Fractionated alkylated cyclodextrin compositions and processes for preparing and using the same

1. A process for preparing a fractionated alkylated cyclodextrin composition comprising an alkylated cyclodextrin, the process comprising:

(a) preparing a solution comprising an alkylated cyclodextrin composition;

(b) passing the solution through a reversed phase high performance liquid chromatography system having a stationary phase and a mobile phase; and

(c) collecting a fractionated alkylated cyclodextrin composition comprising 85% by weight or more alkylated cyclodextrin having a selected single degree of substitution relative to all alkylated cyclodextrin in the composition; wherein the single degree of substitution is 4, 5, 6, 7, 8, 9, 10, 11, or 12;

wherein the alkylated cyclodextrin is a sulfoalkyl ether cyclodextrin of Formula (II):

wherein p is 4, 5, or 6, and R 1 is independently selected at each occurrence from —OH or —O—(C 2 -C 6 alkylene)-SO 3 − -T, wherein T is independently selected at each occurrence from pharmaceutically acceptable cations, provided that at least one R 1 is —OH and at least one R 1 is O—(C 2 -C 6 alkylene)-SO 3 − -T.

2. The process of claim 1 , wherein the chromatographic separation system is high performance liquid chromatography.

3. The process of claim 1 , wherein the stationary phase is a silica gel column.

4. The process of claim 1 , wherein the mobile phase comprises acetonitrile.

5. The process of claim 4 , wherein the mobile phase further comprises an ammonium acetate buffer.

6. The process of claim 1 , wherein R 1 is independently selected at each occurrence from —OH or —O—(C 4 alkylene)-SO 3 − -T, and -T is Na + at each occurrence.

7. The process of claim 1 , further comprising combining the fractionated alkylated cyclodextrin composition with one or more excipients.

8. The process of claim 1 , further comprising combining the fractionated alkylated cyclodextrin composition with an active agent.