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Improved Dehydration Process for Pharmaceutical Synthesis II

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / SBIR
Agency Tracking Number:
R44GM077717
Solicitation Year:
2011
Solicitation Topic Code:
NIGMS
Solicitation Number:
PA10-050
Small Business Information
Compact Membrane Systems, Inc.
335 Water Street Newport, DE 19804-2410
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2011
Title: Improved Dehydration Process for Pharmaceutical Synthesis II
Agency: HHS
Contract: 2R44GM077717-02A2
Award Amount: $1,028,810.00
 

Abstract:

DESCRIPTION (provided by applicant): Compact Membrane Systems (CMS) proposes to develop a perfluoro membrane reactor technology that will provide a generally applicable tool for removing water and oxygen from pharmaceutical synthesis processes. This innovation aims to improve product quality and reduce manufacturing costs of pharmaceutical end products. Manufacturing cost reductions will be derived from improved product yields, increased reaction rates and reduced energy input requirements of the manufacturing process. Product quality improvements will be derived from the elimination of entrainers, azeotropic distillation, and drying reagents in the process as well as operation at lower temperatures and driving the reactant. The project has been expanded toinclude the removal of both oxygen and water in an effort to reduce side reactions and/or catalyst poisoning which should be of broad use in pharmaceutical synthesis. This membrane system has the capability to withstand process temperatures of 2200C endowing it with universal applicability in almost any organic-water environment for water separation in the synthesis of products such as sildenafil, celecoxib, sertraline, and aprepitant. Given the large water-organic compound separation factors achievable, the inertness of the membrane, and the ability to withstand harsh operating conditions, we believe we have an ideal system for reaction water and oxygen removal. The proposer will develop the membrane system and processes while the subcontractors will demonstrate Pd-catalyzed amination reactions. These reactions have revolutionized drug discovery and process chemistry in the past decade. The efficiency of Pd-catalyzed amination reactions can be negatively affected by impurities such as water. The Fox group atthe University of Delaware and recently hired synthesis chemists at CMS (and consultants) will demonstrate the efficacy of the membrane process in Pd-catalyzed amination reactions in a study that will consist of: synthesis of the aryl bromide intermediatefrom the Astra Zeneca AR-A2 process; synthesis of the Pd-catalyzed amination product from the AR-A2 process; development of GC assays for the reactions; study of a control reaction without water/oxygen removal; and, study of amination with drying of the aryl bromide intermediate using the proprietary membrane. With success in Phase I, numerous industrial partners have either already spent over 150,000 on evaluation or committed to major evaluations in Phase II. PUBLIC HEALTH RELEVANCE: Compact Membrane Systems proposes to develop a process technology that will provide a generally applicable tool for removing water and oxygen from pharmaceutical synthesis of products. This will improve product quality and reduce manufacturing costs of pharmaceuticalend products.

Principal Investigator:

Sudipto Majumdar
302-999-7996
smajumdar@compactmembrane.com

Business Contact:

Stuart Nemser
302-999-7996
bkelley@compactmembrane.com
Small Business Information at Submission:

COMPACT MEMBRANE SYSTEMS, INC.
335 WATER STREET NEWPORT, DE 19804-

EIN/Tax ID: 151034825
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No