Fractionated alkylated cyclodextrin compositions and processes for preparing and using the same
The present invention relates to compositions comprising fractionated alkylated cyclodextrin compositions having a single degree of substitution, and processes for preparing and using the same.
1. A fractionated alkylated cyclodextrin composition comprising 85% by weight or more alkylated cyclodextrin having a single degree of substitution relative to all alkylated cyclodextrin in the composition, and 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;
wherein the composition further comprises an active agent selected from bortezomib, disulfiram, epigallocatchin-3-gallate, salinosporamide A, and carfilzomib; and
wherein the single degree of substitution is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12.
2. The composition 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.
3. A composition comprising the fractionated alkylated cyclodextrin composition of claim 1 and one or more excipients.
4. The composition of claim 1 , wherein the fractionated alkylated cyclodextrin composition comprises 90% by weight or more alkylated cyclodextrin having a single degree of substitution relative to all alkylated cyclodextrin in the composition.
5. The composition of claim 1 , wherein the fractionated alkylated cyclodextrin composition comprises 95% by weight or more alkylated cyclodextrin having a single degree of substitution relative to all alkylated cyclodextrin in the composition.