发明名称 |
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. |
申请公布号 |
EP2968194(A1) |
申请公布日期 |
2016.01.20 |
申请号 |
EP20130878085 |
申请日期 |
2013.09.18 |
申请人 |
GALDERMA S.A.;CEROVENE, INC. |
发明人 |
ETCHEGARAY, JEAN-PIERRE;WAGNER, NATHALIE;SHAH, MANISH S.;DIFALCO, RAY J. |
分类号 |
A61K9/48 |
主分类号 |
A61K9/48 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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