NEW FORMULATIONS AND USE THEREOF
A pharmaceutical formulation comprising one or more active pharmaceutical ingredients (APIs) suitable for intraoral uptake, that comprises cocoa powder, a process for manufacturing the formulation and use of the formulation for medical treatment.
1 . An orally administered pharmaceutical formulation comprising at least one active pharmaceutical ingredient capable of intraoral uptake and cocoa powder, wherein the active pharmaceutical ingredient is selected from the group consisting of selegiline, propranolol, and chlorpheniramine.
2 . The formulation according to claim 1 further comprising at least one lipid.
3 . The formulation according to claim 2 wherein said lipid ingredient is selected from the group consisting of cocoa butter, cocoa butter equivalents, cocoa butter substitutes, cocoa butter replacers, cocoa butter improvers, coconut, palmkernel oil, palm oil, shea butter, karite butter, illipe butter, mango kernel oil, sal fat, corn oil, sunflower oil, hybrid sunflower oil, soybean oil, rapeseed oil, canola oil, olive oil, ricebran oil, cottonseed oil, arachis (peanut, groundnut) oil, fish oil, tallow, lard, butterfat and mixtures thereof.
4 . The formulation according to claim 3 , wherein said lipid comprises a member selected from the group consisting of cocoa butter equivalents, cocoa butter substitutes and cocoa butter replacers.
5 . The formulation according to claim 1 , further comprising at least one buffering agent.
6 . The formulation according to claim 5 , wherein said buffering agent is selected from the group consisting of carbonates, bicarbonates, acetates, gluconates, glycerophosphates, phosphates or glycinates of sodium, potassium or ammonium, and mixtures thereof.
7 . The formulation according to claim 1 , further comprising at least one sweetener.
8 . The formulation according to claim 7 , wherein said at least one sweetener is selected from the group consisting of sucrose, aspartame, acesulfame potassium, saccharine, sodium saccharine, cyclamate, glycyrrhizine, thaumatin, sucralose, dihydrochalcon, neohesperidin dihydrochalcone, alitame, miraculin, monellin, stevside and salts and mixtures thereof.
9 . The formulation according to claim 1 , further comprising at least one emulsifier.
10 . The formulation according to claim 9 , wherein said emulsifier is selected from the group consisting of lecithin, poloxamer, polyoxyethylene alkyl ether, polyoxyethylene castor oil derivative, polyoxyethylene sorbitan fatty acid ester, monoglyceride, diglyceride and esther thereof, polyoxyethylene stearate, polyglycerolester of fatty acids sorbitan fatty acid ester, fatty acid, soap of fatty acid, lactylate, especially sodium and/or calcium stearoyllactylate, sodium lauryl sulfate, latanol, phosphatidylcholine, phosphatidylethanolamine, and mixtures thereof.
11 . The formulation according to claim 10 , wherein said one or more emulsifier is lecithin.
12 . The formulation according to claim 1 , further comprising a taste modifier, selected from the group consisting of sodium chloride, monosodium glutamate and ammonium glycyrrhizinate.
13 . The formulation according to claim 1 , further comprising a coloring agent, selected from the group consisting of titanium dioxide, iron oxides and aluminum lakes.