Rider J N, Brunson E L, Chambliss W G, Cleary R W, Hikal A H, Rider P H, Walker L A, Wyandt C M, Jones A B
Department of Pharmaceutics, University of Mississippi, University 38677.
Pharm Res. 1992 Feb;9(2):255-9. doi: 10.1023/a:1018901826635.
A novel dissolution apparatus was developed for medicated chewing gum products. A prototype gum product containing phenylpropanolamine hydrochloride (PPA) was used to evaluate the apparatus. The apparatus consists of a conical Teflon base and a rotating, ribbed Teflon plunger suspended in a dissolution vessel. Parameters evaluated were rotation speed, plunger frequency, medium volume, medium type, medium sampling location, number of plunger ribs, and number of gum pieces. Samples were taken over a 20-min period and samples were analyzed by HPLC. Cumulative percentage released-versus-time profiles were obtained for each parameter evaluated. Statistical analysis of the gum product indicated that the only significant differences occurred at the lowest rotation speed and lowest plunger frequencies. A Level A correlation was found between the in vitro release profile for the 20-rpm and 30-cycles/min plunger frequency and the in vivo chew-out study.
一种用于含药口香糖产品的新型溶出装置被研发出来。一种含盐酸苯丙醇胺（PPA）的原型口香糖产品被用于评估该装置。该装置由一个圆锥形聚四氟乙烯底座和一个悬浮在溶出容器中的旋转带肋聚四氟乙烯柱塞组成。评估的参数有转速、柱塞频率、介质体积、介质类型、介质取样位置、柱塞肋的数量和口香糖片的数量。在20分钟内取样，样品通过高效液相色谱法进行分析。针对每个评估参数获得了累积释放百分比与时间的曲线。口香糖产品的统计分析表明，唯一显著的差异出现在最低转速和最低柱塞频率下。在20转/分钟和30次/分钟柱塞频率的体外释放曲线与体内咀嚼研究之间发现了A级相关性。
