Extended release suspension compositions

Abstract

The present invention relates to a method for preparing a stable extended release suspension composition comprising multiple coated cores of an active ingredient by using a suspension base, wherein the suspension base ensures substantially similar in-vitro dissolution release profile of the active ingredient upon storage of the suspension compositions for at least seven days.

1 - 14 . (canceled) 
     
     
         15 . A stable extended release reconstituted powder for suspension composition comprising multiple coated cores of an active ingredient comprising an active ingredient layered onto an inert particle to form the core, a coating layer over said core comprising one or more release-controlling agents to form coated cores having average diameter ranging from about 150 μm to about 500 μm, wherein upon reconstitution with a suspension base, the composition is homogeneous and ensures substantially similar in-vitro dissolution release profile of the active ingredient upon storage of the composition upon reconstitution for at least seven days and wherein the suspension base used for reconstitution of the composition is characterized by having a viscosity in a range of about 500 cps to about 15,000 cps. 
     
     
         16 . The stable extended release reconstituted powder for suspension composition of  claim 15 , wherein the inert particle is selected from the group consisting of a non-pareil seed, a microcrystalline cellulose sphere, a dibasic calcium phosphate bead, a mannitol bead, a silica bead, a tartaric acid pellet, and a wax based pellet. 
     
     
         17 . The stable extended release reconstituted powder for suspension composition of  claim 15 , wherein the suspension base comprises:
 (i) a suspending agent;   (ii) an osmogent; and   (iii) an aqueous vehicle.   
     
     
         18 . The stable extended release reconstituted powder for suspension composition of  claim 17 , wherein the suspending agent is selected from group consisting of cellulose derivatives; carbomers; gums; pectin; dextran; gelatin; polyethylene glycols; polyvinyl compounds; sugar alcohols; and mixtures thereof. 
     
     
         19 . The stable extended release reconstituted powder for suspension composition of  claim 15 , wherein the release-controlling agent is selected from the group consisting of a pH-dependent release-controlling agent, a pH-independent release-controlling agent, and mixtures thereof. 
     
     
         20 . The stable extended release reconstituted powder for suspension composition of  claim 15 , wherein the pH-dependent release-controlling agent is selected from the group consisting of acrylic copolymers; cellulose acetate phthalate; cellulose acetate succinates; hydroxyalkyl cellulose phthalates; hydroxyalkyl cellulose acetate succinates; vinyl acetate phthalates; vinyl acetate succinate; cellulose acetate trimelliate; polyvinyl derivatives; zein; shellac; and mixtures thereof. 
     
     
         21 . The stable extended release reconstituted powder for suspension composition of  claim 15 , wherein the pH-independent release-controlling agent is selected from the group consisting of cellulosic polymers; acrylic copolymers; cellulose acetate;
 polyethylene derivatives; polyvinyl alcohol; polyvinyl acetate; gums; lipids; fatty acids or their salts/derivatives; a mixture of polyvinyl acetate and polyvinyl pyrrolidone; and mixtures thereof.   
     
     
         22 . The stable extended release reconstituted powder for suspension composition of  claim 15 , wherein the active ingredient is selected from the group consisting of metformin, acarbose, miglitol, voglibose, repaglinide, nateglinide, glibenclamide, glimepride, glipizide, gliclazide, chloropropamide, tolbutamide, phenformin, aloglitin, sitagliptin, linagliptin, saxagliptin, rosiglitazone, pioglitazone, troglitazone, faraglitazar, englitazone, darglitazone, isaglitazone, zorglitazone, liraglutide, muraglitazar, peliglitazar, tesaglitazar, canagliflozin, dapagliflozin, remogliflozin, sergliflozin, verapamil, albuterol, salmeterol, acebutolol, sotalol, penicillamine, norfloxacin, ciprofloxacin, ofloxacin, levofloxacin, moxifloxacin, cefpodoxime, tetracycline, demeclocycline hydrochloride, amoxicillin, clavulanate potassium, azithromycin, losartan, irbesartan, eprosartan, valsartan, diltiazem, isosorbide mononitrate, ranolazine, propafenone, hydroxyurea, hydrocodone, delavirdine, pentosan polysulfate, abacavir, amantadine, acyclovir, ganciclovir, valacyclovir, valganciclovir, saquinavir, indinavir, nelfinavir, lamivudine, didanosine, zidovudine, nabumetone, celecoxib, mefenamic acid, naproxen, propoxyphene, cimetidine, ranitidine, albendazole, mebendazole, thiobendazole, pyrazinamide, praziquantel, chlorpromazine, sumatriptan, bupropion, aminobenzoate, pyridostigmine bromide, potassium chloride, niacin, tocainide, quetiapine, fexofenadine, sertraline, chlorpheniramine, rifampin, methenamine, nefazodone, modafinil, metaxalone, morphine, sevelamer, lithium carbonate, flecainide acetate, simethicone, methyldopa, chlorthiazide, metyrosine, procainamide, entacapone, metoprolol, propanolol hydrochloride, chlorzoxazone, tolmetin, tramadol, bepridil, phenytoin, gabapentin, fluconazole, terbinafine, atorvastatin, doxepine, rifabutin, mesalamine, etidronate, nitrofurantoin, choline magnesium trisalicylate, theophylline, nizatidine, methocarbamol, mycophenolate mofetil, tolcapone, ticlopidine, capecitabine, orlistat, colsevelam, meperidine, hydroxychloroquine, guaifenesin, guanfacine, amiodarone, quinidine, atomoxetine, felbamate, pseudoephedrine, carisoprodol, venlafaxine, etodolac, chondrotin, lansoprazole, pantoprazole, esomeprazole, dexlansoprazole, dexmethylphenidate, methylphenidate, sodium oxybate, valproic acid or its salts, divalproex, topiramate, carbamazepine, oxcarbazepine, and isotretinoin. 
     
     
         23 . The stable extended release reconstituted powder for suspension composition of  claim 15 , wherein the suspension base further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of anti-caking agents, wetting agents, preservatives, buffering agents, flavoring agents, anti-oxidants, chelating agents, solubility enhancing agents, pH modifying agents, adsorbents, complexing agents, and combinations thereof.