Abstract：Objective To determine the solubility of drug in different media,to evaluate the stability of raw material and drug/excipient interactions for the development of Dexibuprofen Sustained-Release Dry Suspensions.Methods The solubility of the drug was determined indifferent pH buffer solutions(pH 1.2,pH 4.5,pH 5.0,pH 6.8 and pH 7.4),water and ethanol.The related substances of raw material were analyzed at the 5th and 10th days after storage under high temperature(60℃),high humidity(RH 92.5%)and strong light(4500 Lx).The drug-excipient interactions were also studied at the 5th and 10th days under high temperature(60℃),high humidity(RH 92.5%)and strong light(4500 Lx).Results The solubility of drug increased as the pH of solution increased in the range from pH 1.2 to pH 7.4.The drug was highly soluble in ethanol.The related substances of raw material slightly increased under high temperature and showed hygroscopicity under high humidity.But the related substancesafter storage under three different conditions were all less than 0.3%.The related substances from drug-excipient interactions under three conditions were below 0.3%.Conclusion The drug solubility showed a pH dependent manner.The raw material was quite sensitive to high temperature.No drug-excipientinteractions were observed between the drug and excipients.
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