Healy A M, McCarthy L G, Gallagher K M, Corrigan O I
Department of Pharmaceutics and Pharmaceutical Technology, School of Pharmacy, Trinity College Dublin, Ireland.
J Pharm Pharmacol. 2002 Mar;54(3):441-4. doi: 10.1211/0022357021778529.
The aim of the present study was to determine the apparent diffusion boundary layer and dissolution rate constant for various surfaces of compacts and at various locations in the USP paddle dissolution apparatus. Benzoic acid compacts were coated with paraffin wax leaving only the surface under investigation free for dissolution. The dissolution rates for various surfaces at varying locations in the paddle dissolution vessel were determined from the slope of the dissolution profile (amount dissolved (mg) versus time (min)). The apparent diffusion boundary layer and dissolution rate constant were calculated and were found to vary depending on the surface of the compact from which dissolution took place and also on the location and size of the compact. It may be concluded that, in developing models to describe the dissolution from solid dosage forms, it is not accurate to assume constant hydrodynamics and mass transfer rates at all surfaces of the system, or in different locations within the test device. A more exact description of the hydrodynamics would be necessary in order to precisely model drug dissolution in the paddle dissolution apparatus.
本研究的目的是测定在USP桨法溶出度试验装置中,不同片芯表面以及不同位置处的表观扩散边界层和溶出速率常数。苯甲酸片芯用石蜡涂覆,仅使待研究的表面可用于溶出。通过溶出曲线的斜率(溶解量(mg)对时间(min))来测定桨法溶出容器中不同位置处不同表面的溶出速率。计算得出表观扩散边界层和溶出速率常数,发现其会因发生溶出的片芯表面以及片芯的位置和尺寸而有所不同。可以得出结论,在开发描述固体剂型溶出的模型时,假设系统所有表面或试验装置内不同位置处的流体动力学和传质速率恒定是不准确的。为了精确模拟桨法溶出试验装置中的药物溶出,需要对流体动力学进行更精确的描述。