Warren E Jaworowicz

US Patent:

6428815, Aug 6, 2002

Filed:

Jul 3, 2001

Appl. No.:

09/898524

Inventors:

Henry R. Costantino - Grantham NH
Warren E. Jaworowicz - Boxboro MA
Mark A. Tracy - Arlington MA
Christopher P. Beganski - Littleton MA

Assignee:

Alkermes Controlled Therapeutics, Inc. - Cambridge MA

International Classification:

A61K 950

US Classification:

424501, 424502, 264 41, 264 433, 264 46, 42840221

Abstract:

Submicron particles of a biologically active agent are prepared by atomizing using multifluid atomization a dispersed system comprising at least one biologically active agent and at least one solvent to produce droplets, freezing the droplets to produce frozen droplets, lyophilizing the frozen droplets to obtain microstructures capable of being further fragmented into submicron particles by techniques such as probe sonication. The submicron particles can be incorporated into sustained release compositions having a reduced initial release of biologically active agent. The sustained release compositions can be administered to a human or animal.

US Patent:

6444223, Sep 3, 2002

Filed:

May 28, 1999

Appl. No.:

09/321091

Inventors:

Mark A. Tracy - Arlington MA
Kevin L. Ward - Arlington MA
Warren E. Jaworowicz - Boxboro MA

Assignee:

Alkermes Controlled Therapeutics, Inc. - Cambridge MA

International Classification:

A61K 910

US Classification:

424486, 424487

Abstract:

The present invention relates to a sustained release composition comprising micron particles of labile agent and a method of preparing and using the sustained release composition. The invention further relates to micron particles of a labile agent and a method of preparing the micron particles. The method of the invention for preparing a composition for the sustained release of a labile agent, comprises forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent. The suspension is then wet milled to achieve micron particles of the labile agent. The polymer solvent is then removed resulting in a solid polymer/labile agent matrix. The method for preparing micron particles of a labile agent comprises forming a suspension comprising the labile agent, dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent, and wet milling of the suspension.

US Patent:

6451347, Sep 17, 2002

Filed:

Mar 1, 1999

Appl. No.:

09/260362

Inventors:

Warren E. Jaworowicz - Boxboro MA

Assignee:

Alkermes Controlled Therapeutics, Inc. - Cambridge MA
Genentech, Inc. - San Francisco CA

International Classification:

A61K 3827

US Classification:

424486, 514 21, 530399

Abstract:

A method of purifying human growth hormone (hGH) from deamidated hGH, oxidized hGH or both. The method comprises the steps of forming a metal cation complexed-hGH composition enriched in native hGH under conditions wherein none or less than all of the deamidated hGH, oxidized hGH or both complex with a metal cation and, isolating the metal cation-complexed hGH composition from the deamidated hGH, oxidized hGH or combination thereof. The method can further comprise the step of releasing purified hGH from the complex. Alternatively, the metal cation-complexed hGH can be encapsulated into a biocompatible polymer for sustained release of hGH. The purification method can be performed one or more times using the hGH released from the metal cation-complexed hGH composition, depending on the purity of the hGH desired.

US Patent:

6479065, Nov 12, 2002

Filed:

Mar 7, 2001

Appl. No.:

09/801272

Inventors:

Warren E. Jaworowicz - Boxboro MA
James I. Wright - Lexington MA

Assignee:

Alkermes Controlled Therapeutics, Inc. - Cambridge MA

International Classification:

C08J 926

US Classification:

424423, 424 78, 424426, 424486, 424491, 514964, 514965, 521 54, 521 64

Abstract:

The invention relates to a sustained release composition and methods of forming and using said composition for the sustained release of biologically active agent. The sustained release compositions of the invention comprise a biocompatible polymer and a biologically active agent characterized by a porous center and a less porous outer layer wherein the center and outer layer consist of essentially the same materials. The sustained release compositions can be prepared by annealing at least a substantial portion of the exterior surface of a polymer/active agent matrix. The compositions which have been annealed exhibit a decrease in the release of agent over the first 24 hours following administration (i. e. , reduced burst) and as a result can show an increase in the duration of sustained release thereby providing increased therapeutic benefits.

