SIL refers to a precancerous condition that causes significant concern for patients. Currently, there are no specific recommendations for non-invasive therapeutic approaches; however, more frequent check-ups are advised for patients with Low-Grade Squamous Intraepithelial Lesions (LSIL). It is generally recommended to strengthen the immune system in these cases.

For patients with High-Grade Squamous Intraepithelial Lesions (HSIL), the recommendation is to remove the affected areas of the cervix using ablative and excisional methods.In the context of treating SIL and preventing cervical cancer, Alpha-Lipoic Acid (ALA) has emerged as a promising option. Recent clinical research indicates that ALA is a potent antioxidant and immunomodulator, particularly effective in inducing complete resolution of LSIL (Divković et al., 2023; Divković et al., 2022). Notably, after three months of administration at a dosage of 600 mg per day, LSIL was resolved in an impressive 95% of patients.

However, it is important to note that the clinical effectiveness of ALA across various indications is significantly limited by its low bioavailability, which results in suboptimal therapeutic outcomes (Salehi et al., 2019; Pop et al., 2021). ALA’s poor solubility, instability under gastrointestinal conditions, and substantial metabolism in the liver contribute to its short plasma half-life and low bioavailability (approximately 30%).

Additionally, ALA is prone to degradation when exposed to light and high temperatures. The available forms of ALA on the market also exhibit considerable variability in content and quality (Lalić-Popović et al., 2023).Given these challenges, it is crucial to develop pharmaceutical formulations for oral administration of ALA that ensure adequate stability during storage, enhance gastrointestinal stability, and possess a clearly defined pharmacokinetic profile.

Based on recent scientific findings, there is an emerging idea for innovative therapeutic solutions aimed at treating SIL and preventing cervical cancer. This initiative focuses on designing a multicomponent pharmaceutical preparation (MKP) based on ALA, enhanced for bioavailability and combined with nutraceuticals known for their antioxidant and/or antiviral properties. Therefore, the research project will concentrate on the following objectives: development of an innovative advanced pharmaceutical form of ALA with satisfactory bioavailability (1); definition of the composition of MKP specifically intended for the treatment of SIL (2); formulation of MKP tailored for the treatment of SIL (3).