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...

Full description

Bibliographic Details
Main Authors: Nicole Fülöpová, Natália Chomová, Jan Elbl, Dagmar Mudroňová, Patrik Sivulič, Sylvie Pavloková, Aleš Franc
Format: Article
Language:English
Published: MDPI AG 2023-03-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/15/3/910
_version_ 1827748093674651648
author Nicole Fülöpová
Natália Chomová
Jan Elbl
Dagmar Mudroňová
Patrik Sivulič
Sylvie Pavloková
Aleš Franc
author_facet Nicole Fülöpová
Natália Chomová
Jan Elbl
Dagmar Mudroňová
Patrik Sivulič
Sylvie Pavloková
Aleš Franc
author_sort Nicole Fülöpová
collection DOAJ
description 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 <i>Lactobacillus plantarum</i> 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<sup>®</sup> NS2N; US2), cellulose derivates (Avicel<sup>®</sup> PH-101), and saccharides (inulin; saccharose; modified starch<sup>®</sup> 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<sup>®</sup> 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.
first_indexed 2024-03-11T06:02:26Z
format Article
id doaj.art-9a98aeaea1884edaa95d94d72f2ce37c
institution Directory Open Access Journal
issn 1999-4923
language English
last_indexed 2024-03-11T06:02:26Z
publishDate 2023-03-01
publisher MDPI AG
record_format Article
series Pharmaceutics
spelling doaj.art-9a98aeaea1884edaa95d94d72f2ce37c2023-11-17T13:16:07ZengMDPI AGPharmaceutics1999-49232023-03-0115391010.3390/pharmaceutics15030910Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized ProbioticsNicole Fülöpová0Natália Chomová1Jan Elbl2Dagmar Mudroňová3Patrik Sivulič4Sylvie Pavloková5Aleš Franc6Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 42 Brno, Czech RepublicDepartment of Microbiology and Immunology, University of Veterinary Medicine and Pharmacy, Komenského 73, 041 81 Košice, SlovakiaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 42 Brno, Czech RepublicDepartment of Microbiology and Immunology, University of Veterinary Medicine and Pharmacy, Komenského 73, 041 81 Košice, SlovakiaDepartment of Natural Drugs, Faculty of Pharmacy, Masaryk University, 612 42 Brno, Czech RepublicDepartment of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 42 Brno, Czech RepublicDepartment of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 42 Brno, Czech RepublicProbiotics 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 <i>Lactobacillus plantarum</i> 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<sup>®</sup> NS2N; US2), cellulose derivates (Avicel<sup>®</sup> PH-101), and saccharides (inulin; saccharose; modified starch<sup>®</sup> 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<sup>®</sup> 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.https://www.mdpi.com/1999-4923/15/3/910lyophilizationantropozoonosesprobiotic bacteriaindividual treatmentprincipal component analysisviability of bacteria
spellingShingle Nicole Fülöpová
Natália Chomová
Jan Elbl
Dagmar Mudroňová
Patrik Sivulič
Sylvie Pavloková
Aleš Franc
Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics
Pharmaceutics
lyophilization
antropozoonoses
probiotic bacteria
individual treatment
principal component analysis
viability of bacteria
title Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics
title_full Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics
title_fullStr Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics
title_full_unstemmed Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics
title_short Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics
title_sort preparation and evaluation of a dosage form for individualized administration of lyophilized probiotics
topic lyophilization
antropozoonoses
probiotic bacteria
individual treatment
principal component analysis
viability of bacteria
url https://www.mdpi.com/1999-4923/15/3/910
work_keys_str_mv AT nicolefulopova preparationandevaluationofadosageformforindividualizedadministrationoflyophilizedprobiotics
AT nataliachomova preparationandevaluationofadosageformforindividualizedadministrationoflyophilizedprobiotics
AT janelbl preparationandevaluationofadosageformforindividualizedadministrationoflyophilizedprobiotics
AT dagmarmudronova preparationandevaluationofadosageformforindividualizedadministrationoflyophilizedprobiotics
AT patriksivulic preparationandevaluationofadosageformforindividualizedadministrationoflyophilizedprobiotics
AT sylviepavlokova preparationandevaluationofadosageformforindividualizedadministrationoflyophilizedprobiotics
AT alesfranc preparationandevaluationofadosageformforindividualizedadministrationoflyophilizedprobiotics