Tabletting process

Abstract

A process for producing a compressed solid dosage form containing an active ingredient. The process includes a step of preparing core elements containing the active ingredient. Optionally the core elements are coated with a pharmaceutically acceptable coating layer to form coated pellets. The core elements or pellets are treated with an anti-static agent and compressed with suitable excipients to form the compressed solid dosage form. Preferred anti static agents are starch, microcrystalline cellulose, kaolin, bentonite, silicates, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate and glyceryl behenate.

1 . A process for producing a tablet containing an active ingredient, the process comprising:
 providing core elements containing the active ingredient;   coating the core elements with a pharmaceutically acceptable coating layer;   dusting the coated core elements with a powdered anti-static agent selected from the group consisting of kaolin, magnesium trisilicate, starch, microcrystalline cellulose, bentonite, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate, and glycerol behenate, the group not including talc, to form coated pellets; and   then compressing the coated pellets with tabletting excipients to form the tablet, wherein the anti-static agent is about 0.5% (by weight) of the coated pellets and wherein the percentage of coated pellets in each tablet is in the range of 20 to 50% by weight of the total tablet weight.   
     
     
         2 . A process according to  claim 1 , wherein the step of dusting the coated core elements with an anti-static agent reduces accumulated static charge or prevents or reduces accumulation of static charge. 
     
     
         3 . A process according to  claim 1 , wherein the process further includes a step of drying the coated core elements or the coated pellets to remove a desired amount of solvent used in the core element preparation or coating steps. 
     
     
         4 . A process according to  claim 3 , wherein the powdered anti-static agent is added to the coated core elements during the drying step 
     
     
         5 . A process according to  claim 3 , wherein the powdered anti-static agent is added to the coated core elements after the drying step. 
     
     
         6 . A process according to  claim 3 , wherein the drying step is carried out in a fluid bed dryer. 
     
     
         7 . A process according to  claim 1 , wherein the anti-static agent is selected from the group including starch, microcrystalline cellulose, magnesium trisilicate and kaolin. 
     
     
         8 . A process according to  claim 1 , wherein the anti-static agent is starch. 
     
     
         9 . A process according to  claim 1 , wherein the compression force at which the tablet is formed is less than 40 kiloNewtons. 
     
     
         10 . A process according to  claim 12 , wherein the strength of the tablet is about 5 to about 15 kiloponds. 
     
     
         11 . A process according to  claim 1 , wherein the active ingredient is a pharmaceutically active ingredient. 
     
     
         12 . A process according to  claim 11 , wherein the pharmaceutically active ingredient is selected from the list including doxycycline, tetracycline, oxytetracycline, minocycline, chlortetracycline, demeclocycline, and pharmaceutically acceptable salts thereof. 
     
     
         13 . A process according to  claim 1 , wherein the active ingredient is present in the core element in an amount from 5 to 95% by weight, based on the total weight of the core element. 
     
     
         14 . A process according to  claim 1 , wherein the percentage of coated pellets in each tablet is in the range of 25 to 35% by weight of the total tablet weight. 
     
     
         15 . A process according to  claim 1 , wherein the percentage of coated pellets in each tablet is about 30% by weight of the total tablet weight. 
     
     
         16 . A tablet that is formed according to the process of  claim 1 . 
     
     
         17 . A tablet comprising coated pellets and tabletting excipients, the coated pellets comprising core elements containing an active ingredient, the core elements having a pharmaceutically acceptable coating layer coated with an anti-static agent selected from the group consisting of kaolin, magnesium trisilicate, starch, microcrystalline cellulose, bentonite, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate, and glycerol behenate, the group not including talc, wherein the anti-static agent is about 0.5% (by weight) of the coated pellets and wherein the percentage of coated pellets in each tablet is in the range of 20 to 50% by weight of the total tablet weight. 
     
     
         18 . A tablet according to  claim 17 , wherein the anti-static agent is selected from the group including starch, microcrystalline cellulose, magnesium trisilicate and kaolin. 
     
     
         19 . A tablet according to  claim 17 , wherein the anti-static agent is starch. 
     
     
         20 . A tablet according to  claim 17 , wherein the strength of the tablet is about 5 to about 15 kiloponds. 
     
     
         21 . A tablet according to  claim 17 , wherein the active ingredient is a pharmaceutically active ingredient. 
     
     
         22 . A tablet according to  claim 21 , wherein the pharmaceutically active ingredient is selected from the list including doxycycline, tetracycline, oxytetracycline, minocycline, chlortetracycline, demeclocycline, and pharmaceutically acceptable salts thereof. 
     
     
         23 . A tablet according to  claim 17 , wherein the active ingredient is present in the core element in an amount from 5 to 95% by weight, based on the total weight of the core element. 
     
     
         24 . A tablet according to  claim 17 , wherein the percentage of coated pellets in each tablet is in the range of 25 to 35% by weight of the total tablet weight. 
     
     
         25 . A tablet according to  claim 17 , wherein the percentage of coated pellets in each tablet is about 30% by weight of the total tablet weight.