含有维生素D3的水包油乳液的喷雾干燥:配方和工艺条件之间的协同作用,以获得微粒。

IF 6 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics Pub Date : 2025-03-30 Epub Date: 2025-02-20 DOI:10.1016/j.ijpharm.2025.125384
Giada Diana , Andrea Milanesi , Alessandro Candiani , Alessandro Sodano , Paolo Rassè , Andrea Foglio Bonda , Laura Alessandroni , Lorella Giovannelli , Lorena Segale , Jean Daniel Coïsson
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引用次数: 0

摘要

喷雾干燥是将水乳状液中的油转化为固体微粒的一种实用方法。在这项工作中,进行了配方研究,以确定维生素D3负载水包油乳液的最佳组成,并通过实验室规模的喷雾干燥机进行加工。乳液由维生素D3油溶液(7 % w/w)、麦芽糖糊精(21 % w/w)、阿拉伯胶(9 % w/w)和豌豆蛋白水解液(1 % w/w)水溶液组成,稳定性最佳(> 24 h)。喷雾干燥过程(锡:160 ℃;宣传:94 °C;气体雾化:1.75 bar;加料速度:8.75 g/min)是成功的,工艺收率好,得到的粉末具有可接受的残留湿度。微颗粒平均直径为23 µm,粒径分布较宽。油和维生素D3的回收率分别为预期的85.69 ± 3.91 %和80.10 ± 9.94 %。加速稳定性和光稳定性研究结果表明,储存后的粉末中维生素D3的含量是相同条件下储存油溶液中维生素D3的两倍。此外,从实验室规模扩大到中试规模的喷雾干燥机是令人鼓舞的。无论顶部还是底部喷雾设置,中试规模处理都提高了生产率并提高了干燥效率。顶部喷雾配置和较低的入口温度保证了产率超过86% %,粉末中残留湿度约为3 %,并保持了油质,保持了与初始值相当的过氧化值。
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Spray drying of an oil-in-water emulsion containing vitamin D3: a synergy between formulation and process conditions to obtain microparticles
Spray drying is a practical solution to convert oil-in-water emulsion into solid microparticles. In this work, a formulation study was conducted to identify the best composition of vitamin D3-loaded oil-in-water emulsion to process via a lab-scale spray dryer. The emulsion was composed of vitamin D3 oily solution (7 % w/w) and maltodextrin (21 % w/w), arabic gum (9 % w/w) and pea protein hydrolysate (1 % w/w) aqueous solution and was characterized by optimal stability (> 24 h). The spray drying process (Tin: 160 °C; Tout: 94 °C; Gas atomization: 1.75 bar; Feeding rate: 8.75 g/min) was successful: the process yield was good, and the obtained powder had an acceptable residual humidity. The average diameter of microparticles was 23 µm with a quite wide particle size distribution. The oil and vitamin D3 recovered from the powder were 85.69 ± 3.91 % and 80.10 ± 9.94 % of the expected, respectively. The accelerated stability and photostability study results showed that the percentage of vitamin D3 present in the powder after storage was twice compared to vitamin D3 in oil solution stored at the same conditions. Moreover, the scale-up of the process from lab- to pilot-scale spray dryer was encouraging. Regardless of the top or bottom spray set-up, the pilot scale treatments increased the production rate and improved drying efficiency. The top spray configuration and a low inlet temperature guaranteed a yield of over 86 %, about 3 % residual humidity in the powder, and preserved the oil quality, maintaining a peroxide value comparable to the initial one.
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来源期刊
CiteScore
10.70
自引率
8.60%
发文量
951
审稿时长
72 days
期刊介绍: The International Journal of Pharmaceutics is the third most cited journal in the "Pharmacy & Pharmacology" category out of 366 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.
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