Vitetta Luis, Zhou Joyce, Manuel Rachel, Dal Forno Serena, Hall Sean, Rutolo David
Sydney Medical School, The University of Sydney, Sydney 2006, Australia.
Medlab Clinical, Sydney 2015, Australia.
J Funct Biomater. 2018 Jan 21;9(1):12. doi: 10.3390/jfb9010012.
The administration of biological compounds that optimize health benefits is an ever-evolving therapeutic goal. Pharmaceutical and other adjunctive biological compounds have been administered via many different routes in order to produce a systemic pharmacological effect. The article summarizes the findings from an Australian comparative study in adults administered vitamin B through different oral delivery platforms. A total of 16 subjects (9 males, 7 females) voluntarily partook in a comparative clinical study of five different vitamin B formulations across a six-month period, completing 474 person-hours of cumulative contribution, that was equivalent to an = 60 participation. A nanoparticle delivered vitamin B through a NanoCelle platform was observed to be significantly ( < 0.05) better absorbed than all other dose equivalent platforms (i.e., tablets, emulsions, or liposomes) from baseline to 1, 3, and 6 h of the study period. The nanoparticle platform delivered vitamin B demonstrated an enhanced and significant absorption profile as exemplified by rapid systemic detection (i.e., 1 h from baseline) when administered to the oro-buccal mucosa with no reports of any adverse events of toxicity. The nanoparticle formulation of methylcobalamin (1000 µg/dose in 0.3 mL volume) showed bioequivalence only with a chewable-dissolvable tablet that administered a five times higher dose of methylcobalamin (5000 µg) per tablet. This study has demonstrated that an active metabolite embedded in a functional biomaterial (NanoCelle) may constitute a drug delivery method that can better access the circulatory system.
施用能优化健康效益的生物化合物是一个不断发展的治疗目标。药物及其他辅助性生物化合物已通过多种不同途径给药,以产生全身药理作用。本文总结了一项澳大利亚针对成年人通过不同口服给药平台施用维生素B的比较研究结果。共有16名受试者(9名男性,7名女性)自愿参与了一项为期六个月的针对五种不同维生素B制剂的比较临床研究,累计贡献了474人时,相当于60次参与。在研究期的基线至1小时、3小时和6小时,观察到通过纳米细胞平台递送维生素B的纳米颗粒比所有其他等效剂量平台(即片剂、乳剂或脂质体)的吸收效果显著更好(P<0.05)。递送维生素B的纳米颗粒平台表现出增强且显著的吸收特性,例如口服给药至口腔颊黏膜时能快速进行全身检测(即基线后1小时),且未报告任何毒性不良事件。甲钴胺纳米颗粒制剂(每剂量1000μg,体积0.3mL)仅与每片施用五倍高剂量甲钴胺(5000μg)的咀嚼可溶片表现出生物等效性。这项研究表明,嵌入功能性生物材料(纳米细胞)中的活性代谢物可能构成一种能更好进入循环系统的药物递送方法。