Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof

摘要

A particulate SAE-CD composition is provided. The SAE-CD composition has an advantageous combination of physical properties not found in known solid forms of SAE-CD. In particular, the SAE-CD composition possesses an advantageous physicochemical and morphological property profile such that it can be tailored to particular uses. The SAE-CD composition of the invention has improved flow and dissolution performance as compared to known compositions of SAE-CD.

主权项

1. A sulfoalkyl ether cyclodextrin composition comprising:
(a) sulfoalkyl ether cyclodextrin; (b) no more than about 20% by weight moisture; (c) a bulk density of about 0.55 g/cm3 to about 0.66 g/cm3; (d) a tapped density of about 0.66 g/cm3, to about 0.75 g/cm3, wherein the tapped density of the sulfoalkyl ether cyclodextrin composition is higher than the bulk density; and (e) a gravitational-flow minimum orifice diameter of about 3 mm to about 12 mm; wherein the sulfoalkyl ether cyclodextrin composition comprises agglomerated particles.