GB2480281A

GB2480281A - Holder for a blister pack forming a monitored dosage system

Info

Publication number: GB2480281A
Application number: GB1007871A
Authority: GB
Inventors: David John Fenn
Original assignee: Individual
Current assignee: Individual
Priority date: 2010-05-11
Filing date: 2010-05-11
Publication date: 2011-11-16
Also published as: GB201007871D0; WO2011141688A1

Abstract

A dispensing pack 1 comprising a first flexible lamina 2 and a second flexible lamina 3. The first flexible lamina 2 includes a first array of apertures 4, and the second flexible lamina 3 includes a second array of apertures and an adhesive layer exposable by a removable protective sheet 9. Wherein the first flexible lamina 2 and second flexible lamina 3 are adapted to be mated via removal of the protective sheet (9) and exposure of the adhesive layer such that the first array 4 and second array of apertures correspond in alignment. It is intended that the a blister pack 24 containing a plurality of individually sealed items is separated into individual blister elements 24, and each blister element 24 is placed into an aperture 4 of the first flexible lamina such that a blister pocket of each individual blister element 24 protrudes through the aperture, the protective sheet 9 is removed from the second flexible lamina 3 to expose the adhesive and the second flexible lamina 3 brought into contact with the first flexible lamina 2 so that each of the individual blister elements 24 is secured in place. A pair of mounting holes 6 may be provided in the dispensing pack 1 so that it can be mounted in a ring binder. The dispensing pack 1 may be formed of a polypropylene base synthetic paper.

Description

Monitored Dosa2e System Pack This invention relates to dispensing packs for blister-packed items. Specifically, this invention relates to monitored dosage system packs for receiving and dispensing pharmaceuticals without the need for prior de-blistering.

Patient monitored dosage system packs (MDS) are currently available in many forms.

They are generally prepared by a pharmacist and are dispensed for use by patients and/or carers in their own homes or nursing homes and the like.

A conventional MDS pack is shown in Figures 1 and 2. The MDS pack 100 comprises an upper card sheet 101 sealed to a lower card sheet 102. Between the upper card sheet 101 and the lower card sheet 102 is frangible foil layer 103.

The MDS pack 100 also includes an anay of deformable raised window segments 104 providing a cavity for the storage of pharmaceutical capsules 105, tablets etc. The MDS packs 100 are pre-loaded with de-blistered pharmaceuticals by a dispensing chemist. Each capsule 105 must be manually removed from the manufactures supplied blister packs and placed in the appropriate window cavity prior to hot or cold sealing of the MDS pack foil layer. Once pre-loaded and sealed, the MDS pack can be supplied to the end-user.

There are many problems associated with a conventional MDS pack: de-blistering pharmaceuticals from the manufacturer supplied blister pack often leads to a loss of the manufacturers guarantee; hot sealing of the MDS pack can adversely affect the efficacy of heat-sensitive medicaments, and cold sealing can lead to moisture ingress into the pack; unused de-blistered medicaments cannot be recycled or reused, leading to a large degree of waste.

Furthermore, both cold and hot seal systems have an inherent risk of imperfect sealing. Imperfect sealing can result in the migration of medicines between window segments.

Many of the MDS packs available on the market have a shelf life up to a maximum of days. Most of the available packs claim compliance with Regulatory Class B USP 24, which provides for a shelf life of between 30 and 60 days.

They are generally prepared in a pharmacy for use in a nursing home, old age home or similar and may also be used for domiciliary care. They may be heat sealed in packs or cold sealed in packs; both require that medicines be removed from the original manufacturers packaging (a process called deblistering") before transfer to the MDS pack. Many original manufacturers do not approve of this deblistering as pack integrity is broken before the pharmaceutical is dispensed to the patient.

Pharmaceutical products are produced to a very high quality in carefully controlled facilities.

Also, the heat-sealing process may adversely affect the efficacy of some heat-sensitive medicines and the cold seal process may not protect sufficiently from moisture ingress.

It will be appreciated that this problem exists for any product delivered in a blister.

Many of these patient packs are returned to the issuing pharmacy with unused, and perhaps expensive, pharmaceuticals unused. The designated patient may have died, the prescription changed or incorrectly dispensed, or there may have been non-compliance.

Unused medicines in conventional packs cannot be re-used and have to be destroyed safely and securely according to the appropriate regulations and at a cost.

Pharmacies and manufacturers of MDS packs have reported both on the wastage of pharmaceutical products, some tablets can cost as much as £40 each and the cost of safe and secure disposal. This could be £1 per pack.

