TAMPER EVIDENT UNIT DOSE PACKAGING

Abstract

A tamper resistant unit dose pouch having a first and second opposing panel sealed together along two peripheral sides and the bottom side. A flap having adhesive is used to seal the top portion of the pouch. When sealed, the pouch provides a moisture resistant unit dose packaging solution.

Description

TECHNICAL FIELD

Exemplary embodiments relate generally to unit dose packaging. More particularly, exemplary embodiments relate to the tamper evident unit dose medication pouches.

BACKGROUND OF THE INVENTION

In the medical profession there has always been a need for unit dose packaging that is both easy to use, for both the medical professional and the patient, and provides protection against moisture. To attempt to meet this unit dose packaging need, medical professionals have used various types of packaging including blister packs. However, traditional solutions including blister packs present several problems. First, most medical professionals rarely have the technology to make proper blister packaging that is specific for their patient. In addition, blister packs may be difficult for certain patients, such as the elderly or those with arthritis, to use given the force required to remove the medication from the blister pack. Blister packs are also not useful for certain types of medication such as ointments, gels or powders.

Consequently, there is a need in the medical field for unit dose packaging that is both easy to fill and easy to use. The unit dose packaging should also have tamper evident features to protect the patient as well as moisture protection for the medication contained within the unit dose packaging. No known references, taken alone or in combination, are seen as teaching or suggesting the presently claimed tamper evident unit dose packaging.

BRIEF SUMMARY OF THE INVENTION

The exemplary embodiments of the inventive concept meet the needs of unit dose packaging in the medical field. The inventive unit dose packaging described herein is a pouch formed by sealing two rectangular panels together along the sides and bottom of the two panels. The top of the pouch remains open in order to fill the interior of the pouch with the desired medication such as tablets, gels, ointments, or powders. In order to seal the pouch, the back panel of the pouch has a greater length than the front panel forming a flap. An adhesive is applied to this flap and the flap is folded over the front panel to create a continuous seal with the front panel and portions of the back panel to protect the medication stored therein. After the pouch has been sealed, tear indicators along the sides of the pouch may be used to allow the pouch to be opened easily. By requiring the pouch to be opened using the tear indicators also acts as a tamper evident feature as it becomes obvious that the top of the inventive pouch has been removed or opened.

The back panel of the pouch can be made from either an opaque PPFP (Paper/Poly/Foil/Poly) laminate material or a transparent PVDC (polyvinylidene chloride) PET/2 mil (polyethylene terephthalate) LLDPE (linear low density polyethylene), while the front panel of the pouch is made from the opaque PPFP (Paper/Poly/Foil/Poly). The panel materials can be used in different configurations to form both HIPAA and non-HIPAA compliant versions of the inventive pouch. More particularly, if both the front and back panels are opaque then the inventive pouch would be HIPAA compliant as the medication stored therein would not be visible when the pouch is sealed. Likewise, a pouch having a transparent back panel would not be HIPAA compliant as the medication is visible. Moreover, the materials used for the pouch panels, when the pouch is sealed, provide an effective moisture barrier needed for effective shelf life of medication. The materials used also allow the inventive pouch to be used as a pouch for use with pill crushers unlike traditional blister packs.

The use of the opaque PPFP front panel provides an important tamper evident feature to the inventive pouch. After sealing the pouch by using the adhesive to seal the flap to the front panel, the flap cannot be removed from the front panel without tearing or causing some kind of damage to the paper of the front panel. This allows both the medical professional and the patient to easily identify when tampering has occurred. Along with providing a tamper evident feature, the paper portion of the panel also provides a surface on which to write or print medical information such as patient and medication identification. The inventive pouch also reduces the storage space required as compared to blister packs that have been traditionally used for dosing medication.

It is an object of this invention to provide a unit does pouch with tamper evident features of the type generally described herein, being adapted for the purposes set forth herein, and overcoming disadvantages found in the prior art. These and other advantages are provided by the invention described and shown in more detail below.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Novel features and advantages of the present invention, in addition to those mentioned above, will become apparent to those skilled in the art from a reading of the following detailed description in conjunction with the accompanying drawings wherein identical reference characters refer to identical parts and in which:

FIG. 1 is a perspective view of a pouch according to the inventive concept in the unsealed configuration;

FIG. 2 is a perspective view of a pouch according to the inventive concept in the sealed configuration; and

FIG. 3 is a close-up side view of the pouch according to the inventive concept in the sealed configuration.

