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Direct Compression of Probiotic Tablets with PROSOLV ® EASYtab Nutra

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Released By JRS Pharma

Abstract
 
Although probiotics are mostly administered in the form of capsules, there are some advantages of tablets in terms of production effort, cost efficiency and stability of the probiotic bacteria. As probiotics are sensitive to high pressure and temperature, it is essential to select appropriate excipients for direct compression to ensure sufficient viability of the bacteria cells during production and storage. The aim of this study was to investigate the performance of the high functional excipient PROSOLV® EASYtab Nutra for direct compression of probiotic tablets. As PROSOLV® EASYtab Nutra is an all-in-one composite, only one mixing step is required before the compaction which makes the tableting process easy and comfortable. In order to evaluate the performance of PROSOLV® EASYtab Nutra, the survival rate of the bacteria and functional tablet properties were determined and compared to a lactose-based formulation. The study showed that PROSOLV® EASYtab Nutra is considerably better suited for direct compression of probiotic tablets because of the remarkable survival rate of 91.5 % of the bacteria cells as well as the quick disintegration within 18 seconds, which is almost 10 times faster compared to the lactose formulation. Furthermore PROSOLV® EASYtab Nutra is characterized by excellent compactibility and an extremely low friability.

Introduction
 
There is an increasing demand for probiotic products worldwide and this trend is expected to continue in the following years. The global probiotic market was amounted to more than 34 billion USD in 2015 and an annual growth rate of 8 % from 2015 to 2020 was forecasted. The major applications are probiotic dietary supplements, food and beverages and animal feed probiotics. 1,2,3,4
 
Probiotics were redefined as “live microorganisms, which when administered in adequate amounts, confer a health benefit on the host” by a FAO/WHO expert group in 2001. Probiotics provide a wide range of health benefits, including positive effects on immunological, digestive, and respiratory functions. 5 The most common microorganisms used in probiotic formulations are bacteria belonging to the genera of Lactobacillus and Bifidobacterium, but also yeasts such as Saccharomyces boulardii can be used as probiotics. 6,7

As only living bacteria can have beneficial effects, it has to be ensured that the probiotic products contain viable bacteria in large enough numbers. 5 The typically used delivery systems in the nutraceutical field are tablets and capsules, which provide increased storage stability compared to liquid preparations due to their low moisture content, as well as their easy and convenient administration. 6 Additionally, tablets are less-expensive, easy to manufacture and allow the highest dosage due to the strong compaction. However, the high compression forces and temperature increase during tablet production can destroy bacteria, leading to a reduced effectiveness of the probiotic products. 6,9 In order to overcome these challenges, particular excipients are required, which are suitable for direct compression of probiotic tablets.

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