Coated chewing gum comprising an active substance having systemic activity

Abstract

A coated chewing gum comprising a core of chewing gum and a coating comprising a coating material and one or more active substance(s) in solid form. The use of an active substance in solid form in the coating of a coated chewing gum provides a fast onset of the effect, a better stability of the active substance, and an increased effect thereof in al chewing phases.

1 . A coated chewing gum comprising a core of chewing gum and a coating, wherein said coating comprises a coating material and one or more active substance(s), said active substance(s) being in the form of a powder when applied to the coating and said active substance(s) being selected from the group consisting of a pharmaceutical, a herbal medicine, a vitamin and a nutrient.  
     
     
         2 . The coated chewing gum according to  claim 1 , wherein the pharmaceutical is selected from the group consisting of caffeine, salicylic acid, and derivatives thereof, such as acetylsalicylic acid, choline salicylate, and magnesium salicylate, paracetamol, salts of pentazocine, buprenorphine, and buprenorphine hydrochloride, codeine hydrochloride and phosphate, morphine and salts thereof, methadone hydrochloride, ketobemidone, beta-blockers, calcium antagonists, verapamil hydrochloride, verapamil, nifedipine, nitroglycerin, erythrityl tetranitrate, strychnine and salts thereof, lidocaine, tetracaine hydrochloride, etorphine hydrochloride, atropine, insulin, alfaamylase, polypeptides such as oxytocin, gonadorelin, and LHRH, desmopressin acetate (DDAVP), isoxsuprine hydrochloride, ergotamine compounds, chloroquine phosphate and sulfate, isosorbide, demoxytocin, heparin, lupeol, sucralfate and salts thereof, nicotine and salts and derivatives thereof, lobeline, cinnarizine, dimenhydrinate, difenhydramine, cyclizine, scopolamine, miconazole, nystatin, metronidazole, hydrocortisone, astemizole, benzocaine, glibenglamide, onsaedantronum, acyclovir, sumatriptan, tropisetron, pizotifen, cisapride, domperidone, itraconazole, omeprazole, terfenadine, fluconazole, naratriptan, zolmiriptan, rizatriptan, eletriptan, almotriptan, sildenafil, tolfenamic acid, tramadol, cetirzine, and loratidine.  
     
     
         3 . The coated chewing gum according to  claim 1 , wherein the herbal medicine is selected from the group consisting of  ginkgo biloba , ginseng, saw palmetto,  stevia , ginger, propolis,  echinacea , St. John's Wort, Siberian ginseng, guarana, and garlic.  
     
     
         4 . The coated chewing gum according to  claim 1 , wherein the vitamin is selected from the group consisting of A, B1, B2, B5, B6, B12, D3, E, K, folic acid, niacin, biotin, beta-carotene, ascorbic acid, and salts thereof.  
     
     
         5 . The coated chewing gum according to  claim 1 , wherein the nutrient is selected from the group consisting of amino acids, glycero-phosphates, minerals in the form of salts, complexes and compounds containing calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, molybdenum, potassium, sodium, or cobalt and ubiquinon.  
     
     
         6 . The coated chewing gum according to  claim 1 , wherein the active substance(s) is/are in an encapsulated form.  
     
     
         7 . The coated chewing gum according to  claim 6 , wherein the active substance(s) is/are encapsulated in one or more material(s) selected among fatty substances, waxes, gelatine, gum arabic, starch, cellulose, cellulose derivatives, shellac, polyvinyl acetate, polyethylene, casein, zein, B cyclodextrine, silica, yeast cells, and a mixture of the above encapsulation materials, preferably a mixture of fatty substances and carnauba wax.  
     
     
         8 . The coated chewing gum according to  claim 1 , wherein the coating furthermore comprises one or more active substance(s) selected from group consisting of a flavour, a high potent sweetener, a salt and an acid.  
     
     
         9 . The coated chewing gum according  claim 8 , wherein the flavour is selected from the group consisting of natural flavours, naturally identical flavours, synthetic flavours, plant extracts and natural vegetable flavouring agents.  
     
     
         10 . The coated chewing gum according to  claim 9 , wherein the natural vegetable flavouring agent is selected among fruits and herbs.  
     
     
         11 . The coated chewing gum according to  claim 8 , wherein the acid is selected from the group consisting of citric acid, malic acid, tartaric acid, lactic acid, and ascorbic acid.  
     
     
         12 . The coated chewing gum according to  claim 8 , wherein the high potent sweetener is selected from the group consisting of aspartame, acesulfame K, saccharin, cyclamate, neohespiridine, thaumatin, glycyrrhizin, and salts thereof, monellin, sucrolase, and alitame.  
     
