Solid dispersion compositions

1. A water-dispersible particulate composition having an overall melting point of 40° C. or higher which is a solid molecular dispersion comprised of:

about 0.01% to about 15% by weight of a sparingly water-soluble compound and about 85-99.99% by weight of a particulatable lipid-based carrier,

wherein the particulatable lipid-based carrier is comprised of:

about 5% to about 50% by weight of a lipid-based surfactant selected from the group consisting of a polyglycolized glyceride, a polyoxyethylene castor oil derivative, a polyoxyethylene stearate having a melting point of from 40° C. to 50° C., and a mixture thereof, and

about 50% to about 95% by weight of a stiffening agent having a melting point of from 50° C. to 80° C. and selected from the group consisting of glycerol monostearate, glycerol palmitostearate, hydrogenated vegetable oil, and a mixture thereof.

2. The water-dispersible particulate composition of claim 1 prepared by a process comprising the steps of:

melting a mixture comprised of the lipid-based surfactant and the stiffening agent, wherein the lipid-based surfactant is a solid lipid-based surfactant having an HLB value greater than or equal to 10;

dissolving the compound in the melted surfactant and the stiffening agent mixture to form a homogeneous liquid composition of the compound, surfactant and stiffening agent;

and cooling the liquid composition.

3. The water-dispersible particulate composition according to claim 1 prepared by a process comprising the steps of:

melting the lipid-based surfactant, wherein the lipid-based surfactant is a solid lipid-based surfactant having an HLB value greater than or equal to 10;

melting the stiffening agent having a melting point of from 50° C. to 80° C.;

dissolving the compound in the melted surfactant;

mixing the stiffening agent with the dissolved compound-surfactant mixture to form a homogeneous liquid composition; and

cooling the liquid composition.

4. The water-dispersible particulate composition according to claim 1 , wherein the compound is present in the composition in an amount of from about 1% to about 10%.

5. The water-dispersible particulate composition according to claim 1 , wherein the compound is present in the composition in an amount of from about 2% to about 5%.

6. The water-dispersible particulate composition according to claim 1 , wherein the lipid-based surfactant is present in an amount of from about 10% to about 50% by weight of the lipid-based carrier.

7. The water-dispersible particulate composition according to claim 1 , wherein the stiffening agent is present in an amount of from about 50% to about 75% by weight of the lipid-based carrier.

8. The water-dispersible particulate composition according to claim 1 , further comprising one or more formulation co-agents selected from the group consisting of a disintegrating agent, a flow agent, a solubilization enhancer and a pore-forming agent.

9. The water-dispersible particulate composition according to claim 8 , wherein the total weight of the one or more formulation co-agents in the composition is 0.01% to 5% by weight of the composition.

10. The water-dispersible particulate composition according to claim 8 , wherein the disintegrating agent is selected from the group consisting of crospovidone, sodium starch glycolate, croscarmellose sodium and a mixture thereof.

11. The water-dispersible particulate composition according to claim 8 , wherein the flow agent is selected from the group consisting of colloidal silicon dioxide, amorphous fumed silica, starch, synthetic amorphous fumed silica, precipitated silica, and fumed silica and a mixture thereof.

12. The water-dispersible particulate composition according to claim 8 , wherein the solubilization enhancer is selected from the group consisting of mid-weight polyethylene glycol having a molecular weight of from 2000 to 8000, and a mixture thereof.

13. The water-dispersible particulate composition according to claim 8 , wherein the pore-forming agent is selected from the group consisting of sucrose, sodium chloride, potassium chloride, dextrose and a mixture thereof.

14. A process for preparing the water-dispersible particulate composition according to claim 1 , comprising the steps of:

melting a mixture comprised of the lipid-based surfactant and the stiffening agent, wherein the lipid-based surfactant is a solid lipid-based surfactant having an HLB value greater than or equal to 10;

dissolving the compound in the melted surfactant and stiffening agent mixture to form a homogeneous liquid composition of the compound, surfactant and stiffening agent;

and cooling the liquid composition.

15. A process for preparing the water-dispersible particulate composition according to claim 1 , comprising the steps of:

melting the lipid-based surfactant, wherein the lipid-based surfactant is a solid lipid-based surfactant having an HLB value greater than or equal to 10;

melting the stiffening agent having a melting point of from 50° C. to 80° C.;

dissolving the compound in the melted surfactant;

mixing the stiffening agent with the dissolved compound-surfactant mixture to form a homogeneous liquid composition; and

cooling the liquid composition.

16. A process according to claim 14 , further comprising cooling the liquid composition using rotary disk processing.

17. A process according to claim 16 , comprising cooling the liquid composition using rotary disk processing to produce microspheres with a median particle size in the range of 50 μm-500 μm.

18. A process according to claim 15 , further comprising cooling the liquid composition using rotary disk processing.

19. A process according to claim 18 , comprising cooling the liquid composition using rotary disk processing to produce microspheres with a median particle size in the range of 50 μm-500 μm.