Usama Farghaly Ali*, Milad Reda Qelliny, Omar Halmey and Khaled Aly Khaled


Preformulation studies and characterization are known as a special fundamental Physico-chemical properties of the drug such as drug solubility, stability, melting point, and drug partitioning. Preformulation studies can help in selecting formulation approach to develop effective, stable, and economic dosage forms. Fundamental Preformulation studies include development of a suitable analytical method for drug analysis, determination of drug solubility, determination of drug stability at different stress conditions which may be applied during the preparation of formulations, determination of water/octanol partition coefficient, measurement of melting point and drug excipients compatibility. Physicochemical properties of budesonide such as aqueous solubility in deionized water, different buffer solutions, and solutions containing surfactants were determined. Partition coefficient using water/ octanol system at different pH values were calculated.Forced degradation studies under different stress conditions such as acid, alkali, photo, oxidative, and neutral conditions were studied using LC-MS-MS spectrophotometer. Budesonide showed aqueous solubility of 0.02566 mg/mL with increased solubility to some extent upon using tween 80. Budesonide have a partition coefficient of 2.14 with good drug stability under different stress conditions except higher alkali conditions in which drug completely degraded into another product. Physicochemical studies for the poorly soluble budesonide offered a suitable data for the preparation of nanoparticles.

Keywords: Budesonide, aqueous solubility, partition coefficient, forced degradation studies.

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