Galderma S.a.

Cerovene, Inc.

Nathalie Wagner

Manish S Shah

Ray J DiFalco

Jean-Pierre Etchegaray

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 Cof the pharmaceutical composition is within 80.00% to 125.00% of a Cvalue of 510&#xb1;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 AUCof the pharmaceutical composition is within 80.00% to 125.00% of a AUCvalue of 9227&#xb1;3212.8 ng&#xb7;hr/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state.

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Pegomas, France

Nathalie Wagner