FIELD

The disclosed concept relates generally to containers adapted to house products that are sensitive to ambient conditions, e.g., certain medications, probiotics and diagnostic test strips. The disclosed concept also relates to inserts for such containers.

BACKGROUND

The efficacy of some products, particularly in the medical field, can be adversely affected by ambient conditions, e.g., through exposure to moisture or oxygen. Medications, for example, may be compromised by moisture. As the medication absorbs moisture, the medication may become less effective for its intended purpose. Diagnostic test strips, such as blood glucose test strips that are used in diabetic care, can also be adversely affected by exposure to moisture. Likewise, it has been found that pharmaceutical administration forms comprising a living microorganism culture (e.g., probiotic microorganism), may be degraded by moisture.

Medication and diagnostic test strips can encounter moisture at multiple times in their lifecycles. Such an encounter may occur during the manufacturing stage, during shipping, while the product is in storage prior to being sold, while the product is in storage after being sold, and each and every time a container containing the product is opened so that the product can be used. Even if the medication or diagnostic test strips have been manufactured and stored in a moisture tight container, each time the container is opened so that the medication or test strips can be extracted, moisture enters the container. The moisture that enters the container surrounds the medication or test strips inside the container after the container is closed. Such exposure to moisture can adversely affect the medication or test strips and reduce shelf life.

Because a medication/test strip container is repeatedly opened and closed, and because moisture enters the container each time it is opened, it is often provided with a desiccating unit adapted to absorb moisture. The desiccating unit typically includes desiccant within a small bag or canister that comingles with the medication. Various problems may be associated with such a small bag or canister. For example, the bag/canister may be ingested by a small child, which can result in a choking hazard. Also, it is possible that the bag/canister may be thrown away after the first time the container is opened. With the bag/canister absent, there is nothing to absorb moisture as the container continues to be opened and closed each time a consumer removes products therefrom.

To address the aforementioned deficiencies associated with loose desiccant bags/canisters, desiccant entrained immovable inserts have been provided in containers. Such inserts may comprise desiccant entrained polymer formulations including a base polymer (for structure), a desiccant and optionally a channeling agent. These types of inserts and methods of making and assembling the same are disclosed, e.g., in Applicant's U.S. Pat. Nos. 5,911,937, 6,214,255, 6,130,263, 6,080,350, 6,174,952, 6,124,006 and 6,221,446, and U.S. Pat. Pub. No. 2011/0127269, all of which are incorporated by reference herein in their entireties. These desiccant inserts provide distinct advantages over loosely placed desiccant bags/canisters.

One challenge with desiccant inserts relates to maximizing exposure of the insert's surface area to the air within the container to absorb moisture to a desired level of efficacy and efficiency. Typical desiccant inserts are provided in the form of a sleeve, liner or the like, having an inner surface exposed to air within the container, but an outer surface that is flush with—or integral with—the inner surface of the container body. As such, only approximately half of the outer surface of the insert is in contact with air inside the container. While desiccant inserts are typically designed to promote communication of moisture in the air to desiccant within the insert (e.g., via channels made by channeling agents in the desiccant entrained polymer), limiting surface contact of the air to only the inner surface of the insert may not provide optimal moisture absorption activity. In addition, for some applications it may be desirable to use channeling agents that provide slower moisture uptake rates, because they may provide other desirable properties. In such circumstances, providing only the inner wall of the insert as exposed surface area to moisture may provide insufficient moisture absorption capacity for some applications.

A drawback to desiccant inserts is the added cost of such insert to the total manufacturing cost. An improved seal would translate to a reduced volume of desiccant needed to achieve the same calculated moisture budget and thus a container which is less expensive to manufacture.

On the other hand, the seal itself should not significantly add to the cost of making the container or else the cost savings through reduced desiccant use would be cancelled out. Additionally, the seal itself must be carefully designed so that it does not require significant force to open while at the same time not be too easy to open such that the container could inadvertently pop open, e.g., due to pressure changes that may occur during transport. Hence, in the pharmaceutical and diagnostics packaging business it is important to balance product improvements with manufacturing efficiencies and cost realities.

SUMMARY

There is thus a need for improved containers for pharmaceutical or diagnostic test strip use which are inexpensive to make and provide a reliably moisture-tight sealing effect during and after several cycles of opening and closing, without requiring high opening forces to open. There is also a need for an improved desiccant inserts that increase surface area contact of the desiccant entrained polymer that may be exposed to air within the container, thus minimizing the amount of desiccant needed. The presently disclosed technology achieves the above and other objectives.

Accordingly, in one aspect, a method for storing and preserving moisture sensitive products, optionally diagnostic test strips, is provided. The method includes providing a moisture tight container which comprises a polymeric material, the container having an internal volume of 12 mL to 30 mL. The container includes a container body having a base and a sidewall extending therefrom, the body defining an interior, the body further having an opening leading to the interior. The container includes a lid that is connected to the body by a hinge and that is pivotable about the hinge with respect to the container body to move the container between a closed position in which the lid covers the opening so as to create a moisture tight seal with the body and an open position in which the opening is exposed. An insert is secured, optionally fixedly secured, within the interior of the container body, the insert comprising a base material and a desiccant. The base material provides structure to the insert and is optionally a polymer. The insert has an insert opening leading to an interior compartment configured for housing products. The method additionally includes disposing a plurality of moisture sensitive products, optionally diagnostic test strips, into the interior compartment when the container is in the open position. The method further includes moving the container into the closed position, thereby creating a moisture tight seal between the lid and the body. The container provides a shelf life to the moisture sensitive products of at least 12 months, optionally at least 18 months, optionally at least 24 months, optionally 18 months to 36 months. The container, when in the closed position, has a moisture vapor transmission rate, at ambient conditions of 30° C. and 75% relative humidity (RH), of less than 500 μg/day, optionally less than 400 μg/day, optionally less than 350 μg/day, optionally less than 325 μg/day, optionally less than 300 μg/day, optionally from 150 μg/day to 300 μg/day, optionally 175 μg/day to 285 μg/day; and the insert is under 3.25 g in mass, optionally 1.5 g to 3 g, optionally 1.5 g to 2.75 g, optionally 1.75 g to 2.75 g, optionally 2 g to 2.75 g, optionally about 2.5 g.

In another aspect, a moisture tight container having an internal volume of 12 mL to 30 mL is provided.

In another aspect a process is provided for manufacturing a group of at least forty (40) moisture tight flip-top vials, wherein each group consists of 17 mL vials or 24 mL vials. The process achieves relatively low moisture ingress with relatively narrow standard deviation from a mean moisture ingress. Optionally, the median ingress at 30° C./75% RH is 159 micrograms for a 17 mL vial and 195 micrograms for a 24 mL vial.

