The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Feb. 18, 2014

Filed:

Jun. 27, 2013
Applicants:

Galderma S.a., Lausanne 30 Grey, CH;

Cerovene, Inc., Valley Cottage, NY (US);

Inventors:

Jean-Pierre Etchegaray, Nice, FR;

Nathalie Wagner, Pegomas, FR;

Manish S. Shah, West Caldwell, NJ (US);

Ray J. Difalco, Ridgewood, NJ (US);

Assignees:

Cerovene, Inc., Valley Cottage, NY (US);

Galderma S.A., Lausanne 30 Grey, CH;

Attorney:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
A61K 9/24 (2006.01); A61K 9/52 (2006.01);
U.S. Cl.
CPC ...
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 Cof the pharmaceutical composition is within 80.00% to 125.00% of a Cvalue 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 AUCof the pharmaceutical composition is within 80.00% to 125.00% of a AUCvalue 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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