Device for the sublingual administration of a medication formed from dissolving a tablet in a liquid

Abstract

A device for self-administration of liquid medication supplied by combining a tablet of medication located within the device with a dissolving liquid from a source which dissolves the tablet upon contact. The formed medication solution is then available for delivery to the sublingual area of a patient.

Claims

1. A device for the sublingual administration of a liquid medication formed from dissolving a tablet in a dissolving liquid comprising: an upper portion connected to a lower portion; the upper portion comprising: a bottom surface having at least one post and opposite the bottom surface, a cylindrical cavity having a base wall; a hollow needle having a piercing tip extending upward from the base wall; the cylindrical cavity sized to receive and align an external source containing a dissolving liquid, said hollow needle capable of piercing one end of the external source by the piercing tip; the lower portion comprising: a recess sized to accept a tablet of medication, the recess having a base wall having an exit pathway to a discharge located at the side of the lower portion opposite the recess for sublingual administration; and, when the upper portion and lower portion are connected, the interior space within the recess bordered by the base wall of the upper portion form a chamber having an interior volume and the at least one post sufficiently extends into the chamber to fracture a tablet of medication positioned within the chamber and the needle is a conduit for a dissolving liquid to enter the chamber.

2. The device of claim 1 where the interior volume of the chamber is no more than 1.5 cc.

3. The device of claim 1 where the upper portion is connected to the lower portion by a threaded connection.

4. The device of claim 1 where the upper portion is connected to the lower portion by a hinge.

5. The device of claim 1 further comprising said upper portion having a set of male threads for threadable engagement with a removable cover having a set of female threads; upon threadable engagement, the cover shrouds the cylindrical cavity.

6. The device of claim 5 where said cover includes an inside surface that is conically tapered.

7. A device for the sublingual administration of a liquid medication formed from dissolving a tablet in a liquid comprising: an upper portion in threadable engagement to a lower portion; the upper portion comprising: a bottom surface having at least one post and opposite the bottom surface, a cylindrical cavity having a base wall; a hollow needle having a piercing tip extending upward from the base wall; the cylindrical cavity sized to receive and align an external source containing a dissolving liquid, for piercing of one end of the external source by the piercing tip; the lower portion comprising: a recess where a chamber is defined by the recess bordered by the bottom surface of the upper portion, the chamber having an interior volume of no more than 1.5 cc and having a tablet of medication therein, the chamber having a base wall having an exit pathway to a discharge located at the side of the lower portion opposite the chamber for positioning upon the sublingual area; and, where said hollow needle defines a conduit through which a dissolving solution can enter the chamber and where the upper portion is in a first position relative to the lower portion in which the at least one post extends into the chamber; and where the upper portion can be rotated to a second position in which the at least one post fractures the tablet of medication.

8. The device of claim 7 further comprising indicia located on the upper portion and lower portion which will align when the upper portion and lower portion are in the second position.

9. The device of claim 7 further comprising said upper portion having a set of male threads for threadable engagement with a removable cover having a set of female threads; upon threadable engagement, the cover shrouds the cylindrical cavity.

10. The device of claim 9 where said cover includes an inside surface that is conically tapered.

11. A device for the sublingual administration of a liquid medication formed from dissolving a tablet in a dissolving liquid comprising: an upper portion comprising: a bottom surface having at least one post and opposite the bottom surface, a cylindrical cavity having a base wall; a hollow needle having a piercing tip extending upward from the base wall; the cylindrical cavity sized to receive and align an external source containing a dissolving liquid, for piercing of one end of the external source by the piercing tip; a lower portion comprising: a recess sized to accept a tablet of medication, the recess having a base wall having an exit pathway to a discharge located at the side of the lower portion opposite the recess for sublingual administration; and, a closure means whereby the interior space within the recess bordered by the base wall of the upper portion form a chamber having an interior volume and the at least one post sufficiently extends into the chamber to fracture a tablet of medication positioned within the chamber and the needle is a conduit for a dissolving liquid to enter the chamber.

