WO2005112672A1

WO2005112672A1 - Tablet dispenser insert for stacked tablets

Info

Publication number: WO2005112672A1
Application number: PCT/US2005/017950
Authority: WO
Inventors: Jean-Pierre Giraud
Original assignee: Csp Technologies, Inc.
Priority date: 2004-05-21
Filing date: 2005-05-20
Publication date: 2005-12-01

Abstract

A solid dosage dispenser insert (10) has been developed that can be attached to a standard drug vial (30) to dispense a predetermined amount of tablets. The insert (10) can be designed to dispense one or more tablets at a time. The insert (10) can be attached to a vial (30) and a cap (34) to form a vial (30), insert (10) and cap assembly (34).

Description

TABLET DISPENSING INSERT FOR STACKED TABLETS Field of the Invention This invention is generally in the field of solid dosage form dispensers. Background of the Invention Solid dosage forms are commonly used to deliver pharmaceutical, medicated confectionary, and confectionary products. These dosage forms include compressed tablets, coated tablets, capsules, caplets, liquid gels, liquid encapsulated beads, et al. Often, too many tablets pour out of a vial during use. Tablets can become damaged due to breakage or exposure to water/moisture. There is a growing consumer demand for presenting one dosage unit at a time via an active dispensing mechanism. In an active dispenser, a user pushes a button or lever, and one dosage form exits the container at a time. It is therefore an object of the present invention to provide an improved dosage form delivery device which is capable of repeated delivery of a single dosage unit. Summary of the Invention A solid dosage dispenser insert has been developed that can be attached to standard drug vials to dispense a predetermined amount of tablets. The insert can be designed to dispense one or more tablets at a time. The insert can be attached to a vial, and a cap to form a vial, insert and cap assembly. The assembly is preferably designed to be mo sture tight. Brief Description of the Drawings Figures 1A, IB, 1C, and ID are different perspectives (side view, 1A; front view, IB; bottom, 1C; and side view, ID) of a tablet dispensing insert. Figures 2A and 2B are cross-sectional views of a container with the closed insert (Figure 2A) and open insert (Figure 2B) with a domed cap which can be closed over the tablet dispensing insert. Detailed Description of the Invention The tablet dispenser minimizes tablet handling by end user, only dispensing the number of tablets required (one or more than one depending on the dispensing configuration). The device is ideally suited for any stacked tablets, such as fast melt tablets, effervescent tablets, and enteric coated tables. However, the device can be used with a wide variety of different types of tablets, including food, pharmaceuticals, nutritional supplements, and denture cleaners. In the preferred embodiment, the dispenser is in the form of an insert that fits into the top of a container, such as a vial. I. Tablet Dispenser Insert The tablet dispenser insert (also referred to herein as "dispenser" or "insert") is illustrated in Figures 1A, IB, 1C, and ID. The insert is preferably formed of a thermoplastic material such as polyolefins, polyamides, polyvinyl chlorides, alone or in conjunction with modifiers to improve flexibility, and thermoplastic elastomers. Examples of suitable polyolefins include polypropylene and polyethylene. The insert 10 can be sized to dispense one tablet or multiple tablets. The flexible side wall 12 height is slightly taller than the average thickness of the tablet or total height of the stack of stack of tablets to be dispensed. Generally, the flexible side wall is about 1 mm taller than the average thickness of the tablet or the total height of the stack of tablets to be dispensed. Typically, tablets are 4 mm to 10 mm thick. Typical diameters for tablets range from 10 mm to about 35 mm. In a preferred embodiment, the insert 10 has a circular base 14 that is press fit into the open end of the container (e.g. vial). The diameter of the insert is selected to be approximately equal to the inside diameter of the container to which it will be attached. Typical diameters for the insert range from about 11 mm to about 40 mm. The insert 10 has an opening 16 along one side sized to accommodate one or more tablets. The opposite side, i.e.180 degrees from the opening 16, has a flexible member 20 extending between 100 and 150 degrees, preferably approximately 120 degrees, around the circumference. The dispensing insert has a top surface 22 that supports the tablet or tablet stack when dispensing. The top surface 22 is perpendicular to the flexible member and attaches to at least a potion of the flexible member. The volume within the dispensing insert is designed to hold the predetermined amount of tablets. A tablet supporting member 24 is located within the insert and is attached to the flexible wall 20. The tablet supporting member 24 supports that edge of the tablet(s)*when inverted and maintains the alignment of the tablet(s) with the opening of the insert 16. II. Container, cap and insert assembly The insert is typically attached to a container that contains the tablets to be administered. The insert may be placed on the open end of the container 32 before or after it is filled with tablets. A preferred method of insertion is a press or snap fit into the top of the container 32. Preferably, the cap 34, such as a domed-shaped cap, is placed over open end of the container 32. When the cap is in the closed position, it covers the insert and forms a moisture tight seal with the container. This forms a container, cap and insert assembly. Any type of cap may be used with the assembly. Optionally, the cap is a child resistant or child proof cap. As illustrated in Figures 2 A and 2B, the insert 10 can be attached to or by molded with a flip-top vial or a two-piece vial 30. Examples of two- piece vials include vials with a screw cap or a snap cap. In one embodiment, the cap 34 and the container 30 may be integrally molded of plastic to form a hinge 36 there between. In another embodiment, the container 30 and the cap 34 may be produced in a conventional molding process. The assembly is preferably molded of plastic. Suitable material for assembly includes plastics like thermoplastics such as polypropylene and polyethylene. The assembly may be produced in accordance with the operation disclosed in U.S. Patent Nos. 4,783,056 or 4,812,116 to Abrams, RE37,676 to Abrams et al. or 6,303,064 to Abrams et al. The container assembly with an attached cap ensures that when the cap is in the open position, the cap is not removed from the container and misplaced. It is also contemplated that, by making the cap integral with container, the time period the container is left in the open position by a user will be a shorter period of time than the time period the container is left in the open position by a user of a two-piece container, such as a container with a screw-off cap. Ensuring that the cap is closed at all times, except when it is necessary to have it open, is useful in maintaining product integrity of a moisture-sensitive product. Optionally, the container includes a lining of a material that absorbs or releases materials. As an example, if the material absorbs water vapor, it may be included to keep the contents at a low relative humidity since any moisture that permeates through the seal or is present in the container would be absorbed. The lining material may be a desiccant entrained plastic. Suitable desiccant plastics include, but are not limited to those disclosed in U.S. Patent Nos. 5,911,937; 6,214,255; 6,130,263; 6,080,350; 6,174,952; 6,124,006; and 6,221,446, all to Hekal. The lining may also release a gas, such as an inert gas that prevents oxidation of the enclosed medicament, a flavoring or fragrance, or moisture, in the case of a medicament that should not be allowed to dry out. The lining material may contain a fragrance, desiccant, gas, or antioxidant. The container assembly may be produced using a two shot injection molding process or an in mold liner process. Optionally, the container assembly may be produced by assembling a molded container and a lining either automatically or manually.

