Stabilized Amine-Containing Actives in Oral Film Compositions

Abstract

The present invention relates to compositions relating to films containing active pharmaceutical agents. In particular, the present invention relates to methods and systems useful for stabilizing amine-containing actives for dispersion in a film product.

1 . An edible film dosage composition comprising:
 a. an active ingredient consisting essentially of ondansetron;   b. a polymeric carrier matrix;   c. sucralose; and   d. monoammonium glycyrrhizinate.   
     
     
         2 . The edible film dosage composition of  claim 1 , wherein said polymeric carrier matrix comprises a polymer selected from the group consisting of polyethylene oxide, hydroxypropylmethyl cellulose, xanthan gum, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polydextrose, polyvinyl alcohol, sodium alginate, propylene glycol alginate, carrageenan, polyethylene glycol, pullulan, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, copolymers of acrylic acid and alkyl acrylate, carboxyvinyl copolymers, starch, gelatin, pectin, ethyl cellulose, hydroxypropyl ethyl cellulose, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, poly(glycolic acid) (PGA), poly(lactic acid) (PLA), polydioxanoes, polyoxalates, poly(α-esters), polyanhydrides, polyacetates, polycaprolactones, poly(orthoesters), polyamino acids, polyaminocarbonates, polyurethanes, polycarbonates, polyamides, poly(alkyl cyanoacrylates), stereopolymers of L- and D-lactic acid, copolymers of bis(p-carboxyphenoxy) propane acid and sebacic acid, sebacic acid copolymers, copolymers of caprolactone, poly(lactic acid)/poly(glycolic acid)/polyethyleneglycol copolymers, copolymers of polyurethane and (poly(lactic acid), copolymers of polyurethane and poly(lactic acid), copolymers of α-amino acids, copolymers of α-amino acids and caproic acid, copolymers of α-benzyl glutamate and polyethylene glycol, copolymers of succinate and poly(glycols), polyphosphazene, polyhydroxy-alkanoates, acrylic polymers, vinyl acetate, sodium sulphonated polyesters, carboxylated acrylics, trimethylpentanediol/adipic acid/glycerin cross polymer, polyglycerol-2-diisostearate/IPDI copolymer, carboxylated vinyl acetate copolymer, vinylpyrrolicone/vinyl acetate/alkylaminoacrylate terpolymers, vinylpyrrolidone/vinyl acetate copolymer, and combinations thereof. 
     
     
         3 . The edible film dosage composition of  claim 2 , wherein said polymeric carrier matrix comprises from about 20% to about 70% by weight of polyethylene oxide and from about 20% to about 70% by weight of hydroxypropylmethyl cellulose based on the total weight of the polymeric carrier matrix. 
     
     
         4 . The edible film dosage composition of  claim 2 , wherein said polymeric carrier matrix comprises from about 20% to about 60% by weight of polyethylene oxide and from about 20% to about 60% by weight of hydroxypropylmethyl cellulose based on the total weight of the polymeric carrier matrix. 
     
     
         5 . The edible film dosage composition of  claim 1 , further comprising an additional sweetener. 
     
     
         6 . The edible film dosage composition of  claim 5 , wherein said additional sweetener is selected from the group consisting of glucose, dextrose, invert sugar, fructose, saccharin and salts thereof, dipeptide sweeteners, dihydrochalcone compounds,  Stevia Rebaudiana , chloro derivatives of sucrose, sugar alcohols, hydrogenated starch hydrolysates, 3,6-dihydro-6-methyl-1-1-1,2,3-oxathiazin-4-one-2,2-dioxide and salts thereof, natural intensive sweeteners, and combinations thereof. 
     
     
         7 . The edible film dosage composition of  claim 6 , wherein said additional sweetener is a sugar alcohol. 
     
     
         8 . The edible film dosage composition of  claim 7 , wherein said sugar alcohol is selected from the group consisting of erythritol, sorbitol, mannitol, xylitol, and combinations thereof. 
     
     
         9 . The edible film dosage composition of  claim 1 , further comprising a flavor. 
     
     
         10 . The edible film dosage composition of  claim 9 , wherein said flavor is selected from the group consisting of mint oils, cocoa, lemon oil, orange oil, grape oil, lime oil, grapefruit oil, fruit essences, fruit flavors aldehydes and esters, and combinations thereof. 
     
     
         11 . The edible film dosage composition of  claim 10 , wherein said flavor is peppermint flavor. 
     
     
         12 . The edible film dosage composition of  claim 1 , further comprising a coloring agent or opacifier. 
     
     
         13 . The edible film dosage composition of  claim 12 , wherein said coloring agent or opacifier is selected from the group consisting of organic pigments, inorganic pigments, coloring agents of natural origin, and combinations thereof. 
     
     
         14 . The edible film dosage composition of  claim 12 , wherein said inorganic pigment is selected from the group consisting of titanium oxides, magnesium oxides, aluminum oxides, silicon oxides, iron oxides, and combinations thereof. 
     
     
         15 . The edible film dosage composition of  claim 14 , wherein said inorganic pigment is titanium dioxide and is present in an amount of from about 0.02 to about 3% by weight based on the total weight of the edible film dosage composition. 
     
     
         16 . The edible film dosage composition of  claim 15 , wherein said inorganic pigment is titanium dioxide and is present in an amount of from about 0.02 to about 1% by weight based on the total weight of the edible film dosage composition. 
     
     
         17 . The edible film dosage composition of  claim 1 , further comprising calcium carbonate, sodium bicarbonate, fumed silica, butylated hydroxytoluene, and combinations thereof 
     
     
         18 . The edible film dosage composition of  claim 1 , further comprising an additional additive selected from the group consisting of excipients, lubricants, buffering agents, stabilizers, blowing agents, fillers, bulking agents, fragrances, release modifiers, adjuvants, plasticizers, flow accelerators, mold release agents, polyols, granulating agents, diluents, binders, buffers, absorbents, glidants, adhesives, anti-adherents, acidulants, softeners, resins, demulcents, solvents, surfactants, emulsifiers, and combinations thereof.