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. 25, 2020

Filed:

Dec. 22, 2017
Applicant:

Adare Pharmaceuticals, Inc., Lawrenceville, NJ (US);

Inventor:

Gopi M. Venkatesh, Vandalia, OH (US);

Assignee:

Adare Pharmaceuticals, Inc., Lawrenceville, NJ (US);

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 9/00 (2006.01); A61K 9/20 (2006.01);
U.S. Cl.
CPC ...
A61K 9/0056 (2013.01); A61K 9/2077 (2013.01);
Abstract

There is provided a method for preparing an orally disintegrating tablet (ODT) composition comprising microparticles of one or more taste-masked active pharmaceutical ingredient(s), rapidly-dispersing microgranules, and other optional, pharmaceutically acceptable excipients wherein the ODT disintegrates on contact with saliva in the buccal cavity in about 60 seconds forming a smooth, easy-to-swallow suspension. Furthermore, the microparticles (crystals, granules, beads or pellets containing the active) applied with a taste-masking membrane comprising a combination of water-insoluble and gastrosoluble polymers release not less than about 60% of the dose is in the stomach in about 30 minutes, thus maximizing the probability of achieving bioequivalence to the reference IR product having rapid onset of action (short T). A process for preparing such compositions for oral administration using conventional fluid-bed equipment and rotary tablet press is also disclosed.


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