DRY-POWDER OF CHITOSAN-COATED LIPID-CORE NANOCAPSULES CONTAINING DAPSONE: DEVELOPMENT, LASER DIFFRACTION CHARACTERIZATION AND ANALYTICAL QUANTIFICATION

R. Cé, D. S. Jornada, J. G. D. Marchi, S. Guterres, A. Pohlmann
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Abstract

Analytical techniques are critical for ensuring physical and chemical stability of a drug both for assessing the stability of drug molecules and for quantifying and identifying the drug content in products. We proposed the development of dry-powders of lipid-core nanocapsules containing dapsone and coated with chitosan, as well as, the analytical quantification of dapsone in dry-powders with 1% and 2% (m/v) of leucine by high-performance liquid chromatography (HPLC). Size is the most relevant physicochemical property of nanoparticulated drug delivery systems. In this context, our results demonstrated that during the powders redispersion in water, could be observed that the mean particle diameters (DAP-LNC-CS-L1 and DAP-LNC-CS-L2) decreased with redispersion times increase. The spray-drying of the lipid-core nanocapsule formulations showed yields ranging from 58 ± 1.0 % (DAP-LNC-CS-L1) to 61 ± 1.5 % (DAP-LNC-CS-L2) indicating an efficient drying process. In this context, the analytical quantifications of dapsone in the dry powders of nanocapsules by HPLC showed that the dapsone content ranged from 92 ± 1.4% (DAP-LNC-CS-L2) to 95 ± 0.8% (DAP-LNC-CS-L1). Can be concluded that spray-drying process of DAP-LNC-CS-L1 and DAP-LNC-CS-L2 formulations showed an efficient aqueous dispersion of nanocapsule powders and the analytical quantification of dapsone in spray-dryed powders were higher than 90%.
壳聚糖包被含氨苯砜脂核纳米胶囊的干粉制备、激光衍射表征及分析定量
分析技术对于确保药物的物理和化学稳定性至关重要,既可以评估药物分子的稳定性,也可以定量和鉴定产品中的药物含量。研究了壳聚糖包被脂核纳米胶囊干粉的制备方法,并采用高效液相色谱法(HPLC)对1%和2% (m/v)亮氨酸干粉中氨苯砜的含量进行了定量分析。尺寸是纳米关节给药系统最相关的物理化学性质。在此背景下,我们的研究结果表明,粉末在水中再分散时,可以观察到随着再分散次数的增加,平均粒径(DAP-LNC-CS-L1和DAP-LNC-CS-L2)减小。脂核纳米胶囊的喷雾干燥收率为58±1.0% (DAP-LNC-CS-L1)至61±1.5% (DAP-LNC-CS-L2),表明喷雾干燥工艺有效。在此背景下,采用高效液相色谱法对纳米胶囊干粉中氨苯砜的含量进行定量分析,其含量范围为92±1.4% (DAP-LNC-CS-L2) ~ 95±0.8% (DAP-LNC-CS-L1)。综上所述,DAP-LNC-CS-L1和DAP-LNC-CS-L2的喷雾干燥工艺均能有效分散纳米胶囊粉末,喷雾干燥粉末中氨苯砜的分析定量均大于90%。
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