Formulation and Evaluation of Lipid-Based Nano Formulation of Luliconazole

Abstract

Abstract The Preformulation study of Luliconazole elucidated its properties and optimization for a self-Nanoemulsifying drug delivery system (SNEDDS). Luliconazole, a tasteless, odorless white powder, exhibited diverse crystalline forms with a melting point of 153.6°C. Notably, it demonstrated high solubility in Oleic Acid and Isopropyl Myristate, corroborated by partition coefficients of 2.80 in n-octanol. UV spectroscopy validated its reliability for analysis, exhibiting a linear standard curve (Y = 0.1013x) with R2 = 0.9988 at 261 nm. The FTIR spectra of Luliconazole and excipients (Isopropyl Myristate, Oleic Acid, Tween 80, and PEG 400) highlighted compatibility crucial for SNEDDS formulation, showcasing distinctive peaks at specific wave numbers. A 32-factorial design optimized IS5 batches, enhancing efficacy and stability through water dilutions (1:1). Thermal analysis, including DSC and XRD, revealed distinct thermal behaviors and crystalline structures, crucial for understanding formulation interactions. The SNEDDS exhibited increased viscosity due to the surfactant, promoting prolonged surface retention and demonstrating significant inhibition of Candida albicans growth, quantified in Table 12 and Fig. 21. In vitro release testing displayed sustained drug liberation in STF (pH 7.4), showcasing diverse kinetics. Entrapment efficiency in IS-4 reached 74 ± 0.8%, ensuring stability (1.54 ± 0.008) vital for emulsification and drug release behavior. HPLC analysis in an ex-vivo permeation study identified a single peak at 6.59 minutes in IS-5, showcasing skin permeation and bloodstream entry, indicating potential bioavailability for fungal infections. The stability study confirmed IS-5's consistent effectiveness, purity, and potency across varied conditions (4°C, 25°C, 40°C; 15%, 65%, 75% RH), crucial for ensuring a reliable and enduring product. Additionally, skin irritation studies validated IS-5's safety for transdermal drug delivery, essential for patient comfort in pharmaceutical applications.