School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland.
Int J Pharm. 2011 Dec 12;421(1):99-109. doi: 10.1016/j.ijpharm.2011.09.021. Epub 2011 Sep 21.
The present study investigated the effect of operating parameters of a laboratory spray dryer on powder characteristics, in order to optimise the production of trehalose and raffinose powders, intended to be used as carriers of biomolecules for inhalation. The sugars were spray dried from 80:20 methanol:n-butyl acetate (v/v) solutions using a Büchi Mini Spray dryer B-290. A 2(4) factorial design of experiment (DOE) was undertaken. Process parameters studied were inlet temperature, gas flow rate, feed solution flow rate (pump setting) and feed concentration. Resulting powders where characterised in terms of yield, particle size (PS), residual solvent content (RSC) and outlet temperature. An additional outcome evaluated was the specific surface area (SSA) (by BET gas adsorption), and a relation between SSA and the in vitro deposition of the sugar NPMPs powders was also investigated. The DOE resulted in well fitted models. The most significant factors affecting the characteristics of the NPMPs prepared, at a 95% confidence interval, were gas flow: yield, PS and SSA; pump setting: yield; inlet temperature: RSC. Raffinose NPMPs presented better characteristics than trehalose NPMPs in terms of their use for inhalation, since particles with larger surface area resulting in higher fine particle fraction can be produced.
本研究考察了实验室喷雾干燥器的操作参数对粉末特性的影响，目的是优化海藻糖和棉子糖粉末的生产，这些粉末拟用作吸入用生物分子的载体。将糖从 80:20 的甲醇/正丁基醋酸酯（体积比）溶液中用 Büchi Mini Spray dryer B-290 喷雾干燥。采用 2(4) 因子设计实验（DOE）。研究的工艺参数为入口温度、气体流速、进料溶液流速（泵设定）和进料浓度。所得粉末的特性为产率、粒径（PS）、残留溶剂含量（RSC）和出口温度。还评估了比表面积（SSA）（通过 BET 气体吸附）这一额外结果，并研究了 SSA 与糖纳米颗粒（NPMPs）粉末体外沉积之间的关系。DOE 得到了拟合良好的模型。在 95%置信区间内，对所制备的 NPMPs 特性有显著影响的因素是：气体流速：产率、PS 和 SSA；泵设定：产率；入口温度：RSC。与海藻糖 NPMPs 相比，棉子糖 NPMPs 在吸入方面具有更好的特性，因为可以生产出具有更大表面积的颗粒，从而产生更高的细颗粒分数。
