Gellan gum tablet film coating

Abstract

A film coated tablet wherein the tablet is film coated with a gellan gum coating composition containing gellan gum, a plasticizer, and a disintegration aid. Optionally a slip enhancer is added to the composition. A method for coating a tablet with the gellan gum composition wherein the composition is applied as a solution. A method of administering the gellan gum film coated tablet as a pharmaceutical.

What is claimed is:  
     
         1 . A film coated tablet comprising a tablet film coated with a gellan gum coating comprising gellan gum and effective amounts of a plasticizer and a disintegration aid, and optionally an effective amount of a slip enhancer.  
     
     
         2 . The film coated tablet of  claim 1  wherein the gellan gum coating comprises from about 0.025 wt % to about 10 wt % of the total tablet weight.  
     
     
         3 . The film coated tablet of  claim 2  wherein the gellan gum coating comprises from about 0.05 wt % to about 5 wt % of the total tablet weight.  
     
     
         4 . The film coated tablet of  claim 3  wherein the gellen gum coating comprises from about 0.075 wt % to about 3 wt % of the total tablet weight.  
     
     
         5 . The film coated tablet of  claim 1  wherein the plasticizer is selected from the group consisting of propylene glycol, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, glycerol triacetate, polysorbate 80, triethyl citrate, PLAS 2, and acetylated monoglycerides.  
     
     
         6 . The film coated tablet of  claim 1  wherein the disintegration aid is selected from the group consisting of lecithin, pregelatinized modified corn starch, glyceryl carpylate, sorbitan oleate, and sodium lauryl sulfate.  
     
     
         7 . The film coated tablet of  claim 1  wherein the gellan gum coating is at least one of a primary coating, a secondary coating, or a tertiary coating.  
     
     
         8 . The film coated tablet of  claim 1  wherein the gellan gum coating is the only coating.  
     
     
         9 . The film coated tablet of  claim 1  wherein the gellan gum coating further comprises a color.  
     
     
         10 . A film coated tablet comprising a primary coating and a secondary coating, wherein one of the primary coating or secondary coating comprises gellan gum and effective amounts of a plasticizer and a disintegration aid, and optionally, an effective amount of a slip enhancer.  
     
     
         11 . The film coated tablet of  claim 10  wherein the other of the primary coating or secondary coating comprises a polymer other than gellan gum.  
     
     
         12 . The film coated tablet of  claim 10  wherein the primary coating comprises gellan gum and a color and the secondary coating comprises gellan gum.  
     
     
         13 . The film coated tablet of  claim 1  having a level of gloss of about 200 to about 400 when characterization is done using a surface system analyzer.  
     
     
         14 . The film coated tablet of  claim 13  wherein the level of gloss is from about 250 to about 350.  
     
     
         15 . The film coated tablet of  claim 1  wherein the tablet comprises an active drug.  
     
     
         16 . A film coated tablet comprising a tablet coated with a gellan gum coating comprising forming the gellan gum coating by spraying onto the tablet an aqueous solution comprising gellan gum and effective amounts of a plasticizer and a disintegration aid, and optionally an effective amount of a slip enhancer.  
     
     
         17 . The film coated tablet of  claim 16  wherein the aqueous solution contains about 0.1 wt % to about 10 wt % by weight gellan gum based on total weight of the aqueous solution.  
     
     
         18 . The film coated tablet of  claim 17  wherein the aqueous solution contains about 0.5 wt % to about 5 wt % gellan gum based on total weight of the aqueous solution.  
     
     
         19 . The film coated tablet of  claim 18  wherein the aqueous solution contains about 0.5 wt % to about 3.5 wt % gellan gum based on total weight of the aqueous solution.  
     
     
         20 . The film coated tablet of  claim 16  wherein the aqueous solution contains about 0.01 wt % to about 10 wt % of the plasticizer based on total weight of the aqueous composition.  
     
