Synthesis, characterization, and dissolution properties of Aceclofenac-isobutabolammonium salt

The solubility issues of Biological Classification System Class II drugs are a challenge for formulation, and salt formation is a potential solution. In this study, we report the synthesis and solid-state characterization of aceclofenac-isobutanolammonium (IBA) salt using 2-Amino-2-methyl propanol (AMP) as the potential counterion. Various techniques, including X-ray powder diffractometry, differential scanning calorimetry, thermogravimetry, solution state nuclear magnetic resonance spectroscopy and, infrared Fourier transform spectroscopy, were used for characterization. The in vitro dissolution study showed a significant increase in solubility and dissolution profile of the salt. The results suggest that aceclofenac-IBA salt has potential as a formulation strategy for enhancing the solubility and bioavailability of Class II drugs.