El Maghraby Gamal M, Ahmed Amal A, Osman Mohamed A
Int J Pharm Compd. 2015 Mar-Apr;19(2):152-60.
Nisoldipine is used for the treatment of hypertension and angina pectoris. However, it has very low bioavailabil-ty, which is attributed to extensive pre-systemic metabolism. In addition, nisol-ipine is highly potent (used at a low dose). Taking into consideration the fact that transdermal delivery avoids the pre-systemic metabolism and is only suit-ble for potent drugs, nisoldipine can be considered as an excellent candidate for transdermal delivery. Accordingly, the purpose of this study was to optimize nisoldipine transdermal delivery. That was achieved initially by investigating the effect of vehicles on skin penetration. The tested vehicles were ranked with respect to transdermal flux of nisoldipine as isopropyl myristate > oleic acid > propylene glycol > water > polyethylene glycol 400. A combination of oleic acid with propylene glycol was synergistic with a ratio of 1:2 w/w being the best. These results were taken further to develop microemulsion systems using either oleic acid or isopropyl myristate as the oil phase. Both cases employed polyoxy-thylene sorbitan monooleate as a surfactant with propylene glycol being uti-ized as a cosurfactant in the case of oleic acid and ethanol in the case of isopropyl myristate. The developed microemulsions produced significant enhancement in nisoldipine transdermal delivery with the flux being even greater than that obtained from the corresponding pure vehicles. This achieve-ent was recorded in optimum microemulsion formulations which contained a cosurfactant. The study provided stepwise optimization of a vehicle for trans-ermal delivery of nisoldipine.
尼索地平用于治疗高血压和心绞痛。然而,它的生物利用度非常低,这归因于广泛的首过代谢。此外,尼索地平效力很强(使用低剂量)。考虑到经皮给药可避免首过代谢且仅适用于强效药物,尼索地平可被视为经皮给药的理想候选药物。因此,本研究的目的是优化尼索地平的经皮给药。这最初是通过研究载体对皮肤渗透的影响来实现的。所测试的载体按照尼索地平的经皮通量排序为:肉豆蔻酸异丙酯>油酸>丙二醇>水>聚乙二醇400。油酸与丙二醇以1:2 w/w的比例组合具有协同作用,此比例最佳。进一步利用这些结果开发了以油酸或肉豆蔻酸异丙酯为油相的微乳体系。两种情况下均使用聚氧乙烯山梨醇酐单油酸酯作为表面活性剂,在以油酸为油相时使用丙二醇作为助表面活性剂,在以肉豆蔻酸异丙酯为油相时使用乙醇作为助表面活性剂。所开发的微乳显著提高了尼索地平的经皮给药量,通量甚至大于相应纯载体的通量。这一成果在含有助表面活性剂的最佳微乳制剂中得以体现。该研究为尼索地平经皮给药的载体提供了逐步优化。