Expanding Precision Particle Fabrication Technology for the Widespread Control of

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$695,173.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43RR030736-01
Award Id:
96517
Agency Tracking Number:
RR030736
Solicitation Year:
n/a
Solicitation Topic Code:
NCRR
Solicitation Number:
n/a
Small Business Information
3901 RAINBOW BLVD., KANSAS CITY, MO, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
828536438
Principal Investigator:
MARIAFLYNN
() -
Business Contact:
STECKLEINFLYNN
() -
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): This overall goal of this project is to develop a scalable process for fabricating oil encapsulated particles with uniform sizes and physical characteristics that contain oil as a vehicle for delivering hydrophobic drug s. Poorly water soluble active pharmaceutical ingredients (APIs) represent 40% of all new chemical entities discovered by the pharmaceutical industry, but investigators often discard them in the RandD phase because their insolubility renders them difficult to formulate, which translates to low and/or variable bioavailability and effectiveness in vivo. Solubility problems also decrease the efficacy of a significant portion of products on the market, including many pain relievers and antibiotics. Our novel Pr ecision Particle Fabrication (PPF) technology is a flexible, single-step process for fabricating oil-containing particles with finely tuned sizes and physicochemical characteristics that enable improved control over drug encapsulation and release. We hypot hesize that a scaled version of this technology will produce dried, oil-filled microcapsules (size lt 100 5m) at a rate of at least 10 kg/min, more than adequate for industry needs. Phase I research will demonstrate the feasibility of scaling PPF technolog y for broad use by pharmaceutical companies. Our research team will develop several scaled prototypes of the existing PPF technology to meet a range of varying microcapsule specifications (Aim 1). We will also integrate the technology with current Good Man ufacturing Practice guidelines given by the FDA (Aim 2) and design a monitoring mechanism and fluid recycling for the process to decrease material waste (Aim 3). Successful scaling of the PPF technology for drug delivery will improve the biological perform ance of existing pharmaceutical products and enable production of new therapeutic solutions using APIs previously discarded in the drug development process. PUBLIC HEALTH RELEVANCE: Development of effective delivery mechanisms for pharmaceutical pro ducts is just as important as the drugs themselves for treatment of disease. However, pharmaceutical companies have yet to discover a reliable, scalable process for consistently fabricating drug particles with controlled physical properties and release pro files. This project aims to test the feasibility of expanding a novel method for fabricating particles with well-defined and tunable properties from the laboratory setting to the broader marketplace by leveraging encapsulated oil as a delivery vehicle for poorly- soluble drugs.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government