Comparative dissolution studies of pitavastatin-fenofibrate FDC dual-layered tablets to evaluate drug release characteristics in the body
The purpose of this study is to predict through a comparative dissolution test whether pitavastatin-fenofibrate FDC dual-layer tablet (PF-T), which is being developed for the treatment of dyslipidemia, acts equally in vivo as the existing capsules dosage form. We attempted to develop a tablet with greater stability and ease of administration compared to the existing formulation and conducted an in vitro study to secure drug release characteristics to establish drug equivalence. Comparative dissolution studies of the reference drug and the test drug were conducted in 4 test solutions (Ministry of Food and Drug Safety Notification) with pH conditions similar to those in the gastrointestinal tract. Since the API is poorly soluble, sodium lauryl sulfate, an anionic surfactant, was added to the test solution. For the test drug, three prescriptions were prepared for each type of disintegrant, and the dissolution pattern was checked, and then the ratio was adjusted using the disintegrant prescription that had the most similar dissolution pattern to the reference drug. As a final result, a prescription was obtained that had similar drug release characteristics to the reference drug in the sink condition of the 4 dissolution test solutions, and was evaluated to meet the standards for pharmaceutical equivalence. We expect a synergistic effect between the two drugs in the PF-T under development, and we think it will be an excellent medicine that will be conveniently used for patients.
2024 Spring Convention