 5716. However, the main problem associated with probiotics is their low resistance to environmental and technological factors. In this sense, capsules can provide a shell protection and a dosage form that is easy to swallow. For these reasons, the aim of this study was to evaluate the survival of Lactobacillus fermentum CECT 5716 in gelatin and gastro-resistant capsules during a period of 12 months at RT (room temperature) and 4 °C. The number of encapsulated cells remained relatively constant after six months of storage, since there were no statistically significant differences compared to the initial time (p > 0.05). Moreover, capsules are able to maintain a therapeutic level of bacteria (10 CFU/capsule) during the total period of storage. Gelatin capsules seem to protect worse probiotic than gastro-resistant (HPMC (hydroxy propyl methyl cellulose)) capsules. Furthermore, capsules stored at 4 °C show a low level of viability. These results suggest that HPMC capsules are an optimal dosage form for L. fermentum CECT 5716 and that the recommended condition of storage is room temperature rather than 4 °C.