2025 CONVENTION
Strategic formulation design for fenofibrate tablets: engineering dissolution profiles through optimization of excipient and disintegrant ratios
This study was conducted to improve the dissolution characteristics of fenofibrate immediate-release tablets for dyslipidemia and to identify an optimal formulation. Tablets were prepared using the wet granulation method, and the effects of excipient and disintegrant types and ratios on dissolution were evaluated. Lactose and microcrystalline cellulose (MCC 101) were used alone or in combination as excipients, while crospovidone and croscarmellose sodium (Ac-di-sol) were used as disintegrants. Dissolution tests were performed in pH 1.2 and 4.0 media containing 1% SLS, and the similarity factor (f2) and mean dissolution were compared between the test and reference products. Analysis indicated that the excipient ratio influenced dissolution, with formulations having a Lactose:MCC ratio of 1:1 showing f2 values approximately 15% higher than those with a 1:3 ratio. Dissolution also varied depending on the disintegrant used; formulations using Ac-di-sol instead of crospovidone tended to exhibit slightly improved overall dissolution. These results suggest that excipient types and ratios, as well as disintegrant selection and combination, may affect dissolution characteristics, providing useful guidance for designing oral formulations to enhance bioavailability. Furthermore, these findings could serve as a reference in future formulation optimization strategies for fenofibrate.