Kunrath Marcel F, Shah Furqan A, Dahlin Christer
Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, P.O. Box 412, SE 405 30, Göteborg, Sweden.
Department of Dentistry, School of Health and Life Sciences, Pontifical Catholic University of Rio Grande Do Sul (PUCRS), Porto Alegre, Brazil.
Mater Today Bio. 2022 Dec 30;18:100540. doi: 10.1016/j.mtbio.2022.100540. eCollection 2023 Feb.
Nanotechnology and drug-release biomaterials have been thoroughly explored in the last few years aiming to develop specialized clinical treatments. However, it is rare to find biomaterials associated with drug delivery properties in the current dental market for application in oral bone- and periodontal-related procedures. The gap between basic scientific evidence and translation to a commercial product remains wide. Several challenges have been reported regarding the clinical translation of biomaterials with drug-delivery systems (BDDS) and nanofeatures. Therefore, processes for BDDS development, application in preclinical models, drug delivery doses, sterilization processes, storage protocols and approval requirements were explored in this review, associated with tentative solutions for these issues. The diversity of techniques and compounds/molecules applied to develop BDDS demands a case-by-case approach to manufacturing and validating a commercial biomaterial. Promising outcomes such as accelerated tissue healing and higher antibacterial response have been shown through basic and preclinical studies using BDDS and nano-engineered biomaterials; however, the adequate process for sterilization, storage, cost-effectiveness and possible cytotoxic effects remains unclear for multifunctional biomaterials incorporated with different chemical compounds; then BDDSs are rarely translated into products. The future benefits of BDDS and nano-engineered biomaterials have been reported suggesting personalized clinical treatment and a promising reduction in the use of systemic antibiotics. Finally, the launch of these specialized biomaterials with solid data and controlled traceability onto the market will generate strong specificity for healthcare treatments.
在过去几年中，人们对纳米技术和药物释放生物材料进行了深入研究，旨在开发专门的临床治疗方法。然而，在当前牙科市场中，用于口腔骨和牙周相关手术的具有药物递送特性的生物材料却很少见。基础科学证据与转化为商业产品之间的差距仍然很大。关于具有药物递送系统（BDDS）和纳米特征的生物材料的临床转化，已经报道了几个挑战。因此，本综述探讨了BDDS的开发过程、在临床前模型中的应用、药物递送剂量、灭菌过程、储存方案和批准要求，并针对这些问题提出了初步解决方案。用于开发BDDS的技术和化合物/分子的多样性要求在制造和验证商业生物材料时采用逐案处理的方法。通过使用BDDS和纳米工程生物材料的基础研究和临床前研究，已经显示出加速组织愈合和更高抗菌反应等有前景的结果；然而，对于含有不同化合物的多功能生物材料，适当的灭菌、储存、成本效益和可能的细胞毒性作用过程仍不清楚；因此，BDDS很少转化为产品。已经报道了BDDS和纳米工程生物材料的未来益处，表明个性化临床治疗以及有望减少全身抗生素的使用。最后，将这些具有可靠数据和可控可追溯性的专门生物材料推向市场，将为医疗保健治疗带来强大的特异性。
