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:
Nov. 23, 2021

Filed:

Jan. 17, 2020
Applicant:

Xiamen Lp Pharmaceutical Co., Ltd., Xiamen, CN;

Inventors:

Liyan Xie, Xiamen, CN;

Yuantao Song, Xiamen, CN;

Shengkai Cao, Xiamen, CN;

Zhoue Gao, Xiamen, CN;

Rongbin Ling, Xiamen, CN;

Assignee:
Attorneys:
Primary Examiner:
Int. Cl.
CPC ...
A61K 9/00 (2006.01); A61K 31/335 (2006.01); A61K 47/10 (2017.01); A61K 47/22 (2006.01); A61K 47/32 (2006.01); A61K 47/38 (2006.01); A61K 47/26 (2006.01);
U.S. Cl.
CPC ...
A61K 9/006 (2013.01); A61K 31/335 (2013.01); A61K 47/10 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01);
Abstract

The present invention provides an oral transmucosal film or patch for delivering doxepin through the buccal mucosa or sublingual mucosa. The film or patch is a bilayer structure containing a mucoadhesive layer with amorphous doxepin and soluble backing layer without doxepin. The film or patch has satisfactory bioavailability and improved palatability. The mucoadhesive layer comprises 0.5-25% (w/w) of doxepin, 50-96% of one or more film-forming agents, 1-30% (w/w) of one or more adhesives, and 0.05-5% (w/v) of one or more stabilizers. The backing layer comprises 80-100% (w/w) of one or more film-forming agents. Preferred adhesives include povidone, carbomer, and polycarbophil. Preferred stabilizers include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), citric acid, and ascorbic acid.


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