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The AAO notes that as new classes of drugs are developed, this coding system may be modified in the future by reassigning the blue color to a new class of drugs while keeping yellow for p-blockers. Abbreviation: AAO, American Academy of Ophthalmology.

The AAO notes that as new classes of drugs are developed, this coding system may be modified in the future by reassigning the blue color to a new class of drugs while keeping yellow for p-blockers. Abbreviation: AAO, American Academy of Ophthalmology.

the cap and bottleneck is provided by the manufacturer, and the container should not be dispensed if these are missing or there is evidence of prior removal and reapplication. The LDPE, MDPE, and HDPE resins used for the bottles and the dispensing tips cannot be autoclaved, and they are sterilized either by ^Co y-irradiation or ethylene oxide. The cap is designed such that when it is screwed tightly onto the bottle, it mates with the dispensing tip and forms a seal. The cap is usually made of a harder resin than the bottle, such as polystyrene or polypropylene, and is also sterilized by y-radiation or ethylene oxide gas exposure. A plastic ophthalmic package has been introduced that uses a special grade of polypropylene that is resistant to deformation at autoclave temperatures. With this specialized packaging, the bottle can be filled, the dispensing tip and cap applied, and the entire product sterilized by steam under pressure at 121°C.

The glass dropper bottle is still used for products that are extremely sensitive to oxygen or contain permeable components that are not sufficiently stable in plastic. Powders for reconstitution also use glass containers, owing to their heat-transfer characteristics, which are necessary during the freeze-drying process. The glass used should be USP type I for maximum compatibility with the sterilization process and the product. The glass container is made sterile by dry heat or steam autoclave. Amber glass is used for light resistance and is superior to green glass. A sterile dropper assembly is usually supplied separately. It is usually gas sterilized in a blister composed of vinyl and Tyvek, a fused, porous polypropylene material. The dropper assembly is made of a glass or LDPE plastic pipette and a rubber dropper bulb. The manufacturer carefully tests the appropriate plastic and rubber materials suitable for use with the product; therefore, they should be dispensed with the product. The pharmacist should place the dropper assembly aseptically into the product before dispensing and instruct the patient on precautions to be used to prevent contamination.

Multidose packaging of unpreserved topical drops In some cases it may be desirable to prescribe a product without an antimicrobial preservative for patients who exhibit sensitivity to various preservatives. This can be accomplished with the use of unit-dose containers but these usually contain more than that needed for a single use, so if the patient ignores the labeling and makes multiple use of the contents, there is increased risk for contamination. Recent product introductions of this type include the VISMED® multilubricant eyedrops from TRB CHEMMEDICA, who are marketing an innovative unpreserved multidose eye lubricant that contains a pump that needs to be primed prior to first use (http://www.trbchemedica.co.uk). The VISMED eyedrops contain a proprietary formulation of highly purified specific fraction of sodium hyaluronate. In this formulation, sodium hyaluronate due to its main physical characteristic, viscoelasticity, delivers a high viscosity between blinks and a low viscosity during blinking, ensuring efficient coating of the surface of the eye. In addition to being unpreserved, the pH of VISMED is adjusted to 7.3, similar to that of the natural tear film, for further potential patient comfort. The VISMED product is currently marketed in the European Union as a medical device under a CE mark, and a clinical trial sponsored by Lantibio Inc., Chapel Hill, North Carolina, U.S. is recruiting patients in the United States.

FDA regulations for ophthalmic liquids allow the use of unpreserved multidose packaging if the product is packaged and labeled in such a manner as to afford adequate protection and minimize the hazards resulting from contamination during use (21 CFR 200.50). Thus, the same unit-dose containers can be modified to use a resealable cap and the labeling modified to limit the usage to a minimum number of doses such as to discard after 12 hours from initial use and limit the content volume to the expected number of doses with only a small overfill if necessary. It may be necessary to use a secondary package to retard moisture vapor transmission significantly, depending on the surface to volume ratio of the primary package.

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