Pharmaceutical compositions

Abstract

Pharmaceutical compositions for oral administration, in particular administration as an oral delivery system to be swallowed directly or capable of disintegration in the oral cavity, comprising iron oxy-hydroxide in high loading.

1 - 25 . (canceled) 
     
     
         26 . A pharmaceutical composition comprising iron oxy-hydroxide, saccharose, starch, and at least one excipient,
 wherein the iron oxy-hydroxide is present in the amount of 10 to 80% (w/w) expressed relative to the total weight of the composition,   wherein the iron oxy-hydroxide is stabilized by at least saccharose and/or starch,   wherein the iron oxy-hydroxide is essentially non-bioabsorbable,   wherein the composition is in a form suitable for oral administration,   wherein the dosage form has a disintegration rate in the range from 1 second to 3 minutes, and   wherein the dosage form is chosen from chewable pills, dry powders, granules, sachets containing granules, and stick packs containing granules.   
     
     
         27 . The pharmaceutical composition according to  claim 26 , wherein the starch comprises native starch and pregelatinized starch. 
     
     
         28 . The pharmaceutical composition according to  claim 27 , wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 
     
     
         29 . The pharmaceutical composition according to  claim 26 , wherein the dosage form is chosen from granules, sachets containing granules, and stick packs containing granules. 
     
     
         30 . The pharmaceutical composition according to  claim 27 , wherein the dosage form is chosen from granules, sachets containing granules, and stick packs containing granules. 
     
     
         31 . The pharmaceutical composition according to  claim 28 , wherein the dosage form is chosen from granules, sachets containing granules, and stick packs containing granules. 
     
     
         32 . The pharmaceutical composition according to  claim 26 , wherein the dosage form is chosen from dry powders. 
     
     
         33 . The pharmaceutical composition according to  claim 27 , wherein the dosage form is chosen from dry powders. 
     
     
         34 . The pharmaceutical composition according to  claim 28 , wherein the dosage form is chosen from dry powders. 
     
     
         35 . The pharmaceutical composition according to  claim 32 , wherein the disintegration rate is less than 30 seconds. 
     
     
         36 . The pharmaceutical composition according to  claim 33 , wherein the disintegration rate is less than 30 seconds. 
     
     
         37 . The pharmaceutical composition according to  claim 34 , wherein the disintegration rate is less than 30 seconds. 
     
     
         38 . The pharmaceutical composition according to  claim 26 , wherein the at least one excipient is chosen from modified starches and cross-linked polyvinylpyrrolidones. 
     
     
         39 . The pharmaceutical composition according to  claim 27 , wherein the at least one excipient is chosen from modified starches and cross-linked polyvinylpyrrolidones. 
     
     
         40 . The pharmaceutical composition according to  claim 32 , wherein the at least one excipient is chosen from modified starches and cross-linked polyvinylpyrrolidones. 
     
     
         41 . The pharmaceutical composition according to  claim 33 , wherein the at least one excipient is chosen from modified starches and cross-linked polyvinylpyrrolidones. 
     
     
         42 . The pharmaceutical composition according to  claim 34 , wherein the at least one excipient is chosen from modified starches and cross-linked polyvinylpyrrolidones. 
     
     
         43 . The pharmaceutical composition according to  claim 35 , wherein the at least one excipient is chosen from modified starches and cross-linked polyvinylpyrrolidones. 
     
     
         44 . The pharmaceutical composition according to  claim 36 , wherein the at least one excipient is chosen from modified starches and cross-linked polyvinylpyrrolidones. 
     
     
         45 . The pharmaceutical composition according to  claim 38 , further comprising at least one additional excipient chosen from starches, methylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, clays, cellulose, powdered cellulose, pregelatinized starch, sodium alginate, alginic acid, guar gum, magnesium aluminum silicate, and polacrilin potassium. 
     
     
         46 . The pharmaceutical composition according to  claim 39 , further comprising at least one additional excipient chosen from starches, methylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, clays, cellulose, powdered cellulose, pregelatinized starch, sodium alginate, alginic acid, guar gum, magnesium aluminum silicate, and polacrilin potassium. 
     
     
         47 . The pharmaceutical composition according to  claim 40 , further comprising at least one additional excipient chosen from starches, methylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, clays, cellulose, powdered cellulose, pregelatinized starch, sodium alginate, alginic acid, guar gum, magnesium aluminum silicate, and polacrilin potassium. 
     
     
         48 . The pharmaceutical composition according to  claim 41 , further comprising at least one additional excipient chosen from starches, methylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, clays, cellulose, powdered cellulose, pregelatinized starch, sodium alginate, alginic acid, guar gum, magnesium aluminum silicate, and polacrilin potassium. 
     
     
         49 . The pharmaceutical composition according to  claim 42 , further comprising at least one additional excipient chosen from starches, methylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, clays, cellulose, powdered cellulose, pregelatinized starch, sodium alginate, alginic acid, guar gum, magnesium aluminum silicate, and polacrilin potassium. 
     
     
         50 . The pharmaceutical composition according to  claim 43 , further comprising at least one additional excipient chosen from starches, methylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, clays, cellulose, powdered cellulose, pregelatinized starch, sodium alginate, alginic acid, guar gum, magnesium aluminum silicate, and polacrilin potassium. 
     
     
         51 . The pharmaceutical composition according to  claim 44 , further comprising at least one additional excipient chosen from starches, methylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, clays, cellulose, powdered cellulose, pregelatinized starch, sodium alginate, alginic acid, guar gum, magnesium aluminum silicate, and polacrilin potassium. 
     
     
         52 . The pharmaceutical composition according to  claim 26 , wherein the composition has an iron release rate of below 2.5% w/w as measure in water at a pH of 3, wherein samples were taken after 2 hours and iron content analysed by titration. 
     
     
         53 . The pharmaceutical composition according to  claim 27 , wherein the composition has an iron release rate of below 2.5% w/w as measure in water at a pH of 3, wherein samples were taken after 2 hours and iron content analysed by titration. 
     
     
         54 . The pharmaceutical composition according to  claim 38 , wherein the composition has an iron release rate of below 2.5% w/w as measure in water at a pH of 3, wherein samples were taken after 2 hours and iron content analysed by titration. 
     
     
         55 . The pharmaceutical composition according to  claim 39 , wherein the composition has an iron release rate of below 2.5% w/w as measure in water at a pH of 3, wherein samples were taken after 2 hours and iron content analysed by titration.