Description

DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a cross sectional view of the lower portion of the device illustrating positioning of a tablet of medication into the recess.

(2) FIG. 2 is a view of one embodiment of the device where the upper portion is threadably connected to the lower portion described in FIG. 1.

(3) FIG. 3 illustrates the insertion of the capsule containing liquid solution into position to be punctured by the device's needle tip.

(4) FIG. 3A illustrates non-aligned indicia arrows on the exterior surface of the upper and lower portions.

(5) FIG. 4 illustrates complete threaded engagement of the upper portion to the lower portion where posts 23 extend sufficiently to fracture the tablet and the method of adding liquid solution to the chamber by applying a force to the exposed end of the punctured capsule.

(6) FIG. 4A illustrates aligned indicia arrows on the exterior surface of the upper and lower portions.

(7) FIG. 5 illustrates the liquid solution in contact with a partially dissolved tablet of medication in the chamber.

(8) FIG. 6 illustrates the medication solution formed from the dissolved tablet and continued force upon the capsule causing the medication solution to be discharged from the device.

(9) FIG. 7 is a view of FIG. 2 taken along line 7-7 illustrating the post.

(10) FIG. 8 is a first alternative embodiment in which a cover is threadably connected to the device for threadably applying force to the capsule to discharge liquid.

(11) FIG. 9 is a second alternative embodiment in which the upper portion and lower portion of the device are attached by a hinge.

(12) FIG. 10 illustrates the second alternative embodiment in the closed position.

(13) FIG. 11 is a third alternative embodiment illustrating the use of a syringe as a dissolving liquid source.

DESCRIPTION OF THE PREFERRED EMBODIMENT

(14) The figures provided herein are not drawn to scale and are provided for representational and instructional purposes.

(15) FIG. 2 illustrates an exploded view of device 10. The exterior configuration is not limited to that disclosed but can be of any configuration suitable to be hand-held. Device 10 comprises an upper portion 12 and a lower portion 14. The top surface of upper portion 12 includes a cylindrical cavity 16 having a base 18. Extending away from base 18 is a hollow needle 20 with a piercing tip 22 which extends into cavity 16. The cavity is sized for receiving and aligning a capsule C so that one end of the capsule can be punctured by piercing tip 22. Capsule C contains a dissolving liquid L to dissolve tablet T as described below. The inserted end of capsule C can be punctured by applying an appropriate force F1 as illustrated in FIG. 4 preferably with a user's thumb and/or forefinger. The bottom surface of upper portion 12 includes a pair of posts 23 extending away in a perpendicular direction. FIG. 7 shows a view of posts 23 taken along line 7-7 of FIG. 2. In the figures presented, posts 23 have a tapered tip and have an arcuate profile. Each post can be of any configuration which is capable of fracturing a tablet T when positioned within chamber 40.

(16) As illustrated in FIG. 1, lower portion 14 includes a recess 30 sized to accept a tablet T of medication and male threads 24 for threadable engagement to upper portion 12. Recess 30 includes a base wall 32 having an exit pathway 34 leading to discharge 36. When positioned within recess 30, tablet T covers exit pathway 34.

(17) FIG. 3 illustrates upper portion 12 and lower portion 14 in threaded engagement in a first position in which recess 30 is now enclosed and thus forms chamber 40. In this first position, posts 23 extend a sufficient distance into chamber 40 to nearly or slightly contact tablet T. The first position is also represented by the non-alignment of indicia arrows 52 and 54 as shown in FIG. 3A.

(18) FIG. 4 illustrates the complete threaded engagement of upper portion 12 to lower portion 14 which defines a second position which is represented by the alignment of indicia arrows 52 and 54 as shown in FIG. 4A. In this second position, posts 23 are fully extended into chamber 40. The full extension of posts 23 into chamber 40 will cause tablet T to fracture. Fracture of tablet T increases the available surface area to be reacted upon by dissolving liquid L. Thereafter, a sufficient force F1 is applied to capsule C in order for needle tip 22 to puncture the capsular wall.

