Novel Dispersible Tablet Composition

Abstract

Disclosed herein is a dispersible tablet composition including a pharmacologically active ingredient and at least one excipient that reduces the sedimentation rate of the active ingredient and a process for preparing the same.

1 . A dispersible tablet composition comprising
 (a) at least one pharmacologically active ingredient;   (b) at least one hydrophilic polymer that reduces the sedimentation rate of the pharmacologically active ingredient; and   (c) at least one disintegrant.   
     
     
         2 . The dispersible tablet composition of  claim 1 , wherein the pharmacologically active ingredient is selected from canti-cancer agents, antitussives, antihistamines, decongestants, alkaloids, mineral supplements, laxatives, vitamins, antacids, anti-cholesterolemic, anti-lipid agents, antiarrhythmics, antipyretics, analgesics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, anti-infectives, psychotropic, antimanics, stimulants, gastrointestinal agents, sedatives, antidiarrheal preparations, anti-anginal drugs, vasodilators, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, antitumor drugs, anticoagulants, antithrombotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypoglycemic agents, thyroid and antithyroid preparation, diuretics, antispasmodics, uterine relaxants, mineral and nutritional additives, antiobesity drugs, anabolic drugs, erythropoietic drugs, antiasthmatics, cough suppressants, mucolytics, anti-uricemic drugs, anti-viral drugs and mixtures thereof. 
     
     
         3 . The dispersible tablet composition of  claim 1 , wherein the pharmacologically active ingredient is selected from calcium carbonate, magnesium hydroxide, magnesium oxide, magnesium carbonate, aluminum hydroxide, sodium bicarbonate, dihydroxyaluminum sodium carbonate, bisacodyl, cascara sagrada, phenolphthalein, famotidine, omeprazole, lansoprazole, sucralfate, misoprostol, prucalopride, clarithromycin, amoxicillin, tetracycline, metronidazole, diphenoxylate, loperamide, glycopyrrolate, ondansetron, ibuprofen, naproxen, ketoprofen. indomethacin, diclofenac, sulindac, tolmetin, mefenamic acid, diflunisal, piroxicam, meloxicam, pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, desloratadine, cetirizine, carbamazepine, oxcarbazepine, phenytoin, phensuximide, perphenazine, erythromycin, acyclovir, azithromycin, doxycycline, acetaminophen, atovaquone, tamsulosin, oxytetracycline, paroxetine, pentoxifylline, prednisolone, rofecoxib, sulfamethoxazole, sulfisoxazole, tacrolimus, chlorothiazide, chlorpheniramine, ciprofloxacin, clavulanate, fluconazole, griseofulvin, nevirapine, ziprasidone, ceclor, cefdinir, cefpodoxime proxetil, cefprozil, cefibuten, colistin sulfate, megestrol acetate, mesalamine, trovafloxacin mesylate, verapamil hydrochloride, mycophenolate mofetil and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof. 
     
     
         4 . The dispersible tablet composition of  claim 1 , wherein the pharmacologically active ingredient is selected from oxcarbazepine, acyclovir, azithromycin, cetirizine, and clarithromyin. 
     
     
         5 . The dispersible tablet composition of  claim 1  wherein the hydrophilic polymer is polyalkylene oxide such as polyethylene oxide; cellulose ether such as hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, sodium carboxy methylcellulose, calcium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, microcrystalline cellulose; gum such as gum arabic alginates, agar, guar gum, locust bean, carrageenan, tara, gum arabic, tragacanth, pectin, xanthan, gellan, maltodextrin, galactomannan, pusstulan, laminarin, scleroglucan, gum arabic, inulin, karaya, whelan; polyols such as propylene glycol, dipropylene glycol, polypropylene glycol, polyethylene glycol (PEG), sorbitol and glycerol; starch and starch-based polymer such as pregelatinized starch, acrylic acid and methacrylic acid polymer, and ester thereof, maleic anhydride polymer; polymaleic acid; poly(acrylamides); poly(olefinic alcohol)s; poly(N-vinyl lactams); polyols; polyoxyethylated saccharides; polyoxazolines; polyvinylamines; polyvinylacetates; polyimines; povidone vinylpyrrolidone/vinyl acetate copolymer and polyvinyl acetate, mixture of polyvinyl acetate and polyvinylpyrrolidone, chitin, cyclodextrin, gelatin, chitosan, and combinations thereof. 
     
     
         6 . The dispersible tablet composition of  claim 1  wherein the hydrophilic polymer is polyethylene oxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, sodium carboxymethylcellulose, microcrystalline cellulose, guar gum, xanthan gum, alginates and combinations thereof. 
     
     
         7 . The dispersible tablet composition of  claim 1  wherein the hydrophilic polymer is present in an amount from about 2% to about 75% by weight of the total composition. 
     
     
         8 . The dispersible tablet composition of  claim 7  wherein the hydrophilic polymer is present in an amount from about 10% to about 70% by weight of the total composition. 
     
     
         9 . The dispersible tablet composition of  claim 7  wherein the hydrophilic polymer is present in an amount from about 5% to about 50% by weight of the total composition. 
     
     
         10 . The dispersible tablet composition of  claim 1  wherein the disintegrant is selected from sodium starch glycolate, pregelatinised starch, crosslinked polyvinyl pyrrolidone, cross linked calcium or sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, ion exchange resin, cross-linked polyacrylic acid, alginates, colloidal magnesium-aluminum silicate, calcium silicate and combinations thereof. 
     
     
         11 . The dispersible tablet composition of  claim 10  wherein the disintegrant is selected from sodium starch glycolate, cross linked polyvinyl pyrrolidone, calcium silicate, croscarmellose sodium and combinations thereof. 
     
     
         12 . The dispersible tablet composition of  claim 1  wherein the disintegrant is present in an amount from about 0.25% to about 50% by weight of the total composition. 
     
     
         13 . The dispersible tablet composition of  claim 12  wherein the disintegrant is present in an amount from about 0.5% to about 30% by weight of the total composition. 
     
     
         14 . The dispersible tablet composition of  claim 12  wherein the disintegrant is present in an amount from about 0.5% to about 20% by weight of the total composition. 
     
     
         15 . The dispersible tablet composition of  claim 1  further comprises pharmaceutically acceptable excipients selected from fillers, pH modifiers, lubricants, granulating aids, surfactants, anti-adherents, glidants, stabilizers, taste modifying agents, flavors, or colorants. 
     
     
         16 . The dispersible tablet composition of  claim 1  wherein the tablet is capable of disintegrating within 3 minutes in water at 15-25° C. 
     
     
         17 . A pharmaceutical dispersion comprising dispersion in aqueous medium of dispersible tablet composition comprising:
 (a) at least one pharmacologically active ingredient;   (b) at least one hydrophilic polymer that reduces the sedimentation rate of the pharmacologically active ingredient; and   (c) at least one disintegrant.   
     
     
         18 . A method of administering pharmacologically active ingredient to a patient comprising orally administering to said patient a dispersion of dispersible tablet composition comprising:
 (a) at least one pharmacologically active ingredient;   (b) at least one hydrophilic polymer that reduces the sedimentation rate of the pharmacologically active ingredient; and   (c) at least one disintegrant.