Effect of Polysorbate 80 and Particle Size of Budesonide API on In-vitro Dissolution Profiles of Budesonide MUPS Tablets 9 mg

The Aim of this work was to study the effect of Polysorbate 80 concentration and particle size of Budesonide API on in-vitro dissolution profiles. Budesonide API was a BCS class-II molecule which is having low solubility and high permeability. To increase solubility particle size need to be reduced by wet milling technique using highpressure homogenizer, Budesonide API is highly hydrophobic in nature, hence it was difficult to wet the API in purified water without wetting agent like Polysorbate-80. The optimal formulation was manufactured by using wet milling technique by using Polysorbate 80 as a wetting agent. The wet milled drug suspension was sprayed on sugar spheres, which was coated with Eudragit L100 and S100 to target the drug release in colon region, further coated with protective layer coating and compressed into MUPS tablets. Polysorbate 80 of 5 mg/unit with API particle size of 1.6 microns was found to be producing similar dissolution profile with the marketed formulation in all media from pH 4.5 to pH 7.5.