Stability and self-nanoemulsification efficiency of ramipril nanoemulsion containing labrasol and plurol oleique
Stability and self-nanoemulsification efficiency of ramipril nanoemulsion containing labrasol and plurol oleique
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DOI：
10.3109/10601330903571691
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发表时间：
2010-02
期刊：
影响因子：
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通讯作者：
S. Shafiq;F. Shakeel
中科院分区：
文献类型：
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作者：
S. Shafiq;F. Shakeel
本研究的目的是评估Labrasol和Plurol oleique作为表面活性剂和助表面活性剂的组合对枝状纳米乳液的自纳米乳化效率的能力。选择Sefsol-218、Labrasol、Plurol oleique和标准缓冲溶液（pH 5.0）分别作为油相、表面活性剂、助表面活性剂和水相。采用自发乳化法制备了雷米普利纳米乳。构建了拟三元相图，以确定纳米乳液区。采用离心、加热-冷却循环和冻融强制降解试验对选定制剂进行热力学稳定性试验评价。在热力学稳定性测试中，发现一些制剂稳定，而其他制剂不稳定。采用热力学稳定的制剂进行自纳米乳化效率测试。所有选定的制剂仅在E级通过自纳米乳化试验，但在A级和B级中未通过。由于A级和B级制剂均未通过自纳米乳化效率测试，因此得出结论，Labrasol和Plurol的组合分别不适合作为表面活性剂和助表面活性剂用于口服或自纳米乳化的雷米普利药物递送系统。
The aim of the present investigations was to evaluate the capacity of a combination of Labrasol and Plurol oleique as surfactant and cosurfactant on self-nanoemulsification efficiency of ramipril nanoemulsion. Sefsol-218, Labrasol, Plurol oleique, and standard buffer solution (pH 5.0) were selected as oil phase, surfactant, cosurfactant, and aqueous phase, respectively. Nanoemulsion formulations of ramipril were developed by a spontaneous emulsification method. Pseudoternary phase diagrams were constructed to identify nanoemulsion zones of ramipril. Selected formulations were evaluated in terms of thermodynamic stability tests using centrifugation, heating–cooling cycles, and freeze–thaw stress test. Some formulations were found stable and other formulations were unstable upon thermodynamic stability tests. Thermodynamically stable formulations were taken for self-nanoemulsification efficiency test. All the selected formulations passed self-nanoemulsification test in grade E only but not in grades A and B. Because none of the formulations passed the self-nanoemulsification efficiency test in grades A and B, it was concluded that a combination of Labrasol and Plurol is not suitable as surfactant and cosurfactant, respectively, for oral or self-nanoemulsifying drug delivery system of ramipril.