SBIR Phase I: Delivering living probiotic cells in topical skin application

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是扩展先进的封装技术，使新的生物治疗在皮肤上成功交付。研究已经证明了将活的益生菌直接应用于皮肤的有益效果，并且在局部面霜中提供活的益生菌的需求正在出现。然而，生物制剂的应用目前受到限制，因为其在生产、运输、储存过程中的失活/分解带来了挑战，这往往导致低递送效率和产品类型的限制。此外，目前的含生物制品往往保质期短，冷藏成本高。该项目将创建一个强大的封装平台，为局部皮肤配方提供具有长期储存能力的活益生菌，同时为未来的生物相关应用提供关键方法。该项目将使新的生物治疗应用成为可能。该SBIR一期项目旨在利用微胶囊技术开发解决方案，以延长复杂水油皮配方中益生菌的存活时间。多项研究证实了活性益生菌对皮肤健康的有利作用；然而，局部益生菌产品的开发仍然是一个巨大的挑战，因为益生菌必须在长期储存期间保持活性和活力。为了减轻这些挑战，该提案将重点放在完整性增强的微结构上，这种微结构可以在高度湿润的环境中包裹、固定和维持活的益生菌细胞。将开发不同类型的富含益生菌的皮肤保湿剂配方，并研究益生菌在加速储存条件下的活力和稳定性。具体而言，本项目将通过对以下方面进行详细分析，提高益生菌在护肤品配方中的稳定性和活力：(1)包装益生菌的工艺参数和操作温度；(2)使用合适的益生菌友好成分开发配方；(3)微胶囊微结构稳定性和益生菌相容性；(4)不同pH和温度条件下的益生菌存活率；(5)益生菌与抗菌药物的相互作用；(6)制剂中益生菌的释放和输送。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to extend advanced encapsulation technologies to allow successful delivery of new biological treatments on the skin. Research has proven the beneficial effects of applying living probiotics directly to skin, and there are emerging needs to deliver such probiotics alive in topical creams. However, applications of biologics are currently limited because of the challenges associated with its inactivation/decomposition during production, transport, storage, which often lead to low delivery efficacy and constraints in product type. Additionally, current biologic-containing products often have short shelf-life and high refrigeration cost. This project will create a robust encapsulation platform tailored toward delivering living probiotics in topical skin formulations featuring long storage capabilities, while providing critical methods for prospective biologic-related applications. This project will enable novel biologic therapeutic applications.This SBIR Phase I project proposes to develop solutions to prolong probiotics’ survival in complex water-oil skin formulations utilizing microencapsulation technology. Multiple studies have validated the advantageous effect of active probiotics for skin health; however, development of topical probiotic products remains a great challenge as the probiotics must remain active and viable within formulations during long storage periods. To mitigate such challenges, this proposal will focus on integrity-enhanced microstructures that can encase, immobilize and sustain living-probiotic cells in a highly moisturized environment. Different types of probiotic-enriched skin moisturizer formulations will be developed, and the viability and stability of probiotics will be studied under accelerated storage conditions. Specifically, this project will improve the stability and viability of probiotics in skincare formulations by carrying out detailed analysis on: (1) the processing parameters and operating temperatures to encase probiotics; (2) developing formulations using suitable probiotic-friendly ingredients; (3) the stabilities of the microencapsulation microstructures and probiotic compatibility; (4) probiotic viabilities stored under different pH and temperature conditions; (5) probiotics’ interaction with antimicrobial agents; and (6) the release and delivery of probiotics from the formulation.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.