Abstract
One of the antiretroviral treatments (ART) used to treat Human Immunodeficiency Virus (HIV) disease is efavirenz (EFV). EFV itself has bioavailability issues during oral therapy due to its poor solubility. When injected, administration issues arise. Hence, creating medication delivery methods was crucial to creating EFV delivery. HIV therapy benefits from the vaginal medication delivery system's ease of use, higher bioavailability, and quick systemic absorption in the surface folds. In this study, an inclusion complex (IC) was added to the EFV formulation to increase solubility, and dissolving microneedles (DMN) was used for delivery to increase penetration. Here, in support of this formulation creation process, we carried out validation utilizing spectrophotometric and colorimetric techniques. The amount of EFV was determined by validating ethanol and artificial vaginal fluid (AVF) using UV–Vis spectrophotometry. Vaginal tissue and plasma were also validated using colorimetric with the β-naphthol reagent. The International Council for Harmonization (ICH) and US Food and Drug Administration (FDA) requirements were adhered to in verifying the creation of analytical procedures. The outcomes demonstrated a linear correlation value of ≥0.9998. The LLOQ levels were 0.99 g/mL, 0.97 g/mL, 0.66 g/mL, 0.74 g/mL, and 0.74 g/mL in ethanol, AVF, porcine vaginal tissue, rat vaginal tissue, and vaginal plasma, respectively. The developed precision and accuracy were confirmed. The approach was successfully used to determine the amount of EFV in inclusion complex integration and DMN platform. The outcomes demonstrated high IC-EFV incorporation release and penetration profiles, permeation and high drug retention andex vivokinetics in the vagina and enhanced bioavailability fromin vivostudy pharmacokinetic profiles of DMN-IC-EFV.
Published Version
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