Fülöpová Nicole, Chomová Natália, Elbl Jan, Mudroňová Dagmar, Sivulič Patrik, Pavloková Sylvie, Franc Aleš
Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 42 Brno, Czech Republic.
Department of Microbiology and Immunology, University of Veterinary Medicine and Pharmacy, Komenského 73, 041 81 Košice, Slovakia.
Pharmaceutics. 2023 Mar 10;15(3):910. doi: 10.3390/pharmaceutics15030910.
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 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.
多年来，益生菌已被用于人类医学和兽医学，以增强对病原体的抵抗力，并抵御外界影响。病原体常常通过食用动物产品传播给人类。因此，人们认为保护动物的益生菌也可能保护食用这些动物产品的人类。许多经过测试的益生菌菌株可用于个体化治疗。最近分离出的R2 Biocenol™已被证明在水产养殖中具有优势，预计对人类也有潜在益处。应通过合适的制备方法，即冻干法，开发一种简单的口服剂型来验证这一假设，使细菌能存活更长时间。冻干制剂由硅酸盐（Neusilin NS2N；US2）、纤维素衍生物（微晶纤维素PH-101）和糖类（菊粉、蔗糖、变性淀粉1500）制成。对它们的物理化学性质（pH值渗滤液、水分含量、吸水性、湿润时间、差示扫描量热法测试、密度和流动性质）进行了评估；在包括4℃下6个月的相关研究条件下测定其细菌活力，并在电子显微镜下进行扫描。由Neusilin NS2N和蔗糖组成的冻干制剂在活力方面似乎最具优势，且没有任何显著下降。其物理化学性质也适合胶囊封装、后续的临床评估和个体化治疗。
