Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics

Probiotics have been used in human and veterinary medicine to increase resistance to pathogens and provide protection against external impacts for many years. Pathogens are often transmitted to humans through animal product consumption. Therefore, it is assumed that probiotics protecting animals may also protect the humans who consume them. Many tested strains of probiotic bacteria can be used for individualized therapy. The recently isolated Lactobacillus plantarum R2 Biocenol™ has proven to be preferential in aquaculture, and potential benefits in humans are expected. A simple oral dosage form should be developed to test this hypothesis by a suitable preparation method, i.e., lyophilization, allowing the bacteria to survive longer. Lyophilizates were formed from silicates (Neusilin^® NS2N; US2), cellulose derivates (Avicel^® PH-101), and saccharides (inulin; saccharose; modified starch^® 1500). They were evaluated for their physicochemical properties (pH leachate, moisture content, water absorption, wetting time, DSC tests, densities, and flow properties); their bacterial viability was determined in conditions including relevant studies over 6 months at 4 °C and scanned under an electron microscope. Lyophilizate composed of Neusilin^® NS2N and saccharose appeared to be the most advantageous in terms of viability without any significant decrease. Its physicochemical properties are also suitable for capsule encapsulation, subsequent clinical evaluation, and individualized therapy.

2.1. Materials

MRS broth, MRS agar (both Biolife Italiana S.r.l., Milano, Italy), and sodium chloride (Slavus, Bratislava, Slovakia) were used in the cultivation and examination processes of the bacteria. MRS broth and MRS agar were prepared according to the manufacturer’s technical sheet [51]. Neusilin^® US2, Neusilin^® NS2N (magnesium aluminosilicates, Fuji Chemical Industries Cp., Ltd., Toyama, Japan), and Avicel^® PH-101 (microcrystalline cellulose, FMC Biopolymer, Wallingstown, Ireland) were used as constitutional excipients for the formation of the lyophilizate. In addition, inulin (Glentham Life Sciences, Ltd., Corsham, UK), saccharose (Sigma-Aldrich, St. Louis, MO, USA), and starch 1500^® (Colorcon^®, Limited, Dartford, UK) were used as cryoprotectants in the lyophilization process. Various experiments used purified water (prepared in-house) as a solvent. Methylene blue (Fagron a.s., Olomouc, Czech Republic) was used in the determined evaluation.

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Fülöpová, N.; Chomová, N.; Elbl, J.; Mudroňová, D.; Sivulič, P.; Pavloková, S.; Franc, A. Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics. Pharmaceutics 2023, 15, 910. https://doi.org/10.3390/pharmaceutics15030910

excipients formulation