Cydex Pharmaceuticals, Inc.

Cydex, Inc.

Diane O Thompson

Gerold L Mosher

James D Pipkin

Rupert O Zimmerer

D Pipkin; James

An inhalable formulation containing SAE-CD and corticosteroid is provided. The formulation is adapted for administration to a subject by nebulization with any known nebulizer. The formulation can be included in a kit. The formulation is administered as an aqueous solution, however, it can be stored as a dry powder, ready-to-use solution, or concentrated composition. The formulation is employed in an improved nebulization system for administering corticosteroid by inhalation. SAE-CD present in the formulation significantly enhances the chemical stability of budesonide. A method of administering the formulation by inhalation is provided. The formulation can also be administered by conventional nasal delivery apparatus.

Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid

A capsule containing an aqueous fill composition that comprises water, a derivatized cyclodextrin, such as sulfoalkyl ether cyclodextrin (SAE-CD) or hydroxypropyl cyclodextrin (HPCD), optionally one or more active agents and optionally one or more excipients is stabilized from degradation, erosion, swelling or dissolution of its shell during storage. The derivatized cyclodextrin is present in an amount sufficient to reduce, eliminate or inhibit degradation, erosion, swelling and/or dissolution of the shell by water present in the fill composition. Alternatively, the derivatized cyclodextrin and another shell-stabilizing material together stabilize the shell from degradation, erosion, swelling and/or dissolution by water present in the fill composition. The derivatized cyclodextrin can reduce the water activity of the fill composition.

Capsules containing aqueous fill compositions stabilized with derivatized cyclodextrin

An injectable formulation of a sedative hypnotic drug, such as the anesthetic drug propofol, that is pharmaceutically stable and demonstrates a reduced incidence of pain upon injection. The formulation of the present invention employs a sulfoalkyl ether cyclodextrin solubilizing and complexing excipient, such as CAPTISOL&#xae; cyclodextrin (sulfobutyl ether &#x3b2;-cyclodextrin) to form a true aqueous solution and not a suspension. This formulation minimizes the allergic response and microbial contamination issues typically associated with propofol parenteral formulations. The present formulation may also reduce pain on injection as compared to the known emulsion type propofol formulations. The liquid formulation can be sterile filtered unlike emulsion-type formulations of sedative hypnotics. The liquid formulation can be lyophilized or otherwise dried to yield a solid formulation.

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Overland Park, KS, United States of America

Diane O Thompson