DETAILED DESCRIPTION OF THE INVENTION

Directing attention to FIG. 1, a unit dose pouch 5 according to the inventive concept is illustrated and includes first and second panels 10, 15. The panels 10, 15 are preferably made from layered materials. The panels 10, 15 can be made from either a PPFP (Paper/Poly/Foil/Poly) or a PVDC (polyvinylidene chloride) PET/2 mil (polyethylene terephthalate) LLDPE (linear low density polyethylene). To form the pouch 5, the first panel 10 is sealed to the second panel 15. The seal 35 may be accomplished by heat seal, adhesive seal, or other types of seals known to one of skill in the art. The pouch is a generally rectangular configuration sealed along the respective pouch sides 20, 25 and the pouch bottom 30.

In embodiments utilizing one or more panels 10, 15 made from PPFP, the paper portion of the panel 10, 15 is faced away from the opposing panel 10, 15 when the panels 10, 15 are sealed one to another. In this manner, the paper layer of the panel 10, 15 is always presented as the exterior of the pouch 5. In addition, the first panel (back panel) 10 also has a greater length than the second panel (front panel) 15, this additional material forms a flap 40, used to seal the top portion of the pouch 5.

An adhesive 45 is applied across the surface of the flap 40 portion of the first panel 10. The adhesive 45 may be pressure sensitive adhesive. The adhesive 45 allows the pouch 5 to self seal upon closing and the application of pressure along the adhesive area. Pressure sensitive adhesives typically include a release liner not shown in the drawings. The positioning of the adhesive 45 will be discussed more fully below.

In the embodiment shown in FIG. 1, the flap 40 on the first panel 10 extends beyond the unsealed top edge 50 of the second panel 15. A fold line 55 is provided an x-distance away from the top edge 50 of the second panel 15. The fold line 55 may be identified by either a perforated line or a crease in the material of the first panel 10. The adhesive 45 begins at y-distance above the fold line 55 and extends to the end of the flap 40. Although the x and y distances may be adjusted according to the size of the pouch 5, the x-distance will be greater than the y-distance to ensure a good seal of the pouch 5. The length of the flap 40 is sufficient to cover a portion of the second panel 15, when the flap 40 is folded along the fold line 55. Given the x and y distances, this ensures that the adhesive 45 on flap 40 forms a continuous seal with the top edge 50 of the first panel 15 and the area adjacent the top edge 50. Accordingly, the adhesive 45 forms a seal with both the first and second panels 10, 15 as shown in FIG. 2.

The embodiment in FIG. 2 illustrates the embodiment of FIG. 1 in a closed position. The closure of FIG. 2 is accomplished by folding flap 40 at the fold line 55. The flap 40 is folded over which seals the first panel 10 to itself and to the area of the second panel 15 adjacent its top edge 50, as shown in the close up in FIG. 3. As shown in FIG. 3, the flap 40 is sealed by way of the adhesive 45 to the first panel 10 and the second panel 15. The seal generated by the adhesive is continuous across the entire width of the pouch 5.

As discussed herein, embodiments of the pouch 5 includes tamper evident features. As provided above, the second panel (front panel) 15 is made from PPFP wherein the paper layer is positioned away from the first panel and acts as the exterior of the pouch 5. This paper layer in conjunction with the adhesive 45 provides a tamper evident feature. Thus, the minimum bond strength of the adhesive 45 and the tear-resistance strength of the paper layer should be such that at least a portion of the paper will be damaged or torn from the second panel 15 when the flap 40 is pulled away from the second panel 15 subsequent to the flap 40 being sealed thereto. This tearing of the paper layer of the second panel 15 evidences that a sealed pouch 5 has been tampered with. Another tamper evident feature is the use of a perforated line as the fold line 55. The use of a perforated line creates a weakness in the flap 40 that will likely tear when the flap 40 is unsealed. If the perforated line is torn it is evidence that the pouch 5 has been tampered with.

To open the pouch 5, the sides 20, 25 each have a tear indicator 60 located thereon. The tear indicators 60 are shown as notches provided in the sides 20, 25. To open the pouch, a user simply tears open the pouch 5 at the tear indicators 60. This method of opening the pouch 5 provides another tamper evident feature, as it is easily discernible if the pouch 5 has been opened using the tear indicators 60. The tear indicators 60 should be positioned close to the end of the flap 40 when in the closed position in order to maximize the storage capacity of the inventive pouch 5, when opened.

As indicated, since the inventive pouch 5 is used as a single dose medication storage solution, it is important that the pouch 5 eliminate or reduce moisture permeation. Accordingly, testing was conducted to determine the moisture permeation of the inventive pouch 5. In the testing procedure discussed below, both the test group and the control group are pouches 5 wherein both the first and second panels 10, 15 are PPFP.

