Methods and formulations for treating sialic acid deficiencies

Abstract

The present invention relates to compositions and methods for treating sialic acid deficiencies comprising extended release formulations.

1 .- 39 . (canceled) 
     
     
         40 . An extended release pharmaceutical formulation for a human patient in solid oral unit dosage form comprising:
 a) N-acetylneuraminic acid (NeuAc), or a pharmaceutically acceptable salt, or solvate thereof;   b) one or more hydrophilic polymers;   c) one or more anionic, pH-dependent, gel-forming polymers; and   d) one or more hydrocolloid polymers or one or more cationic polymers;   wherein the formulation provides a therapeutically effective and a steady plasma concentration of NeuAc over a period of greater than 6 hours.   
     
     
         41 . The extended release pharmaceutical formulation of  claim 40 , comprising about 20% to about 80% w/w NeuA. 
     
     
         42 . The extended release pharmaceutical formulation of  claim 40 , comprising about 30% to about 60% w/w NeuA. 
     
     
         43 . The extended release pharmaceutical formulation of  claim 40 , comprising about 40% to about 45% w/w NeuA. 
     
     
         44 . The extended release pharmaceutical formulation of  claim 40 , wherein the one or more hydrophilic polymers comprise one or more water-swellable, pH independent polymers selected from the group consisting of hypromellose; hydroxypropyl ethyl cellulose; hydroxypropyl cellulose; hydroxyethyl cellulose; and methyl cellulose. 
     
     
         45 . The extended release pharmaceutical formulation of  claim 41 , wherein the one or more water-swellable, pH independent polymers comprise hypromellose. 
     
     
         46 . The extended release pharmaceutical formulation of  claim 40 , comprising about 20% to about 50% w/w of one or more hydrophilic polymers. 
     
     
         47 . The extended release pharmaceutical formulation of  claim 40 , comprising about 20% to about 30% w/w of one or more hydrophilic polymers. 
     
     
         48 . The extended release pharmaceutical formulation of  claim 40 , wherein one or more anionic, pH-dependent, gel-forming polymers comprise an alginate salt. 
     
     
         49 . The extended release pharmaceutical formulation of  claim 40 , wherein the alginate salt comprises sodium alginate. 
     
     
         50 . The extended release pharmaceutical formulation of  claim 40 , comprising about 15% to about 30% w/w of one or more anionic, pH-dependent, gel-forming polymers. 
     
     
         51 . The extended release pharmaceutical formulation of  claim 40 , comprising about 20% to about 25% w/w of one or more anionic, pH-dependent, gel-forming polymers. 
     
     
         52 . The extended release pharmaceutical formulation of  claim 40 , wherein the one or more hydrocolloid polymers comprise one or more carrageenans. 
     
     
         53 . The extended release pharmaceutical formulation of  claim 47 , wherein the one or more carrageenans comprise lamda carrageenan. 
     
     
         54 . The extended release pharmaceutical formulation of  claim 40 , comprising about bout 1% to about 10% w/w of one or more hydrocolloid polymers or one or more cationic polymers. 
     
     
         55 . The extended release pharmaceutical formulation of  claim 40 , comprising about bout 1% to about 5% w/w of one or more hydrocolloid polymers or one or more cationic polymers. 
     
     
         56 . The extended release pharmaceutical formulation of  claim 40 , further comprising about 1% to about 10% of a mixture of microcrystalline cellulose and colloidal silicon dioxide. 
     
     
         57 . The extended release pharmaceutical formulation of  claim 40 , further comprising about 0.1% to about 1% of one or more lubricants. 
     
     
         58 . The extended release pharmaceutical formulation of  claim 57 , wherein the one or more lubricants comprise magnesium stearate. 
     
     
         59 . The extended release pharmaceutical formulation of  claim 40 , which provides a therapeutically effective amount of sialic acid over a period of about 8 to about 10 hours. 
     
     
         60 . The extended release pharmaceutical formulation of  claim 40 , which is a tablet or capsule. 
     
     
         61 . The extended release pharmaceutical formulation of  claim 40 , wherein the formulation is administered two, three or four times a day.