Patent ID: 8206727

Claim:
A pharmaceutical composition for oral delivery, comprising a pharmaceutically effective amount of prednisolone acetate particles in suspension in the composition, wherein the prednisolone acetate has a median particle size in the range of about 1 μm to about 30 μm and wherein the composition, when administered to humans, exhibits pharmacokinetic parameters within the 80-125% confidence interval, with a statistical power of at least 80%, of one or more of the following values: a. C max of 176.27 ng/mL; b. T max of 1.00 hour; c. AUC T of 812.39 ng·h/mL; d. AUC ∞ of 846.53 ng·h/mL; e. K el of 0.2629 hr −1 ; and f. T 1/2 el of 2.66 hours; and wherein the composition is suitable for oral delivery.