SBIR-STTR Award

A novel means of maintaining the sterility of ophthalmic solutions will be created wherein a membrane type dispenser is employed to provide sterile preservative free solutions. The device protects a sterile solution through the use of a specially treated membrane that prevents the growth of micro organisms from the septic side of the bottle. The dispenser maintains sterility by employing two distinct mechanisms, these being the filtration of pathogens from a solution through physical exclusion, as related to the size of the pores of the membrane. Secondly, and most importantly, pathogens cannot "grow- through" the membrane because it is chemically treated to be toxic to such pathogens.Awardee's statement of the potential commercial applications of the research:Commercial applications of a multi-dose dispensing device envisaged in Phase II upon successful completion of Phase I will include preservative free artificial tears, lens cleaning solutions and ophthalmic drugs. Based on the current trend in the dollar market trend of these products, such a device is expected to make a substantial impact on the market.National Eye Institute (NEI)

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 and microbially 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. This 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 tip can be readily substituted for standard bottle tips and hence adapts easily into existing aseptic filling lines for solution bottling. This technology, therefore, offers the advantage of low cost, ready manufacturability and user friendliness while eliminating the need for preservatives in ophthalmic solutions.National Eye Institute (NEI)