Field of the Invention The present invention relates to a blister pack with notches for easy retrieval of fragile dosage forms.
Background of the Invention The containment, safe storage and easy retrieval are the fundamental principles in pharmaceutical packaging. The design of packaging must take into account needs of the product, manufacturing and distribution. But another important requirement is the user friendliness of the packaging.
Blister packs for drugs in tablet form or in the form of powder or liquid enclosed in a capsule have been known for a long time. The blister pack consists of flat sheets of foils covering each other and being attached to each other. One, relatively rigid foil, most commonly called the blister layer, comprises cavities or open "blisters", for accommodating a tablet or capsule each, while the other foil that is flat and most commonly called the lid or base layer, seals the opening of the cavities or blisters. The most commonly used sealing process is heat sealing, with at least one of the foils having thermoplastic properties, and at present the manufacture of the pack is most rationally carried out by continuously joining webs of the foils for said sealing, and cutting them to said packs.
There are number of products which need to be packed as unit dose packs for adequate protection of the medicament. Further, as the size of medicament to be packed decreases or if the dosage form is fragile, they cannot be packed in conventional blisters, for they might break when being removed.
There are lots of products that are available in the market that have notches e.g. sachet, tamper resistant or child resistant blisters etc. The child resistant or tamper resistant blisters are made of tear resistant or puncture resistant material that resists opening the blister by conventional methods such as pushing through the blister, even by adults and thus can only be opened by tearing along the notch.
PCT Application WO00/54231 discloses a blister package that comprises a blister layer having an article receiving blister formed therein for holding medicaments, and a base layer. The blister layer has one or more tearing blisters joined to the base layer except in the areas of the article receiving blister and the tearing blisters. The portions of the base layer and the blister layer that are joined together cannot be readily torn from the outer edges of the blister package, but the portion of the blister layer that forms the tearing blister is thin enough so that the tearing
blister and the portion of the base layer under the tearing blister can be readily torn from the outer edge of the blister package.
U.S. Patent 5,088,603 discloses a novel child resistant blister foil package for use with oblong medicaments, such as caplets, comprising a base layer and a rigid, substantially rectangular blister layer composed of low-extensible film joined to the base layer. The blister layer of this package has an oblong, longitudinally oriented blister formed on one end thereof and a longitudinally directed tear slit disposed through the opposing edge thereof. Tear tabs are thus provided between the blister and the slitted edge which permit the package to be torn open through the entire length of the oblong blister. The preferred package exhibits a tear propagation resistance, in accordance with ASTM method D1938, which, unlike flexible pouch packages, is substantially continuous during the opening of the package.
U.S. Patent 3,809,220 discloses a sealed package that is openable by adults but which is sufficiently difficult for children to open. The sealed package is preferably in the form of an envelope of the type having a pocket or cavity for receiving and storing a material such as a drug. The sealed package is preferably made from a plastic film which is flexible, liquid impervious and resists tearing even by adults but which will tear when manipulated to expose a hidden tear zone positioned away from any of the exposed sealed edge portions. Thus, the package in the sealed and unmanipulated position is in an inoperative tear resistant position and when manipulated is in an operative tear or opening position.
U.S. Patent 4,398,635 discloses a child-proof medication package where the medication is arranged between sheets, where an individual accommodation chamber is provided for each drug unit, which is formed by heat-sealing of the sheets and which is accessible from the edge by tearing along the serrated edge of the package. The sheets are endowed with such a strength and/or ductility that a tear cannot be made therein without a special tool, nor can the medication be forced through one of the sheets. In order to open the package, marginal notches are provided in such a configuration that, by means of the notch, only an adult, however not a child, is capable of opening the package.
U.S. Patent 6,155,423 discloses a blister package for containing frangible dosage forms while protecting the dosage forms from damage during transport and opening of the package. A blister sheet defines one or more recesses in which frangible dosage forms are disposed and a peelable sheet of lidding material overlies the recesses to cover the dosage forms therein. Each recess has walls extending between the open top and the closed bottom. The frangible dosage form is disposed in each recess in such way that the walls hold the dosage form away from the bottom of the recess and the adjacent lidding material. The user of the package may peel back the lidding material to gain excess to the dosage form.
The prior art describes various child resistant blister packages and for fragile dosage form, peelable blister packs are disclosed. Thus there is still a need for a simpler blister pack that provides easy retrieval of fragile dosage forms.
Thus the present invention relates to a blister pack with notches for easy retrieval of fragile dosage forms. The blister pack with notches can be opened by conventional method unlike prior art blister packs, but specifically requires tearing through the notches in order to retrieve the fragile dosage form in intact form.
Summary Of The Invention
According to one embodiment there is provided a blister pack comprising: i) a base layer; and ii) a blister layer, having one or more blisters formed for holding a fragile dosage form; and one or more notches formed therein such that the fragile dosage form is retrieved intact on tearing the blister along the one or more notches.
According to another embodiment there is provided a blister pack comprising: i) a base layer; and ii) a blister layer, having one or more blisters formed for holding a fragile dosage form; and one or more notches formed along the one or more edges of the blister pack such that the fragile dosage form is retrieved intact on tearing along the one or more notches.
According to another embodiment there is provided there is provided a blister pack comprising: i) a base layer; and ii) a blister layer, having one or more blisters formed for holding a fragile dosage form; and one or more notches formed inside the blister pack such that the fragile dosage form is retrieved intact on tearing along the one or more notches.
