Solid State Characterization and Tableting Studies of Ethanol Based Cocrystals of Fenofibrate with Nicotinamide

Abstract:

Objectives: The pharmaceutical cocrystals can be defined as dissociable “API-excipient” molecular complexes or Co-crystals are solids that are crystalline materials composed of two or more molecules in the same crystal lattice as per U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2013. The objectives of present investigation were to formulate cocrystals of fenofibrate with nicotinamide by solution cocrystallization technique. Methods: The cocrystals were prepared by solution cocrystallization technique by using ethanol as a solvent and nicotinamide as a coformer in the ratio of 1:1 & 1:2. The prepared cocrystals were evaluate for, solid state characterization by FTIR, PXRD, Raman spectroscopy and evaluated for tableting performance. Results: The formation of cocrystals has been confirmed by FTIR and Raman spectroscopy. The formulations 1:1 and 1:2 ratios showed better flow properties. The order of tableting performance 1:2 ratio cocrystals > 1:1 ratio cocrystals > Recrystallized nicotinamide > Nicotinamide >> Recrystallized Fenofibrate >> Fenofibrate. Conclusion: The cocrystals showed superior tableting performance. This might be due to the co-crystals, contains hydrogen-bonded two dimensional flat slip planes which exhibits higher plasticity.

Key words: Cocrystals, Crystallizaton, Fenofibrate, Nicotinamide, Tableting.