In order to, retain the original pharmaceutical manufacturer's shelf life, which could be up to two years, it is desirable to have a system which both places the pharmaceutical in its original packaging in an MDS pack and also allows the safe and efficient removal of the pharmaceutical, tablet or capsule from its original packaging for delivery to the patient.

There should also be a means for recovering the pill, capsule or tablet still in its original manufacturer's packaging.

Another conventional dispensing package is described in EP-A-0 189 276. Here, and as shown in Figure 3, a hinged book-shaped cover 200 is provided with a series of openings 201 for receiving and holding in place a complete blister pack. The cover 200 includes a plurality of press fasteners ananged around the periphery [not shown] of the cover to enable the cover to be folded and fastened together. The cover 200 is constructed from a stiff plastics material.

Because such a conventional cover 200 is inflexible, users with compromised dexterity or a loss of finger manipulation will find it very difficult, if not impossible, to dispense medicament capsules from the blister pack enclosed by the cover 200.

Furthermore, such plastic hinged covers are prohibitively costly for general use within a pharmacy or dispensary.

Furthermore, cleaning and sterilising the cover before it is re-used, checking and auditing to ensure that proper procedures are followed also add to the cost, and if these procedures are not followed there may be a danger of cross-infection.

The present invention arose from consideration of the above mentioned problems

associated with the prior art.

According to an aspect of the present invention there is provided a dispensing pack comprising a first flexible lamina and a second flexible lamina; the first flexible lamina includes a first array of apertures, and the second flexible lamina includes a second array of apertures and an adhesive layer exposable by a removable protective sheet; wherein the first flexible lamina and second flexible lamina are adapted to be mated via removal of the protective sheet and exposure of the adhesive layer such that the first array and second array of apertures correspond in alignment.

Preferably, the first flexible lamina and the second flexible lamina are fabricated from a polypropylene-based synthetic paper.

Preferably, the synthetic paper is YUPO ©.

According to another aspect of the present invention there is provided a method of providing a dispensing pack including a plurality of sealed items, the method including: providing a dispensing pack as described in claim 1; dividing a blister pack containing a plurality of individually sealed items into individual separated blister elements; placing each individual separated blister element into an aperture of the first flexible lamina such that a blister pocket of each individual separated blister element protrudes through the aperture; removing the protective sheet from the second flexible larnina to expose the adhesive layer; bringing the second flexible lamina into alignment and contact with the first flexible lamina such that the first lamina adhesively mates with the second flexible lamina and holds each of the individual blister elements securely in place.

An advantage of this method is that the manufacturer's shelf-life guarantee is retained since the pharmaceutical remains in its original packaging, and any contamination is avoided. Also, no hot or cold sealing of the pack is required. Also, the cost and time of deblistering with its attendant disadvantages and possible dangers is avoided.

Although the specific embodiment of the present invention relates to patient packs or monitored dosage systems, this invention can be applied to the re-packaging or distribution of any product where it is desirable to present, display or dispense the product without removing the product from the manufacturer's blister pack.

An embodiment of the present invention will now be described, by way of example only, and with reference to the accompanying schematic drawings, in which: Figure 1 shows a conventional MDS pack; Figure 2 shows a cross-sectional view of the MDS pack of Figure 1; Figure 3 shows a plan view of a prior art dispensing cover; Figures 4A to 4C show a dispensing operation of the MDS pack of Figure 1; Figure 5 shows an embodiment of a dispensing pack of the present invention; Figure 6 shows an alternative embodiment of a dispensing package of the present invention; Figure 7A shows a conventional pharmaceutical blister pack; Figure 7B shows a cross-sectional view of the blister pack of Figure 7A; Figures 8A to 8D show pre-loading and dispensing operations of a dispensing package of the present invention.

Figures 4A to 4C show a cross-sectional view of the prior art MDS pack 100 shown in Figure 1. A de-blistered pharmaceutical capsule 105 is held within a deformable transparent pocket 106. Downward finger pressure 107 deforms the pocket 106 and the capsule 105 is forced downwards 108 through the frangible foil layer 103 and is dispensed.

Figures 5 and 6 show alternative embodiments of a dispensing pack 1 of the present invention. The pack 1 comprises a front lamina 2 and a rear lamina 3. Figure 5 shows an example of a dispensing pack having separate front and rear laminae, and Figure 6 shows an alternative pack wherein the front and rear laminae are joined via a fold line.

