Department of Pharmacy, University of Salerno, via Giovanni Paolo II, 132, 84084 Fisciano, SA, Italy.
Department of Pharmacy, University of Salerno, via Giovanni Paolo II, 132, 84084 Fisciano, SA, Italy.
Carbohydr Polym. 2015 Nov 20;133:464-72. doi: 10.1016/j.carbpol.2015.07.064. Epub 2015 Jul 23.
The treatment of gastro-esophageal reflux disease (GERD) shows several issues among paediatric patients. This work aims to the formulation of enteric alginate beads loaded with omeprazole (OME) allowing age- and weight-related personalized dosages in children. OME was entrapped in SBA-15 mesoporous compound, characterized and loaded into alginate beads by prilling at different OME and alginate concentrations. The beads resulted of homogeneous size, spherical morphology and very consistent in drug loading and distribution. Formulations demonstrated limited swelling and release (about 10%) in simulated gastric fluid (SGF) after 2h and a prolonged release in simulated intestinal fluid (SIF), till 6h, due to a mixed diffusion-case II transport mechanism. The beads were superior to the market product, which showed lower release in SGF but immediate dissolution in SIF. The high alginate beads uniformity and release properties make them a potential novel tool for a personalized treatment of GERD in children.
胃食管反流病 (GERD) 的治疗在儿科患者中存在一些问题。本工作旨在开发载奥美拉唑 (OME) 的海藻酸钠珠粒的制剂，以实现儿童的个体化年龄和体重相关剂量。OME 被包埋在 SBA-15 介孔化合物中，并通过在不同 OME 和海藻酸钠浓度下进行造粒将其负载到海藻酸钠珠粒中。得到的珠粒粒径均匀，呈球形，药物负载和分布非常一致。在模拟胃液 (SGF) 中 2h 后，制剂的膨胀和释放（约 10%）有限，在模拟肠液 (SIF) 中释放时间延长至 6h，这归因于混合扩散-二级传输机制。这些珠粒优于市售产品，后者在 SGF 中的释放较低，但在 SIF 中立即溶解。高海藻酸钠珠粒的均匀性和释放特性使它们成为治疗儿童 GERD 的个性化治疗的一种有前途的新型工具。
