Xiamen LP Pharmaceutical Co., Ltd.

Zhoue Gao

Rongbin Ling

Haijian Zhu

Avinash Singh

Liyan Xie

Shengkai Cao

Yuantao Song

Ying Ye

The present invention provides an oral transmucosal film for delivering agomelatine through the buccal mucosa or sublingual mucosa. The film is a bilayer structure containing a mucoadhesive layer with amorphous agomelatine and a water-soluble backing layer without agomelatine. The film has improved bioavailability and improved palatability. The mucoadhesive layer comprises comprising 0.1%-40% by weight of amorphous agomelatine, or a pharmaceutical acceptable salt thereof, 50-98% by weight of a first film-forming material, 0.5-20% by weight of an oil phase excipient, and 0.5-17% by weight of a surfactant. The backing layer comprises 60-100% (w/w) of one or more film-forming agents.

Agomelatine oral transmucosal film

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.

Doxepin oral transmucosal film

Growing community of inventors

Xiamen, China

Zhoue Gao