Quality by design (QbD) was utilized to develop and optimize a vaginal film loaded with Tenofovir and Levonorgestrel for the prevention of HIV, other STIs and unintended pregnancies. Poly-vinyl-alcohol was employed as a film forming polymer, chitosan was deployed to improve the mucoadhesive properties of the film and polyethylene glycol as a plasticizer. Risk assessment was carried out using Ishikawa diagram to identify the critical variables which were further subjected as factors of 3-level central composite design of experiments. The vaginal film loaded with Tenofovir and Levonorgestrel was successfully developed using solvent casting technique and optimized via QbD approach. The vaginal films were colorless, transparent and flexible with a pH of 4.27 ± 0.032, thickness 0.173 ± 0.006 mm, weight 0.0551 ± 0.0006g and moisture content 8.8 ± 08 %. The optimized formulation had a degradation time of 3.1087 ± 0.388 minutes, percentage cumulative release of Tenofovir and Levonorgestrel (91.261 ± 0.26 and 91.132 ± 0.4 respectively) with 76 % ± 0.5 of mucoadhesion achieved. Histological studies of the vaginal tissue using rabbit model suggest the safety of the optimized loaded vaginal film. QbD provided in-depth knowledge on product and process via Quality target product profile and Critical quality attributes, which ensured built-in quality in the product and manufacturing processes. The QbD approach facilitates regulatory compliance and accelerates product development, reducing product out of specification and providing women with better prevention options with ease of use during self-administration.

View Article