The test was conducted using the USP Standard Test Method I from Section 671—Containers-Permeation. Desiccant pellets were dried at 110° C. for one hour prior to use. The desiccant pellets used were Item No. TK1002S purchased from Medical Packaging Inc. located in Ringoes, N.J. These pellets indicate a change in moisture content through weight gain over time and a change in color (from green to pink) when saturated. The test group of pouches 5 (10) were labeled T1 to T10 and the control group of pouches 5 (10) were labeled C1 to C10. One desiccant pellet was placed into each test pouch 5 and no desiccant pellets were placed in the control pouches 5. Each sample (test and control) was identified by numbered markings on each packaging (either T or C 1-10) to be able to keep track of each during the weighing period. Next, both the test pouches 5 and the control pouches 5 were sealed by removing the liner from the adhesive 45 and folding the flap 40 along the fold line 55 so that the adhesive 45 on the flap 40 is contacted with the first and second panels 10, 15. A metal rod was then rubbed over the adhesive 45 portion of the flap 40 to ensure the bonding between the adhesive 45 and the first and second panels 10, 15.

The weights of each pouch 5 were logged as the initial weight for the start of the test procedure. The weighing was carried out using an electrical analytical balance and the values were recorded to 4 decimal places. The control pouches 5 were weighed individually and recorded and an average weight was determined for each control pouch 5. The average weight was used in the moisture permeability formula.

All pouches 5 (test and control) were stored in a constant humidity tank at 75+/−3% relative humidity and at a temperature of 23° C.+/−2° C. for a period of 30 days. It took a few days to stabilize the temperature and humidity in the tank to achieve these test temperature and humidity parameters. Weighing continued at 24 hour intervals for the first ten days after the initial weighing on day zero then weighing was done at 3-4 day intervals to 30-days. Before each weighing session, the sample pouch 5 (test and control) were removed from the tank and allowed to equilibrate for an hour to room temperature.

To calculate the moisture permeation, the USP formula (1) was used to determine the milligram gained per day.

Moisture Permeation=(1/N)[(W_f-W_i)−(C_f-C_i)]  (1)

Where N is the number of days (24 hr increments) expired during the test. (W_f-W_i) is the milligram difference between the final and the initial weight on each sample. (C_f-C_i) is the average milligram difference between the final and initial weight of the control. The result (moisture permeation) is then expressed in mg/day of moisture gain. The testing was taken through an 11 day testing period including the zero initial weight day. At the end of the 30 day period these pouches 5 exhibit properties of a Class “B” package in that none of the pouches 5 exceeded 5 mg/day moisture permeation. The results of the moisture permeation test are provided in TABLE 1 below, wherein moisture gains for test pouches T1-T10 are expressed in milligrams per day (mg/day):

TABLE 1
Day	T1	T2	T3	T4	T5	T6	T7	T8	T9	T10
1	—	—	—	—	—	—	—	—	—	—
2	0.00	0.00	0.00	0.00	0.00	0.00	0.00	0.00	0.00	0.00
3	−0.57	−0.23	−0.57	−0.90	−0.57	−0.23	0.10	−0.23	0.43	0.43
4	−1.03	−0.78	−0.78	−0.53	−0.28	−1.03	−0.03	−0.28	−0.03	−0.03
5	−0.44	−0.44	−0.64	−0.64	−0.84	−0.44	−1.04	−0.24	−0.24	0.16
6	−0.20	−0.37	−0.37	−0.87	−0.53	−0.20	−0.20	−0.20	−0.20	0.13
7	−0.26	−0.11	0.03	−0.11	−0.26	−0.26	0.03	0.03	0.03	0.31
8	−0.11	−0.24	−0.24	−0.36	−0.36	−0.11	0.01	−0.11	−0.24	0.14
9	0.22	0.00	0.00	−0.22	−0.22	0.00	0.22	0.22	0.00	0.22
10	0.31	0.01	−0.09	−0.29	−0.19	0.01	0.11	0.01	0.01	0.41
14	0.76	0.19	0.05	0.26	−0.02	0.26	0.26	0.19	−0.02	0.19
18	0.69	0.14	1.92	3.08	3.31	−0.42	−0.36	−0.36	−0.42	−0.36
22	0.85	−0.02	0.35	0.48	1.30	−0.06	0.03	0.03	0.03	0.25
26	0.35	−0.57	0.43	0.50	0.23	−0.34	0.04	0.00	0.04	0.27
30	0.77	−0.13	0.20	0.00	0.67	0.10	0.14	−3.26	0.04	0.30

Any embodiment of the present invention may include any of the optional or preferred features of the other embodiments of the present invention. The exemplary embodiments herein disclosed are not intended to be exhaustive or to unnecessarily limit the scope of the invention. The exemplary embodiments were chosen and described in order to explain the principles of the present invention so that others skilled in the art may practice the invention. Having shown and described exemplary embodiments of the present invention, those skilled in the art will realize that many variations and modifications may be made to the described invention. Many of those variations and modifications will provide the same result and fall within the spirit of the claimed invention. It is the intention, therefore, to limit the invention only as indicated by the scope of the claims.

