DISPENSING DEVICE FOR MICRO-TABLETS

FIELD OF THE INVENTION

The instant invention relates to devices that are useful for storing and dispensing micro-tablets. In particular, the devices store micro-tablets and dispense a determined number of micro-tablets.

BACKGROUND OF THE INVENTION

Micro-tablets, also referred to as compressed granules, are a desirable dosage form for many applications, including pediatric dosage, for patients with dysphagia (swallowing difficulties), and in applications where rapid and/or flexible dose adjustments are needed.

Micro-tablets having a diameter range of 1.0mm to 3.0mm can be produced relatively simply, with uniform size and consistent active substance content. A very precise individual division of the dose could be carried out by counting the micro-tablets.

For pediatric patients, micro-tablets allow for the use of weight-based dosage forms to children as young as six months to two years of age. Micro-tablets can also easily be mixed with liquid and soft foods to assist in administration to younger pediatric patients.

There are known dosing devices for dispensing the exact number of mini-tablets. See, for example, US 6,811,054 and NL66782. A disadvantage of these devices is that they only allow for accurate dispensing of a predetermined number of mini-tablets, corresponding to the number of fixed tablet-nests (also referred to as cavities) in the dosing chamber.

The known devices do not allow for adjustment of the number of tablets to be dispensed, and there is the potential for miscount, because the devices are not equipped with the means to set or verify the required number of the micro-tablets. In addition, the known devices require separate storage of the micro-tablets. The micro-tablets are stored separately and must be added to the device, with excess tablets returned to the storage container. These types of devices exhibit low accuracy and under/over dosing. SUMMARY OF THE INVENTION

The present disclosure relates to devices for storing and dispensing to a patient a specific number of micro-tablets, said device comprising a) a cover, comprising a claw seal and a plug; b) a base, comprising a shaft; c) a spring; d) a reservoir; e) an indexing plate, comprising a disc portion that comprises a slot and a solid web, numbers along the circumference of the disc portion, and teeth; f) a dosing plate, comprising a disc portion having a set number of openings that correspond to the numbers located on the indexing plate, teeth, and a number of protrusions; g) an adaptor, comprising a disc portion having a slot and a solid web, threads and a display window that displays a number located on the indexing plate; and h) an overcap, comprising threads, which engage the threads of the adaptor, and vertical slots, which engage protrusions of the dosing plate.

Other embodiments, aspects and features of the present invention are either further described in or will be apparent from the ensuing description, examples and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 illustrates an exploded view of the micro-tablet dispenser, showing the cover (1), the base (2), the spring (3), the reservoir (4), the indexing plate (5), the dosing plate (6), the adaptor (7), and the overcap (8).

Figure 2 illustrates a side view of an assembled micro-tablet dispenser.

Figure 3 illustrates a cross-section of the assembled micro-tablet dispenser.

Figure 4 illustrates a side view of a partially assembled micro-tablet dispenser, including reservoir (4), indexing plate (5), and dosing plate (6).

Figure 5 illustrates an additional side view of a partially assembled micro-tablet dispenser, including reservoir (4), indexing plate (5), and dosing plate (6).

Figure 6 illustrates a top view of a partially assembled micro-tablet dispenser, including the dosing plate (6) engaged with the indexing plate (5).

Figure 7 illustrates a bottom view of a partially assembled micro-tablet dispenser, including the dosing plate (6) engaged with the indexing plate (5).

Figure 8 illustrates a bottom view of a partially assembled micro-tablet dispenser, including the dosing plate (6) engaged with the indexing plate (5).

Figure 9 illustrates an exploded cross-section of a partially assembled micro-tablet dispenser, including the dosing plate (6), adaptor (7), and the overcap (8).

Figure 10 illustrates a cross-section of a partially assembled micro-tablet dispenser, including the dosing plate (6), adaptor (7), and the overcap (8). Figure 11 illustrates a top view of a partially assembled micro-tablet dispenser, including the dosing plate (6) engaged with the adaptor (7).

Figure 12 illustrates a top view of a partially assembled micro-tablet dispenser, including the dosing plate (6) engaged with the adaptor (7).

Figure 13 illustrates a top view of a partially assembled micro-tablet dispenser, including the indexing plate (5) and dosing plate (6), engaged with the adaptor (7).

