The manufacture of a prototype multidose ophthalmic solution dispenser that maintains the sterility of preservative free solutions is proposed. The device protects sterile solutions through the use of an antimicrobially treated membrane that prevents """"""""grow- through"""""""" of micro organisms from the septic side of the bottle. Additionally, the downstream side of the dispensing tip is also coated with an antimicrobial treatment to preclude bacterial colonization in the dead volume of the septic side. The proposed dispenser maintains sterility via two distinct mechanisms. The first one entails prevention of pathogen respiration from the solution in the tip by physical exclusion, as related to the size of the pores of the membrane. The second, and most important mechanism relies upon the killing of microbes upon contact with our novel antimicrobial coating without the release of toxic or soluble agents into the stored solution. The proposed tip can be readily substituted for standard bottle tips and hence adapts easily into existing aseptic filling lines for solution bottling. The proposed technology, therefore, offers the advantage of low cost, ready manufacturability and user friendliness while eliminating the need for preservatives in ophthalmic solutions.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
3R44EY010787-03S1
Application #
2395387
Study Section
Special Emphasis Panel (ZRG5-MBC-2 (01))
Project Start
1994-09-01
Project End
1997-08-31
Budget Start
1996-09-01
Budget End
1997-08-31
Support Year
3
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Biopolymerix, Inc.
Department
Type
DUNS #
City
Tyngsboro
State
MA
Country
United States
Zip Code
01879