Ernest John Lee

US Patent:

8399016, Mar 19, 2013

Filed:

Mar 3, 2010

Appl. No.:

12/716755

Inventors:

Gregory Everett Amidon - Portage MI, US
Loksidh Devi Ganorkar - Kalamazoo MI, US
John Mark Heimlich - Portage MI, US
Ernest J. Lee - Kalamazoo MI, US
Robert Martin Noack - Ann Arbor MI, US
Joseph Peter Reo - Kalamazoo MI, US
Connie Jo Skoug - Portage MI, US

Assignee:

Boehringer Ingelheim International GmbH - Ingelheim am Rhein

International Classification:

A61K 9/22

US Classification:

424468, 424464, 424474, 424475, 424480, 424482

Abstract:

A sustained-release pharmaceutical composition in a form of an orally deliverable tablet comprises a water-soluble salt of pramipexole, dispersed in a matrix comprising a hydrophilic polymer and a starch having a tensile strength of at least about 0. 15 kN cmat a solid fraction representative of the tablet.

US Patent:

20030129236, Jul 10, 2003

Filed:

Dec 19, 2002

Appl. No.:

10/324718

Inventors:

John Heimlich - Portage MI, US
Robert Noack - Grand Rapids MI, US
Steven Cox - Schoolcraft MI, US
Loksidh Ganorkar - Kalamazoo MI, US
Ronald VerHage - Lawton MI, US
Ernest Lee - Kalamazoo MI, US

International Classification:

A61K031/704
A61K009/22
A61K009/26

US Classification:

424/470000, 514/035000

Abstract:

The present invention is directed to an oral dosage form for multiple-pulsed delivery of at least two fractions of clindamycin to a subject, one in an immediate-release form and the other in an extended release form. The oral dosage forms of the present invention provide a means for treating or preventing gram-positive bacterial infections with a minimal number of treatments per day, potentially, as little as once or twice per day.

US Patent:

20030133982, Jul 17, 2003

Filed:

Dec 19, 2002

Appl. No.:

10/324719

Inventors:

John Heimlich - Portage MI, US
Loksidh Ganorkar - Kalamazoo MI, US
Ernest Lee - Kalamazoo MI, US
Robert Noack - Grand Rapids MI, US
Ronald VerHage - Lawton MI, US

International Classification:

A61K009/26
A61K009/14
A61K031/445

US Classification:

424/469000, 514/317000, 514/049000, 514/152000, 514/262100, 514/192000, 514/561000, 514/252160, 514/253080, 424/679000, 514/211070

Abstract:

The present invention relates to zero-order sustained release solid dosage forms suitable for administration of a wide range of therapeutically active medicaments, especially those that are water-soluble, and to a process of making same. The solid dosage form comprises (a) a matrix core comprising ethylcellulose and the active agent and (b) a hydrophobic polymer coating encasing the entire matrix core.

US Patent:

20040137156, Jul 15, 2004

Filed:

Jul 24, 2003

Appl. No.:

10/626374

Inventors:

Ernest Lee - Kalamazoo MI, US
John Heimlich - Portage MI, US
Robert Noack - Ann Arbor MI, US
David Grant - Minneapolis MN, US

International Classification:

B05D003/02

US Classification:

427/385500, 427/212000

Abstract:

A method of preparing a coated solid dosage form is disclosed wherein a solid dosage form, such as a compressed tablet with active agent dispersed therein, is coated at least twice with a coating solution comprising a water-insoluble coating polymer and a water-soluble pore former, and cured after at least the first coating step. The method of the present invention allows for the production of cured coated solid dosage forms using very short curing times. Coated solid dosage forms produced according to the present invention have been found to have long extended release characteristics.

US Patent:

20040146556, Jul 29, 2004

Filed:

Oct 29, 2003

Appl. No.:

10/696044

Inventors:

Robert Noack - Grand Rapids MI, US
John Heimlich - Portage MI, US
Ernest Lee - Kalamazoo MI, US

International Classification:

A61K009/22

US Classification:

424/468000

Abstract:

The present invention is directed to oral dosage forms for extended release, including a dosage form for pH independent extended release, of at least one drug to a subject. The present invention is also directed to methods of making and using the dosage forms to treat or prevent a subject for various conditions. Specific extended release formulations of crystalline clindamycin free base are also provided. The crystalline clindamycin free base oral formulations of the present invention provide a means for treating or preventing gram-positive bacterial infections with a minimal number of treatments per day, potentially, as little as once or twice per day.

US Patent:

20040228915, Nov 18, 2004

Filed:

Apr 2, 2004

Appl. No.:

10/816699

Inventors:

Robert Noack - Ann Arbor MI, US
John Heimlich - Portage MI, US
Ernest Lee - Kalamazoo MI, US

International Classification:

A61K031/704
A61K009/26
A61K009/24

US Classification:

424/471000, 514/035000

Abstract:

The present invention is directed to an extended release multiparticulate formulation of a therapeutic agent, wherein coated core multiparticulate particles of the therapeutic agent are overcoated with a binder-dispersing agent, such as povidone or cross-povidone. The invention is also directed to compressed tablets of the extended release multiparticulate formulation of the invention, and to a method of oral administration of compressed tablets of clindamycin to a subject to treat or prevent a gram-positive bacterial infection therein. The binder-dispersing agent in the formulations of the present invention ensure that compressed tablets formed therefrom will remain intact through oral administration, and dissolve shortly thereafter, enabling the multiparticulates to release the therapeutic agent contained therein over an extended period of time.

US Patent:

20050175691, Aug 11, 2005

Filed:

Jul 24, 2003

Appl. No.:

10/626275

Inventors:

Ernest Lee - Kalamazoo MI, US
Gerard Bredael - Portage MI, US
John Baldwin - Kalamazoo MI, US
Steven Cox - Schoolcraft MI, US
Mark Heintz - Portage MI, US

International Classification:

A61K009/20

US Classification:

424465000

Abstract:

An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.

US Patent:

20050226926, Oct 13, 2005

Filed:

Jul 23, 2003

Appl. No.:

10/626166

Inventors:

Gregory Amidon - Portage MI, US
Loksidh Ganorkar - Kalamazoo MI, US
John Heimlich - Portage MI, US
Ernest Lee - Kalamazoo MI, US
Robert Noack - Ann Arbor MI, US
Joseph Reo - Kalamazoo MI, US
Connie Skoug - Portage MI, US

International Classification:

A61K009/22

US Classification:

424468000

Abstract:

A sustained-release pharmaceutical composition in a form of an orally deliverable tablet comprises a water-soluble salt of pramipexole, dispersed in a matrix comprising a hydrophilic polymer and a starch having a tensile strength of at least about 0.15 kN cmat a solid fraction representative of the tablet.