DETAILED DESCRIPTION OF THE INVENTION

The device of the disclosure comprises eight parts: the cover (1), the base (2), the spring (3), the reservoir (4), the indexing plate (5), the dosing plate (6), the adaptor (7), and the overcap (8). The cover (1), the base (2), the reservoir (4), the indexing plate (5), the dosing plate (6), the adaptor (7), and the overcap (8) may each be constructed of pharmaceutical grade materials, such as pharmaceutical grade plastics. Examples of pharmaceutical grade plastics that may be suitable for use in the device of the disclosure include polyvinyl chlorides, poly ethylenes, poly olefins, polypropylenes, polyethylene terephthalates, polyethylene terephthalate G, polybutylene terephthalates, polyamides (nylon), polyurethanes, polyethylene vinyl acetates, acrylonitrile butadiene styrenes, polytetrafluoroethylenes, polycarbonates, polystyrenes, polysulfones, and poly(vinylidene chloride)s; in particular embodiments, the device may be constructed from pharmaceutical grade plastics selected from polypropylenes and acrylonitrile butadiene styrenes.

The cover (1) contains a claw seal, which allows hermetic storage of micro-tablets (9), and a plug that closes a filling hole in the reservoir (4).

The base (2) contains a shaft (2a) that provides proper coaxial orientation of the device parts, and allows the rotation of the dosing plate (6) and the indexing plate (5) relative to the reservoir (4) from the loading position to the dispensing position. The shaft (2a) also allows straight vertical movement of the indexing plate (5), dosing plate (6), and the reservoir (4), while compressing the spring (3). This vertical movement allows for changing the number of openings (6a) on the dosing plate (6) that are exposed through the slot (5c) on the indexing plate (5). The vertical movement allows the teeth (5b) on the indexing plate (5) to be engaged or disengaged with the teeth (6c) of the dosing plate (6), which allows the number of openings (6a) to be set.

The spring (3) allows for proper axial engagement of the parts during operation and storage. The reservoir (4) contains a chamber in which micro-tablets (9) are stored.

The indexing plate (5) comprises, along the circumference of the indexing plate (5), numbers (5a) corresponding to the openings; one of these numbers is viewable through a display window (7a) in the adaptor (7). These numbers (5a) correspond to the number of micro- tablets (9) to be dispensed. The number of micro-tablets (9) is set by changing the angular position relative of the indexing plate (5) to the dosing plate (6). The numbers (5a) may be provided on the circumference of the indexing plate by one or more of printing, engraving, embossing, or other appropriate methods. Beneath the numbers (5a), the lower circumference of the indexing plate (5) is notched with teeth (5b). In addition, the indexing plate (5) has a disc portion containing a slot (5c) and a solid web (5d). This slot (5c) and solid web (5d) allow a specified number of openings (6a) in the dosing plate (6) to be exposed, corresponding to the number (5a) viewable through the display window (7a) of the adaptor (7). The slot (5c) allows micro-tablets (9) to load into openings (6a) of the dosing plate (6), when the openings (6a) are positioned under the slot (5c) of the indexing plate. The solid web (5d) blocks openings (6a) in the dosing plate (6) and prevents micro-tablets (9) from loading into the blocked openings (6a).

The dosing plate (6) receives a pre-set number of micro-tablets (9) from the reservoir (4) and carries them from a loading position to a dispensing position. The loading position is located under the reservoir's chamber, and the dispensing position allows passage of individual micro-tablets (9) into the overcap (8). The dosing plate (6) incorporates a set number of openings (6a), into which the micro-tablets (9) may be loaded. Each opening (6a) is sized to allow loading of a single micro-tablet (9); single micro-tablets may be 2 to 3mm in diameter. Any number of openings (6a) may be provided in embodiments of the device. In exemplary, non-limiting embodiments, the dosing plate (6) may incorporate from 1 to 50, or from 1 to 30, such as from 1 to 20, openings. The dosing plate (6) also contains teeth (6b) that engage with notched lower circumference of the indexing plate (5) to set the specific number of micro-tablets (9) for dosing; by engaging in such a manner, the delivery of the desired number of micro-tablets (9) may be "locked". In embodiments, the teeth (5b) on the indexing plate (5) are engaged with the teeth (6b) of the dosing plate (6), and in additional embodiments, the teeth (5b) on the indexing plate (5) are disengaged from the teeth (6b) of the dosing plate (6). The dosing plate (6) also includes protrusions that engage with the overcap (8).

