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.
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