Oral suspension of prednisolone acetate
AssigneeTaro Pharmaceutical North America, Inc.
InventorsSatish ASOTRA, Shen Gao, Avraham Yacobi
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Abstract
The present invention relates to novel oral suspension formulation comprising prednisolone acetate, a pharmaceutically acceptable vehicle and a thickening agent. The present invention further provides a method of treating patients in need of prednisolone with the novel formulation.
Claims21
1-23. (canceled)
A pharmaceutical composition comprising a pharmaceutically effective amount of prednisolone acetate particles dispersed in suspension in the composition, wherein the composition is suitable for oral delivery, comprises components that are mutually compatible, comprises carbomer and a wetting agent, has a pH between about 4.0 and 5.9, is palatable, and is storage stable.
A pharmaceutical composition for oral delivery, comprising a pharmaceutically effective amount of prednisolone acetate particles in suspension in the composition, 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. Cmax of 176.27 ng/mL;
- b. Tmax of 1.00 hour;
- c. AUCT of 812.39 ng·h/mL;
- d. AUC28 of 846.53 ng·h/mL;
- e. Kel of 0.2629 hr−1;
- and
- f. T1/2el of 2.66 hours;
- and wherein the composition is suitable for oral delivery.
Dependencies are inferred from the claim text.