📄 Abstract
Objective: The primary goal of this study was to develop and evaluate the stability of Probiotic capsules containing Lactobacillus and Bifidobacterium strains, comparing traditional gelatin shells with hydroxypropyl methylcellulose (HPMC) shells under various ICH climatic conditions. Methods: Probiotic capsules were formulated using a lyophilized microbial blend with microcrystalline cellulose and magnesium stearate. The formulations (Formulation A: Gelatin; Formulation B: HPMC) were subjected to long-term (25°C ± 2°C / 60% RH ± 5% RH) and accelerated (40°C ± 2°C / 75% RH ± 5% RH) stability testing for six months. Viability was assessed using the standard plate count method (Log10 CFU/capsule), and water activity (aw) was monitored. Results: Initial viability for both formulations was 9.5 Log10 CFU. After six months of accelerated testing, Formulation B (HPMC) maintained a significantly higher viability (8.10 ± 0.22 Log10 CFU) compared to Formulation A (6.40 ± 0.45 Log10 CFU). The HPMC capsules exhibited superior moisture barrier properties, maintaining water activity below 0.25 for a longer duration, which prevented premature metabolic activation and cell death. Conclusion: The study demonstrates that HPMC capsules are a superior delivery vehicle for moisture-sensitive Probiotics. The optimized formulation meets the therapeutic threshold (>106 CFU) required for clinical efficacy throughout the tested shelf life, providing a robust platform for the commercial development of Probiotic nutraceuticals.
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📚 How to Cite:
G. Neelamma , Ramesh Adepu , DEVELOPMENT STRATEGIES AND STABILITY ASSESSMENT OF PROBIOTIC CAPSULES: A COMPREHENSIVE REVIEW , Volume 11 , Issue 7, July 2026, EPRA International Journal of Research & Development (IJRD) , Pages: 280 - 282 ,