Abstract

FORMULATION, OPTIMIZATION AND CHARACTERIZATION OF PRONIOSOMAL GEL FOR TRANSDERMAL DELIVERY OF NAPROXEN

Mishra S*, Vasistha P, Sachdeva M, Sara U V S

Raj Kumar Goel Institute of Technology, Ghaziabad (U.P.) INDIA, 201003.

ABSTRACT

The objective of the study was to formulate a modified proniosomal gel of Naproxen (a poorly soluble drug) by coacervation phase separation technique based on nonionic surfactants (span 40, span 60) and cholesterol. Naproxen is a widely used NSAID with due potential for the treatment of rheumatic diseases (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis etc). Its oral administration is associated with severe side effects in the gastrointestinal tract. Transdermal drug delivery has been recognized as an alternative route for oral delivery of Naproxen. Proniosomes with span 40 and span 60 increase the permeation of Naproxen across skin via two mechanisms either by the penetration enhancer effect of the nonionic surfactants or vesicle skin interaction. Proniosomes are proved to be the potential carriers for delivery of lipophilic or amphiphilic drugs which is an approach to stabilize niosomal drug delivery system without affecting its properties and merits and proniosome derived niosomes are good or better than conventional niosomes. The object of present investigation was to encapsulate Naproxen in proniosomes and incorporate the prepared proniosomes into suitable dermal base (carbopol gel) to improve the therapeutic index and patient compliance of the topical dosage form. 32 factorial design of experiments was used to optimize the various formulation variables. The concentration of non-ionic surfactant and cholesterol were taken as independent variables whereas entrapment efficiency and drug flux were taken as dependent variables. The optimized formulation was evaluated for entrapment efficiency, spontaneity, vesicle size, TEM, FTIR, in vitro diffusion study and stability study. The effects of different formulation variables such as surfactant chain length, cholesterol content, drug content, pH of hydration medium were observed on Naproxen entrapment efficiency. This formulation of proniosomes is a practical and simple method and could constitute a promising approach for the immediate preparation of niosomal carrier system for transdermal delivery of Naproxen.

Keywords: Proniosomes, Niosomes, Naproxen, Transdermal drug delivery, Rheumatic diseases, Factorial design.