Barrett-Catton Emma, Arrigali Elizabeth M, Serban Bogdan A, Sandau Kolton C, Serban Monica A
Department of Biomedical and Pharmaceutical Sciences, University of Montana, Missoula, MT 59812, USA.
Montana Biotechnology Center (BIOTECH), University of Montana, Missoula, MT 59812, USA.
Pharmaceutics. 2024 Oct 29;16(11):1392. doi: 10.3390/pharmaceutics16111392.
This study assessed the effects of formulation components on the long-term stability of a previously described tetraethyl orthosilicate-based drug delivery system. Early stability studies of a product concept are crucial not only to provide information on the overall system stability and individual components' contributions to it, but also to identify opportunities for dosage form optimization and to define its use case. We assessed the time-dependent thixogel properties-specifically, mechanical strength, thixotropy, release of model drug, and dry substance-in both real-time and accelerated shelf-life determination set-ups. Our findings indicate that the concentration and molecular weight of hyaluronic acid, one of the main constituents of the investigated thixotropic systems, are key determinants of formulation stability. We further showed that changes in both of these parameters reflect on the drug release properties and stiffness of the formulation and could inform subsequent product development based on several use cases. Overall, this study provides an understanding of some key factors that would need to be considered prior to and in the final product development process of thixogels in preparation for commercialization.
本研究评估了制剂成分对先前描述的基于原硅酸四乙酯的药物递送系统长期稳定性的影响。产品概念的早期稳定性研究至关重要，不仅能提供有关整个系统稳定性以及各个成分对其贡献的信息，还能识别剂型优化的机会并确定其使用场景。我们在实时和加速保质期测定设置中评估了随时间变化的触变凝胶特性，具体包括机械强度、触变性、模型药物释放以及干物质。我们的研究结果表明，所研究的触变系统的主要成分之一透明质酸的浓度和分子量是制剂稳定性的关键决定因素。我们进一步表明，这两个参数的变化会反映在制剂的药物释放特性和硬度上，并可为基于多种使用场景的后续产品开发提供参考。总体而言，本研究有助于了解在触变凝胶商业化准备的最终产品开发过程之前及过程中需要考虑的一些关键因素。
