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Paper ID:IJSREM66654

Preparation and characterisation of nitrofurantoin with sodium dihydrogen orthophosphate co crystal

Stream/Area:

-

Subject:

-

Paper ID:

IJSREM66654

Volume:

10 |

8 |

Aug 2026

Pages:

1-8

Publication Frequency:

Monthly (12 issues per year)

DOI
Digital Object Identifier
Not assigned

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.

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Authors

G

Gowtham.G

M.pharm

SRI Vijay Vidhyalaya College of Pharmacy

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NC

Nithish C

Bachelor of Pharmacy

SRI Vijay Vidhyalaya College of Pharmacy

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NKS

Naveen Kumar S

Bachelor of Pharmacy

SRI Vijay Vidhyalaya College of Pharmacy

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S

S.Nivedhitha

Bachelor of Pharmacy

SRI Vijay Vidhyalaya College of Pharmacy

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Abstract

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

Nitrofurantoin Co-crystal Sodium dihydrogen orthophosphate Organoleptic properties pH Solubility enhancement Pharmaceutical co-crystal; FTIR Spectroscopy; X-ray diffraction(XRD)

Cite This Article

Gowtham.G, Nithish C, Naveen Kumar S, S.Nivedhitha, "Preparation and characterisation of nitrofurantoin with sodium dihydrogen orthophosphate co crystal," International Journal of Scientific Research in Engineering and Management, vol. 10, no. 8, pp. 1-8, Aug 2026.

Full Article/Conclusion

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.

References

1. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill Education; 2018. 2. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12(3):413-20. 3. Schultheiss N, Newman A. Pharmaceutical cocrystals and their physicochemical properties. Cryst Growth Des. 2009;9(6):2950-67. 4. Sekhon BS. Pharmaceutical co-crystals – a review. Ars Pharm. 2009;50(3):99-117. 5. Aitipamula S, Banerjee R, Bansal AK, Biradha K, Cheney ML, Choudhury AR, et al. Polymorphs, salts, and cocrystals: what's in a name? Cryst Growth Des. 2012;12(5):2147-52. 6. Blagden N, de Matas M, Gavan PT, York P. Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates. Adv Drug Deliv Rev. 2007;59(7):617-30. 7. Rodrigues M, Baptista B, Lopes JA, Sarraguca MC. Pharmaceutical cocrystallization techniques. Advances and challenges. Int J Pharm. 2018;547(1-2):404-20. 8. Karimi-Jafari M, Padrela L, Walker GM, Croker DM. Creating cocrystals: a review of pharmaceutical cocrystal preparation routes and applications. Cryst Growth Des. 2018;18(10):6370-87. 9.  Abdulkarem, Ahmed Talib, Zainulabdeen, Shaimaa M.S, and Abed, Saif Mazeel "Overview          of urinary tract infection caused by bacteria," Muthanna Medical Journal”, 2023; Vol. 10: Iss. 2, Article 3. DOI: 10.52113/1/2/2023-227-239. 10. Bent, Stephen, et al. Does this woman have an acute uncomplicated urinary tract infection?. Jama, 2002;( 287)20: 2701-2710.

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Publication Date

8/10/2026

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