Packaging System for Medicated Starch-Based Powder Formulations

Abstract

Medicated starch-based powder formulations are packaged to ensure the medication remains stable for a desired shelf life. The medicated starch-based powder formulation may be packaged in a sealed container so as to maintain medicament functionality for at least one year. The container may be fabricated and/or lined with a low permeability coefficient and sealed with a foil heat induction seal liner. The container may be treated with a media to alter the surface properties of the container to increase the integrity of the container. The medicated starch-based powder formulation may include cornstarch and menthol.

Claims

1. A packaged medicated powder, comprising: a powder formulation that includes (i) a starch, and (ii) a medicament; a container defining an opening and an internal container volume within which the powder formulation is positioned; and a foil sealing mechanism mounted with respect to the opening of the container; wherein the container includes a material that has a permeability coefficient that in combination with the sealing mechanism and in the absence of an oxygen scavenger or other freshness keeping agent ensures that medicament functionality is maintained for at least one year.

2. The packaged medicated powder of claim 1, wherein the container is fabricated from or lined with a material selected from the group consisting of PET, PETG, PVC, PVDC, nylon-6, and a combination thereof.

3. The packaged medicated powder of claim 1, wherein the container is selected from the group consisting of a bottle, a pouch, a flask, a jar, a jug, a bag, a tube, a cylinder, and any combination thereof.

4. The packaged medicated powder of claim 1, wherein the sealing mechanism is a foil heat induction seal liner.

5. The packaged medicated powder of claim 4, wherein the sealing mechanism further comprises a cover.

6. The packaged medicated powder of claim 1, wherein the sealing mechanism is applied to the container using a heat-sealing process.

7. The packaged medicated powder of claim 1, wherein the medicament is menthol.

8. The packaged medicated powder of claim 1, wherein the starch is cornstarch.

9. The packaged medicated powder of claim 1, wherein the container is treated with a media to alter the surface properties of the container.

10. A method of packaging a medicated starch-based powder, the method comprising: introducing a medicated starch-based powder formulation through an opening and into an internal volume of a container; and applying a foil sealing mechanism over the opening of the container; wherein the container includes a material that has a permeability coefficient that in combination with the sealing mechanism and in the absence of an oxygen scavenger or other freshness keeping agent ensures that medicament functionality of the medicated starch-based powder is maintained for at least one year.

11. The method of packaging a medicated starch-based powder of claim 10, wherein the container is selected from the group consisting of a bottle, a pouch, a flask, a jar, a jug, a bag, a tube, a cylinder, and any combination thereof.

12. The method of packaging a medicated starch-based powder of claim 10, wherein the sealing mechanism is a foil heat induction seal liner.

13. The method of packaging a medicated starch-based powder of claim 12, wherein the sealing mechanism further comprises a cover.

14. The method of packaging a medicated starch-based powder of claim 10, wherein the sealing mechanism is a heat-sealing process.

15. The method of packaging a medicated starch-based powder of claim 10, wherein the container is fabricated from or lined with a material selected from the group consisting of PET, PETG, PVC, PVDC, nylon-6, and a combination thereof.

16. The method of packaging a medicated starch-based powder of claim 10, wherein the container is treated with a media to alter the surface properties of the container.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0011] Illustrative embodiments are shown by way of example in the accompanying figures and should not be considered as a limitation of the present disclosure:

[0012] FIG. 1 depicts a process flow chart for packaging medicament-containing powders according to the present disclosure;

[0013] FIG. 2 is a plot of percent menthol and time for an experimental test according to the present disclosure; and

[0014] FIG. 3 is a plot of percent menthol and time for an experimental test according to the present disclosure.

DETAILED DESCRIPTION OF THE DRAWINGS

[0015] Exemplary embodiments of the present disclosure include packaging systems for reducing dissipation and evaporation of a medication, e.g., menthol, when combined with a starch-based, e.g., cornstarch, powder formulation for topical use. In an exemplary embodiment, the packaging includes a container for housing a powder and a cover to seal the container. The container may also include labeling that sets forth a description of the product, the dosage amount, the quantity, among other informative details concerning the product, as required or desired. Although the following embodiments may only highlight one or more specific containers when describing the details of the disclosed packaging systems, the embodiments are merely for illustrative purposes and the present disclosure is not limited by or to only those containers mentioned.