The dispensing pack 1 includes rows and columns of apertures 4. For clarity, only the front lamina 2 is shown with an aperture matrix. It will be clear however, that a corresponding aperture matrix also exists on the rear lamina 3.

To facilitate storage in an appropriate filing system, the dispensing pack 1 includes mounting holes 6 through which the rings of a ring-binder or a pair of parallel hanging bars can be passed.

Legends 7 and 8 can be printed onto the front lamina 2 to assist the user or carer in dispensing the conect medication. In the examples shown the days of the week and the week number are shown. However, it should be understood that any appropriate labeling system and/or number of columns and rows of apertures can be implemented.

The dispensing pack 1 is preferably manufactured from a synthetic paper such as YUPO © which is polypropylene-based synthetic paper. Such synthetic paper can be readily printed upon, is light, flexible and provides adequate strength such that a user cannot inadvertently tear or damage the pack during a dispensing operation.

Most pharmaceuticals are provided by the manufacturer in a blister pack 20 as shown in Figure 7A. Blister packs are well known so no detailed description of their form or function is required here.

In use with the present invention, the blister pack 20 is divided along the broken lines 21, 22 into individual blister elements 24 by a suitable cutting operation. The cutting operation may be manual or achieved using an appropriate cutting machine. Figure 7B shows the direction and position of the cutting planes for the desired separation of individual blister elements 24. The original blister pack 20 may be supplied pre-perforated along the broken lines to facilitate easier separation.

Referring now to Figures 8A, each individual blister element 24 produced by the aforementioned cutting operation is positioned in alignment with an aperture 4 of the front lamina 1 [it should be noted that in practice the front lamina would be orientated upside down so that the blister elements would be held in the apertures by gravity].

Once all individual blister elements 24 are in place, protective sheet 9 is removed to reveal and adhesive layer on the rear lamina 2 [Figure 8B].

Once the adhesive layer [not shown] has been exposed by removal of the protective sheet 9, the rear lamina 2 can be brought into contact with the front lamina 1 and the two laminae will be bonded to one another securing all the individual blister elements 24 in place, with the front and rear apertures in alignment [Figure 8C].

In use [see Figure 8D], and an individual pharmaceutical capsule 26 is dispensed by downward pressure 27 on an individual blister element 24 which forces the capsule 26 into contact with the intact foil backing 25 of the blister element 24. Further pressure will rupture the foil backing 25 and the capsule 26 will be dispensed as shown.

Unused pharmaceuticals can be recovered by soaking or wetting a returned dispensing pack with a suitable release agent to neutralises the adhesive enabling removal of unused blister elements.

Unused blister elements may include manufacturer's markings to provide a logistics trail to ensure that each blister element can be identified.

Claims

Claims 1. A dispensing pack comprising a first flexible lamina and a second flexible lamina; the first flexible larnina includes a first array of apertures, and the second flexible lamina includes a second array of apertures and an adhesive layer exposable by a removable protective sheet; wherein the first flexible lamina and second flexible lamina are adapted to be mated via removal of the protective sheet and exposure of the adhesive layer such that the first anay and second array of apertures correspond in alignment.
2. A dispensing pack as claimed in claim 1, wherein the first flexible lamina and the second flexible lamina are fabricated from a polypropylene-based synthetic paper.
4. A dispensing pack as claimed in any claim 1 to 3, wherein the dispensing pack includes mounting holes through which the rings of a ring-binder or a pair of parallel hanging bars can be passed.
5. A method of providing a dispensing pack including a plurality of sealed items, the method including: providing a dispensing pack as claimed in claim 1; dividing a blister pack containing a plurality of individually sealed items into individual separated blister elements; placing each individual separated blister element into an aperture of the first flexible lamina such that a blister pocket of each individual blister element protrudes through the aperture; removing the protective sheet from the second flexible lamina to expose the adhesive layer; bringing the second flexible lamina into alignment and contact with the first flexible lamina such that the first lamina adhesively mates with the second flexible lamina and holds each of the individual blister elements securely in place.
6. A method as claimed in claim 5, wherein the first flexible lamina and the second flexible lamina are fabricated from a polypropylene-based synthetic paper.
8. A method as claimed in any claim 5 to 7, wherein the dispensing pack includes mounting holes through which the rings of a ring-binder or a pair of parallel hanging bars can be passed.
9. A method as claimed in any claim 5 to 8, wherein the or each of the plurality of sealed items is a pharmaceutical or medicament.