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Packaging solutions

Packaging solutions description/claims

1. Technical Field

The present invention generally relates to packaging solutions for ophthalmic devices such as contact lenses.

2. Description of Related Art

Blister-packs and glass vials are typically used to individually package each soft contact lens for sale to a customer. Saline or deionized water is commonly used to store the lens in the blister-packs, as mentioned in various patents related to the packaging or manufacturing of contact lenses. Because lens material may tend to stick to itself and to the lens package, packaging solutions for blister-packs have sometimes been formulated to reduce or eliminate lens folding and sticking. For this reason, poly(vinyl alcohol) (PVA) has been used in contact lens packaging solutions.

It has been stated that if a lens is thoroughly cleaned before insertion, lacrimal fluid can adequately wet the lens. Furthermore, the difficulties of adding a surfactant to a packaging solution, including the possibility of lowering shelf-life and/or adverse reactions during heat sterilization, have further limited the use of surfactants in a packaging solution for the purpose of providing any possible or marginal effect on lens comfort. It is only after a lens has been worn, when proteins or other deposits have formed on the surface of the lens, that surfactants have been used in standard lens-care solutions.

It is highly desirable that contact lens be as comfortable as possible for wearers. Manufacturers of contact lenses are continually working to improve the comfort of the lenses. Nevertheless, many people who wear contact lenses still experience dryness or eye irritation throughout the day and particularly towards the end of the day. An insufficiently wetted lens at any point in time will cause significant discomfort to the lens wearer. Although wetting drops can be used as needed to alleviate such discomfort, it would certainly be desirable if such discomfort did not arise in the first place.

U.S. Pat. No. 5,882,687 discloses a package containing a contact lens suitable for immediate use which comprises (a) a solution comprising a soluble polyanionic component and having a viscosity of less than 50 cps at 25° C., an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 9; (b) at least one contact lens, and (c) a container for holding the solution and contact lens sufficient to preserve the sterility of the solution and contact lens, wherein the solution contains no additional disinfectant component. However, a polyanion such as carboxymethylcellulose alone can possess a shape of a sphere or random coil and has a Mark-Houwink Constant (α) of 0 when in the shape of a sphere and 0.5 to 0.8 when in the shape of a random coil. This type of polyanion may not coat uniformly a surface of a contact lens, resulting in the lens being relatively uncomfortable during use.

Accordingly, it would be desirable to provide an improved packaging system for ophthalmic devices such as an ophthalmic lens that the lens would be comfortable to wear in actual use and allow for extended wear of the lens without irritation or other adverse effects to the cornea.

In accordance with one embodiment of the present invention, a method of preparing a package comprising a storable, sterile ophthalmic device is provided comprising:

(a) immersing an ophthalmic device in an aqueous packaging solution comprising an anionic polymer and a non-ionic polyol, wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 9;

(b) packaging the solution and the device in a manner preventing contamination of the device by microorganisms; and

(c) sterilizing the packaged solution and device.

In accordance with a second embodiment of the present invention, a method for packaging and storing a contact lens is provided comprising, prior to delivery of the contact lens to the customer-wearer, immersing the contact lens in an aqueous packaging solution inside a package and heat sterilizing the solution, wherein the aqueous packaging solution comprises an anionic polymer and a non-ionic polyol, wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH of about 6 to about 9.

In accordance with a third embodiment of the present invention, a packaging system for the storage of an ophthalmic device is provided comprising a sealed container containing one or more unused ophthalmic devices immersed in an aqueous packaging solution comprising an anionic polymer and a non-ionic polyol, wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg, a pH of about 6 to about 9 and is heat sterilized.

In accordance with a fourth embodiment of the present invention, a packaging system for the storage of an ophthalmic device is provided comprising:

(a) an aqueous packaging solution comprising an anionic polymer and a non-ionic polyol, wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 9;

(b) at least one ophthalmic device; and

(c) a container for holding the solution and ophthalmic device sufficient to preserve the sterility of the solution and ophthalmic device, wherein the solution does not contain an effective disinfecting amount of a disinfecting agent.

By combining a non-ionic polyol with an anionic polymer such as an anionic carboxymethylcellulose to form an aqueous packaging solution, a more uniform coating of the anionic polymer may be obtained. It is believed that the Mark-Houwink Constant (α) of the anionic polymer increases to a level resulting in a coating that is more uniform over the lens, and hydrogen bonding of the anionic polymer is more effective. Thus, the lens will be more comfortable to wear in actual use and may allow for the extended wear of the lens without irritation or other adverse effects to the cornea.

• Provisional Patent
• Utility Patent

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