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Stream/Area:
-
Subject:
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Paper ID:
IJSREM66654
Volume:
10 |
8 |
Aug 2026
Pages:
1-8
Publication Frequency:
Monthly (12 issues per year)
License:International Journal of Scientific Research in Engineering and Management follows the Creative Commons Attribution 4.0 (CC BY 4.0) License, allowing free use and distribution with proper attribution.
M.pharm
SRI Vijay Vidhyalaya College of Pharmacy
Bachelor of Pharmacy
SRI Vijay Vidhyalaya College of Pharmacy
Bachelor of Pharmacy
SRI Vijay Vidhyalaya College of Pharmacy
Bachelor of Pharmacy
SRI Vijay Vidhyalaya College of Pharmacy
Objective: Nitrofurantoin is a BCS Class IV antibacterial drug widely used in the treatment of uncomplicated urinary tract infections; its clinical utility is limited by poor aqueous solubility and consequent low and variable oral bioavailability. The objective of the present study was to prepare a pharmaceutical co-crystal of nitrofurantoin with sodium dihydrogen orthophosphate as a co-crystal former, and to characterize the co-crystal with a view to improving the aqueous solubility and dissolution rate of the drug. Methods: Nitrofurantoin–sodium dihydrogen orthophosphate co-crystals were prepared in state stoichiometric used.1:1 molar ratio by the liquid-assisted grinding technique. The physical mixture and co-crystals obtained were characterized by organoleptic properties, pH determination, Fourier transform infrared (FTIR) spectroscopy, powder X-ray diffraction (PXRD), and Saturation solubility studies were carried out and compared with pure nitrofurantoin. Results: FTIR analysis showed changes in the characteristic N–H and C=O stretching bands of Nitrofurantoin, together with changes in the C=N and NO₂ vibration regions, suggesting possible hydrogen-bonding interactions between Nitrofurantoin and sodium dihydrogen orthophosphate. PXRD analysis showed sharp diffraction peaks indicating a crystalline material; however, the presented co-crystal diffractogram should be verified against the actual Nitrofurantoin–sodium dihydrogen orthophosphate sample before claiming formation of a new crystalline phase. The saturation solubility increased from 75.7 ± 2.4 µg/mL for pure Nitrofurantoin to 197.6 ± 15 µg/mL for the co-crystal, representing a 2.61-fold improvement in solubility. Conclusion: The results confirm successful formation of a nitrofurantoin–sodium dihydrogen orthophosphate co-crystal with improved physicochemical characteristics, indicating that co-crystallization with sodium dihydrogen orthophosphate is a promising, excipient-based approach to enhance the solubility and dissolution, and hence the oral bioavailability, of nitrofurantoin.
KEYWORDS
A co-crystal of nitrofurantoin with sodium dihydrogen orthophosphate was successfully prepared by the solvent evaporation method and characterized by FTIR, DSC, PXRD and SEM. Spectral and thermal data confirmed hydrogen-bond-mediated interaction between the drug and the co-crystal former and the formation of a new crystalline phase distinct from the physical mixture. The co-crystal exhibited markedly improved saturation solubility and in vitro dissolution rate compared with pure nitrofurantoin, indicating that co-crystallization with sodium dihydrogen orthophosphate is a simple, cost-effective and pharmaceutically viable approach to enhance the biopharmaceutical performance of nitrofurantoin. Further in vivo and stability studies are warranted to fully establish the pharmaceutical potential of this co-crystal.
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Publication Date
8/10/2026
Peer Review Type
Double-Blind Peer Review
Review Rounds: 2
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