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Quality by Design of orally inhaled drug products: Chemistry, Manufacturing and C

Award Number: U01FD004321
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 11/01/2011
PERIOD OF PERFORMANCE END DATE: 07/31/2013

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Quality by Design of orally inhaled drug products: Chemistry, Manufacturing and C - There are many scientific challenges that need to be overcome to manufacture carrier based dry powder inhaler (DPI) products that are safe and therapeutic for treating respiratory diseases. Of these, controlling the manufacture and critical quality attributes (CQAs) of raw materials (both the active pharmaceutical ingredient and excipients) is critical to the successful development of a safe and efficacious DPI product. In this proposal, we seek to determine how primary crystallization and secondary processing of APIs directly influence formulation structure and product functionality of single component and combination based DPI products. The major research objective is to identify and provide a science based understanding of the CQAs of primary and secondary processed APIs. A greater understanding of this relationship between primary crystallization, its CQAs and their influence on surface interfacial properties of micronized APIs, will provide the necessary science and tools to enable greater control of product safety, efficacy, potency, quality and performance. The exploration into the relationship between the physicochemical properties of primary crystals, surface interfacial properties of secondary processed micronized API and the CQAs of these particles will aid the FDA to direct both brand and generic industries to define quality and functionality in DPI drug products.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2017 ( Subtotal = -$27,685 )
2017	2011	UNIVERSITY OF BATH	THE AVENUE	BATH	AVON	BA2 7AY		GBR	Food and Drug Administration Research	000	1	4/4/2017	NEW	-$27,685
														Subtotal = -$27,685

Issue Date FY: 2014 ( Subtotal = -$27,685 )
2014	2011	University of Bath	Claverton Down	Bath				GBR	Food and Drug Administration Research	000	1	6/16/2014	NEW	-$27,685
														Subtotal = -$27,685

Issue Date FY: 2013 ( Subtotal = $0 )
2013	2011	University of Bath	Claverton Down	BATH		BA2 7		GBR	Food and Drug Administration Research	000	1	12/19/2012	NEW	$0
														Subtotal = $0

Issue Date FY: 2011 ( Subtotal = $160,000 )
2011	2011	University of Bath	Claverton Down	Bath				GBR	Food and Drug Administration Research	000	1	9/16/2011	NEW	$160,000
2011	2011	University of Bath	Claverton Down	Bath				GBR	Food and Drug Administration Research	001	1	9/16/2011	NEW	$0
														Subtotal = $160,000

Grand Total All Awards = $104,630

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Quality by Design of orally inhaled drug products: Chemistry, Manufacturing and C

Award Number: U01FD004321

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 11/01/2011

PERIOD OF PERFORMANCE END DATE: 07/31/2013

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