Diane L Thompson

US Patent:

7829114, Nov 9, 2010

Filed:

Mar 9, 2005

Appl. No.:

11/076072

Inventors:

Diane O. Thompson - Overland Park KS, US
James D. Pipkin - Lawrence KS, US
Rupert O. Zimmerer - Lawrence KS, US

Assignee:

CyDex Pharmaceuticals, Inc. - Lenexa KS

International Classification:

A61K 9/48
A61K 9/66

US Classification:

424451, 424452, 424455

Abstract:

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.

US Patent:

20030073665, Apr 17, 2003

Filed:

Mar 19, 2002

Appl. No.:

10/102066

Inventors:

Diane Thompson - Overland Park KS, US
Gerold Mosher - Kansas City MO, US

International Classification:

A61K031/724

US Classification:

514/058000

Abstract:

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 cyclodextrin (sulfobutyl ether -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.

US Patent:

20050164986, Jul 28, 2005

Filed:

Mar 19, 2003

Appl. No.:

10/505713

Inventors:

Gerold Mosher - Kansas City MO, US
James Pipkin - Lawrence KS, US
Rupert Zimmerer - Lawrence KS, US
Christina Fulk - Platte City MO, US
Diane Thompson - Overland Park KS, US

International Classification:

A61K031/724
C12N005/00
C12N001/20

US Classification:

514058000, 435404000, 435253600

Abstract:

A method of preserving formulations is provided. The method includes the step of including a derivatized cyclodextrin in a formulation capable of sustaining microbial growth. One embodiment of the formulation employs a sulfoalkyl ether cyclodextrin as a preservative and optionally as a solubilizing and complexing agent. A suitable cyclodextrin is the CAPTISOL” brand cyclodextrin (sulfobutyl ether R-cyclodextrin). Whether or not the formulation includes a conventional preservative, the formulation will remain preserved for at least a minimum predetermined period. Specific embodiments of the invention include a carrier, a derivatized cyclodextrin and optionally one or more active agents, one or more water activity-reducing agents, and/or one or more complexation-enhancing agents. The derivatized cyclodextrin reduces the water activity of the formulation. A liquid formulation can be lyophilized or otherwise dried to yield a solid formulation that is optionally reconstitutable.