Treatment of allergic conditions

Abstract

Orally administered sodium cromoglycate has been found to be effective in the treatment of allergic conditions such as asthma, general food allergies, ulcerative colitis, atopic eczema, chronic urticaria and irritable bowel syndrome if it is presented such that the sodium cromoglycate becomes bioavailable within 10 minutes of exposure to intestinal fluid. The sodium cromoglycate may be presented as enteric-coated tablets or individually enteric-coated pellets or microgranules packaged with disintegrant in a ratio of at least 1.2:1 disintegrant:sodium cromoglycate (w:w). Optionally, the patients are first selected to have a total serum IgE level of at least 150 iu/ml.

1 . An oral drug delivery composition comprising a chromone wherein (1) not more than 10% of the chromone dissolves after two hours exposure of the composition to simulated gastric fluid and (2) at least 15% of the chromone dissolves within 10 minutes of subsequent exposure of the composition to simulated intestinal fluid, said composition further comprising a material to aid bioavailability of the chromone, which material consists essentially of at least one disintegrant and optionally one or more surfactants, and wherein the disintegrant is present at a ratio of at least 1.2:1 (w:w) of disintegrant to chromone and wherein said disintegrant is selected from the group consisting of microcrystalline cellulose, croscarmellose sodium, crosprovidone, sodium starch glycolate, and combinations thereof.  
     
     
         2 . A composition according to  claim 1  wherein the composition is formulated as a tablet.  
     
     
         3 . A composition according to  claim 2  wherein the tablet has an enteric coating.  
     
     
         4 . A composition according to  claim 2  wherein the composition is still in the form of a tablet at the end of the exposure of the composition to gastric fluid.  
     
     
         5 . The composition according to any one of claims  2  wherein the tablet comprises between about 50 mg and 200 mg of chromone.  
     
     
         6 . A composition according to  claim 1  wherein the composition comprises substantially spherical pellets of up to 5 mm diameter comprising the chromone, each pellet having an enteric coating.  
     
     
         7 . A composition according to  claim 1  wherein the disintegrant is microcrystalline cellulose.  
     
     
         8 . A composition according to  claim 1  wherein the chromone is sodium cromoglycate  
     
     
         9 . An oral drug delivery composition comprising a chromone wherein the composition further comprises a material to aid bioavailability of the chromone, which material consists essentially of at least one disintegrant and optionally one or more surfactants, and wherein the disintegrant is present at a ratio of at least 1.5:1 (w:w) of disintegrant to chromone.  
     
     
         10 . A composition according to  claim 9  wherein the ratio of disintegrant to chromone is between about 1.5:1 and 2.5:1  
     
     
         11 . A composition according to  claim 9  wherein the disintegrant is microcrystalline cellulose.  
     
     
         12 . A composition according to  claim 1  wherein said one or more surfactants are selected from the group consisting of an amphoteric surfactant and a surfactant having a hydrophile-lipophile balance (HLB) value of less than about 10.  
     
     
         13 . A composition according to  claim 9  wherein the chromone is sodium cromoglycate.  
     
     
         14 . An oral drug delivery composition comprising a chromone wherein (1) not more than 10% of the chromone dissolves after two hours exposure of the composition to simulated gastric fluid, and (2) at least about 80% of the chromone dissolves within about 5 minutes of subsequent exposure of the composition to simulated intestinal fluid, said composition further comprising a material to aid bioavailability of the chromone, which material consists essentially of at least one disintegrant and optionally one or more surfactants, and wherein the disintegrant is microcrystalline cellulose present at a ratio of at least 1.4:1 (w:w) of microcrystalline cellulose to chromone.  
     
     
         15 . An oral drug delivery composition comprising a chromone wherein (1) not more than 10% of the chromone dissolves after two hours exposure of the composition to simulated gastric fluid, and (2) at least about 27% of the chromone dissolves within about 10 minutes of subsequent exposure of the composition to simulated intestinal fluid, said composition further comprising a material to aid bioavailability of the chromone, which material consists essentially of at least one disintegrant and optionally one or more surfactants, and wherein the disintegrant is present at a ratio of at least 1.2:1 (w:w) of disintegrant to chromone, wherein said disintegrant is selected from the group consisting of croscarmellose sodium, crosprovidone, sodium starch glycolate, and a blend of croscarmellose sodium and microcrystalline cellulose at a ratio of about 1:9 (w:w) of croscarmellose sodium to microcrystalline cellulose.  
     
     
         16 . An oral drug delivery composition comprising a chromone wherein (1) not more than 10% of the chromone dissolves after two hours exposure of the composition to simulated gastric fluid, and (2) at least about 21% of the chromone dissolves within about 5 minutes of subsequent exposure of the composition to simulated intestinal fluid, said composition further comprising a material to aid bioavailability of the chromone, which material consists essentially of at least one disintegrant and optionally one or more surfactants, and wherein the disintegrant is present at a ratio of at least 1.4:1 (w:w) of disintegrant to chromone, wherein said disintegrant is selected from the group consisting of super disintegrants in the form of a cross-linked cellulose, a cross-linked polymer, a cross-linked starch, and microcrystalline cellulose.