(19) As best illustrated in FIG. 5, upon sufficient force F2 applied to the non-punctured end of the capsule C, the capsule will be progressively crushed and liquid L will be forced through needle 20 and into chamber 40 which houses tablet T. The volume of chamber 40 is no more than approximately 1.5 cc.

(20) Exit pathway 34 leads to discharge 36 from which the medication solution can exit the device for sublingual administration. As tablet T is dissolved by liquid L, a medication solution is formed MS. Once the liquid L present in chamber 40 reacts to at least partially dissolve tablet T, medication solution MS can flow through exit pathway 34 to discharge 36. Preferably, the diameter of exit pathway 34 should be small enough for droplets to form at discharge 36. Most preferably, the diameter should approximate or be slightly larger than the diameter of needle 20. Because of the narrow diameters of both needle 20 and pathway 34, force must be applied to cause the medication solution to exit the device for application to the sublingual area. This force is either applied to the top of the capsule C or by suction where the user places his lips about discharge 36 and applies suction.

(21) In practice, when force is applied to have the MS exit the device, two or three droplets of MS will be discharged from device 10. Once the droplets have been applied, the user waits between 30 seconds and one minute to determine whether additional MS is necessary. During this waiting period, dissolving liquid L, which was used to force MS past discharge 36, now is within chamber 40 reacting to dissolve any remaining portion of tablet T. After the waiting time, this volume of liquid L in chamber 40 has dissolved any remaining portion of tablet T after the first sublingual application to create a medication solution MS for a second sublingual application, if necessary. Most preferably, the second sublingual application, if necessary, would be applied by placing the user's lips about the discharge and applying a suction force to withdraw the medication solution present within the chamber.

(22) In a first alternative embodiment of the device as illustrated in FIG. 8, a cover 50 is threadably mounted to male threads 42 present on upper portion 12a. The interior surface 56 of cover 50 is preferably conically tapered. As cover 50 is rotated, capsule C is progressively crushed. Cover 50 can be rotated until substantially all of liquid L has been displaced from the capsule.

(23) After the first fraction of the total volume dosage has been delivered to the sublingual area, the patient need only wait a matter of 30-60 seconds. If the cardiac event does not subside, cover 50 can be rotated relative to upper portion 12a to allow a second fraction of the total volume dosage to flow from discharge 36.

(24) In a second alternative embodiment of the device as illustrated in FIG. 9, rather than threadable engagement of upper and lower portions, upper portion 112 and lower portion 114 are attached by a hinge 160. To fracture tablet T, upper portion 112 is rotated to a final position as illustrated in FIG. 10. It should be noted that FIGS. 9 and 10 illustrate the method by which the tablet is fractured. Posts 23 could also be provided as part of an upper portion where they are orientated 90 degrees about needle 20 so posts 23 contact tablet T at the same time. A clasp 170 engages lip 180 to ensure proper closure for obtaining a liquid tight seal between both portions. A capsule C is then utilized in the same manner as discussed earlier for delivery of dissolving liquid to chamber 40.

(25) In a third alternative embodiment of the device as illustrated in FIG. 11, rather than using a capsule as the source of the dissolving liquid, a syringe S is provided. Syringe S incorporates male threads 250 to create a liquid tight seal by engagement with female threads 252 located on the interior wall of upper portion 212. Preferably, syringe S has a protective film 270 located at the tip. Syringe S is inserted into the cavity so needle tip 22 pierces protective film 270 for needle 20 to be a conduit for dissolving liquid L to pass into chamber 40. Force would be applied to the syringe plunger (not shown) for dispensing dissolving liquid L into chamber 40.

(26) It should be understood that the cavity of upper portion 212 could also receive a capsule containing dissolving liquid rather than a syringe as illustrated.