Department of Pharmaceutics, Faculty of Pharmacy, Universiti Teknologi MARA, Cawangan Selangor, 42300 Puncak Alam, Malaysia.
Curr Drug Deliv. 2019;16(7):672-686. doi: 10.2174/1567201816666190620110748.
In this study, four nanoparticle formulations (F1 to F4) comprising varying ratios of alginate, Pluronic F-68 and calcium chloride with a constant amount of insulin and chitosan as a coating material were prepared using polyelectrolyte complexation and ionotropic gelation methods to protect insulin against enzymatic degradation.
This study describes the formulation design, optimisation, characterisation and evaluation of insulin concentration via oral delivery in rats. A reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated to quantify insulin concentration in rat plasma. The proposed method produced a linear response over the concentration range of 0.39 to 50 µg/ml.
In vitro release study showed that dissolution of insulin in simulated gastric juice of pH 1.2 was prevented by alginate core and chitosan coating but rapidly released in simulated intestinal fluid (pH 6.8). Additionally, Formulation 3 (F3) has a particle size of 340.40 ± 2.39 nm with narrow uniformity exhibiting encapsulation efficiency (EE) of 72.78 ± 1.25 % produced highest absorption profile of insulin with a bioavailability of 40.23 ±1.29% and reduced blood glucose after its oral administration in rats.
In conclusion, insulin oral delivery system containing alginate and chitosan as a coating material has the ability to protect the insulin from enzymatic degradation thus enhance its absorption in the intestine. However, more work should be done for instance to involve human study to materialise this delivery system for human use.
在这项研究中,使用聚电解质络合和离子凝胶化方法制备了四种包含不同比例海藻酸钠、泊洛沙姆 F-68 和氯化钙的纳米颗粒制剂(F1 至 F4),并使用恒定量的胰岛素和壳聚糖作为包衣材料,以保护胰岛素免受酶降解。
本研究描述了通过口服途径在大鼠体内递送胰岛素的配方设计、优化、表征和评价。开发并验证了反相高效液相色谱(HPLC)方法来定量大鼠血浆中的胰岛素浓度。该方法在 0.39 至 50μg/ml 的浓度范围内产生线性响应。
体外释放研究表明,海藻酸钠核心和壳聚糖涂层阻止了胰岛素在 pH 1.2 的模拟胃液中的溶解,但在模拟肠液(pH 6.8)中迅速释放。此外,制剂 3(F3)的粒径为 340.40±2.39nm,具有窄的均匀性,包封效率(EE)为 72.78±1.25%,在大鼠口服后表现出最高的胰岛素吸收曲线,生物利用度为 40.23±1.29%,并降低了血糖。
总之,含有海藻酸钠和壳聚糖作为包衣材料的胰岛素口服递送系统能够保护胰岛素免受酶的降解,从而增强其在肠道中的吸收。然而,还需要做更多的工作,例如进行人体研究,将这种递送系统应用于人体。