Claims

1. A tamper resistant pouch comprising: a front panel having inner and outer surfaces defined by a bottom edge, two side edges and a top edge;a back panel having inner and outer surfaces defined by a bottom edge, two side edges and a top edge, wherein the distance from the top edge to the bottom edge of the back panel is greater than the distance from the top edge to the bottom edge of the front panel, thereby defining a flap extending beyond the top edge of the front panel when the inner surfaces and bottom edges of the front and back panels are in registration;a seal, whereby the bottom edge and two side edges of the back panel are each respectively joined to the bottom edge and two side edges of the front panel;a fold line extending across the flap of the back panel at an x-distance above the top edge of the front panel;an adhesive applied across the inner surface of the back panel and extending from the top edge of the back panel to a y-distance above the fold line; anda tear indicator formed in each of the two sides.

2. The tamper resistant pouch of claim 1, wherein the x-distance is greater than the y-distance.

3. The tamper resistant pouch of claim 2, wherein the x-distance is less than half of a flap length, wherein the flap length is defined by the distance between the top edge of the back panel and the top edge of the front panel.

4. The tamper resistant pouch of claim 1, wherein the adhesive is a pressure-sensitive adhesive.

5. The tamper resistant pouch of claim 1, wherein at least one of the front panel and the back panel comprise a layered material.

6. The tamper resistant pouch of claim 1, wherein at least one of the front panel and the back panel comprise a paper/poly/foil/poly layered material.

7. The tamper resistant pouch of claim 5, wherein the layered material comprises: a polyvinylidene chloride layer;a polyethylene terephthalate layer; anda linear low density polyethylene layer.

8. The tamper resistant pouch of claim 1, wherein the front panel comprises a paper/poly/foil/poly layered material, and wherein the paper layer is the outer surface of the front panel.

9. The tamper resistant pouch of claim 8, wherein the adhesive comprises a minimum bond strength greater than a tear-resistance strength of the paper layer.

10. The tamper resistant pouch of claim 1, wherein the fold line comprises a perforated line.

11. The tamper resistant pouch of claim 1, wherein each tear indicator is a notch extending inwardly from the corresponding side edge and into, but not through, the seal.

12. The tamper resistant pouch of claim 11, wherein each tear indicator is positioned in close proximity to the top edge of the flap when folded at the fold line.

13. A tamper resistant pouch comprising: a front panel comprising a plurality of layers and having inner and outer surfaces defined by a bottom edge, two side edges and a top edge;a back panel comprising multiple layers and having inner and outer surfaces defined by a bottom edge, two side edges and a top edge, wherein the distance from the top edge to the bottom edge of the back panel is greater than the distance from the top edge to the bottom edge of the front panel, thereby defining a flap extending beyond the top edge of the front panel when the inner surfaces and bottom edges of the front and back panels are in registration;a seal, whereby the bottom edge and two side edges of the back panel are each respectively joined to the bottom edge and two side edges of the front panel;a perforated line extending across the flap of the back panel at an x-distance above the top edge of the front panel;a pressure-sensitive adhesive applied across the inner surface of the back panel and extending from the top edge of the back panel to a y-distance above the fold line; anda tear indicator formed in each of the two sides and positioned in close proximity to the top edge of the flap when folded at the fold line.

14. The tamper resistant pouch of claim 13, wherein the front panel comprises a paper/poly/foil/poly layered material, and wherein the paper layer is the outer surface of the front panel.

15. The tamper resistant pouch of claim 14, wherein the x-distance is greater than the y-distance.

16. The tamper resistant pouch of claim 15, wherein the x-distance is less than half of a flap length, wherein the flap length is defined by the distance between the top edge of the back panel and the top edge of the front panel.

17. The tamper resistant pouch of claim 16, wherein the adhesive comprises a minimum bond strength greater than a tear-resistance strength of the paper layer.

18. The tamper resistant pouch of claim 17, wherein each tear indicator is a notch extending inwardly from the corresponding side edge and into, but not through, the seal.