Povidone-iodine ovules, semi-solid forms used for the prevention and treatment of vaginal infections. However, their current excipients, such as gelatin or synthetic lipids, face limitations such as high costs, fluctuating availability, allergy risks, limited stability, and insufficient emollient properties. This study aimed to develop and evaluate a povidone-iodine ovule formulation using shea butter as a natural excipient.

The methodology included the characterization of shea butter and povidone-iodine according to the European Pharmacopoeia. Various ovule formulations were then developed, and the optimal formulation underwent physicochemical, pharmacotechnical, and microbiological evaluations. The in vitro antimicrobial efficacy of the formulation of interest was verified using the Kirby-Bauer method.

The results showed that shea butter exhibited optimal properties, including a melting point of 34.5°C, acid values (9.72 mg KOH/g) and peroxide values (14.96 meq O?/kg) consistent with the European Pharmacopoeia, and the absence of pathogens. Povidone-iodine was also identified with an iodine content of 9.98%, consistent with the European Pharmacopoeia. The optimal formulation (F2), composed of povidone-iodine (8.33%), shea butter (80%), beeswax (10%), lecithin (1%), and vitamin E (0.67%), demonstrated satisfactory properties, including a melting point of 36.7°C (adapted to vaginal temperature) and microbiological cleanliness. Furthermore, its in vitro antimicrobial efficacy test revealed zones of inhibition equivalent to those of BETADINE®, the ovules.

In conclusion, the combination of shea butter and beeswax constitutes a natural, pharmaceutical-grade excipient, allowing for optimal formulation of povidone-iodine ovules. This advance represents a promising solution for more accessible management of vaginal infections.