title: Development of gastro-resistant tablets for the protection and intestinal delivery of Lactobacillus fermentum CECT 5716.
abstract: 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.
authors.affiliation: Department of Technology and Pharmacy, School of Pharmacy, Campus de Cartuja s.n., University of Granada, Granada 18071, Spain. Electronic address: mjmv@ugr.es.
authors.forename: María José Martín
authors.initials: MJ
authors.lastname: Villena
authors.affiliation: Nutrition and Food Safety, Lactalis Puleva, Camino de Purchil n° 66, 18004 Granada, Spain.
authors.forename: Ferderico
authors.initials: F
authors.lastname: Lara-Villoslada
authors.affiliation: Department of Technology and Pharmacy, School of Pharmacy, Campus de Cartuja s.n., University of Granada, Granada 18071, Spain.
authors.forename: María Adolfina Ruiz
authors.initials: MA
authors.lastname: Martínez
authors.affiliation: Department of Technology and Pharmacy, School of Pharmacy, Campus de Cartuja s.n., University of Granada, Granada 18071, Spain.
authors.forename: María Encarnación Morales
authors.initials: ME
authors.lastname: Hernández
mesh_terms: D002626:Chemistry, Pharmaceutical; D015169:Colony Count, Microbial; D004339:Drug Compounding; D016503:Drug Delivery Systems; D004355:Drug Stability; D005079:Excipients; D006801:Humans; D007413:Intestinal Mucosa / Q000378:metabolism*; D052197:Limosilactobacillus fermentum; D011109:Polymethacrylic Acids; D019936:Probiotics / Q000008:administration & dosage*; D013608:Tablets, Enteric-Coated
chemical_list: D005079:Excipients; D011109:Polymethacrylic Acids; D013608:Tablets, Enteric-Coated; C038300:methylmethacrylate-methacrylic acid copolymer
keywords: Lactobacillus fermentum; Probiotics; Protection; Tablets