Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, CB3 0AS, Cambridge, UK.
Colorcon Ltd, Flagship House, Victory Way, Dartford DA2 6QD, UK.
Int J Pharm. 2023 Jan 5;630:122456. doi: 10.1016/j.ijpharm.2022.122456. Epub 2022 Nov 26.
Coated tablets introduce complexity to the dissolution process, even with readily soluble immediate release coating layers. Therefore, a more detailed understanding of the physical steps involved in the dissolution process can improve the efficiency of formulation and process design. The current study uses terahertz pulsed imaging to visualise the hydration process of microcrystalline cellulose (MCC) tablet cores that were film coated with an immediate release coating formulation upon exposure to the dissolution medium. Film coated tablets that were prepared from three levels of core porosity (10%, 20% and 30%) and with coating thickness in the range of 30μm to 250μm were investigated. It was possible to resolve and quantify the distinct stages of wetting of the coating layer, swelling of the MCC particles at the core surface, and dissolution of the coating layer followed by the ingress of dissolution media into the tablet core. The liquid transport process through the coating layer was highly consistent and scalable. The penetration rate through the coating layer and the tablet core both strongly depended on coating thickness and core porosity.
包衣片剂即使具有速释包衣层,也会给溶出过程带来复杂性。因此,更详细地了解溶出过程中涉及的物理步骤可以提高配方和工艺设计的效率。本研究使用太赫兹脉冲成像技术可视化了暴露于溶出介质后用速释包衣配方对微晶纤维素(MCC)片剂芯进行薄膜包衣的水合过程。研究了三种芯孔隙率(10%、20%和 30%)和 30μm 至 250μm 范围内的包衣厚度制备的包衣片剂。可以分辨和量化包衣层的润湿、芯表面 MCC 颗粒的溶胀以及包衣层的溶解,随后溶出介质进入片剂芯的不同阶段。通过包衣层的液体传输过程非常一致且可扩展。通过包衣层和片剂芯的穿透速率都强烈取决于包衣厚度和芯孔隙率。