Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants
Patent
1996-12-13
1999-02-09
Levy, Neil S.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Biocides; animal or insect repellents or attractants
424404, 424407, 424 7834, 424 7835, 424617, 424618, 514634, 514635, 523122, A01N 2532
Patent
active
058690735
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to liquid dispensers, specifically, the provision of liquid dispensers capable of maintaining the sterility of sterile solutions during storage, during dispensing, and subsequent to dispensing of the solution, as well as methods of manufacture and use of such dispensers.
BACKGROUND OF THE INVENTION
Many indications require administration of sterile solutions. In general, such solutions, and the dispensers in which they are stored, are sterilized prior to closure of the dispenser. Contamination can occur, however, after the dispenser is opened and used. Various approaches have been employed in attempts to minimize this contamination problem.
Single dose dispensers are available. Such dispensers, however, are made only for one time use, and then are discarded, adding considerably to packaging costs and waste. Moreover, more sterile solution than is required for a single dose usually is packaged which adds to the expense of the treatment. Another problem is that persons may attempt to use the single dose dispenser multiple times, which can result in contamination of the liquid being dispensed.
Alternatively, preservatives have been added to multi-dose dispensers to prevent microbial contamination after the dispenser is initially used. Such preservatives, however, often are toxic to mammalian cells, as well as microbial cells. For example, many preservatives used in eye drop formulations are toxic to the goblet cells in the eye. Such toxicity is detrimental to persons requiring prolonged application of the solutions. Moreover, persons often develop chemical sensitivity to the preservative, resulting in significant allergic reactions to the preparations. Such allergies can appear in some persons after prolonged exposure, as well as in others after only a single exposure.
Membrane filters have also been used in liquid dispensers in attempts to prevent microbial contamination of the stored sterile liquid. If a hydrophilic filter is used, however, the filter can allow the phenomenon known as "grow-through," in which microbial progeny on the downstream (non-sterile) side of the filter can pass through the filter pores because of their smaller size during cell division, and thereby contaminate the sterile solution contents in the dispenser.
Hydrophobic filters have been employed in liquid dispensers. Hydrophobic surfaces are non-wetting, and therefore are significantly more difficult for microbes to grow on. Such filters, however, because of their hydrophobicity prevent the flow of sterile aqueous solutions through the filter.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a multi-dose liquid dispenser which prevents external microbial contamination of the liquid during repeated use.
According to the invention, an article of manufacture is provided--a liquid dispenser for dispensing a sterile liquid. The liquid dispenser comprises a container for storing the sterile liquid and a nozzle assembly which is attached to the container. The nozzle-assembly has a passageway which enables the sterile liquid to flow from the container through the passageway in order to dispense the liquid. The liquid dispenser further comprises an integral, non-leaching antimicrobial element for inhibiting microbial contamination of the solution. In one embodiment, the antimicrobial element comprises a filter or filters attached to the nozzle assembly and positioned across the passageway so that liquid and air flow are directed through the filter.
The filter comprises a substrate having an antimicrobial agent attached to the surface and in the pores thereof. The substrate may be an organic or inorganic material. The antimicrobial agent can be a metallic or non-metallic material having anti-bacterial, anti-viral and/or anti-fungal properties, or a combination thereof. In one embodiment, the filter is at least partially coated on the downstream surface with a metallic material, e.g., a metal, metal oxide, metal salt, metal complex, metal alloy, or mixtures thereof
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Gravens et a
Sawan Samuel P.
Shalon Tadmor
Subramanyam Sundar
Yurkovetskiy Alexander
Biopolymerix, Inc
Levy Neil S.
Surfacine Development Company, Inc.
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