Systems and Methods for Troche Production

Abstract

A troche/rapidly dissolving tablet production system includes a temperature-controlled heating plate, a score plate configured to confront said heating plate, and a cavity plate configured to confront said scoring plate, said cavity plate comprising a plurality of cavities.

Claims

1. A system for the production of troches and rapid-dissolve tablets, comprising: a temperature-adjustable heat plate; a score plate, said score plate comprising an array of raised scoring marks; and a cavity plate, said cavity plate comprising an array of cavities equal in number and arrangement to said array of raised scoring marks; wherein said score plate is configured to be placed atop said heat plate in a confronting relationship, and wherein said cavity plate is configured to be placed atop said scoring plate in a confronting relationship.

2. The system of claim 1, further comprising a thermostat configured to provide temperature regulation of said heat plate.

3. The system of claim 1, wherein each cavity of said array of cavities has a volume of about one (1) milliliter when said cavity plate and said score plate are in a confronting relationship.

4. The system of claim 1, wherein each of said raised scoring marks defines a scoring pattern allowing a troche or rapid-dissolve tablet produced by said system to be separated into one-half, one-quarter or one-eighth component pieces.

5. The system of claim 4, wherein said scoring pattern is a plus (+) shape.

6. The system of claim 4, wherein said scoring pattern is a minus (−) shape.

7. The system of claim 1, wherein said cavity plate comprises a raised lip about its outer perimeter.

8. The system of claim 1, further comprising a tamper plate, said tamper plate comprising: a flat plate surface; and a plurality of protrusions extending from said flat plate surface; wherein said plurality of protrusions matches said array of cavities in number.

9. The system of claim 8, wherein each protrusion of said plurality of protrusions has a length and width dimension, each parallel with said flat plate surface, said length and width dimensions being selected to allow each protrusion to fit within each cavity of said array of cavities.

10. The system of claim 9, wherein each protrusion further comprises a depth dimension, said depth dimension being less than the depth of each cavity of said array of cavities when said cavity plate is in a confronting relationship with said score plate.

11. The system of claim 1, wherein said cavity plate is formed of a non-stick material.

12. The system of claim 1, further comprising a powder dam, wherein said power dam comprises a frame structure configured to surround said array of cavities.

13. The system of claim 1, wherein said cavity plate and said score plate are formed of a non-stick material.

14. The system of claim 13, wherein said non-stick material is coated aluminum.

15. A method for the production of a plurality of troches, comprising: providing the system according to claim 1; providing a compounded formula comprising a liquid troche base and an active ingredient; warming said heating plate to a temperature sufficient to maintain said compounded formula in liquid form; placing said score plate atop said heating plate; placing said cavity plate atop said score plate; filling said array of cavities of said cavity plate with said compounded formula; and allowing said heating plate to cool.

16. The method of claim 15, wherein said active ingredient is a pharmaceutical agent.

17. A method for the production of a plurality of rapid-dissolve tablets, comprising: providing the system according to claim 1; providing a powder compounded formula comprising a powdered base matrix for rapidly-dissolving tablets and an active ingredient; placing said cavity plate atop said score plate; filling said array of cavities of said cavity plate with said powder compounded formula; placing said score plate and said cavity plate atop said heating plate; and heating said heating plate until said compounded formula solidifies.

18. The method of claim 17, further comprising: providing a tamper plate, said tamper plate comprising: a flat plate surface; and a plurality of protrusions extending from said flat plate surface; wherein said plurality of protrusions matches said array of cavities in number and arrangement; and compressing said compounded formula within said array of cavities utilizing said tamper plate.

19. The method of claim 18, further comprising placing said tamper plate atop said cavity plate until said compounded formula solidifies.

20. The method of claim 17, wherein said active ingredient is a pharmaceutical agent.

Description

DESCRIPTION OF DRAWINGS

[0028] The present embodiments are illustrated by way of the figures of the accompanying drawings, which may not necessarily be to scale, in which like references indicate similar elements, and in which:

[0029] FIG. 1 is an exploded view of a troche/RDT molding system according to one embodiment;

[0030] FIG. 2 is a top view of the troche/RDT molding system of FIG. 1 as assembled;

[0031] FIG. 3 is a side view of the troche/RDT molding system of FIG. 1 as assembled;

[0032] FIG. 4 is a top view of a cavity plate of a troche/RDT molding system according to one embodiment;

[0033] FIG. 5 is a perspective view of the troche/RDT molding system of FIG. 1 according to one embodiment; and

[0034] FIG. 6 is a powder dam, according to one embodiment.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0035] FIG. 1 shows an exploded view, and FIGS. 2-3 show an assembled view of a troche/rapidly dissolvable tablet (RDT) molding system (hereinafter ‘system’) 100 according to one embodiment. In this embodiment, the system 100 includes a cavity plate 1 with an overflow lip 15 disposed about its perimeter. FIG. 4 shows a top plan view of the cavity plate 1. The cavity plate 1 includes a plurality of cavities 20 (in this example, one hundred ninety-six cavities) for receiving a compounded formulation of an active ingredient and base. Troche bases usually consist of a sweetened blend of polyethylene glycols. In this embodiment, each cavity 20 holds a volume of about one milliliter, e.g., 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, although other volumes can be used that are appropriate for troches. When utilizing the system 100 for RDT production, the cavities are suitable to provide a 750 mg RDT.

[0036] The system 100 further includes an optional cavity plate 2 that does not include an overflow lip, a score plate 3, a tamper plate 4, a heating plate 5, a plurality of leveling feet 6 and a series of hardware for joining the aforementioned components in an assembled configuration (e.g., washers 7, jam nuts 8, vibration dampening loop clamps 9, stainless steel screws 10 that secure the vibration dampening loops, a plurality of dowels 11, a plurality of thumb screws 12 and helical inserts 13).

