Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof

1. A process for preparing a composition comprising sulfoalkyl ether cyclodextrin (SAE-CD), wherein the process comprises:

(a) forming a fluidized bed of particles comprising SAE-CD in a drying chamber of a fluidized bed spray dryer apparatus with an attached 3-chamber fluidization bed;

(b) recycling fine particles from the fluidized bed back into the drying chamber at a location adjacent to a liquid feed atomizer; and

(c) collecting the composition from the third chamber of the 3-chamber fluidization bed, wherein the composition comprises agglomerated particles.

2. The process of claim 1 , wherein the process comprises an atomization pressure of 10 bar to 50 bar.

3. The process of claim 1 , wherein the process comprises a solution temperature of 45° C. to 55° C.

4. The process of claim 1 , wherein the process comprises an inlet temperature of 150° C. to 170° C.

5. The process of claim 1 , wherein the process comprises an outlet temperature of 70° C. to 90° C.

6. The process of claim 1 , wherein the process comprises an inlet temperature of 100° C. to 150° C. in the first chamber of the 3-chamber fluidization bed.

7. The process of claim 1 , wherein the process comprises a bed temperature of 60° C. to 100° C. in the first chamber of the 3-chamber fluidization bed.

8. The process of claim 1 , wherein the composition comprises: SAE-CD; no more than about 20% by weight moisture; a bulk density of about 0.38 g/cm 3 to about 0.66 g/cm 3 ; and a tapped density of about 0.49 g/cm 3 to about 0.75 g/cm 3 , wherein the tapped density of the composition is higher than the bulk density.

9. The process of claim 8 , wherein the composition comprises a gravitational-flow minimum orifice diameter of about 3 mm to about 12 mm.

10. The process of claim 8 , wherein the SAE-CD is a compound, or a mixture of compounds, of the Formula 1:

wherein:

n is 4, 5, or 6;

R 1 , R 2 , R 3 , R 4 , R 5 , R 6 , R 7 , R 8 , and R 9 are each, independently, O − or a O—(C 2-6 alkylene)-SO 3 − group, wherein at least one of R 1 and R 2 is, independently, the O—(C 2 —C 6 alkylene)-SO 3 − group; and

S 1 , S 2 , S 3 , S 4 , S 5 , S 6 , S 7 , S 8 , and S, are each, independently, a pharmaceutically acceptable cation.

11. The process of claim 8 , wherein the composition comprises a bulk density of about 0.55 g/cm 3 to about 0.66 g/cm 3 and a tapped density of about 0.66 g/cm 3 to about 0.75 g/cm 3 .

12. The process of claim 8 , wherein the composition comprises a bulk density of about 0.38 g/cm 3 to about 0.55 g/cm 3 and a tapped density of about 0.49 g/cm 3 to about 0.66 g/cm 3 .

13. The process of claim 8 , wherein the composition comprises a gravitational-flow minimum orifice diameter of about 10 mm or less.

14. The process of claim 8 , wherein the composition comprises a true density of about 1.1 g/cm 3 to about 1.5 g/cm 3 .

15. The process of claim 8 , wherein the composition comprises a CARR's index of about 12% to about 24%.

16. The process of claim 8 , wherein the composition comprises particles with a mean particle diameter of about 75 microns to about 200 microns.

17. The process of claim 16 , wherein at least 90% of the particle volume of the composition comprises particles having calculated diameters greater than or equal to about 25 microns.

18. The process of claim 8 , wherein the composition comprises a moisture content of about 2% to about 3% by weight and a compression crushing strength of about 1.0 kP to about 20 kP when compressed into a tablet using a Pmax of about 30 MPa to about 275 MPa.

19. The process of claim 8 , wherein the composition comprises a moisture content of about 5% to about 6% by weight and a compression crushing strength of about 0.5 to about 11 kP when compressed into a tablet using a Pmax of about 15 MPa to about 70 MPa.

20. The process of claim 8 , wherein 2.5 g of the composition has an average dissolution time of about 2 min to about 4.5 min when placed in water.