Invention Grant
- Patent Title: Doxycycline formulations, and methods of treating rosacea
- Patent Title (中): 强力霉素制剂和治疗酒渣鼻的方法
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Application No.: US13929598Application Date: 2013-06-27
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Publication No.: US08652516B1Publication Date: 2014-02-18
- Inventor: Jean-Pierre Etchegaray , Nathalie Wagner , Manish S. Shah , Ray J. Difalco
- Applicant: Galderma S.A. , Cerovene, Inc.
- Applicant Address: US NY Valley Cottage CH Lausanne 30 Grey
- Assignee: Cerovene, Inc.,Galderma S.A.
- Current Assignee: Cerovene, Inc.,Galderma S.A.
- Current Assignee Address: US NY Valley Cottage CH Lausanne 30 Grey
- Agency: Hoffmann & Baron, LLP
- Main IPC: A61K9/24
- IPC: A61K9/24 ; A61K9/52

Abstract:
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.
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