     
         13 . The coated chewing gum according to  claim 8 , wherein the salt is selected from the group consisting of sodium chloride, potassium chloride, ammonium chloride, sodium bicarbonate, and carbamide.  
     
     
         14 . A method for the preparation of a coated chewing gum, said method comprising the following steps: 
 1) preparing a core of chewing gum in a manner known per se,    2) preparing a coating suspension, also in a manner known per se,    3) applying the coating suspension onto the cores of chewing gum in a manner known per se, thus forming a layer of coating suspension,    4) applying one or more active substance(s) in the form a powder, in one or more increment(s), onto the cores of chewing gum of step 3), said active substance(s) being selected from the group consisting of a pharmaceutical, a herbal medicine, a vitamin and a nutrient,    5) repeating step 3) and 4),    6) optionally, applying one or more liquid active substance(s) in one or more increment(s) between the applications of the coating suspension,    7) optionally, finally applying a polishing suspension.    
     
     
         15 . The method according to  claim 14 , wherein step 4) further comprises that the layer of coating suspension on the core of chewing gum is still soft when the active substance(s) is/are applied.  
     
     
         16 . The method according to  claim 14 , wherein the pharmaceutical is selected from the group consisting of caffeine, salicylic acid, and derivatives thereof, such as acetylsalicylic acid, choline salicylate, and magnesium salicylate, paracetamol, salts of pentazocine, buprenorphine, and buprenorphine hydrochloride, codeine hydrochloride and phosphate, morphine and salts thereof, methadone hydrochloride, ketobemidone, beta-blockers, calcium antagonists, verapamil hydrochloride, verapamil, nifedipine, nitroglycerin, erythrityl tetranitrate, strychnine and salts thereof, lidocaine, tetracaine hydrochloride, etorphine hydrochloride, atropine, insulin, alfaamylase, polypeptides such as oxytocin, gonadorelin, and LHRH, desmopressin acetate (DDAVP), isoxsuprine hydrochloride, ergotamine compounds, chloroquine phosphate and sulfate, isosorbide, demoxytocin, heparin, lupeol, sucralfate and salts thereof, nicotine and salts and derivatives thereof, lobeline, cinnarizine, dimenhydrinate, difenhydramine, cyclizine, scopolamine, miconazole, nystatin, metronidazole, hydrocortisone, astemizole, benzocaine, glibenglamide, onsaedantronum, acyclovir, sumatriptan, tropisetron, pizotifen, cisapride, domperidone, itraconazole, omeprazole, terfenadine, fluconazole, naratriptan, zolmiriptan, rizatriptan, eletriptan, almotriptan, sildenafil, tolfenamic acid, tramadol, cetirzine, and loratidine.  
     
     
         17 . The method according to  claim 14 , wherein the herbal medicine is selected from the group consisting of  ginkgo biloba , ginseng, saw palmetto,  stevia , ginger, propolis,  echinacea , St. John's Wort, Siberian ginseng, guarana, and garlic.  
     
     
         18 . The method according to  claim 14 , wherein the vitamin is selected from the group consisting of A, B1, B2, B5, B6, B12, D3, E, K, folic acid, niacin, biotin, beta-carotene, ascorbic acid, and salts thereof.  
     
     
         19 . The method according to  claim 14 , wherein the nutrient is selected from the group consisting of amino acids, glycero-phosphates, minerals in the form of salts, complexes and compounds containing calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, molybdenum, potassium, sodium, or cobalt and ubiquinon.  
     
     
         20 . The method according to  claim 14 , wherein the active substance is in an encapsulated form.  
     
     
         21 . The method according to  claim 20 , wherein the active substance is encapsulated in one or more material(s) selected among fatty substances, waxes, gelatine, gum arabic, starch, cellulose, cellulose derivatives, shellac, polyvinyl acetate, polyethylene, casein, zein, B cyclodextrine, silica, yeast cells, and a mixture of the above encapsulation materials.  
     
     
         22 . The method according to  claim 14 , wherein the coating suspension comprises an aqueous solution of a sugar, a sugar alcohol, an artificial sweetener or mixtures thereof.  
     
     
         23 . The method according to  claim 14 , wherein the coating suspension comprises an aqueous solution of one or more constituent(s) selected among saccharose, dextrose, sorbitol, xylitol, tagatose, mannitol, maltitol, isomalt, aspartame, acesulfame K, saccharine, cyclamate, taline, and neohespiridine.  
     
     
         24 . The method according to  claim 14 , wherein the coating suspension is applied in 2 to 90 increments.  
     
     
         25 . The method according to  claim 14 , wherein the active substance(s) applied in the form of a powder is/are applied in 1 to 10 increment(s) between the dosages of the coating suspension.