Purpose of work: Probiotics are manufactured as pharmaceutical-dosage forms registered on the marked as: drugs, food supplements, or as medical devices. The main goal of this paper was to set probiotic production stages in order to obtain high quality finished product.
Materials and methods: Viability of probiotic species (bacteria or fungi) was determined by the method of counting the number of microorganisms in suitable medium, after packaging in different packaging materials: a) PVC foil; b) PVdC foil; c) PVdC foil in laminate flow pack foil; or d) PVdC foil in laminate flow pack foil with inert gas, using the same manufacturing conditions prior to packaging phase. Manufactured product was tested under conditions of long-term stability study according to ICH guidelines. The analysis confirmed that the moisture content was important parameter of the probiotic stability, which was analysed on the same set of conditions as additional parameter that influences the probiotic viability under the following conditions: a) with air humidity control and b) without it.
Results: Analyses have presented that probiotic content was the smallest in PVC foil (under the declared value), because it has no barrier properties to temperature and humidity. The product packaged using other materials showed satisfactory results regarding the probiotic viability, whereas the best results were observed using the PVdC foil in laminate flow pack foil with inert gas. Additionally, the study confirmed the hypothesis that moisture content negatively affects the viability of probiotic, since the results obtained with air humidity control were significantly higher than without it.
Conclusion: In order to obtain quality probiotic product which is effective and safe during the declared shelf life, it is necessary to provide optimal conditions during its manufacture, which was confirmed in this study.