TAILORING OF SOLUBILITY OF IBUPROFEN IN THE PRESENCE OF HYDROPHILIC EXCIPIENTS IN WATER-ETHANOL MIXTURES BY CRYSTALLIZATION METHOD

• Published in: International journal of applied pharmaceutics pp. 102 - 109
• Main Authors: AFROSE, AFRINA, T. WHITE, EDWARD, RASHID, MD ABDUR, HOWES, TONY, ALHAMHOOM, YAHYA
• Format: Journal Article
• Language: English
• Published: 07.03.2022
• DOI: 10.22159/ijap.2022v14i2.43871
• ISSN: 0975-7058

Objective: The objective of this study was to determine the effect of some commonly used pharmaceutical excipients on the solubility of Ibuprofen (Ibu) in a co-solvent consisting of water (W) and ethanol (E).  Methods: The Ibu solubility studies were carried out by dissolving the drug to equilibrium into aqueous ethanol solvents at a fixed temperature. The temperature of the water bath was kept constant (±0.1 °C of the desired temperatures 10, 25 and 40 °C). The solubility of Ibu was measured by using UV spectrophotometry.  Results: The low solubility (~ 50 ppm) of Ibu without excipients in water (zero ethanol) was observed. However, Ibu solubility was increased near exponentially with excipient containing co-solvent system. The maximum solubility of Ibu (1726 ppm) was occurred in a co-solvent containing 1.52% leucine, 5.22% mannitol, 0.25% HPMC, 1.55% Pl F127 and 10.75% w/w ethanol. The phase separation between 34% and 63% w/w E/(E+W) was observed at 40 °C. The individual effect of Pl F127 on enhancing the Ibu solubility was significant.  Conclusion: The individual addition of leucine, mannitol and HPMC has limited impact on the solubility of Ibu. However, the effect of combining these excipients together on Ibu solubility is significantly high.