US 11,980,686 B1
Agomelatine oral transmucosal film
Ying Ye, Xiamen (CN); Haijian Zhu, Xiamen (CN); Rongbin Ling, Xiamen (CN); Zhoue Gao, Xiamen (CN); and Avinash Singh, Xiamen (CN)
Assigned to XIAMEN LP PHARMACEUTICAL CO., LTD., Xiamen (CN)
Filed by Xiamen LP Pharmaceutical Co., Ltd., Xiamen (CN)
Filed on Sep. 6, 2023, as Appl. No. 18/462,245.
Claims priority of application No. 202311054277.8 (CN), filed on Aug. 21, 2023.
Int. Cl. A61K 9/00 (2006.01); A61K 31/165 (2006.01); A61K 47/26 (2006.01); A61K 47/38 (2006.01)
CPC A61K 9/006 (2013.01) [A61K 31/165 (2013.01); A61K 47/26 (2013.01); A61K 47/38 (2013.01)] 11 Claims
 
1. An oral transmucosal film, comprising:
(a) a mucoadhesive layer 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, 1%-5% by weight of an oil phase excipient, and 1%-5% by weight of a surfactant; and
(b) a water-soluble backing layer comprising 60%-100% by weight of a second film-forming material, wherein the backing layer prevents agomelatine from diffusing into the oral cavity of a patient during oral administration of the film;
wherein the first film-forming material comprises one or more materials selected from the group consisting of: hypromellose (HPMC), hydroxypropyl cellulose (HPC), ethylene glycol and vinyl ethanol graft copolymer, polyvinyl alcohol (PVA), copovidone (PVP), and polyethylene oxide (PEO), and
the second film-forming material comprises one or more materials selected from the group consisting of: hypromellose, hypromellose acetate succinate, cellulose acetate phthalate, hydroxyethyl cellulose, polyvinyl alcohol, hypromellose phthalate, and polyvinyl alcohol phthalate; and
wherein the oil phase excipient is glyceryl monolinoleate and the surfactant is sodium dodecyl sulfate, the oil phase excipient is diethylene glycol monoethyl ether and the surfactant is sodium dodecyl sulfate, the oil phase excipient is glyceryl monolinoleate and the surfactant is linoleoyl polyoxyl-6 glyceride, or the oil phase excipient is propylene glycol monolaurate and the surfactant is polyoxyl 15 hydroxystearate.