Formulation process method to produce spray dried products

1. A spray drying method for preparing powders having a particle size of about less than 10 μm and with increased density comprising:

a) providing a feedstock comprising an organic material in a solvent system comprising a non-solvent, wherein:

the organic material comprises polyvinylpyrrolidine,

the non-solvent comprises a non-solvent for polyvinylpyrrolidine under ambient conditions,

the solvent system functions as a non-solvent for the polyvinylpyrrolidine under ambient conditions, and

the feedstock is at an elevated temperature of about 40° C. to about 200° C. and an elevated pressure of greater than 1 atmosphere (gauge) to about 20 atmospheres (gauge) such that the solvent system functions as a solvent for the polyvinylpyrrolidine;

b) delivering the feedstock to a device capable of atomizing the feedstock into droplets; and

c) evaporating the solvent system from the droplets of the feedstock, thereby forming particles of the organic material.

2. The method of claim 1 wherein the organic material further comprises a pharmaceutically active material.

3. The method of claim 2 wherein the organic material further comprises a polymer other than polyvinyl pyrrolidine.

4. The method of claim 3 wherein the feedstock further comprises one or more pharmaceutically acceptable ingredients.

5. The method of claim 1 wherein the solvent system comprises a solvent and non-solvent pair for at least one organic material present at a ratio of from about 5% solvent:95% non-solvent to about 95% solvent:5% non-solvent.

6. The method of claim 1 wherein the concentration of the organic material in the feedstock is from about 1% to about 90% by weight.

7. The method of claim 1 wherein the feedstock further comprises a second organic material.

8. The method of claim 7 wherein the second organic material is a pharmaceutically active agent.

9. The method of claim 2 wherein the pharmaceutically active material exhibits an increased rate of release compared to a control composition prepared using a solvent system without a non-solvent.

10. The method of claim 2 wherein the pharmaceutically active material exhibits an increased extent of release compared to a control composition prepared using a solvent system without a non-solvent.

11. The method of claim 8 wherein the solvent system comprises a solvent and a non-solvent for the polymer.

12. The method of claim 11 wherein steps b) and c) comprise spray drying the feedstock to form a spray-dried composition.

13. The method of claim 12 wherein said spray dried composition comprises at least about 25% by weight pharmaceutically active material.

14. The method of claim 12 wherein said spray dried composition comprises at least about 75% by weight pharmaceutically active material.

15. The method of claim 12 wherein said spray dried composition exhibits a dissolution profile wherein the percent active released is at least about 25% greater than a control composition prepared from a system comprising the same polymer and active spray dried from the same solvent without the non-solvent.

16. The method of claim 12 wherein said spray dried composition exhibits a dissolution profile wherein the initial rate of active released is at least about 25% greater than a control composition prepared from a system comprising the same polymer and active spray dried from the same solvent without the non-solvent.

17. The method of claim 12 wherein said spray dried composition exhibits a dissolution profile wherein the percent active released is at least about 100% greater than a control composition prepared from a system comprising the same polymer and active spray dried from the same solvent without the non-solvent.

18. The method of claim 1 wherein the solvent system consists of a non-solvent.

19. The method of claim 18 wherein the non-solvent is selected from the group consisting of acetone, toluene, ethyl acetate, and mixtures thereof.