[0037] In this embodiment, the individual cavities 20 of the cavity plate are bottomless. The bottom of each cavity is formed when the cavity plate is placed in confrontation with score plate 3. The score plate 3 is used for producing a score mark onto resultant troches so that they may be broken into half- or quarter-sized doses by the user. In this embodiment, the score plate 3 includes raised score marks in the shape of plus (+) symbols; however, it should be understood that the score marks can be any desired shape and size.

[0038] In this embodiment, the cavity plate 2 rests on the score plate 3 when the system 100 is in an assembled and operative configuration. When a troche formulation is poured into the troche cavities 20 of the cavity plate 2, the score marks are transferred to the resulting troches. After the troches solidify, they may be cleanly broken into quarter- or half-size doses. It should be understood that a score mark can be used for dividing troches into other fractional sizes and is not limited to half- or quarter-sized portions.

[0039] In this embodiment, the system 100 can be used for making troches on a benchtop setting or in a clean containment hood. One advantage of this approach is that heating plate 5 can be used to heat the cavity plates 1 or 2 without need for a convection oven, which is common in the troche industry. This advantage results in that the troches can be produced in a containment hood, e.g., a controlled environment which can reduce contamination. When current troche methods are used using a convection oven, active drug product powders can escape into the pharmacy which can result in contamination of surfaces, other pharmaceuticals and products, and can be a violation of USP codes.

[0040] Referring to FIG. 5, a perspective view of the system 100 is shown in an assembled configuration. In this embodiment, a digital temperature controller 30 is used to provide controllable temperature regulation of the cavity plate 1 or 2 (depending on which is used) by way of heating plate 5. In this embodiment, power for the digital temperature controller 30 is provided by way of plug 35 which can be adapted or configured for use with residential or commercial power supply. The digital temperature controller 30 is programmable and has a feedback loop via at least one thermocouple configured to measure the temperature of the heating plate 5. Accordingly, a desired temperature can be set by way of the controller 30; because the cavity plate 1 or 2 rests on the heating plate, the cavity plate 1 or 2 will become warmed by the heating plate 5.

[0041] Still referring to FIG. 5, in this embodiment, the system can be used for preparing RDT's from powdered ingredients. Tamper plate 4 includes an array of protrusions matching the array of cavities 20. Each protrusion 40 has a length and width parallel with the top 45 of the tamper plate 4 sufficient to allow each protrusion to fit within a corresponding cavity 20. The depth of each protrusion 40 is less than the depth of each cavity 20, thereby allowing the tamper plate to be used for compacting powdered RDT ingredients within the cavities 20.

[0042] In this embodiment, the system 100 can be used to make troches by way of the following example. First, the heating plate 5 can be heated to a temperature sufficient to keep a chosen troche base and any pharmaceuticals or active ingredients disposed therein in liquid form. Next, the score plate 3 and cavity plate 1 or 2 can be placed onto the heating plate 5. In practice, it can be beneficial to allow the heating plate and the cavity plate 1 or 2 to achieve thermal equilibrium with the heating plate.

[0043] Next, a liquid troche base can be poured onto the cavity plate 1 or 2, filling all of the cavities 20. A spatula or scraper can be used to wipe excess troche base from the cavity plate 1 or 2. In the case that cavity plate 1 is used, the overflow lip 15 can be useful in containing excess troche base on the cavity plate. In one embodiment, the cavity plate 1 or overflow lip 15 can include a recess enabling one to collect excess troche base therein or allow the excess troche base to be poured off.

[0044] Next, once the troche base is level across the cavities 20 and excess troche base has been removed, the heat plate can be turned off to allow it to return to room temperature. After the troche has cooled and solidified, the cavity plate 1 or 2 can be removed from the heating plate and the individual troches removed.

[0045] In this embodiment, the system 100 can be used to make RDT's by way of the following example. First, on a flat, clean surface the cavities 20 are filled with the powder mixture. To aid in filling all of the cavities, and to ensure consistency, a powder scraper can be used. Excess powder should be removed. Referring briefly to FIG. 6, the use of a powder dam 50 can assist in proper powder spreading. The powder dam 50 is similar to a frame that provides a border around the array of cavities 20 on the cavity plate, preventing excess powder from spilling over the edge of the cavity plate 2 and allowing better management of powder when filling the cavities.

[0046] Next, the powder in the cavities 20 is compacted. Referring to FIG. 5, tamper plate 4 includes protrusions, as described herein, for the purpose of compacting powder into the cavities 20. In general, it may take multiple iterations of adding RDT powder to the cavity plate 1 or 2 and compressing the powder with the tamper plate in order to fill each cavity 20 completely and compactly.

[0047] Next, the heating plate 5 is pre-heated to a desired temperature, depending on the RDT formula requirements. Next, the score plate 3 is placed on the heating plate, and the cavity plate 2 is placed on top of the score plate 3. The tamper plate 4 is then inverted and placed on top of the cavity plate 2, so that the protrusions 40 of the tamper plate 4 confront the filled cavities 20 of the cavity plate 2. Having the tamper plate 4 atop the cavity plate 2 can aid in retaining heat within the cavities, resulting in a more uniform heating process.

[0048] Once the heating cycle has finished, per the RDT formulation used, the heat is turned off and the tamper plate 4 is removed. Before the score plate 3 and the cavity plate 2 are separated, they are removed together and allowed to cool slightly at room temperature. The individual RDT's can then be removed from the cavity plate.

[0049] A number of illustrative embodiments have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the various embodiments presented herein. Accordingly, other embodiments are within the scope of the following claims.