Author(s):
Pratik P. Disale, Anilkumar J. Shinde, Dinanath T. Gaikwad, Firoj A. Tamboli, Vijaykumar T. Pawar
Email(s):
disalepratik24@gmail.com , ajshinde70@gmail.com , dinanath.gaikwad@bharatividyapeeth.edu , firojtamboli143@gmail.com , vijaykumar.pawar@bharatividyapeeth.edu
DOI:
10.52711/0974-360X.2026.00469 
Address:
Pratik P. Disale1*, Anilkumar J. Shinde2, Dinanath T. Gaikwad3, Firoj A. Tamboli3, Vijaykumar T. Pawar4
1Research Scholar, Dept. of Pharmaceutical Quality Assurance, Bharati Vidyapeeth College of Pharmacy, Kolhapur. - 416013 Maharashtra, India, https://orcid.org/0009-0009-8734-5303.
2Dept. of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur. – 416013 Maharashtra, India, https://orcid.org/0000-0003-1857-3133.
3Dept. of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur. – 416013 Maharashtra, India, https://orcid.org/0000-0002-2780-8216.
4Dept. of Pharmacognosy, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur (M.S.) India.
5Dept. of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur (M.S.) India, https://orcid.org/0000-0002-7369-5355.
*Corresponding Author
Published In:
Volume - 19,
Issue - 7,
Year - 2026
ABSTRACT:
Nitrendipine, a poorly water soluble dihydropyridine calcium channel antagonist, suffers from low oral bioavailability (10–20%) due to dissolution rate-limited absorption. This study aimed to enhance Nitrendipine's solubility and stability by forming cocrystals with Gallic acid, a coformer identified as suitable through COSMOquick software based on favorable thermodynamic interactions (Gmix=–1.12kcal/mol, Hex=–2.72 kcal/mol, Hhb = –2.05kcal/mol). Cocrystals, eutectic mixtures, and binary mixtures were prepared via solvent evaporation. A 1:4 stoichiometric ratio (0.2M Nitrendipine and 0.8 M Gallic acid) yielded a distinct crystalline phase, confirmed through Differential Scanning Calorimetry (DSC) with a new melting endotherm at 244.31°C, and Powder X-ray Diffraction (PXRD), which revealed new peaks and disappearance of parent compound reflections. Fourier-Transform Infrared Spectroscopy (FTIR) showed characteristic peak shifts (e.g., C=O stretch from 1700 cm?¹ to 1692 cm?¹), indicating hydrogen bond formation. The Nitrendipine-Gallic acid cocrystals exhibited a 54.7% increase in aqueous solubility in distilled water compared to pure Nitrendipine (7.69 mg/mL vs. 4.97mg/mL at 37°C). Solubility improvements were also observed in methanol (48.4%) and 0.1N HCL (47.5%). In vitro dissolution studies demonstrated a 111% increase in drug release from the cocrystals (74%) versus pure Nitrendipine (35%) at 120mins in phosphate buffer (pH 7.4, 37°C), with statistically significant differences (p<0.05). These findings confirm that Gallic acid was a highly effective coformer for enhancing the solubility, dissolution rate, and solid-state stability of Nitrendipine, potentially improving its oral bioavailability and therapeutic performance.
Cite this article:
Pratik P. Disale, Anilkumar J. Shinde, Dinanath T. Gaikwad, Firoj A. Tamboli, Vijaykumar T. Pawar. Improved Solubility and Dissolution of Nitrendipine through Gallic Acid Cocrystals Formation. Research Journal of Pharmacy and Technology. 2026;19(7):3295-3. doi: 10.52711/0974-360X.2026.00469
Cite(Electronic):
Pratik P. Disale, Anilkumar J. Shinde, Dinanath T. Gaikwad, Firoj A. Tamboli, Vijaykumar T. Pawar. Improved Solubility and Dissolution of Nitrendipine through Gallic Acid Cocrystals Formation. Research Journal of Pharmacy and Technology. 2026;19(7):3295-3. doi: 10.52711/0974-360X.2026.00469 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-7-56
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