Fabrication, ‘Optimisation,’ Characterization, and In Vivo Pharmacokinetic Evaluation of Testosterone Undecanoate Loaded Proniosome Capsule for Enhanced Oral Bioavailability

Abstract

This study focuses on creating and evaluating proniosome capsules as a potential drug delivery method to increase the oral bioavailability of testosterone undecanoate. The three main stages of the study are proniosome capsule fabrication optimization, characterization, and in vivo pharmacokinetic evaluation. The most prominent response surface approach (CCD – Central Composite Design) was used in the fabrication-optimization phase to determine the appropriate ratios of the factors that have the greatest effects on the particle size, PDI, and percentage of drug entrapment of testosterone undecanoate proniosomes. Creating testosterone undecanoate-loaded proniosomal formulations was possible using various ratios of span 60 and cholesterol. The physical and chemical characteristics of proniosome capsules, such as size, shape, surface charge, and drug-release kinetics, such as percentage drug entrapment, Vesicle size (nm), and PDI, must be thoroughly analyzed. Animal models were used to determine how the proniosome capsules affect the bioavailability of testosterone undecanoate after oral administration. Factors like absorption, distribution, metabolism, and excretion are carefully evaluated to determine whether the capsules successfully enhance drug delivery. The reduced particle size, polydispersity index (PDI, 282.33 ± 1.52 nm and 0.181 ± 0.003), and the highest entrapment efficiency (98.12 ± 1.03%) made the optimized formulation the ideal formulation. The Higuchi model provided the most comprehensive justification for releasing the testosterone undecanoate from proniosome compositions. Up to six months of storage, no changes of any type, even those to the proniosomes' color, were seen. There was no drug leakage during the stability study, according to the percentage of drug entrapment data. Positive findings from the in vivo pharmacokinetic investigation also suggested that testosterone undecanoate proniosome formulations may last significantly longer than a pure drug in vivo.