Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Matunga, 400019, India.
AAPS PharmSciTech. 2021 May 18;22(5):156. doi: 10.1208/s12249-021-02024-8.
Probiotics have gained a lot of interest in recent years as an alternative as well as adjuvant therapy for several conditions owing to their health benefits. These live microorganisms have proven efficacy for treating gut disorders, inflammation, bacterial vaginosis, hepatic and depressive disorders, and many more. There are conventional as well as non-conventional formulations available for the delivery of probiotics with the latter having fewer regulatory guidelines. The conventional formulations include the pharmaceutical formulations specifically designed to deliver an efficacious number of viable microorganisms. Studies have indicated 10-10 CFU/g as an ideal dose of probiotics for achieving health benefits, and hence, all the formulations must at least contain the said number of viable bacteria to show a therapeutic effect. The most crucial feature of probiotic formulations is that the bacteria are prone to several environmental and processing factors which all together reduce the viability of the bacteria in the final formulation. These factors include processing parameters like temperature, humidity, pressure, and storage conditions. Thus, the present review primarily focuses on the critical process parameters affecting the probiotic viability during stabilization process and formulation development. Understanding these factors prior to processing helps in delivering probiotics in the required therapeutic numbers at the target site.
近年来，由于益生菌具有健康益处，因此作为替代疗法和辅助疗法，其受到了广泛关注。这些活微生物已被证明对治疗肠道疾病、炎症、细菌性阴道病、肝脏和抑郁障碍等多种疾病有效。有常规和非常规的益生菌制剂可供选择，后者的监管指南较少。常规制剂包括专门设计用于输送有效数量活菌的药物制剂。研究表明，达到健康益处的理想益生菌剂量为 10-10 CFU/g，因此，所有制剂至少必须含有所述数量的活菌才能显示治疗效果。益生菌制剂最重要的特点是，细菌容易受到几种环境和加工因素的影响，这些因素共同降低了最终制剂中细菌的存活率。这些因素包括加工参数，如温度、湿度、压力和储存条件。因此，本综述主要关注在稳定过程和制剂开发过程中影响益生菌活力的关键工艺参数。在加工前了解这些因素有助于在靶部位以所需的治疗数量输送益生菌。
