PROCESS FOR MANUFACTURING PHENYLEPHRINE RESINATE PARTICLES; PHENYLEPHRINE RESINATE PARTICLES; AND USE OF PHENYLEPHRINE RESINATE PARTICLES IN PHARMACEUTICAL FORMULATIONS

1 .- 18 . (canceled)

19 . A process for preparing a drug-resin complex, comprising:

Step A:

mixing purified water and resin in a container to form a first mixture;

filtering the first mixture to form a wet cake containing resin;

rinsing the wet cake containing resin with purified water;

filtering the rinsed wet cake containing resin;

Step B:

mixing purified drug and water in a container to form a drug solution;

Step C:

mixing the filtered wet cake containing resin and a portion of the drug solution in a container to form a second mixture;

filtering the second mixture to form a first loaded resinate;

Step D:

mixing the first loaded resinate and a portion of the drug solution in a container to form a third mixture;

filtering the third mixture to form a second loaded resinate;

Step E:

optionally, repeating step D multiple times; and

Step F:

drying the loaded resinate to form the drug-resin complex.

20 . The process of claim 19 , wherein the drug is phenylephrine.

21 . The process of claim 20 , wherein the resin is a cation polystyrene sulfonate.

22 . The process of claim 21 , wherein the cation polystyrene sulfonate comprises particle sizes of about 74 μm to about 177 μm prior to being combined with the phenylephrine.

23 . The process of claim 22 , wherein the drug resin complex comprises phenylephrine:resin in a ratio of greater than about 1:1.

24 . The process of claim 23 , wherein the drug resin complex comprises phenylephrine:resin in a ratio of about 1.4:1.