Ronald S Vladyka

US Patent:

7988994, Aug 2, 2011

Filed:

Sep 22, 2006

Appl. No.:

12/067712

Inventors:

Ramachandran Radhakrishnan - Fremont CA, US
Ronald Vladyka - Somerset NJ, US
Kenneth Sultzbaugh - Bridge Water NJ, US

Assignee:

Intermune, Inc. - Brisbane CA

International Classification:

A61K 9/48
A61K 9/14
A01N 43/40

US Classification:

424452, 514345, 424451, 424489

Abstract:

A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.

US Patent:

8383150, Feb 26, 2013

Filed:

Jun 16, 2011

Appl. No.:

13/162048

Inventors:

Ramachandran Radhakrishnan - Fremont CA, US
Ronald Vladyka - Somerset NJ, US
Kenneth Sultzbaugh - Bridge Water NJ, US

Assignee:

Intermune, Inc. - Brisbane CA

International Classification:

A61K 9/48
A61K 9/14
A01N 43/40

US Classification:

424452, 514345, 424451, 424489

Abstract:

A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.

US Patent:

20020012706, Jan 31, 2002

Filed:

Jun 21, 2001

Appl. No.:

09/886100

Inventors:

Ronald Vladyka - Somerset NJ, US
David Erkoboni - Pennington NJ, US
Pamela Stergios - Plainsboro NJ, US

Assignee:

FMC Corporation

International Classification:

A61K009/50
A61K031/496

US Classification:

424/499000, 424/501000, 514/254070

Abstract:

A formulation of a sparingly water-soluble, crystalline pharmaceutically active agent wherein the active agent is converted to and stabilized in its amorphous form as a solid solution of a normally hydrophobic vehicle is described. The amorphous state is stabilized by the composition of the formulation, providing long shelf life of the improved composition. This stabilized formulation also provides increased solubility and bioavailability of the active agent. Solutions of the active agent are stabilized by the composition, preventing recrystallization and precipitation of the less soluble, crystalline form of the active agent from aqueous solutions thereof.

US Patent:

20020037324, Mar 28, 2002

Filed:

Jun 21, 2001

Appl. No.:

09/886493

Inventors:

Ronald Vladyka - Somerset NJ, US
David Erkoboni - Pennington NJ, US
Pamela Stergios - Plainsboro NJ, US

Assignee:

FMC Corporation

International Classification:

A61K009/50
A61K031/496

US Classification:

424/499000, 514/254070

Abstract:

A formulation of a sparingly water-soluble, crystalline pharmaceutically active agent wherein the active agent is converted to and stabilized in its amorphous form as a solid solution of a normally hydrophobic vehicle is described. The amorphous state is stabilized by the composition of the formulation, providing long shelf life of the improved composition. This stabilized formulation also provides increased solubility and bioavailability of the active agent. Solutions of the active agent are stabilized by the composition, preventing recrystallization and precipitation of the less soluble, crystalline form of the active agent from aqueous solutions thereof.

US Patent:

20040081701, Apr 29, 2004

Filed:

Jun 9, 2003

Appl. No.:

10/457270

Inventors:

David Erkoboni - Pennington NJ, US
Ronald Vladyka - Somerset NJ, US
Christopher Sweriduk - Chalfont PA, US
Andrew Favara - New Egypt NJ, US

International Classification:

A61K009/50

US Classification:

424/499000

Abstract:

The present invention provides a method for preparing a spray-dried, compressible granular formulation for preparing pharmaceutical tablets in which essentially water-insoluble, acidic, amphoteric, and basic pharmaceutically active agents are converted to more water-soluble salts which are granulated with hydrolyzed cellulose, drug-containing slurries, the resulting granulations, capsules containing granulations, and pharmaceutical tablets compressed from such granules. In these formulations there is employed from 1% to 85% by weight of the pharmaceutically active agent in its salt form, from 5% to 99% of hydrolyzed cellulose, based on the dry weight of the granulation, and optionally, conventional granulation and/or tableting additives such as surfactants, disintegrants, and antiadherents/flow aids. Said tablets have significantly increased dissolution of the pharmaceutically active agent at the pH of the gastrointestinal tract in comparison with the unconverted free pharmaceutically active agent.

US Patent:

20070148237, Jun 28, 2007

Filed:

Nov 27, 2006

Appl. No.:

11/563618

Inventors:

Anthony McKinney - San Diego CA, US
Gary Tollefson - Indianapolis IN, US
Simon Yau - Watchung NJ, US
Ronald Vladyka - Somerset NJ, US
Rick Soltero - Holly Springs NC, US

Assignee:

Orexigen Therapeutics, Inc. - San Diego CA

International Classification:

A61K 9/22
A61K 31/42

US Classification:

424468000, 514379000

Abstract:

Pharmaceutical formulations comprise sustained-release zonisamide. Methods of preparing such pharmaceutical formulations involve intermixing zonisamide with a suitable excipient configured to control the dissolution profile of the zonisamide. Methods of treatment involve administering the pharmaceutical formulations to patients in need of such treatment.

US Patent:

20080161335, Jul 3, 2008

Filed:

Nov 14, 2007

Appl. No.:

11/985094

Inventors:

Ronald S. Vladyka - Somerset NJ, US
David C. Dalgarno - Brookline MA, US
John D. Iuliucci - Andover MA, US

International Classification:

A61K 31/436
A61K 47/38

US Classification:

514291, 514781

Abstract:

A solid pharmaceutical composition containing AP23573 suitable for oral administration is disclosed.

US Patent:

20090191265, Jul 30, 2009

Filed:

Apr 17, 2009

Appl. No.:

12/426182

Inventors:

Ramachandran Radhakrishnan - Fremont CA, US
Ronald Vladyka - Somerset NJ, US
Kenneth Sultzbaugh - Bridge Water NJ, US

International Classification:

A61K 9/48
A61K 31/4402
A61P 1/00

US Classification:

424452, 514345

Abstract:

A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.