Abstract
Objective: The purpose of the present investigation was to develop and optimize nitrendipine loaded niosomal gel for transdermal delivery using quality by design approach.
 Methods: Niosomal formulations were developed by application of the thin-film hydration method using different ratios of span 60, cholesterol, temperature, and optimized by three factors-three levels Box-Behnken statistical design. The independent variables were non-ionic surfactant, cholesterol, and temperature, while vesicle size, polydispersity index, and entrapment efficiency were dependent variables. The nitrendipine loaded optimized formulation was incorporated into gel and evaluated for in vitro release, ex-vivo skin permeation, confocal laser scanning microscopy, and histopathological studies.
 Results: The optimized formulation showed the vesicular size of 226.1±4.36 nm, polydispersity index of 0.282±0.012, and entrapment efficiency of 95.34±3.18% with spherical morphology. The optimized niosomal gel formulation showed transdermal flux 127.60 µg/cm2h through albino Wistar rat skin. Niosomal gel was proved significantly superior by confocal laser scanning microscopy for satisfactory permeation and distribution of gel, deep into the rat skin. Furthermore, dermal safety was confirmed by histopathological studies for transdermal application.
 Conclusion: It was concluded that the developed niosomal gel overcomes the limitation of low penetration through rat skin and could be a potential nano vesicular system for transdermal delivery.
Highlights
Hypertension is a chronic condition responsible for a cardiovascular event and is ranked the third most important cause of public health issues in developed countries [1, 2]
Nitrendipine loaded niosomal gel was successfully prepared by the thin-film hydration method
Developed formulation was optimized by box-behnken statistical design to achieve desired properties using different ratios of span 60 and cholesterol, whereas the addition of carbopol 934P found to produce niosomal gel with suitable viscosity for transdermal application
Summary
Hypertension is a chronic condition responsible for a cardiovascular event and is ranked the third most important cause of public health issues in developed countries [1, 2]. More than one billion adults, and by 2025, 1.5 billion populations are estimated to get effected by uncontrolled hypertension [3]. Genetic and synergistic factors like stress, tobacco, alcohol intake, sedentary lifestyle, smoking, and obesity play a remarkable role in hypertension [4]. Various classes of drug and treatment have been advocated for the control of hypertension, due to its incidence and morbidity. Treatment with antihypertensive agents decreases cardiovascular events such as heart attack, heart failure, and stroke [5, 6]. Calcium channel blockers have been well established in the management of coronary heart disease by inhibiting calcium ion entry into a cardiac and vascular smooth muscle to promote vasodilatation [7, 8]
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