Formulation Science, Pharmaceutical Development, AstraZeneca, Macclesfield, UK.
Pharm Res. 2012 Jan;29(1):198-208. doi: 10.1007/s11095-011-0535-1. Epub 2011 Aug 11.
In order to achieve an improved understanding of disintegration and dissolution phenomena for an immediate release tablet formulation, a technique to monitor the number and size of particles entrained within the dissolution media was developed in combination with a population balancing model.
Tablets were first characterized for crushing force, disintegration time and dissolution performance using standard USP methodologies. The performance of the tablets was then assessed using a new measurement system which links a "QicPic" particle imaging device to a USP dissolution vessel. This system enables us to measure the number and size of particles generated during tablet dissolution. The population balance mathematical model allowed a tablet erosion rate to be manipulated to fit the experimental data.
Results showed that tablets with differing crushing forces showed different dissolution behaviors that could be explained by differing rates of particle release into the dissolution media. These behaviors were then successfully modeled to provide a description of the dissolution and disintegration behavior of the tablets in terms of a tablet erosion rate.
A new approach was developed that allowed the description of the dissolution behaviors of the tablets in terms of the rate that they release particles into solution. This was then successfully modeled in terms of a tablet erosion rate.
为了更好地理解速释片制剂的崩解和溶解现象，本研究结合群体平衡模型，开发了一种监测溶解介质中夹带颗粒数量和大小的技术。
首先使用标准 USP 方法对片剂的破碎力、崩解时间和溶解性能进行了表征。然后，使用一种新的测量系统对片剂的性能进行了评估，该系统将“QicPic”颗粒成像设备与 USP 溶解容器相连接。该系统能够测量片剂溶解过程中产生的颗粒数量和大小。群体平衡数学模型允许对片剂侵蚀率进行操作，以拟合实验数据。
结果表明，具有不同破碎力的片剂表现出不同的溶解行为，这些行为可以用不同的颗粒释放速率来解释。然后，这些行为成功地建模为片剂侵蚀率，以描述片剂的溶解和崩解行为。
开发了一种新的方法，可以根据片剂释放颗粒进入溶液的速率来描述片剂的溶解行为。然后，成功地以片剂侵蚀率为模型进行了描述。