Detailed Description of the Invention
The specification discloses blister pack with notches for fragile dosage forms that can be opened by conventional method, but specifically requires tearing through the notches in order to retrieve the fragile dosage form in intact form.
According to one embodiment there is provided a blister pack comprising a base layer; and a blister layer having one or more blisters formed therein for holding a fragile dosage form, said blister pack having one or more notches formed therein such that the fragile dosage form is retrieved in intact form from the one or more blisters by tearing along the one or more notches.
The base layer may comprise of one or more of hard tempered aluminium foil coated with heat seal lacquer (HSL), soft tempered aluminium foil coated with heat seal lacquer (HSL), or aluminium foil coated with heat seal lacquer (HSL) and laminated with PET on the outer side.
The blister layer may comprise of one or more of oriented polyamide (OPA) laminated with aluminium foil and PVC, or oriented polyamide (OPA) laminated with aluminium foil and polypropylene (PP).
The base layer or blister layer may optionally be printed.
The one or more notches are provided to initiate a tear by the user to extract the dosage form from the blister. The notches may be of any size or shape. Preferably the notch may be a slit or through cut, perforated slit, vee shaped, semi-circular, modified vee shaped or square shaped.
The notch may be placed anywhere along the edge of the blister pack. Preferably the notch may be placed substantially on the central axis of the plan view of the blister, more preferably on the central axis of the plan view of the blister (Figures 6a, 6b). The notch e.g.; square shaped may also be placed inside a package having an array of separable blister packs, the separation being provided as perforations, such that each blister pack can be removed by tearing along the perforations and then the dosage form being retrieved by tearing along the notches so obtained (figure 7).
The term "dosage form" as used herein may be selected from tablet, capsule, pellet, caplet or bead of any shape and preferably containing one or more therapeutically active agent.
The term "fragile dosage form" means a dosage form that when generally retrieved from the blister using conventional methods such as pushing through the blister, breaks or cracks e.g. dispersible tablets, divisible tablets and such like.
Brief description of the drawings Referring to the drawings, Figures 1a, 1b and 1c shows the shape of the blister for the blister pack. There is no limitation for the shape of the blister to contain the fragile dosage form.
Figures 2, 3, 4 and 5 are enlarged views of some of the possible notches. The basic intention of the notch is to provide a place to initiate a tear by the user to extract the dosage form from the blister. Fig 2a shows the notch being made as a through cut or slit. Figure 2b.
shows the notch as a perforation. After the sealing of the blister; the blister layer is advanced into a perforating station, where a hot or cold blade cuts through across the sealed blister layer to produce a through cut; or a perforating blade cuts across to make a perforation.
Figure 3 shows a "vee" shaped notch. Fig. 4 shows notch as a semi circle. Fig 5 shows a modified "vee" notch. In all of the above cases (figures 3, 4 and 5) the various notches or marks may be incorporated in the punching tool of the machine. Alternatively, after forming the blisters punching station is incorporated which cuts into the blister layer and extracts the mark-profiled waste from the blister layer. This results in a blister layer consisting of blisters and notches. The product filling takes place thereafter followed by sealing and punching of the blisters. The blister pack so obtained show a straight edge profile when viewed from the base layer side and a jagged edge profile covered with blister layer when viewed from the blister side.
Figure 6. exemplifies the position of the notch. The notch may be placed anywhere along the edges of the blister pack. Preferably the notch may be placed substantially on the central axis of the plan view of the blister, more preferably on the central axis of the plan view of the blister.
In another embodiment alternative placement of the notch is disclosed (Fig. 7). The notch in the form of square is placed inside a blister pack along with perforations. One blister (Fig. 7a) at a time can be removed by tearing along the perforations (Fig. 7) and then the product is exposed by tearing from the pocket with blister so obtained.

WE CLAIM:
1. A blister pack comprising:
i) a base layer; and
ii) a blister layer
having one or more blisters formed for holding a fragile dosage form; and one or more
notches formed therein such that the fragile dosage form is retrieved intact on tearing
the blister along the one or more notches.
2. The blister pack according to claim 1, wherein the notches are formed along one or more edges of the blister pack.
3. The blister pack according to claim 1, wherein the notches are formed inside the blister pack.
4. The blister pack according to claim 2, wherein the shape of the notch is selected from one or more of slit, through cut, perforated slit, vee shape, semi-circle and modified vee shape.
5. The blister pack according to claim 3, wherein the shape of the notch is square.
6. The blister pack according to claim 2, wherein the notch is placed on the central axis of the plan view of the blister.
7. The blister pack according to claim 1, wherein the base layer comprises of one or more of hard tempered aluminium foil coated with heat seal lacquer, soft tempered aluminium foil coated with heat seal lacquer, or aluminium foil coated with heat seal lacquer and laminated with polyethylene terephthalate on the outer side.
8. The blister pack according to claim 1, wherein the blister layer comprises of one or more of Oriented polyamide laminated with Aluminium foil and polyvinyl chloride, or Oriented polyamide laminated with aluminium foil and polypropylene.
9. The blister pack according claim 1, wherein the dosage form is selected from one or more of tablet, capsule, pellet, caplet and bead.
10. A blister pack substantially described and exemplified herein.