Along the Process Chain to Probiotic Tablets: Evaluation of Mechanical Impacts on Microbial Viability

压片 微晶纤维素 低温保护剂 乳糖 食品科学 益生菌 冷冻干燥 赋形剂 活力测定 保质期 材料科学 化学 纤维素 色谱法 细胞 细菌 生物 生物化学 低温保存 胚胎 细胞生物学 遗传学
作者
Karl Vorländer,Ingo Kampen,Jan Henrik Finke,Arno Kwade
出处
期刊:Pharmaceutics [MDPI AG]
卷期号:12 (1): 66-66 被引量:22
标识
DOI:10.3390/pharmaceutics12010066
摘要

Today, probiotics are predominantly used in liquid or semi-solid functionalized foods, showing a rapid loss of cell viability. Due to the increasing spread of antibiotic resistance, probiotics are promising in pharmaceutical development because of their antimicrobial effects. This increases the formulation requirements, e.g., the need for an enhanced shelf life that is achieved by drying, mainly by lyophilization. For oral administration, the process chain for production of tablets containing microorganisms is of high interest and, thus, was investigated in this study. Lyophilization as an initial process step showed low cell survival of only 12.8%. However, the addition of cryoprotectants enabled survival rates up to 42.9%. Subsequently, the dried cells were gently milled. This powder was tableted directly or after mixing with excipients microcrystalline cellulose, dicalcium phosphate or lactose. Survival rates during tableting varied between 1.4% and 24.1%, depending on the formulation and the applied compaction stress. More detailed analysis of the tablet properties showed advantages of excipients in respect of cell survival and tablet mechanical strength. Maximum overall survival rate along the complete manufacturing process was >5%, enabling doses of 6 × 10 8 colony forming units per gram ( CFU g total − 1 ), including cryoprotectants and excipients.

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