eng Oriental Scientific Publishing Company Biosciences Biotechnology Research Asia 0973-1245 2025-03-25 22 1 191 200 10.13005/bbra/3353 54061 article Shivraj Popat Jadhav 1 Sushant Mothabhau Ahire 2 Vijay Vithoba Shewale 3 Chandrashekhar Dinkar Patil 4 Rahul Yuvraj Pagar 5 Deepak Devidas Sonawane 1 Department of Pharmaceutics, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India. Department of Pharmaceutical Chemistry, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India. Department of Pharmacognosy, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India. Department of Pharmacology, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India. Department of Pharmaceutics, K.B.H.S.S. Trust's Institute of Pharmacy, Malegaon, Nashik, Maharashtra, India. Nifedipine is commonly prescribed for preterm labor, hypertension, and angina pectoris. According to the Biopharmaceutics Classification System (BCS), nifedipine is categorized as a Class II drug due to its low solubility and high permeability. This study aimed to enhance nifedipine's solubility using a co-crystal approach. Co-crystals are multi-component systems composed of a stoichiometric ratio of an active pharmaceutical ingredient (API) and an approved co-former. Through solvent-assisted grinding, nifedipine co-crystals were successfully prepared with glutaric acid, succinic acid, cinnamic acid, and fumaric acid in a 1:1 stoichiometric ratio. The physicochemical properties of the co-crystals, including infrared spectroscopy, melting point, X-ray diffraction, differential scanning calorimetry, and solubility profiles, were compared to those of pure nifedipine. Among the four co-crystals, the nifedipine-fumaric acid (NFD-FA) co-crystal exhibited a remarkable 90-fold improvement in solubility over pure nifedipine. Consequently, the NFD-FA co-crystal was further characterized. Excipient compatibility studies were conducted, and tablets were formulated using the wet granulation method. In-vitro drug release studies revealed that NFD-FA co-crystal tablets achieved a 45% cumulative drug release within 60 minutes, significantly outperforming the marketed formulation, which released only 27% of the drug in the same period. The observed improvement in solubility is likely due to the formation of hydrogen bonds between nifedipine and the fumaric acid co-former, demonstrating the effectiveness of co-crystallization as a strategy for enhancing drug solubility and dissolution. https://www.biotech-asia.org/vol22no1/formulation-of-tablet-of-nifedipine-co-crystal-for-enhancement-of-solubility-and-other-physical-properties/ Co-Crystal; Co-Former; Hypertension; Nifedipine; Solubility