US 12,109,304 B1
Oral patch for treating mouth ulcers
Haijian Zhu, Xiamen (CN); Rongbin Ling, Xiamen (CN); Avinash Singh, Xiamen (CN); Liyan Xie, Xiamen (CN); and Xiaojin Xiao, Xiamen (CN)
Assigned to XIAMEN LP PHARMACEUTICAL CO., LTD., Xiamen (CN)
Filed by Xiamen LP Pharmaceutical Co., Ltd., Xiamen (CN)
Filed on Nov. 28, 2023, as Appl. No. 18/522,062.
Claims priority of application No. 202311502784.3 (CN), filed on Nov. 13, 2023.
Int. Cl. A61K 9/00 (2006.01); A61K 9/70 (2006.01); A61K 31/245 (2006.01); A61K 31/573 (2006.01); A61K 47/08 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 47/26 (2006.01); A61K 47/32 (2006.01); A61K 47/34 (2017.01); A61K 47/36 (2006.01); A61K 47/38 (2006.01); A61K 47/42 (2017.01); A61K 47/44 (2017.01); A61P 1/04 (2006.01); A61P 17/02 (2006.01)
CPC A61K 9/006 (2013.01) [A61K 9/7046 (2013.01); A61K 9/7053 (2013.01); A61K 9/7061 (2013.01); A61K 9/7069 (2013.01); A61K 31/245 (2013.01); A61K 31/573 (2013.01); A61K 47/08 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01); A61K 47/34 (2013.01); A61K 47/36 (2013.01); A61K 47/38 (2013.01); A61K 47/42 (2013.01); A61K 47/44 (2013.01); A61P 1/04 (2018.01); A61P 17/02 (2018.01)] 17 Claims
 
1. A bilayer oral patch, comprising:
(a) a drug layer comprising 3%-20% by weight (w/w) of amorphous tetracaine or a pharmaceutically acceptable salt thereof, 0.1%-2.0% w/w of amorphous triamcinolone or a pharmaceutically acceptable salt thereof, 20-90% w/w of a first film-forming material, 1-12% w/w of an adhesive, and 1-20% w/w of a cooling excipient; and
(b) a backing layer comprising 70-95% by weight of a second film-forming material and 2-10% by weight of a plasticizer, wherein the backing layer prevents the tetracaine, the triamcinolone, or their pharmaceutically acceptable salts, from diffusing into the oral cavity;
wherein the first film-forming material comprises (a) hypromellose acetate succinate (HPMCAS) and povidone (PVP), (b) ethyl cellulose and PVP, (c) HPMCAS and polyethylene glycol (PEG), or (d) HPMCAS and hydroxypropyl cellulose (HPC);
the adhesive is selected from the group consisting of: polyacrylic acid, sodium alginate, copolymer of ethyl acrylate methyl methacrylate, guar gum, sodium carboxyl methyl cellulose, 5-methyl pyrrolidone chitosan, polyglutamic acid, polycarbophil, dextran sulfate, and any combination thereof;
the cooling excipient is selected from the group consisting of: camphor, menthol, mint oil, clove oil, menthyl acetate, xylitol, sorbitol, thymol, and any combination thereof; and
the second film-forming material is selected from the group consisting of: HPMC, HPC, hydroxyethyl cellulose (HEC), hydroxypropylated high amylose starch, methylmethacrylate-based copolymer, povidone, collagen, gelatin, pectin, cellulose acetate phthalate (CAP), polyvinyl alcohol (PVA), polyvinyl alcohol phthalate (PVAP), and any combination thereof.