Gary Ewing37674 Summers St, Livonia, MI 48154

2003016, Aug 28, 2003

May 30, 2002

10/158342

Guang Lu - Ann Arbor MI, US
Gary Ewing - Kalamazoo MI, US
Praveen Tyle - Kalamazoo MI, US
Brenda Stoller - Portage MI, US
Rajeev Gokhale - Libertyville IL, US
Ashwini Gadre - St. Louis MO, US

A61K031/50
A61K031/415
A61K009/70
A61K031/365
A61K031/195
A61K031/12

424/449000, 514/247000, 514/406000, 514/471000, 514/567000, 514/684000

A dermally deliverable pharmaceutical composition comprises at least one selective cyclooxygenase-2 (COX-2) inhibitory drug or prodrug thereof solubilized in a pharmaceutically acceptable carrier that comprises a low molecular weight monohydric alcohol, and exhibits a skin permeation rate of the therapeutic agent at least equal to that exhibited by a reference solution of the therapeutic agent in 70% aqueous ethanol. A method of effecting targeted delivery of a selective COX-2 inhibitory drug to a site of pain and/or inflammation in a subject comprises topically administering such a composition to skin of the subject, preferably at a locus overlying or adjacent to the site of pain and/or inflammation. A method of effecting systemic treatment of a subject having a COX-2 mediated disorder comprises transdermally administering such a composition, preferably by contacting the composition with an area of skin of the subject not greater than about 400 cm.

2004012, Jul 1, 2004

Oct 10, 2003

10/683943

Guang Lu - Ann Arbor MI, US
Gary Ewing - Kalamazoo MI, US
Brenda Stoller - Ypsilanti MI, US
Kathryn Kienle - Kalamazoo MI, US

A61K031/42
A61K009/70

424/449000, 514/378000

A pharmaceutical composition for application to an area of skin of a subject for local and/or systemic treatment of a COX-2 mediated disorder comprises a backing sheet that is flexibly conformable to the area of skin, the backing sheet having opposing surfaces that are respectively distal and proximal to the skin when applied; and a coating on the proximal surface of the backing sheet that comprises (a) an adhesive and (b) a water-soluble active agent selected from selective COX-2 inhibitory drugs, prodrugs and salts thereof, the active agent being in a therapeutically effective total amount and dispersed in a matrix that comprises zero to less than an active agent solubilizing effective amount in total of one or more solvents other than the adhesive. A method of local treatment of a site of pain and/or inflammation in a subject comprises applying the composition to a skin surface of the subject, preferably at a locus overlying or adjacent to the site of pain and/or inflammation, and leaving the composition in place for a time period effective to permit delivery of a locally therapeutic amount of the active agent. A method of systemic treatment of a subject having a COX-2 mediated disorder comprises applying the composition to a skin surface of the subject, and leaving the composition in place for a time period effective to permit transdermal delivery of a therapeutic amount of the active agent.

2004012, Jul 1, 2004

Oct 28, 2003

10/695025

Guang Lu - Ann Arbor MI, US
Gary Ewing - Kalamazoo MI, US
Brenda Stoller - Ypsilanti MI, US
Kathryn Kienle - Kalamazoo MI, US

A61K031/42
A61K031/415

514/378000, 514/406000

A pharmaceutical composition for application to an area of skin of a subject for local and/or systemic treatment of a COX-2 mediated disorder comprises a backing sheet that is flexibly conformable to the area of skin, the backing sheet having opposing surfaces that are respectively distal and proximal to the skin when applied; and a coating on the proximal surface of the backing sheet that comprises (a) an adhesive and (b) an active agent comprising valdecoxib or a prodrug thereof or a salt thereof, the active agent being in a therapeutically effective total amount and dispersed in a matrix that comprises zero to less than an active agent solubilizing effective amount in total of one or more solvents other than the adhesive. A method of local treatment of a site of pain and/or inflammation in a subject comprises applying the composition to a skin surface of the subject, preferably at a locus overlying or adjacent to the site of pain and/or inflammation, and leaving the composition in place for a time period effective to permit delivery of a locally therapeutic amount of the active agent. A method of systemic treatment of a subject having a COX-2 mediated disorder comprises applying the composition to a skin surface of the subject, and leaving the composition in place for a time period effective to permit transdermal delivery of a therapeutic amount of the active agent.