Phosphate-binding magnesium salts and uses thereof
The present invention provides, among other things, compositions and methods suitable for the treatment of hyperphosphatemia based on phosphate-binding magnesium salts. In some embodiments, the present invention provides compositions and methods suitable for the treatment of hyperphosphatemia based on the combination of phosphate-binding magnesium and calcium salts.
1. A therapeutic composition comprising magnesium glycinate, wherein the composition comprises about 20 mg to about 1200 mg magnesium, the composition is formulated for oral administration and the composition comprises an enteric coating.
2. The composition of claim 1 , wherein the composition comprises about 20 mg to about 600 mg magnesium.
3. The composition of claim 1 , wherein the enteric coating comprises one or more of acetyltributyl citrate, carbomers, cellulose acetate phthalate, cellulose acetate succinate, ethyl cellulose, guar gum, hypromellose acetate succinate, hypromellose phthalate, polymethacrylates, polyvinyl acetate phthalate, shellac, tributyl citrate, triethyl citrate, white wax or zein.
4. The composition of claim 1 , further comprising at least one calcium salt.
5. The composition of claim 4 , wherein the at least one calcium salt is selected from the group consisting of calcium acetate, calcium aceturate, calcium adipate, calcium alaninate, calcium alginate, calcium aminobutyrate, calcium arginate, calcium ascorbate, calcium aspartate, calcium benzoate, calcium besylate, calcium betainate, calcium bromide, calcium buteprate, calcium butyrate, calcium caproate, calcium carbesilate, calcium carbonate, calcium carboxymethylcellulose, calcium camitinate, calcium chloride, calcium ciclotate, calcium citrate, calcium cypionate, calcium enanthate, calcium esylate, calcium ethandisulfonate, calcium formate, calcium fumarate, calcium glucarate, calcium gluceptate, calcium gluconate, calcium glucuronate, calcium glutamate, calcium glycinate, calcium hippurate, calcium hyclate, calcium hydroxide, calcium iodide, calcium isethionate, calcium lactate, calcium lactobionate, calcium levulinate, calcium lysinate, calcium malate, calcium maleate, calcium mesylate, calcium metilsulfate, calcium methylsulfate, calcium naphthoate, calcium napsylate, calcium nicotinate, calcium nitrate, calcium oleate, calcium orotate, calcium oxide, calcium oxoglurate, calcium pamoate, calcium pantothenate, calcium picolinate, calcium pivalate, calcium polygalacturonate, calcium propionate, calcium sorbate, calcium steaglate, calcium stearate, calcium stearyl-2-lactylate, calcium succinate, calcium sulfate, calcium sulfite, calcium tartrate, calcium tebutate, calcium tosylate, calcium triflutate, calcium xinafoate, and combination thereof.
6. The composition of claim 4 , wherein the mass ratio of the at least one calcium salt to magnesium glycinate is between about 100:1 and about 1:100.
7. The composition of claim 4 , wherein the mass ratio of the at least one calcium salt to magnesium glycinate is between about 5:4 and about 4:5.
8. The composition of claim 4 , wherein the mass ratio of the at least one calcium salt to magnesium glycinate is about 1:1.
9. The composition of claim 4 , wherein the at least one calcium salt comprises calcium acetate.
10. The composition of claim 4 , wherein the composition is in a form of a tablet, a cachet, a hard gelatin capsule, a soft gelatin capsule, a lozenge, suspension, or a bead.
11. A method of treating hyperphosphatemia comprising administering the composition of claim 1 to a subject in need thereof.
12. The method of claim 11 , wherein the composition comprises about 20 mg to about 600 mg magnesium.
13. The method of claim 11 , wherein the enteric coating comprises one or more of acetyltributyl citrate, carbomers, cellulose acetate phthalate, cellulose acetate succinate, ethyl cellulose, guar gum, hypromellose acetate succinate, hypromellose phthalate, polymethacrylates, polyvinyl acetate phthalate, shellac, tributyl citrate, triethyl citrate, white wax or zein.
14. The method of claim 11 , wherein the composition further comprises at least one calcium salt.
15. The method of claim 14 , wherein the at least one calcium salt is selected from the group consisting of calcium acetate, calcium aceturate, calcium adipate, calcium alaninate, calcium alginate, calcium aminobutyrate, calcium arginate, calcium ascorbate, calcium aspartate, calcium benzoate, calcium besylate, calcium betainate, calcium bromide, calcium buteprate, calcium butyrate, calcium caproate, calcium carbesilate, calcium carbonate, calcium carboxymethylcellulose, calcium camitinate, calcium chloride, calcium ciclotate, calcium citrate, calcium cypionate, calcium enanthate, calcium esylate, calcium ethandisulfonate, calcium formate, calcium fumarate, calcium glucarate, calcium gluceptate, calcium gluconate, calcium glucuronate, calcium glutamate, calcium glycinate, calcium hippurate, calcium hyclate, calcium hydroxide, calcium iodide, calcium isethionate, calcium lactate, calcium lactobionate, calcium levulinate, calcium lysinate, calcium malate, calcium maleate, calcium mesylate, calcium metilsulfate, calcium methylsulfate, calcium naphthoate, calcium napsylate, calcium nicotinate, calcium nitrate, calcium oleate, calcium orotate, calcium oxide, calcium oxoglurate, calcium pamoate, calcium pantothenate, calcium picolinate, calcium pivalate, calcium polygalacturonate, calcium propionate, calcium sorbate, calcium steaglate, calcium stearate, calcium stearyl-2-lactylate, calcium succinate, calcium sulfate, calcium sulfite, calcium tartrate, calcium tebutate, calcium tosylate, calcium triflutate, calcium xinafoate, and combination thereof.
16. The method of claim 14 , wherein the mass ratio of the at least one calcium salt to magnesium glycinate is between about 100:1 and about 1:100.
17. The method of claim 14 , wherein the mass ratio of the at least one calcium salt to magnesium glycinate is between about 5:4 and about 4:5.
18. The method of claim 14 , wherein the mass ratio of the at least one calcium salt to magnesium glycinate is about 1:1.
19. The method of claim 14 , wherein the at least one calcium salt comprises calcium acetate.
20. The method of claim 14 , wherein the composition is in a form of a tablet, a cachet, a hard gelatin capsule, a soft gelatin capsule, a lozenge, suspension, or a bead.