[0016] In order to reduce the permeation of a medicament (e.g., menthol) and extend the shelf life for a medicated cornstarch-based powder formulation according to the present disclosure, a container including a material with a low permeability coefficient is preferred. In an illustrious embodiment, the oxygen permeability range is 0.1 cc/100 square inches to 400 cc/100 square inches. More preferably, the oxygen permeability range is 0.1 cc/100 square inches to 200 cc/100 square inches. The container may be fabricated from and/or coated/lined with PET, PETG, PVC, PVDC, nylon-6, or a combination thereof. In an exemplary embodiment, the container is treated with a media that alters the surface properties of the container (e.g., inside and outside surfaces) to increase the integrity of the container (e.g., reduce permeation). Treatment may be applied to conventional plastics (e.g., not high performance plastics) to transform the plastic into a high performance plastic (e.g., a plastic with a low permeability coefficient). The opening of the container is generally sealed to provide shelf stability to the powder formulation, e.g., by way of a foil heat induction seal liner, which tightly seals the container and reduces the loss of medicament (e.g., menthol) through flashing. The liner may further include a tab for easy tear-off by the consumer.

[0017] To further ensure a tight seal and to protect the liner from puncture, a screw-on or snap-on cover may encase the liner between the top edge of the container and the inside face of the cover. The cover may be rigid or flexible and may further include child restraint features. The combination of a container that includes (i.e., fabricated, treated and/or coated/lined with) one or more materials with a low permeability coefficient, sealed with the foil heat induction seal liner, and capped with a cover, has been shown to be effective in maintaining medicament functionality in a cornstarch-based powder for a desired period of time, e.g., for at least one year.

[0018] In another embodiment, the container that stores the cornstarch-based powder formulation with a medicament (e.g., menthol) may take the form of a bag that is sealed using traditional bag-sealing methods, e.g., heat-sealing. In order to reduce the permeation of a medicament through the bag, the bag is advantageously fabricated from and/or coated/lined with a material that has a low permeability coefficient, e.g., PET, PETG, PVC, PVDC, nylon-6, or a combination thereof. In an exemplary embodiment, the container is treated with a media that alters the surface properties of the container (e.g., inside and outside surfaces) to increase the integrity of the container (e.g., reduce permeation), as discussed above. In an illustrious embodiment, the oxygen permeability range is 0.1 cc/100 square inches to 400 cc/100 square inches. More preferably, the oxygen permeability range is 0.1 cc/100 square inches to 200 cc/100 square inches. The combination of a container that includes (e.g., fabricated, treated, and/or coated/lined with) one or more materials with a low permeability coefficient, and sealed by traditional bag-sealing methods, has been shown to be effective in maintaining medicament (e.g., menthol) functionality in a cornstarch-based powder for a desired period of time, e.g., for at least one year.

[0019] FIG. 1 depicts a process flow chart 100 outlining an exemplary method for filling and sealing a container with a medicated starch-based powder formulation according to the present disclosure. At step 102, a container is obtained and filled with a medicated starch-based powder formulation, to the desired quantity. The size and type of container chosen will depend on the desired quantity and the prospective market. At step 104, the desired quantity is confirmed and then a foil heat induction seal liner is applied over the opening of the container.

[0020] At step 106, the assembled container is placed onto an induction heating machine and operated as required.

[0021] At step 108, the container is tested to ensure that it is fully sealed. For example, this may require squeezing the container to ensure that none of the powder is released as a result of an unset foil heat induction seal liner.

[0022] At step 110, repeat the above-described steps as necessary to achieve the desired amount of assembled containers.

[0023] In order to ensure a tight seal, a screw-on or snap-on cover may be tightened onto the container, thereby encasing the foil heat induction seal liner between the top edge of the container and the inside face of the cover.

[0024] FIG. 2 is a plot of percent menthol and time (in months) for a cornstarch-based medicated foot powder. The plot summarizes the results of an accelerated stability study conducted on the disclosed packaging over a three-month period of storage at 40 C. Based on linear regression calculations, the percent menthol would drop below the preferred range of percent menthol, i.e., 0.8%-1.2%, after month three at accelerated conditions. However, the three-month accelerated study is equivalent to 24 months of preferred storage conditions. Therefore, based on the percent menthol at accelerated storage conditions and linear regression, the packaging supports a 24-month expiration date.

[0025] FIG. 3 is a plot of percent menthol and time (in months) for cornstarch-based medicated body powder. The plot summarizes the results of an accelerated stability study conducted on the disclosed packaging over a three-month period of storage at 40 C. Based on linear regression calculations, the percent menthol would drop below the preferred range of percent menthol, i.e., 0.13%-0.17%, after month three at accelerated conditions. However, the three-month accelerated study is equivalent to 24 months of preferred storage conditions. Therefore, based on the percent menthol at accelerated storage conditions and linear regression, the packaging supports a 24-month expiration date.

[0026] The present embodiments are to be considered as merely illustrative and not restrictive and may be embodied in other specific forms without departing from the spirit or essential characteristics thereof.