Pasquali Irene, Comi Lidia, Pucciarelli Francesca, Bettini Ruggero
Department of Pharmacy, University of Parma, Viale G. P. Usberti 27/A, 43100 Parma, Italy.
Int J Pharm. 2008 May 22;356(1-2):76-81. doi: 10.1016/j.ijpharm.2007.12.048. Epub 2008 Jan 17.
The knowledge of the solubility of PEG 1500 as well as the swelling and melting point variation in supercritical CO(2) in a relatively high-pressure range is a necessary prerequisite to set-up pharmaceutical processes dealing with the polymer in the molten state. Experiments carried out in a pressurized view cell indicated that the PEG 1500 progressively decreases its melting point and increases its volume as a consequence of the absorption of the CO(2). The melting point depression was pronounced (from 46 to 28 degrees C) up to 8.7 MPa. Thereafter a constant value was attained. Analogously, under CO(2) the polymer increased its volume (about 34%) until 10 MPa; after this pressure, the polymer volume no longer increased. PEG 1500 showed solubility in SC-CO(2) at 35 and 55 degrees C in the 10-40 MPa range in the order of 10(-6)mole fraction. An empirical model based on solubility parameters was used to fit the experimental data and to predict the maximum concentration achievable by the polymer in the dense gas, as well as to quantify the polymer concentration at low pressures where the experimental determination may be extremely difficult.
了解聚乙二醇1500(PEG 1500)在相对高压范围内于超临界CO₂中的溶解度以及其溶胀和熔点变化,是建立处理处于熔融状态聚合物的制药工艺的必要前提。在加压视窗池中进行的实验表明,由于吸收了CO₂,PEG 1500的熔点逐渐降低,体积逐渐增大。在高达8.7 MPa时,熔点降低显著(从46℃降至28℃)。此后达到恒定值。类似地,在CO₂作用下,聚合物体积增加(约34%)直至10 MPa;在此压力之后,聚合物体积不再增加。PEG 1500在35℃和55℃、10 - 40 MPa范围内于超临界CO₂中的溶解度约为10⁻⁶摩尔分数。基于溶解度参数的经验模型用于拟合实验数据,预测聚合物在致密气体中可达到的最大浓度,以及量化在实验测定可能极其困难的低压下的聚合物浓度。