Pharmaceutical Cocrystallization of Naproxen and Paracetamol: A Rational Design Approach toward Enhanced Solubility, Stability, and Formulation Efficiency
1
Dr. Rajendra Gode College of Pharmacy, Malkapur, Dist-Buldana, Maharashtra, India
2
PRMSS Anuradha College of Pharmacy, Chikhli, Dist-Buldana, Maharashtra, India
3
Shradhha Institute of Pharmacy, Washim, Maharashtra, India
4
Dr. R.N. Lahoti Institute of Pharmaceutical Education and Research Centre, Sultanpur, Dist-Buldana, Maharashtra, India
Received: 2025-08-14
Revised: 2025-08-25
Accepted: 2025-09-17
Published: 2025-09-30
Fixed Dose Combination (FDCs) Therapy was widely used due to the limitations of monotherapy in the complex disease condition such as cardiovascular disease, Cancer, Diabetics, Infectious disease etc. Therefore Drug-Drug Cocrystals of Naproxen and Paracetamol was synthesized by using solvent grinding and Solvent crystallization Techniques. The Naproxen, a BCS Class II drug act as API and Paracetamol slightly soluble drug act as conformer. The Naproxen and Paracetamol in the molar ratio 1:1.230 mg of Naproxen (1 mMole) and 151 mg Paracetamol (1 mMole) were used in the formation of Cocrystals. The Naproxen- Paracetamol Cocrytsals were characterized by FTIR, DSC, XRD and SEM analysis. The melting point, solubility, in vitro dissolution and stability studies were conducted for the cocrystals. The formation of Naproxen-ParacetamolCocrystals were supported and confirmed based on the data of the FTIR, DSC and XRD. The SEM also showed change in the habit of Cocrystals compared to pure drugs. The Naproxen- Paracetamol Cocrytsals showed 11-fold increase in the solubluity in water compared to Naproxen. The dissolution rate Naproxen- Paracetamol Cocrytsals were also dramatically improved compared to pure drugs. The pharmacokinetic study of Naproxen-ParacetamolCocrystals showed increased in the bioavailability of fixed dose combination.
Cocrystals, Solubility, Physico-chemical properties, SEM, XRD.