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Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations

Award Number: U01FD006700
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Abstract In addition to the defined therapeutic effect caused by an active drug in a product, there is also a placebo and, potentially, a nocebo effect associated with that product. In topical products, these latter effects may account for 30% to 50% of the overall response for some products. They may also explain why some topical products with apparently identical bioavailability are associated with different patient outcomes. This application seeks to address the question of when do subtle excipient and manufacturing changes in a topical product cause a sensorial perception by subjects such that the “feel” of a product has changed either before and/or after it is applied to human skin. A second question is whether the “feel” of a product both before and after application can be quantified by instrumental rheology, tribology and texture analysis methods and whether these, in turn, can be related to the reported sensorial behaviour. We will manufacture topical formulations that systematically vary in Q1, Q2, and/or Q3 attributes and have large and borderline perceptive differences. We will then characterize these products using a range of rheology, tribology and texture analysis methods along with characterization of rate of drying, particle and globule size. In parallel, these products will be evaluated by perceptive testing focus groups, with controls, for their sensory properties or the ‘feel’ of the products. We will then relate these sensorial findings with the variations in formulation nature, composition and manufacture, and their resulting instrumental test results. Our goals are, firstly, to understand the relationships between product nature, instrumental findings and sensorial analyses and, secondly, to derive criteria for instrument tests that indicate what product composition subjects suggest do not differ, uncertain if they differ and do differ in their sensorial behaviour. It is anticipated that we can define the simplest, robust test that accurately and robustly aligns with sensory perceptions. A range of statistical methods, including (potentially) sophisticated, machine learning and deep learning tools will then be used to model the most appropriate instrumental analysis that can, with reasonable confidence predict perceptive attributes. A key outcome is a potential regulatory guideline advocating that generic products should exhibit similar sensorial behaviour as a reference listed drug product, giving boundaries in rheology, tribology and texture analysis as defined by Q1, Q2 and Q3 differences when sensorial behaviour between topical products is likely to be different.


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: 2023 ( Subtotal = $0 )
2023	2022	THE UNIVERSITY OF QUEENSLAND	THE UNIVERSITY OF QUEENSLAND	ST LUCIA				AUS	Food and Drug Administration Research	000	4	4/7/2023	NON-COMPETING CONTINUATION	$0
2023	2022	THE UNIVERSITY OF QUEENSLAND	THE UNIVERSITY OF QUEENSLAND	ST LUCIA				AUS	Food and Drug Administration Research	001	4	8/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $250,000 )
2022	2022	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	005	4	7/22/2022	NON-COMPETING CONTINUATION	$250,000
2022	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	003	3	1/31/2022	COMPETING CONTINUATION	$527,180
2022	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	004	3	2/9/2022	COMPETING CONTINUATION	$0
2022	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	000	3	11/23/2021	COMPETING CONTINUATION	$0
2022	2020	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	002	2	1/31/2022	NON-COMPETING CONTINUATION	-$499,990
2022	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	001	1	1/31/2022	NEW	-$27,190
														Subtotal = $250,000

Issue Date FY: 2021 ( Subtotal = $250,000 )
2021	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	001	3	7/14/2021	COMPETING CONTINUATION	$250,000
2021	2020	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	000	2	12/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $250,000

Issue Date FY: 2020 ( Subtotal = $499,990 )
2020	2020	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	002	2	8/5/2020	NON-COMPETING CONTINUATION	$499,990
2020	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	000	1	11/6/2019	NEW	$0
2020	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	001	1	3/13/2020	NEW	$0
														Subtotal = $499,990

Issue Date FY: 2019 ( Subtotal = $250,000 )
2019	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	000	1	8/20/2019	NEW	$250,000
														Subtotal = $250,000

Grand Total All Awards = $1,249,990

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Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations

Award Number: U01FD006700

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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