Development of technical regulations for the capsulated probiotic manufacture


A.P. Paliy, S.O. Gujvinska, M.V. Kalashnyk, O.V. Ivleva, R.V. Petrov, Yu.A. Baidevliatov, Yu.V. Baidevliatova, V.O. Husiev, S.M. Hilko, I.I. Kiralhazi, M.V. Lohvynenko, A.P. Palii, Yu.Yu. Bakun

The aim of this work was to develop a technological regulation for the production of probiotic based on lacto- and bifidobacteria in the form of intestinal-soluble capsules for farm animals. Three experimental series of probiotic drug were made in the form of enteric capsules based on lactic acid bacteria. It has been established that the Bifidobacterium adolectentis No 17-316 strain and the Lactobacillus plantarum No 7-317 strain are the most adapted for the bacterial consortium. These strains have high biological activity and correspond to certain authentic characteristics. The pharmaceutical composition is proposed in the form of capsules with following ingredients: 50% of dry biomass of Lactobacillus plantarum No 7-317 and Bifidobacterium adolectentis No 17-316 strains, 5% of glucose, 5% of lactose, 9% of aerosil and 31% of starch. The content of lyophilized bacteria in one capsule is not less than 1 × 107 CFU of bifidobacteria/cm3 and 1 × 107 CFU of lactobacilli/cm3. A scheme of the manufacturing process of the drug in form of capsules includes the following stages: production of nutrient media and working solutions; growing cultures of lacto- and bifidobacteria, freeze drying of cultures of lacto- and bifidobacteria, obtaining a dry mass of lactic acid bacteria for encapsulation, encapsulation of the drug, control of the manufactured product before release, marking, packaging of capsules, transportation, storage of a drug.

Keywords: Lactobacilli; Bifidobacteria; Glucose; Lactose; Aerosol; Starch; Encapsulated drug


Alayande, K. A., Aiyegoro, O. A., & Ateba, C. N. (2020). Probiotics in Animal Husbandry: Applicability and Associated Risk Factors. Sustainability, 12(3), 1087. doi: 10.3390/su12031087

Bakr, S. A. (2015). The potential applications of probiotics on dairy and non-dairy foods focusing on viability during storage. Biocatalysis and Agricultural Biotechnology, 4(4), 423-431. doi: 10.1016/j.bcab.2015.09.010

Broeckx, G., Vandenheuvel, D., Claes, I. J., Lebeer, S., & Kiekens, F. (2016). Drying techniques of probiotic bacteria as an important step towards the development of novel pharmabiotics. International journal of pharmaceutics, 505(1-2), 303-318. doi: 10.1016/j.ijpharm.2016.04.002

Burgain, J., Gaiani, C., Linder, M., & Scher, J. (2011). Encapsulation of probiotic living cells: From laboratory scale to industrial applications. Journal of Food Engineering, 104(4), 467-483. doi: 10.1016/j.jfoodeng.2010.12.031

Candela, M., Maccaferri, S., Turroni, S., Carnevali, P., & Brigidi, P. (2010). Functional intestinal microbiome, new frontiers in prebiotic design. International journal of food microbiology, 140(2-3), 93-101. doi: 10.1016/j.ijfoodmicro.2010.04.017

Chen, T., Wu, Q., Zhou, H., Deng, K., Wang, X., Meng, F., Yang, S., Wang, X., Shah, N.P., & Wei, H. (2017). Assessment of commercial probiotic products in China for labelling accuracy and probiotic characterisation of selected isolates. Dairy Technology, 70(1), 119-126. doi: 10.1111/1471-0307.12331

Da Silva, L. A., Lopes Neto, J. H. P., & Cardarelli, H. R. (2019). Safety and probiotic functionality of isolated goat milk lactic acid bacteria. Ann Microbiol., 69, 1497-1505. doi: 10.1007/s13213-019-01533-z

Davis, ?. (2014). Enumeration of probiotic strains: Review of culture-dependent and alternative techniques to quantify viable bacteria. Journal of Microbiological Methods, 103, 9-17. doi: 10.1016/j.mimet.2014.04.012

D'Aimmo, M. R., Mattarelli, P., Biavati, B., Carlsson, N. G., & Andlid, T. (2012). The potential of bifidobacteria as a source of natural folate. Journal of applied microbiology, 112(5), 975-984. doi: 10.1111/j.1365-2672.2012.05261.x

De Souza, K. C. B., Petrovick, P. R., Bassani, V. L., & Ortega, G. G. (2000). The Adjuvants Aerosil 200 and Gelita-Sol-P Influence on the Technological Characteristics of Spray-Dried Powders from Passiflora edulis var. flavicarpa. Drug Development and Industrial Pharmacy, 26(3), 331-336. doi: 10.1081/DDC-100100361

Di Cerbo, A., & Palmieri, B. (2015). Review: The market of probiotics. Pakistan journal of pharmaceutical sciences, 28(6), 2199-2206. PMID: 26639512

Dimidi, E., Christodoulides, S., Scott, S. M., & Whelan, K. (2017). Mechanisms of Action of Probiotics and the Gastrointestinal Microbiota on Gut Motility and Constipation. Advances in nutrition, 8(3), 484-494. doi: 10.3945/an.116.014407

Donohue, D. C., & Salminen, S. (1996). Safety of probiotic bacteria. Asia Pacific journal of clinical nutrition, 5(1), 25-28. PMID: 24394461

Drago, L., Rodighiero, V., Celeste, T., Rovetto, L., & De Vecchi, E. (2010). Microbiological Evaluation of Commercial Probiotic Products Available in the USA in 2009. Journal of Chemotherapy, 22(6), 373-377. doi: 10.1179/joc.2010.22.6.373

Ephrem, E., Najjar, A., Charcosset, C., & Greige-Gerges, H. (2018). Encapsulation of natural active compounds, enzymes, and probiotics for fruit juice fortification, preservation, and processing: An overview. Journal of Functional Foods, 48, 65-84. doi: 10.1016/j.jff.2018.06.021

Fasoli, S., Marzotto, M., Rizzotti, L., Rossi, F., Dellaglio, F., & Torriani, S. (2003). Bacterial composition of commercial probiotic products as evaluated by PCR-DGGE analysis. International journal of food microbiology, 82(1), 59-70. doi: 10.1016/s0168-1605(02)00259-3

Fenster, K., Freeburg, B., Hollard, C., Wong, C., Rønhave Laursen, R., & Ouwehand, A. C. (2019). The Production and Delivery of Probiotics: A Review of a Practical Approach. Microorganisms, 7(3), 83. doi: 10.3390/microorganisms7030083

Floch, M. H., Walker, W. A., Madsen, K., Sanders, M. E., Macfarlane, G. T., Flint, H. J., Dieleman, L. A., Ringel, Y., Guandalini, S., Kelly, C. P., & Brandt, L. J. (2011). Recommendations for probiotic use-2011 update. Journal of clinical gastroenterology, 45(Suppl), 168-171. doi: 10.1097/MCG.0b013e318230928b

Forssten, S. D., Sindelar, C. W., & Ouwehand, A. C. (2011). Probiotics from an industrial perspective. Anaerobe, 17(6), 410-413. doi: 10.1016/j.anaerobe.2011.04.014


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