Optimization of Novel Topical Cubosomal Gel Containing Lidocaine Hydrochloride by Design of Experiment

Abstract

Background: Cubosomal gels have emerged as a favourable mode for delivery of drugs, contributing to release of drug in controlled mode with increased effectiveness. The study aimed to develop an optimized cubosomal gel formulation containing Lidocaine Hydrochloride for sustained pain relief, particularly in post-operative pains.Materials and Methods: Bottom-up method of approach was employed to prepare cubosomes utilizing Glyceryl Mono Oleate (GMO) and Poloxamer 407 (P-407). The formulations underwent comprehensive characterization analysis, entrapment efficiency determination and zeta potential measurement. Utilizing Design of Experiment methodology, an optimized formulation LH8, prepared with medium concentration of GMO and high concentration of P-407 was derived. Subsequently, LH8 was incorporated into a gel base and evaluated for various parameters including viscosity, drug content, extrudability, and spreadability. In vitro and ex vivo permeation studies were conducted to assess the sustained release profile.Results: The optimized formula LHG8 prepared with medium concentration of Carbopol and high concentration of Propylene glycol showed flux of 38.29 μg/cm2, 66.8% permeability, 7.1 cm spreadability and 91.2% extrudability. Importantly, LHG8 demonstrated excellent sustained release activity, indicating its potential for effective post-operative pain management.Conclusion: This study highlights the promise of cubosomal gels as a viable strategy for optimizing drug delivery, with implications for improving patient outcomes in pain management

Keywords: Cubosomal Gel; Drug Delivery; Factorial Design; Lidocaine Hydrochloride; Optimization; Sustained Release