The adaptor (7) keeps the parts of the device together. The adaptor (7) contains threads that mate with the threads of the overcap (8), and a display window (7a), which allows for dose setting by displaying a number (5a) corresponding to the number of micro-tablets (9) to be administered, according to embodiments. In addition, the adaptor (7) has a disc portion, comprising a slot (7b) and a solid web (7c), as shown in Figure 11. The slot (7b) allows micro- tablets (9) to pass from the dosing plate (6) into the overcap (8) when the device is in the dispensing position. The solid web (7c) prevents micro-tablets (9) from falling from the dosing plate (6) when the device is in the loading position.

The overcap (8) contains a thread that engages threads of the adaptor (7), and vertical slots that engage the protrusions of the dosing plate (6). These features provide rotation of the overcap (8), the dosing plate (6), and the indexing plate (5) relative to the adaptor (7) and the base (2). The rotation allows the change of position from loading to dispensing and from dispensing to loading.

The device can be used to conveniently and accurately measure whole number amounts of micro-tablets (9) by adjusting the rotational alignment of the indexing plate (5) relative to the dosing plate (6), so that the display window (7a) in the adaptor (7) displays the number (5a) corresponding to the desired number of micro-tablets (9). When the desired number of micro-tablets (9) is displayed as through the display window (7a), the appropriate number of openings (6a) on the dosing plate will be in position to receive and contain a micro- tablet (9), and the remaining openings (6a) will be blocked and unable to receive or contain a micro-tablet (9).

An embodiment of the device comprises indexing dosing plate (6) having from 1 to 50 openings (6a), and an indexing plate (5) having from 1 to 50 corresponding numbers (5a), into which the micro-tablets (9) may be loaded. In instances of this embodiment, the device comprises indexing dosing plate (6) having from 1 to 30 openings (6a), and an indexing plate (5) having from 1 to 30 corresponding numbers (5a), and in particular instances, the device comprises indexing dosing plate (6) having from 1 to 20 openings (6a), and an indexing plate (5) having from 1 to 20 corresponding numbers (5a).

The device provides the user with a tool for obtaining a desired number of micro- tablets (9) from reservoir (4) in one-unit increments and delivering the micro-tablets (9) to the overcap (8), from which the micro-tablets (9) may be delivered to the patient, directly or into a target dispense site, such as a liquid, or solid food, to be consumed by a patient.

The device can be used with any program that utilizes micro-tablets. The device can be used to deliver any dose count, e.g., from 1 to 50, in one-unit increments. In embodiments, the device can be used to deliver a dose comprising from 1 to 50 individual micro- tablets (9), such as from 1 to 30 individual micro-tablets (9), or from 1 to 20 individual micro- tablets (9).

Advantages of the device include its ease of use, as well as the minimal risk of broken or crushed micro-tablets. The display window (7a) provides easy verification of the proper count of micro-tablets for delivery, and the rotational control for setting the desired dose, in the form of the desired number of micro-tablet units, offers a highly reliable and accurate mechanism for delivering doses of micro-tablets in one-unit increments. In addition, the device may be recycled and/or refilled.

An embodiment of the device described herein may be seen in Figure 2, which shows the assembled micro-tablet dispenser. An exploded view of the micro-tablet dispenser as described herein, showing the cover (1), the base (2), the spring (3), the reservoir (4), the indexing plate (5), the dosing plate (6), the adaptor (7), and the overcap (8), is shown in Figure 1, and a cross-sectional view of the assembled micro-tablet dispenser, including micro-tablets (9) housed in the reservoir (4) is shown in Figure 3.

Figures 4 and 5 show how the reservoir (4), indexing plate (5), and dosing plate (6) may be engaged with each other. Figures 6, 7, and 8 illustrate the manner in which the dosing plate (6) may be engaged with the indexing plate (5).

Figures 9 and 10 show cross-sectional views of how the reservoir (4), dosing plate (6), and adaptor (7) may be engaged together.

Figures 11 and 12 show top views of the dosing plate (6) engaged with the adaptor (7), in which the openings (5a) are fully closed (Figure 11) and fully opened (Figure 12). Figure 13 provides an additional top view in which the indexing plate (5) and dosing plate (6) are engaged with the adaptor (7), and individual micro-tablets (9) are seated in openings (5a).

It will be appreciated that various of the above-discussed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Also that various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.