III. Method of Using Container, cap and insert assembly The container, cap and insert assembly is illustrated in Figures 2A and 2B. To use the assembly the user inverts the vial and insert so that the predetermined number of tablets enter the dispensing insert 10. Optionally with the user removes the cap 34 prior to inverting the vial and insert.

Alternatively, the user removes the cap 34 after inverting the vial and insert. The tablet supporting member 24 supports that edge of the tablets when inverted and maintains the alignment with the opening of the insert 16. While keeping the vial in the inverted position, the user presses the flexible member 20 of the insert. This action pushes the predetermined number of tablets through the opening of the insert 16. Then the user removes the tablet(s) from the opening of the insert 16. Then the user rotates the vial 30 to the upright position, and closes the cap 34. In one embodiment, one tablet is administered when the user presses the flexible member 20. In another embodiment, more than one tablet is administered when the user presses the flexible member 20.

Claims

I claim: 1. A tablet dispensing insert for use in a vial comprising a circular base that secures the insert to the vial, an opening on one side of the insert above the circular base, wherein the opening is sized to accommodate one or more tablets, a flexible member on a side of the insert above the circular base and distal to and opposite the opening,

2. The insert of claim 1 wherein the insert further comprises a tablet supporting member.

3. The insert of claim 1 wherein the flexible member extends approximately 120 degrees around the circumference of the insert.

4. The insert of claim 1 wherein the opening and the flexible members are located approximately 180 degrees apart.

5. The insert of claim 1 wherein the circular base is designed to be snapped or secured to the open end of a vial.

6. The insert of claim 1 manufactured of a thermoplastic polymer.

7. The insert of claim 1 comprising a thermoplastic polymer in combination with a flexomeric polymer.

8. The insert of claim 1 made by injection molding.

9. A container assembly comprising an insert comprising a circular base that secures the insert to the vial, an opening on one side of the insert above the circular base, wherein the opening is sized to accommodate one or more tablets, a flexible member on a side of the insert above the circular base and distal to and opposite the opening, a vial comprising an opening and a cap, wherein the insert is attached to the opening in the vial, and wherein the cap forms a seal over the insert attached to the vial, when the cap is in the closed position.

10. The assembly of claim 9, further comprising tablets oriented in a stacked arrangement in the vial.

11. The assembly of claim 10, wherein the tablets are effervescent tablets. 12 The assembly of claim 10, wherein the tablets are fast melt tablets. 13. A method for dispensing tablets comprising providing a vial containing tablets, the vial comprising an open end and a closed end, and an insert comprising a circular base that secures the insert to the open end of the vial, an opening on one side of the insert above the circular base, wherein the opening is sized to accommodate one or more tablets^* a flexible member on a side of the insert above the circular base and distal to and opposite the opening, and a cap, wherein the cap forms a seal over the insert attached to the vial, when the cap is in the closed position, opening the cap, and inverting the vial so that a single tablet enters the opening on one side of the insert. 14. The method of claim 13 wherein the tablets form an oriented stacked arrangement in the vial.