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首页> 外文期刊>European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fuer Pharmazeutische Verfahrenstechnik e.V >Spray-drying enteric polymers from aqueous solutions: a novel, economic, and environmentally friendly approach to produce pH-responsive microparticles.
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Spray-drying enteric polymers from aqueous solutions: a novel, economic, and environmentally friendly approach to produce pH-responsive microparticles.

机译：从水溶液中喷雾干燥肠溶性聚合物：生产pH响应性微粒的新颖，经济，环保的方法。

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We describe a novel method to fabricate pH-responsive microparticles suitable for oral delivery using an aqueous-based spray-drying approach. The approach involves the neutralization and generation of water-soluble salt forms of enteric polymers. The methacrylic acid polymers (Eudragit L and Eudragit S) were added separately to aqueous solutions of ammonium hydrogen carbonate; the solutions were then spray-dried. FTIR analysis of the harvested microparticle products identified the presence of ammonium methacrylate with the appearance of a peak at 1550 cm(-1) corresponding to the stretching of the N-H bond. Incubating the microparticles for three hours at 70 degrees C and 130 degrees C for the Eudragit S and L products, respectively, was sufficient to eradicate the ammonium residues. The microparticles, loaded with the model drug prednisolone, were spherical and small in size (2-5 mum). Moreover, the particles were gastro-resistant, and release was rapid and complete at small intestinal conditions. The pH threshold of release of the Eudragit S and Eudragit L microparticles was lowered from 7 and 6 to 6.5 and 5.5, respectively. In bicarbonate media, which are physiological and representative of the conditions of the proximal small intestine (mHanks) and the distal small intestine (Kreb's), drug release from these spray-dried microparticles was faster compared to microparticles produced from conventional emulsion solvent evaporation methods. This new microparticle preparation concept obviates the need for organic solvents and utilizes spray-drying techniques that are amenable to industrial application; the approach therefore offers economic, safety, and environmental benefits.
机译：我们描述了一种新颖的方法来制造适合pH响应的微粒，适合使用基于水的喷雾干燥方法进行口服给药。该方法涉及中和和产生肠溶性聚合物的水溶性盐形式。将甲基丙烯酸聚合物（Eudragit L和Eudragit S）分别添加到碳酸氢铵水溶液中;然后将溶液喷雾干燥。收获的微粒产品的FTIR分析确定了甲基丙烯酸铵的存在，在1550 cm（-1）处出现一个峰，对应于N-H键的拉伸。将微米级的Eudragit S和L产物分别在70°C和130°C下孵育三个小时，足以消除铵残留物。装有模型药物泼尼松龙的微粒是球形的，尺寸很小（2-5微米）。而且，该颗粒具有抗胃性，并且在小肠条件下释放迅速且完全。 Eudragit S和Eudragit L微粒释放的pH阈值分别从7和6降低到6.5和5.5。在碳酸氢盐介质中，这些介质是生理性的，代表了近端小肠（mHanks）和远端小肠（Kreb's）的状况，与传统乳液溶剂蒸发方法制得的微粒相比，这些喷雾干燥微粒的药物释放速度更快。这种新的微粒制备概念消除了对有机溶剂的需求，并采用了适合工业应用的喷雾干燥技术。因此，该方法具有经济，安全和环境效益。

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