FORMULATION OF SODIUM POLYSTYRENE SULFONATE SUSPENSION FOR THE TREATMENT OF HYPERKALEMIA

1 . A pharmaceutically acceptable formulation of sodium polystyrene sulfonate for treatment of hyperkalemia comprising a pharmaceutically acceptable amount of sodium polystyrene sulfonate a suspending agent and a vehicle wherein the formulation is free of sorbitol.

2 . The formulation of claim 1 wherein the vehicle is selected from water, propylene glycol, glycerin, polyethylene glycol, polyglyceryl-6 oleate and mixtures thereof.

3 . The formulation of claim 2 wherein the vehicle is water.

4 . The formulation of claim 1 wherein the suspending agent is selected from gums, cellulosics, clays, carbomer NF, gelatin, polyethylene glycols and lecithin.

5 . The formulation of claim 4 wherein the suspending agent is magnesium aluminum silicate clay.

6 . The formulation of claim 1 which is a ready-to-use formulation.

7 . The formulation of claim 1 wherein the formulation has the following composition:

Sodium Polystyrene Sulfonate

15.0 g/60.0 mL

Solvent/vehicle

0–99%

w/v

Preservative

0–5%

w/v

Suspending Agent

0–50%

w/v

Sweetening Agent

0–5%

w/v

Buffers/pH Adjusters

0–2%

w/v

Flavors

0–3%

v/v

8 . The formulation of claim 7 having the following composition:

Sodium Polystyrene Sulfonate

15.0

g

Propylene Glycol, USP

10%

w/v

Methylparaben, NF

0.18%

w/v

Propylparaben, NF

0.02%

w/v

Magnesium Aluminum Silicate, NF

1.75%

w/v

Saccharin Sodium, USP

0.025%

w/v

Citric Acid, USP (Anhydrous, Fine Gran.)

0.125%

w/v

Flavor

0.75%

v/v

Water, Purified USP

QS

9 . A storage stable pharmaceutically acceptable formulation of sodium polystyrene sulfonate for treatment of hyperkalemia comprising a pharmaceutically acceptable amount of sodium polystyrene sulfonate and a suspending agent wherein the formulation is free of sorbitol.

10 . The formulation of claim 9 wherein the composition is stable when stored under temperatures of about 25° C. and a relative humidity of about 60% to for a period of up to at least 18 months.

11 . The formulation of claim 9 wherein the composition is stable when stored under temperatures of about 40° C. and a relative humidity of about 75% to for a period of up to at least 3 months.

12 . The formulation of claim 9 wherein the formulation meets FDA stability requirements for sodium polystyrene sulfonate suspensions for one of more of pH, potassium exchange capacity, sodium content, methylparaben content, propylparaben content, and resuspendability.

13 . A method of treating a patient suffering from hyperkalemia by administering a formulation according to claim 1 to a patient in need thereof.

14 . The method of claim 13 wherein the formulation is administered orally.

15 . The method of claim 13 wherein the formulation is administered rectally.

16 . A method of treating a patient suffering from hyperkalemia by administering a formulation according to claim 8 to a patient in need thereof.

17 . The method of claim 16 wherein the formulation is administered orally.

18 . The method of claim 16 wherein the formulation is administered rectally.

19 . A process for preparing a formulation comprising sodium polystyrene sulfonate and a suspending agent wherein the formulation is free of sorbitol, wherein the process comprises dispersion of the sodium polystyrene sulfonate and the suspending agent through a rotor-stator system.

20 . The process of claim 19 wherein the suspending agent is magnesium aluminum silicate.