Gelling multiparticulates

1. A multiparticulate composition comprising a plurality of particles comprising:

>60 wt % of an active agent;

1-6 wt % of a gelling agent;

0.05-1 wt % of an inorganic salt; and

up to 38.95 wt % of a water-soluble polymer, wherein the water-soluble polymer comprises polyvinylpyrrolidone (PVP), a copolymer of vinylpyrrolidone and vinyl acetate (PVP-VA), polyethylene glycol (PEG), polyethylene oxide (PEO), or any combination thereof.

2. The multiparticulate composition of claim 1 , wherein the gelling agent comprises gellan gum, carrageenan, agar, pectin, or any combination thereof.

3. The multiparticulate composition of claim 1 , wherein the inorganic salt comprises an alkali metal salt, an alkaline earth metal salt, or a combination thereof.

4. The multiparticulate composition of claim 3 , wherein:

(i) the gelling agent comprises gellan gum and the inorganic salt comprises calcium chloride; or

(ii) the gelling agent comprises carrageenan and the inorganic salt comprises potassium chloride.

5. The multiparticulate composition of claim 1 , wherein the water-soluble polymer comprises PVP having a weight average molecular weight of from 30,000 to 50,000 daltons.

6. The multiparticulate composition of claim 1 , wherein the plurality of particles has an average diameter within a range of from 100 μm to 2 mm as measured by laser diffraction.

7. The multiparticulate composition of claim 1 , further comprising a colorant.

8. The multiparticulate composition of claim 1 , further comprising an outer coating on the particles.

9. A dosage form comprising the multiparticulate composition of claim 1 , wherein the dosage form is a capsule, a tablet, or a powder mix.

10. The multiparticulate composition of claim 1 , consisting essentially of:

the active agent;

the gelling agent;

the inorganic salt;

the water-soluble polymer;

0-2 wt % of a colorant; and

optionally, an outer coating on the particles.

11. A multiparticulate composition comprising a plurality of particles comprising:

>60 wt % of caffeine:

1-6 wt % of a gelling agent; and

up to 39 wt % of a water-soluble polymer, wherein the water-soluble polymer comprises polyvinylpyrrolidone (PVP), a copolymer of vinylpyrrolidone and vinyl acetate (PVP-VA), polyethylene glycol (PEG), polyethylene oxide (PEO), or any combination thereof.

12. A multiparticulate composition comprising a plurality of particles comprising:

75-95 wt % caffeine;

1-3 wt % gellan gum, carrageenan, or a combination thereof;

0.05-0.3 wt % calcium chloride, potassium chloride, or a combination thereof; and

1-23.95 wt % PVP.

13. A method of making the multiparticulate composition of claim 1 , the method comprising:

preparing an aqueous suspension comprising an active agent, a gelling agent, an inorganic salt, and a water-soluble polymer, wherein (i) the water-soluble polymer comprises polyvinylpyrrolidone (PVP), a copolymer of vinylpyrrolidone and vinyl acetate (PVP-VA), polyethylene glycol (PEG), polyethylene oxide (PEO), or any combination thereof, (ii) a concentration of the active agent in the aqueous suspension exceeds a solubility limit of the active agent in the aqueous suspension such that the active agent is not completely dissolved in the aqueous suspension, and (iii) a combined mass of the active agent, the gelling agent, and the water-soluble polymer includes >60 wt % of the active agent, 1-6 wt % of the gelling agent, 0.05-1 wt % of the inorganic salt, and up to 38.95 wt % of the water-soluble polymer;

forming droplets of the aqueous suspension, wherein the droplets are formed at a temperature above a gelation temperature of the aqueous suspension;

forming congealed particles from the droplets, the congealed particles comprising the active agent, the gelling agent, the water-soluble polymer, and water; and

drying the congealed particles to form a plurality of dried particles comprising >60 wt % of the active agent, 1-6 wt % of the gelling agent, and up to 39 wt % of the water-soluble polymer.

14. The method of claim 13 , wherein forming droplets of the aqueous suspension comprises dispensing the aqueous suspension onto a spinning disk of a rotary atomizer, whereby the aqueous suspension is atomized into droplets.

15. The method of claim 13 , wherein forming the congealed particles from the droplets comprises cooling the droplets of the aqueous suspension to a temperature below the gelation temperature of the aqueous suspension.

16. The method of claim 15 , wherein cooling the droplets of the aqueous suspension comprises convective cooling.

17. The method of claim 13 , wherein preparing the aqueous suspension further comprises:

combining a first portion of the active agent with water preheated to a temperature above the gelation temperature of the aqueous suspension and mixing to form an aqueous solution;

adding the gelling agent and the water-soluble polymer to the aqueous solution and mixing to dissolve the gelling agent and the water-soluble polymer while maintaining the aqueous solution at a temperature above the gelation temperature;

adding the inorganic salt to the aqueous solution and mixing the aqueous solution while maintaining the aqueous solution at a temperature above the gelation temperature;

adding a second portion of the active agent to the aqueous solution to form the aqueous suspension; and

maintaining a temperature of the aqueous suspension above the gelation temperature until forming the droplets of the aqueous suspension.

18. The method of claim 13 , further comprising applying a coating to the plurality of dried particles.