Silicone-free glass pre-filled syringe system for Biological Drugs.

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$229,475.00
Award Year:
2009
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL092649-01A1
Award Id:
93919
Agency Tracking Number:
HL092649
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
TRIBOFILM RESEARCH, INC., 625 HUTTON ST, STE 105, RALEIGH, NC, 27606
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
115690369
Principal Investigator:
VINAY SAKHRANI
(919) 838-2844
VINAY@TRIBOFILMRESEARCH.COM
Business Contact:
CHARLES TOMASINO
() -
vinay@tribofilmresearch.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): In the medical device industry, silicone oil is a ubiquitous lubricant - used in the manufacture and assembly of components and also as the terminal lubricant for proper device operation. For prefilled syringes, the pro blem arises when micro-droplets of silicone oil migrate into the drug medium and act as a contaminant and possible reactant for the packaged drug. In the case of biological drugs, such silicone oil contamination has been implicated in protein conformationa l changes and aggregation. Glass syringes for prefilled applications predominantly use silicone oil as a lubricant. A silicone oil-free glass prefilled device is highly desired, but before it would be accepted, stability testing with various pharmaceutical ingredients as well as particulate and force testing after extended storage is required. We propose the development of glass prefilled syringes with the TriboGlide(r) silicone-free lubrication system based on perfluoropolyether chemistry. The effect of ac celerated storage conditions on break-loose and extrusion syringe forces along with comparison of the particulate generation between standard silicone oil lubricated and TriboGlide(r) silicone-free syringes is proposed. In collaboration with the University of Colorado Denver, UCD, TriboGlide(r) syringes will be compared to standard siliconized syringes as devices for packaging of protein formulations. Protein precipitation (UV/Vis spectroscopy), loss of soluble protein (SE-HPLC), influence of adsorbed prote in on syringe forces, and pH shifts in water for injection will be assessed. The proteins selected for this study are human serum albumin, human IgG, insulin, and abatecept (monoclonal antibody by Bristol Myers Squibb). In phase II, we propose to evaluate the TriboGlide(r) glass syringes for effects on secondary and tertiary structural changes of the proteins, using circular dichroism and fluorescence spectroscopy. Differential scanning calorimetry will be used to detect changes in the thermodynamic stabili ty of the proteins after extended storage in the syringes. Finally, with the extensive experience in vaccines brought by Dr. LaToya Jones Braun from UCD, we will evaluate the stability of various vaccine formulations stored in the syringes. The medical dev ice and pharmaceutical industries have long desired a completely silicone-free system that does not affect the stability of the packaged drug in solution. If successful, TriboGlide will be the first universal silicone-free system for glass prefilled syring es with applications extending to other medical devices. PUBLIC HEALTH RELEVANCE: Patient controlled self-therapy is a big driving factor for drugs packaged in single-dose prefilled syringe formats for treatment of chronic ailments such as rheumatoid arthr itis and diabetes. Other advantages include reduced errors, ease of use, accurate dosage, elimination of preservatives in case of multi-dose vaccines and above all reduced overfill of drugs that are required for packaging in vials. Silicone oil, which serv es as a lubricant for easy operation of the syringe, can contaminate the drug product and adversely interact with the sensitive drugs. The proposed TriboGlide system will be the first silicone oil-free system for glass prefilled syringes that overcomes the problems of lubricant migration and drug contamination.

* 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