DOXYCYCLINE FORMULATIONS, AND METHODS OF TREATING ROSACEA

摘要

The present invention is directed to a pharmaceutical composition in unit dose form for orally delivering doxycycline to a human, the pharmaceutical composition comprising: a capsule, wherein the capsule is coated with a delayed release layer; wherein the delayed release layer comprises about 4 to 6 mg of doxycycline monohydrate and a binding agent, and wherein the delayed release layer is coated with an enteric coating; wherein the enteric coating dissolves at pH of about 5 to 6, and wherein the enteric coating is coated with an immediate release layer; wherein the immediate release layer comprises about 32 mg of doxycycline monohydrate and a binding agent, wherein the relative mean Cmax of the pharmaceutical composition is within 80.00% to 125.00% of a Cmax value of 510±220.7 ng/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state; and wherein the relative mean AUC(0-∞) of the pharmaceutical composition is within 80.00% to 125.00% of a AUC(0-∞) value of 9227±3212.8 ng·hr/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state.