Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof

A process for preparing a particulate sulfoalkyl ether composition, the process comprising:

• a. providing an aqueous liquid feed comprising water and sulfoalkyl ether cyclodextrin;
• and
• b. subjecting the liquid feed to a combination fluidized bed spray drying process whereby the sulfoalkyl ether cyclodextrin is dried to below the point of deliquescence to form a particulate sulfoalkyl ether cyclodextrin composition comprising agglomerated particles and having a CARR's index of less than or equal to 24%, a bulk density in the range of 0.55 to 0.66 g/cm3, and a tapped density in the range of 0.66 to 0.75 g/cm3,
• wherein the fluidized bed spray drying process comprises:
• providing an aqueous liquid feed comprising a liquid carrier and sulfoalkyl ether cyclodextrin;
• providing in a drying chamber a fluidized bed of sulfoalkyl ether cyclodextrin particles having a first mean particle diameter, wherein the bed is fluidized with a stream of heated gas flowing in a first direction;
• atomizing the liquid feed with an atomizer onto particles in the drying chamber to form a particulate sulfoalkyl ether cyclodextrin composition comprising agglomerated particles having a greater second mean particle diameter, wherein the atomization is conducted in a second direction and a majority of the liquid carrier has been removed from the particulate composition;
• and
• collecting the particulate composition to form the sulfoalkyl ether cyclodextrin composition;
• and
• wherein the sulfoalkyl ether cyclodextrin composition, wherein the SAE-CD is a compound of the Formula 1, or a combination thereof:
• wherein:
• n is 4, 5 or 6;
• R1, R2, R3, R4, R5, R6, R7, R8 and R9 are each, independently, —O— or a —O—(C2-C6 alkylene)-SO3− group, wherein at least one of R1 to R9 is independently a —O—(C2-C6 alkylene)-SO3− group, a —O—(CH2)mSO3− group wherein m is 2 to 6, —OCH2CH2CH2SO3−, or —OCH2CH2CH2CH2SO3−;
• and
• Si, S2, S3, S4, S5, S6, S7, S8 and S9 are each, independently, a pharmaceutically acceptable cation.