Objective: Through fenofibrate (Fen) and excipient compatibility assessments and the development of Fen pellets, the current study aims to discover suitable excipients to improve performance and stability of oral solid formulations. Methods: Analytical instruments [Differential Scanning Calorimetry – Q20, TA Instruments, Fourier Transform Infrared Spectroscopy Spectrum RX 1, Bruker Advance Neo 500MHz Nuclear Magnetic Resonance Spectrometer, and Thin Layer Chromatography)] were used to characterize Fen and to study the compatibility. Excipients and Fen were obtained from Loba chemie and Biocon, correspondingly. USP1-type dissolution apparatus was used to study the dissolution, and Auto Dock VINA 1.2.0 software was utilized to know the interaction of Fen with different excipients. Results: Different analytical techniques confirmed that Fen was compatible with used excipients. Docking score for combination of Fen with microcrystalline cellulose (MCC) was found -2.3 and it showed minimum interaction with each other. Additionally, an instant release of Fen tablet was deliberated utilizing a combination of various excipients. Maximum drug release (93.03% in 60min) was obtained with physical mixture of Fen and MCC. Tablet batches 1, 2 and 3 showed 94%, 88% and 87% percent drug release respectively at 90min. It was observed that batch 1 displayed extreme drug release and lowest disintegration time. Conclusion: From several analytical procedures, it was discovered that Fen was compatible with excipients used in pharmaceutical manufacturing, including lactose, magnesium stearate, MCC, talc, dicalcium phosphate, and mannitol. Physical mixture of MCC with Fen disclosed extreme amount of % drug release in shorter period. Docking studies displayed possible interactions among Fen and excipients. It was observed that Fen was more soluble when combined with the microcrystalline complex. Developed immediate release tablets demonstrated fast disintegration and drug release.
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Pawar et al. (2024) studied this question.