James M Clevenger

US Patent:

7387793, Jun 17, 2008

Filed:

Nov 14, 2003

Appl. No.:

10/713929

Inventors:

Gopi Venkatesh - Vandalia OH, US
James M. Clevenger - Vandalia OH, US

Assignee:

Eurand, Inc. - Vandalia OH

International Classification:

A61K 9/14

US Classification:

424489

Abstract:

A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc. ) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

US Patent:

7544372, Jun 9, 2009

Filed:

Feb 6, 2008

Appl. No.:

12/026887

Inventors:

Gopi Venkatesh - Vandalia OH, US
James M. Clevenger - Vandalia OH, US

Assignee:

Eurand, Inc. - Vandalia OH

International Classification:

A61K 9/14

US Classification:

424489, 424401

Abstract:

A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc. ) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration-time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

US Patent:

7790199, Sep 7, 2010

Filed:

Sep 24, 2008

Appl. No.:

12/236723

Inventors:

Gopi Venkatesh - Vandalia OH, US
James M. Clevenger - Vandalia OH, US

Assignee:

Eurand, Inc. - Vandalia OH

International Classification:

A61K 9/14

US Classification:

424489, 424401

Abstract:

A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc. ) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

US Patent:

7820203, Oct 26, 2010

Filed:

Feb 6, 2008

Appl. No.:

12/026882

Inventors:

Gopi Venkatesh - Vandalia OH, US
James M. Clevenger - Vandalia OH, US

Assignee:

Eurand, Inc. - Vandalia OH

International Classification:

A61K 9/14

US Classification:

424489, 424401

Abstract:

A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc. ) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

US Patent:

7829121, Nov 9, 2010

Filed:

Sep 24, 2008

Appl. No.:

12/236719

Inventors:

Gopi Venkatesh - Vandalia OH, US
James M. Clevenger - Vandalia OH, US

Assignee:

Eurand Inc. - Vandalia OH

International Classification:

A61K 9/14

US Classification:

424489, 424401

Abstract:

A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc. ) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

US Patent:

8137734, Mar 20, 2012

Filed:

Jun 18, 2009

Appl. No.:

12/487339

Inventors:

Gopi M. Venkatesh - Vandalia OH, US
James M. Clevenger - Vandalia OH, US
Timothy Grinstead - Beavercreek OH, US

Assignee:

Aptalis Pharmatech, Inc. - Vandalia OH

International Classification:

A61K 9/28

US Classification:

427 214, 424269, 424472, 424469, 424489, 424464, 424468, 424471, 424482, 424484, 34 27, 427 215, 427 216, 427402, 427414

Abstract:

The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.

US Patent:

8545881, Oct 1, 2013

Filed:

Apr 19, 2004

Appl. No.:

10/827106

Inventors:

Gopi M. Venkatesh - Vandalia OH, US
Ken Kangyi Qian - Cincinnati OH, US
Shyam Vangala - Huber Heights OH, US
James M. Clevenger - Vandalia OH, US
Donald Guenther - Brookville OH, US

Assignee:

Eurand Pharmaceuticals, Ltd. - Dublin

International Classification:

A61K 9/20
A61K 9/50

US Classification:

424464, 424441, 424465, 424484, 424489

Abstract:

A tablet that rapidly disintegrates in the oral cavity comprising a compressed blend of rapidly dispersing microgranules prepared by granulating a sugar alcohol or a saccharide or a mixture thereof having an average particle size less than about 30 microns and a disintegrant, and a taste-masked microcapsule containing at least one drug, the microcapsule being prepared by granulating a pharmaceutically acceptable formulation comprising at least one drug in a therapeutically effective amount and at least one polymeric binder that improves resilience of the microgranules, wet milling the granulated mass, and microencapsulating the milled granules to provide microcapsules.

US Patent:

20090148532, Jun 11, 2009

Filed:

Dec 8, 2008

Appl. No.:

12/314290

Inventors:

Gopi M. Venkatesh - Vandalia OH, US
James M. Clevenger - Vandalia OH, US
Timothy Grinstead - Beavercreek OH, US

International Classification:

A61K 9/14
A61K 31/137

US Classification:

424495, 514654, 424490, 424494

Abstract:

The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing the drug layering composition and a seal coating composition to form IR beads, then coating the IR beads with an extended release coating to form ER beads.