Mechanistic Approach to Stability Studies as a Tool for the Optimization and Development of New Products Based on L. rhamnosus Lcr35® in Compliance with Current Regulations

摘要: Probiotics are of great current interest in the pharmaceutical industry because their multiple effects on human health. To beneficially affect host, an adequate dosage probiotic bacteria product must be guaranteed from time manufacturing to expiration date. Stability test guidelines as laid down by ICH-Q1A stipulate a minimum testing period 12 months. The challenge for producers is reduce this time. In paper, mechanistic approach using Arrhenius model proposed predict stability. Applied first laboratory and industrial powders, was able provide reliable mathematical representation temperature bacterial death (R2>0.9). destruction rate (k) determined according process, strain storage conditions. marketed demonstrated better stability (k = 0.08 months−1) than sample 0.80 months−1). With batches, k obtained at 6 months studies comparable that months, evidence model’s robustness. addition, predicted values were greatly similar (±30%) those real-time assessing reliability. This method could interesting length against (ICH guideline) or 24 (expiration date).