Formulation, Optimization and in vitro Evaluation of Ibuprofen-Loaded Cubosomal Nano-Formulation for Effective Topical Delivery

Abstract

Objectives: This research aims to formulate and assess an Ibuprofen-loaded cubosomal gel that would improve the drug's skin absorption and minimize its oral adverse effects. Hence, clinically relevant drug concentration reaches the skin surface for effective transdermal delivery. Materials and Methods: Ibuprofen-loaded Cubosomal Nanoformulation was prepared using a top-down approach by varying Glyceryl Mono-Oleate (GMO) and Polaxomer 407 (PF 127). The prepared cubosomal nanoformulations were subjected to characterization such as Poly Dispersibility Index, Particle Size and Entrapment Efficiency. The optimized formulation of Ibuprofen-loaded Cubosomes was incorporated in Carbopol 940 (1%) gel base. The gel formulations were evaluated for pH, viscosity, spreadability, in vitro drug diffusion through a cellophane membrane and ex vivo diffusion studies using rat skin. Results: A 32 factorial design was utilized for formulation optimization. The optimized cubosomal nanoformulation (F5) produced particles with an average particle size of 150.7 nm and PDI of <1, zeta potential of -29mV and %drug entrapment efficiency of 74.36±0.66%. The formulated Cubosomal Gel revealed a neutral pH value with a viscosity of 1123±0.45cps, 75% in vitro drug diffusion and 78.6% ex vivo drug diffusion. Conclusion: pH, viscosity, spreadability, drug release and stability studies were performed on the Cubosomal gel formulation. The optimized Formulation (F5) performed better in terms of pH, viscosity, spreadability and drug release percentage. In vitro and ex vivo studies shows that Ibuprofen-loaded Cubosomal gel releases the drug more slowly than plain formulated Ibuprofen Gel. The formulated Cubosomal Gel also showed no significant change in physical characteristics. Hence, concluded that the formulated Cubosomal gel can be used as an effective transdermal drug delivery system.