Nghiên cứu phát triển chế phẩm cốm vi sinh chứa Bacillus subtilis và Bacillus clausii

The crucial role of the gut microbiota in human health is increasingly recognized, with dysbiosis linked to various gastrointestinal diseases. Probiotics, defined as live microorganisms conferring a health benefit when administered in adequate amounts, offer a promising solution to restore microbial balance. Among various probiotic strains, spore-forming Bacillus species like Bacillus subtilis and Bacillus clausii are particularly valued for their resilience against harsh conditions, including gastric acid. However, their viability can be significantly compromised during manufacturing processes, particularly wet granulation, which involves moisture and heat—factors detrimental to spore survival. Therefore, developing an optimized formulation and robust manufacturing process, coupled with stringent quality control and stability assessment, is paramount for ensuring product efficacy and market viability, especially in challenging environments like tropical regions. This study aimed to develop an optimal probiotic granule formulation containing B. subtilis M70 and B. clausii M31, establish in-house quality specifications, and evaluate the stability of the final product.

Researchers in pharmaceutical sciences, food technology, microbiology, and probiotic development; manufacturers of dietary supplements; and regulatory bodies concerned with product quality and stability.

This study successfully developed and optimized a probiotic granule formulation containing two key beneficial strains, Bacillus subtilis M70 and Bacillus clausii M31, along with a robust manufacturing process and comprehensive quality specifications. The research focused on optimizing the wet granulation method, meticulously evaluating critical process parameters such as environmental humidity, drying temperature (30-50°C), drying time (5-15 minutes), and excipient types, to maximize spore survival. Quality control tests, adhering to the Vietnamese Pharmacopoeia V, assessed sensory properties, uniformity of mass, moisture content, disintegration time, and viable microorganism enumeration. A key finding was the establishment of an optimized wet granulation process, specifically drying at 40°C for 10 minutes, which remarkably achieved a spore survival rate of 97.0%. The resulting granule product consistently met all in-house specifications, exhibiting a low moisture content (2.51%), rapid disintegration (2.19 minutes), and a high viable count (> 10^9 CFU/g for both strains), surpassing minimum requirements. Stability assessments further demonstrated that the product remained stable for at least 5 months under real-time conditions (30°C/75% RH), with controlled degradation observed under accelerated conditions (40°C/75% RH). These findings provide a strong scientific and technical foundation for the potential commercial development of this probiotic granule, offering a stable and effective product particularly suited for regions with high humidity and temperature, thus contributing to public health by ensuring the quality and efficacy of probiotic supplements.