Coated particles and pharmaceutical dosage forms

Abstract

The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.

1 - 32 . (canceled)  
   
   
       33 . A coated particle comprising an active ingredient and a coating, wherein said coating comprises a film-forming substance selected from the group consisting of polyvinyl alcohol, a cellulose derivative, and combinations thereof.  
   
   
       34 . The coated particle according to  claim 33 , wherein the cellulose derivative is sodium carboxymethylcellulose.  
   
   
       35 . The coated particle according to  claim 33 , wherein the active substance is selected from the group consisting of pravastatin, atorvastatin, rosuvastatin, itavastatin, simvastatin, lovastatin, captopril, chlorpromazine, morphine, L-ascorbic acid, vitamin E, phenylbutazone, tetracyclines and omeprazole.  
   
   
       36 . The coated particle according to  claim 35  wherein the active substance is atorvastatin calcium.  
   
   
       37 . The coated particle according to  claim 33 , wherein the coating further comprises a pharmaceutical excipient selected from the group consisting of a buffering agent, alkalizing agent, and surface active agent.  
   
   
       38 . The coated particle according to  claim 37 , wherein the buffering agent is selected from the group consisting of an alkali metal salt, alkali-earth metal salt, ammonium salt of citric acid, ascorbic acid, maleic acid, sorbic acid, succinic acid, benzoic acid, phosphoric acid, carbonic acid, sulfuric acid, nitric acid, boric acid, silicic acid, an amine in combination with a strong or weak acid, ion exchanger, and combinations thereof.  
   
   
       39 . The coated particle according to  claim 38 , wherein the buffering agent is tromethamine.  
   
   
       40 . The coated particle according to  claim 37 , wherein the alkalizing agent is selected from the group consisting of oxides and hydroxides of alkaline and/or alkali-earth metals, oxides of Group the 4, 5 and/or 6 group of the periodic table, amines and alkali amino acids.  
   
   
       41 . The coated particle according to  claim 37 , wherein the surface active agent is selected from the group consisting of an ionic surfactant, nonionic surfactant, cationic surfactant, and combinations thereof.  
   
   
       42 . The coated particle according to  claim 41 , wherein the surface active agent is sodium lauryl sulphate.  
   
   
       43 . The coated particle according to  claim 37 , wherein the coating further comprises a pharmaceutical excipient selected from the group consisting of a plasticizer, viscosity-increasing agent of a coating dispersion, filler, lubricant, and colorant.  
   
   
       44 . The coated particle according to  claim 43 , wherein the plasticizer is selected from the group consisting of glycerol, diglycerol, ethanolamine, ethylene glycol, polyethylene glycols, glycerol monomethyl ether, glycerol monochloridine, 2,3-butylene glycol, 1,2,6-hyxanetriol, 2-nitro-2-methyl-1,3-propandiol, propylene glycol, glyceryl triacetate, polyoxyethylene/polyoxypropylene copolymers, triethyl citrate, oleic acid, fractionated coconut oil, and combinations thereof.  
   
   
       45 . The coated particle according to  claim 43 , wherein the viscosity-increasing agent is selected from the group consisting of carboxymethylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, xanthan, alginates, chitosan, and combinations thereof.  
   
   
       46 . The coated particle according to  claim 43 , wherein the filler is selected from the group consisting of lactose, polydextrose, maltodextrin, mannitol, starch, and combinations thereof.  
   
   
       47 . The coated particles according to  claim 43 , wherein the lubricant is selected from the group consisting of talc, magnesium stearate, colloidal silicon dioxide, stearic acid, calcium stearate, and combinations thereof.  
   
   
       48 . A composition comprising particles, wherein said particles comprise an active ingredient and a coating, wherein said coating comprises a film-forming substance selected from the group consisting of polyvinyl alcohol, a cellulose derivative, and combinations thereof.  
   
   
       49 . The composition according to  claim 48  which has a water content less than 5 weight percent, based on the total weight of the composition.  
   
   
       50 . The composition according to  claim 49 , wherein the water content is less than 4 weight percent, based on the total weight of the composition.  
   
   
       51 . The composition according to  claim 49 , wherein the water content is less than 3 weight percent, based on the total weight of the composition.