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Formulation and solid state characterization of nicotinamide-based co-crystals of fenofibrate

Author(s): Sheetal Shewale1, AS Shete2, RC Doijad2, SS Kadam2, VA Patil2, AV Yadav3
1Department of Pharmaceutics, Satara College of Pharmacy, Degaon, Satara-415 004, India 2Research Group, Department of Pharmaceutics and Quality Assurance, Shree Santkrupa College of Pharmacy, Ghogaon, Karad-415 111, India 3Gourishankar Institute of Pharmaceutical Education and Research, Limb, Satara-415 002, India

Correspondence Address:
Sheetal Shewale Department of Pharmaceutics, Satara College of Pharmacy, Degaon, Satara-415 004 India E-mail: [email protected]

The present investigation deals with formulation of nicotinamide-based co-crystals of fenofibrate by different methods and solid-state characterization of the prepared co-crystals. Fenofibrate and nicotinamide as a coformer in 1:1 molar ratio were used to formulate molecular complexes by kneading, solution crystallization, antisolvent addition and solvent drop grinding methods. The prepared molecular complexes were characterized by powder X-ray diffractometry, differential scanning calorimetry, Fourier transform infrared spectroscopy, nuclear magnetic resonance spectroscopy and in vitro dissolution study. Considerable improvement in the dissolution rate of fenofibrate from optimized co-crystal formulation was due to an increased solubility that is attributed to the super saturation from the fine co-crystals is faster because of large specific surface area of small particles and prevention of phase transformation to pure fenofibrate. In vitro dissolution study showed that the formation of co-crystals improves the dissolution rate of fenofibrate. Nicotinamide forms the co-crystals with fenofibrate, theoretically and practically.

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