US Patent:

6713087, Mar 30, 2004

Filed:

Jul 18, 2002

Appl. No.:

10/200057

Inventors:

Mark A. Tracy - Arlington MA
Kevin L. Ward - Arlington MA
Warren E. Jaworowicz - Boxboro MA

Assignee:

Alkermes Controlled Therapeutics, Inc. - Cambridge MA

International Classification:

A61K 910

US Classification:

424486, 424487

Abstract:

The present invention relates to a sustained release composition comprising micron particles of labile agent and a method of preparing and using the sustained release composition. The invention further relates to micron particles of a labile agent and a method of preparing the micron particles. The method of the invention for preparing a composition for the sustained release of a labile agent, comprises forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent. The suspension is then wet milled to achieve micron particles of the labile agent. The polymer solvent is then removed resulting in a solid polymer/labile agent matrix. The composition for sustained release of a labile agent is likewise prepared according to the method of the invention. The sustained release composition of the present invention can be used in a method for providing a therapeutically effective blood level of a labile agent, in a subject in need of treatment with said agent, for a sustained period comprising administering to the subject the sustained release composition described herein.

US Patent:

7658998, Feb 9, 2010

Filed:

Jan 21, 2004

Appl. No.:

10/762220

Inventors:

Josiah Brown - Somerville MA, US
Warren E. Jaworowicz - Bolton MA, US
Gregory C. Troiano - Weymouth MA, US

Assignee:

Alkermes Controlled Therapeutics, Inc. - Cambridge MA

International Classification:

B32B 5/66

US Classification:

428403, 428407, 4272133, 42721331, 42721332, 42721333, 42721334, 42721335, 514 12, 514 13, 514 14, 514 15, 514 16, 530303, 530304, 424489

Abstract:

The present invention relates to a method for preparing an injectable composition of microparticles for the sustained release of a biologically active agent. The microparticles include a biocompatible polymer and a biologically active agent. The invention provides an improved process for the preparation of microparticles, wherein the physical characteristics of the microparticles, for example, the morphology, density and size, are independent of the process used to prepare the initially formed polymer/drug matrix. The method includes the steps of (a) providing a polymer/biologically active agent matrix; (b) compressing the polymer/biologically active agent matrix, thereby forming a compressed matrix; and (c) fragmenting the compressed matrix, thereby forming an injectable microparticle composition. The polymer/drug matrix can be provided by any suitable method.

US Patent:

20040224018, Nov 11, 2004

Filed:

Feb 5, 2004

Appl. No.:

10/773124

Inventors:

Mark Tracy - Arlington MA, US
Kevin Ward - Arlington MA, US
Warren Jaworowicz - Boxboro MA, US

Assignee:

Alkermes Controlled Therapeutics, Inc. - Cambridge MA

International Classification:

A61K009/26
B02C023/18

US Classification:

424/469000, 241/015000

Abstract:

The present invention relates to a sustained release composition comprising micron particles of labile agent and a method of preparing and using the sustained release composition. The invention further relates to micron particles of a labile agent and a method of preparing the micron particles. The method of the invention for preparing a composition for the sustained release of a labile agent, comprises forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent. The suspension is then wet milled to achieve micron particles of the labile agent. The polymer solvent is then removed resulting in a solid polymer/labile agent matrix. The composition for sustained release of a labile agent is likewise prepared according to the method of the invention. The sustained release composition of the present invention can be used in a method for providing a therapeutically effective blood level of a labile agent, in a subject in need of treatment with said agent, for a sustained period comprising administering to the subject the sustained release composition described herein. The method for preparing micron particles of a labile agent comprises forming a suspension comprising the labile agent, dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent, and wet milling of the suspension. The submicron particles of labile agent, as described herein, are prepared according to this method.

US Patent:

20100184659, Jul 22, 2010

Filed:

Dec 19, 2007

Appl. No.:

12/516922

Inventors:

Warren Jaworowicz - Bolton MA, US

International Classification:

A61K 38/16
C07K 14/00
A61P 19/02
A61P 1/02
A61P 3/14
A61P 9/10
A61P 25/00
A61P 25/16
A61P 27/02

US Classification:

514 12, 530350

Abstract:

The present invention is directed to sustained release formulations of biologic agents which permit persistent bioavailability. Preferred biologic agents include bone morphogenetic proteins. Diseases susceptible to amelioration and/or treatment with the formulations of the present invention include skeletal tissue diseases such as, but not limited to, osteoarthritis and other osteochondral diseases. The sustained release formulations of the present invention are especially suitable for treatment of minimally-vascularized or non-vascularized tissue sites such as, but not limited to, intra joint, interarticular, or intraminiscal sites.