Michael J Crowley

US Patent:

8173152, May 8, 2012

Filed:

Mar 22, 2007

Appl. No.:

12/294367

Inventors:

Michael W. Crowley - Austin TX, US
Justin M. Keen - Austin TX, US
John J. Koleng - Austin TX, US
Feng Zhang - Austin TX, US

Assignee:

Auxilium US Holdings, LLC - Wilmington DE

International Classification:

A61F 13/02

US Classification:

424434

Abstract:

A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e. g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.

US Patent:

8465759, Jun 18, 2013

Filed:

Mar 22, 2007

Appl. No.:

12/294372

Inventors:

Michael M. Crowley - Austin TX, US
Justin M. Keen - Austin TX, US
John J. Koleng - Austin TX, US
Feng Zhang - Austin TX, US

Assignee:

Auxilium US Holdings, LLC - Wilmington DE

International Classification:

A61F 13/00
A61K 47/00
A61L 15/00
B29C 47/06
B32B 37/00

US Classification:

424424, 264148, 264153, 2641731, 26417312, 26417315, 26417316, 264211, 424425, 424426, 424427, 424428, 424430, 424434, 424435, 424436, 424437, 424439, 424443, 424445, 424447, 424448, 424449, 514953, 514954, 514956

Abstract:

A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.

US Patent:

20050220865, Oct 6, 2005

Filed:

Apr 2, 2004

Appl. No.:

10/816771

Inventors:

John Koleng - Austin TX, US
Michael Crowley - Austin TX, US

International Classification:

A61K009/48
A61K009/20
A61K033/08

US Classification:

424451000, 424464000, 424692000

Abstract:

An oral solid compress composition comprising a magnesium salt is provided. The composition provides a rapid dissolution of the magnesium salt, wherein not less than 75% of the magnesium salt dissolves within 45 minutes after placement in hydrochloric acid (0.1 N, 900 mL) as per USP Method . In a particular embodiment, the magnesium salt is an inorganic salt such as MgO, Mg(OH), MgCl, and others. The composition can be prepared by dry granulation, direct compression or another suitable process. The composition provides a substantially stable dissolution profile for the magnesium salt so that the dissolution profile changes only minimally even after an extended period of storage under pharmaceutically acceptable conditions when packaged in a sealed container-enclosure system. The solid composition may also exclude a cellulose-based composition. The compressed composition can be prepared and stored under anhydrous conditions.

US Patent:

20080020032, Jan 24, 2008

Filed:

Jul 20, 2007

Appl. No.:

11/781088

Inventors:

Michael Crowley - Austin TX, US
Feng Zhang - Austin TX, US
John Koleng - Austin TX, US
Justin Keen - Round Rock TX, US
Jason Vaughn - Round Rock TX, US
Justin Hughey - Austin TX, US

International Classification:

A61K 31/4355
A61K 9/48

US Classification:

424452, 514282

Abstract:

Disclosed herein are oral dosage forms of hydromorphone that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described.

US Patent:

20100047345, Feb 25, 2010

Filed:

Nov 4, 2009

Appl. No.:

12/612511

Inventors:

Michael M. Crowley - Austin TX, US
Feng Zhang - Austin TX, US
John Koleng - Austin TX, US
Justin Keen - Round Rock TX, US
Jason Vaughn - Round Rock TX, US
Justin Hughey - Austin TX, US

International Classification:

A61K 9/22
A61K 31/485

US Classification:

424468, 514282

Abstract:

Disclosed herein are oral dosage forms of hydromorphone that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described.

US Patent:

20120214777, Aug 23, 2012

Filed:

May 3, 2012

Appl. No.:

13/463375

Inventors:

Michael M. Crowley - Austin TX, US
Justin M. Keen - Austin TX, US
John J. Koleng - Austin TX, US
Feng Zhang - Austin TX, US

Assignee:

Auxilium U.S. Holdings, LLC - Wilmington DE

International Classification:

A61K 31/4468
A61P 5/24
A61K 31/568

US Classification:

514178, 514329

Abstract:

A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion. Various functional excipients can be included in the carrier system to improve process performance and/or improve the chemical or physical properties of the HME composition.

US Patent:

20130131628, May 23, 2013

Filed:

Oct 24, 2012

Appl. No.:

13/659064

Inventors:

THE BOARD OF REGENTS OF THE UNIVERSIT - Austin TX, US
Enrica de Rosa - Houston TX, US
Randy Goodall - Austin TX, US
Lee Hudson - Elgin TX, US
Michael Crowley - Austin TX, US

Assignee:

THE BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM - Austin TX

International Classification:

A61M 5/00
A61K 9/00

US Classification:

604500, 604 9301

Abstract:

Devices and methods for administering a therapeutic agent, comprising an implantable delivery device. Exemplary embodiments comprise a reservoir in fluid communication with a channeled member, and a solid matter therapeutic agent disposed within the reservoir.