     
         21 . The film coated tablet of  claim 16  wherein the aqueous solution contains about 0.01 wt % to about 10 wt % of the disintegration aid based on total weight of the aqueous composition.  
     
     
         22 . An aqueous gellan gum composition suitable for forming film coated tablets comprising gellan gum, effective amounts of a plasticizer and a disintegration aid, optionally an effective amount of a slip enhancer, and water wherein said gellan gum is present in an amount of about 0.1 wt % to about 10 wt % based on the total weight of the aqueous composition.  
     
     
         23 . The aqueous gellan gum composition of  claim 22  wherein the gellan gum is present in an amount from about 0.5 wt % to about 5 wt % based on total weight of the aqueous solution.  
     
     
         24 . The aqueous gellan gum composition of  claim 23  wherein the gellan gum is present in an amount from about 0.5 wt % to about 3.5 wt % based on total weight of the aqueous solution.  
     
     
         25 . The aqueous gellan gum composition of  claim 22  further comprising a sequestrant.  
     
     
         26 . The aqueous gellan gum composition of  claim 25  wherein the sequestrant is selected from the group consisting of sodium citrate, ammonium citrate, potassium citrate, and EDTA.  
     
     
         27 . The aqueous gellan gum composition of  claim 22  further comprising a preservative.  
     
     
         28 . The aqueous gellan gum composition of  claim 22  further comprising at least one of a sweetener or a flavorant.  
     
     
         29 . A method of treating a patient or animal which comprises administering to said patient a therapeutically effective amount of a coated tablet, wherein the coated tablet comprises a tablet coated with a coating comprising gellan gum and effective amounts of a plasticizer and a disintegration aid, and optionally an effective amount of a slip enhancer, wherein the tablet comprises a therapeutically effective amount of a therapeutically effective drug beneficial to said patient.  
     
     
         30 . The method of  claim 29  wherein the coating comprises from about 0.025 wt % to about 10 wt % of the total coated tablet weight.  
     
     
         31 . The method of  claim 30  wherein the coating comprises from about 0.05 wt % to about 5 wt % of the total coated tablet weight.  
     
     
         32 . The method of  claim 31  wherein the coating comprises from about 0.075 wt % to about 3 wt % of the total coated tablet weight.  
     
     
         33 . A process for preparing a film coated tablet comprising: 
 a. admixing gellan gum, a plasticizer, a disintegration aid, optionally a slip enhancer, and water under shear to prepare an aqueous gellan gum coating composition; and    b. applying the aqueous coating composition in an adherent fashion to a tablet, wherein the gellan gum does not gel prior to application to the tablet.    
     
     
         34 . The process according to  claim 33  further comprising drying the coated tablet.  
     
     
         35 . The process of  claim 33  further comprising applying the aqueous coating composition using an air atomization pressure of about 22 to about 29 psi.  
     
     
         36 . The process of  claim 33  further comprising applying the aqueous coating composition with a nozzle wherein the distance from the nozzle to the tablet is about 2 to about 4 inches.  
     
     
         37 . The process of  claim 33  wherein the aqueous gellan gum composition has a viscosity from about 44 cps to about 55,000 cps.  
     
     
         38 . The process of  claim 37  wherein the viscosity is from about 2,200 to about 50,000 cps.  
     
     
         39 . The process of  claim 33  wherein the aqueous gellan gum composition comprises about 0.1 wt % to about 10 wt % gellan gum based on total weight of the composition.  
     
     
         40 . The process of  claim 39  wherein the aqueous gellan gum composition comprises about 0.5 wt % to about 5 wt % gellan gum based on total weight of the composition.  
     
     
         43 . The process of  claim 40  wherein the aqueous gellan gum composition comprises about 0.5 wt % to about 3.5 wt % gellan gum based on total weight of the composition.  
     
     
         44 . The process of  claim 33  wherein the aqueous gellan gum coating composition is applied at least once to the tablet.