Greg Allen Brubaker

US Patent:

8501764, Aug 6, 2013

Filed:

Jun 13, 2012

Appl. No.:

13/495277

Inventors:

Greg A. Brubaker - Sunbury OH, US
Thomas D. Mahon - West Jefferson OH, US

Assignee:

Roxane Laboratories, Inc. - Columbus OH

International Classification:

A61K 31/436
A61P 37/06

US Classification:

514291, 4242781

Abstract:

The present invention relates to a pharmaceutical formulation and process for preparing the same comprising an oral dosage formulation, such as a capsule formulation, of a macrolide compound, such as tacrolimus, wherein the capsule formulation contains both a solid dispersion of the macrolide along with a non-dispersed form of the macrolide. The pharmaceutical formulation according to the invention is bioequivalent to the FDA approved product according to a bioavailability study conducted in humans.

US Patent:

20020028794, Mar 7, 2002

Filed:

May 24, 2001

Appl. No.:

09/864841

Inventors:

Greg Brubaker - Sunbury OH, US
Mahendra Dedhiya - Nanuet NY, US
Thomas Mahon - West Jefferson OH, US

International Classification:

A61K031/57

US Classification:

514/177000

Abstract:

An oral pharmaceutical composition in the form of a stable suspension in water, said composition comprising: (a) about 10 to 200 mg per ml of micronized megestrol acetate; (b) about 0.04 to 0.4% weight/volume of a wetting agent; and (c) about 1.2 to 1.8% weight/volume of a suspending agent, wherein said composition contains less than about 1.0% weight/volume of propylene glycol and does not contain polysorbate, polyethylene glycol, glycerol or sorbitol. The pH of the suspension can be controlled with an appropriate buffer system. In a preferred embodiment, the suspension has a pH of greater than about 3.3. The oral pharmaceutical composition is useful in the treatment of anorexia, cachexia or significant weight loss resulting from or associated with acquired immunodeficiency syndrome (AIDS).

US Patent:

20090258895, Oct 15, 2009

Filed:

Apr 11, 2008

Appl. No.:

12/101500

Inventors:

Greg A. BRUBAKER - Sunbury OH, US
Thomas D. MAHON - West Jefferson OH, US

Assignee:

ROXANE LABORATORIES, INC. - Columbus OH

International Classification:

A61K 31/436
A61P 37/06

US Classification:

514294

Abstract:

The present invention relates to a pharmaceutical formulation and process for preparing the same comprising an oral dosage formulation, such as a capsule formulation, of a macrolide compound, such as tacrolimus, wherein the capsule formulation contains both a solid dispersion of the macrolide along with a non-dispersed form of the macrolide. The pharmaceutical formulation according to the invention is bioequivalent to the FDA approved product according to a bioavailability study conducted in humans.