Raza Kaisar, Shareef Mohammad Afroz, Singal Parteek, Sharma Gajanand, Negi Poonam, Katare Om Prakash
Division of Pharmaceutics, University Institute of Pharmaceutical Sciences, UGC-Centre of Advanced Study, Panjab University , Chandigarh , India .
J Liposome Res. 2014 Dec;24(4):290-6. doi: 10.3109/08982104.2014.911314. Epub 2014 Apr 25.
Capsaicin (CP), a recent FDA-approved drug for the topical treatment of neuropathic pain, is associated with several side effects like irritation, burning sensation, and erythema, resulting in poor patient compliance. The present study is an attempt to study the effect of CP encasement in nano-lipoidal carriers (NLCs) on skin-transport characteristics, in vivo pharmacological performance, skin compliance, and stability of the finished product. The study also compares two methods of NLC preparation, namely microemulsification and rotary-evaporation for various attributes. The results demonstrated that microemulsion technique produced smaller nanoparticles vis-à-vis the rotary-evaporation method. Out of the various studied solid lipids, NLCs from stearic acid offered smallest size and the highest negative zeta potential. The NLC-gel offered higher skin permeation and skin retention of CP across LACA mice skin as compared with the conventional cream. The analgesic effect was observed to be enhanced substantially than that of the conventional cream when tested on a radiant mouse tail-flick model. The most alarming problems of skin-irritation and redness were successfully taken care by NLC-gel while the mice group receiving conventional cream showed marked changes in the skin histopathology. Besides the enhanced efficacy and decreased skin-irritation, the developed CP-NLCs also found to be stable and rheologically accepted formulation for the treatment of pain-associated disorders.
辣椒素(CP)是美国食品药品监督管理局(FDA)最近批准用于局部治疗神经性疼痛的药物,它伴有多种副作用,如刺激、烧灼感和红斑,导致患者依从性差。本研究旨在探讨纳米脂质载体(NLCs)包裹CP对皮肤转运特性、体内药理性能、皮肤顺应性和成品稳定性的影响。该研究还比较了NLCs制备的两种方法,即微乳化法和旋转蒸发法的各种属性。结果表明,与旋转蒸发法相比,微乳化技术产生的纳米颗粒更小。在各种研究的固体脂质中,硬脂酸制成的NLCs粒径最小,zeta电位负值最高。与传统乳膏相比,NLC凝胶在LACA小鼠皮肤上对CP具有更高的皮肤渗透率和皮肤滞留率。在辐射小鼠甩尾模型上进行测试时,观察到其镇痛效果比传统乳膏显著增强。NLC凝胶成功解决了最令人担忧的皮肤刺激和发红问题,而接受传统乳膏的小鼠组皮肤组织病理学出现明显变化。除了增强疗效和减少皮肤刺激外,所研制的CP-NLCs还被发现是一种稳定且流变学上可接受的用于治疗疼痛相关疾病的制剂。