You are here

STTR Phase I: Ultrasonic Measurement Instrument for Pharmaceutical Tablet Design, Development, and Continuous Manufacturing

Award Information
Agency: National Science Foundation
Branch: N/A
Contract: 2051895
Agency Tracking Number: 2051895
Amount: $255,962.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: PT
Solicitation Number: N/A
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2022-01-01
Award End Date (Contract End Date): 2022-06-30
Small Business Information
United States
DUNS: 081938994
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Cetin Cetinkaya
 (315) 276-8051
Business Contact
 Cetin Cetinkaya
Phone: (315) 276-8051
Research Institution
 Clarkson University
 Xiaochi Xu
8 Clarkson Avenue
Potsdam, NY 13676
United States

 Nonprofit College or University

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to improve quality control in pharmaceutical manufacturing. The compressed tablet is the most popular pharmaceutical dosage form in use worldwide. Despite its well-established manufacturing processes, issues with tablet quality are frequent. Issues in its design and manufacturing have the potential to make significant medical and financial impacts as failures in quality may result in harm to patients, product recalls, and medicine shortages. The proposed Ultrasonic Measurement Instrument (UMI) unit will substantially shorten drug tablet design/development cycles and detect/identify manufacturing and quality problems before release. Its utilization in modern continuous manufacturing lines will minimize the risk of defective tablet production/disposition and costly product recalls/disposals. The UMI unit will lead to two distinct solutions: (i) a real-time preventive quality monitoring device for continuous manufacturing production line and (ii) a stand-alone laboratory equipment for characterizing tablet physical properties. The target users for our UMI-based products include pharmaceutical manufacturers; equipment providers; generic drug manufacturers; R&D groups and drug development teams in corporations and universities; and compounding pharmacies. This Small Business Technology Transfer (STTR) Phase I project and its ultrasonic approach have several critical advantages over the competing quality assessment and monitoring technologies for pharmaceutical manufacturing. Unlike other detection techniques, ultrasound directly interacts with the mass density, material elasticity/viscoelasticity, defects/cracks, and inhomogeneities of a medium and piezoelectric transducers are the most sensitive devices for transient strain sensing. Operating in MHz frequency, ultrasonic techniques make rapid (micro-seconds scale) measurements at relevant wavelengths for tablet and defect sizes (micrometer to millimeter scales). Challenges to be addressed include: (i) existing wave propagation models for viscoelastic tablet materials with microstructures are inadequate for accurate materials characterization/valuation with ultrasound, and (ii) a precise handling and positioning apparatus for tablets is needed, as for machine learning and data analytics/mining, the repeatable acquisition and processing of large data sets are required. The main outcome of the project is a proof-of-concept testing/measurement unit (UMI) with a precise tablet handling sub-system and its accompanying mathematical algorithms for the formation of large data sets. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government