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"Tamper Evident Kit Packaging System For Injectable Products"

Abstract: A tamper evident kit packaging system for injectable products wherein the kit package is formed of a top panel, a bottom panel, a spine panel, a front closing panel and two side closing panels to form a box type kit pack, wherein the said box type kit pack comprises of one or more independent compartments on the inner side of the bottom panel and one or more "D" thumb cut pockets on the inner side of the top panel. The box type kit pack is made tamper evident by providing series of perforations on front closing panel and on independent compartments for tear opening and/or by placing a tamper evident holographic sticker at the final closing position. The independent compartments on the inner side of the bottom panel comprises of one or more of product pack, sterile water for injection and one or more of other relevant delivery devices like appropriate needle and syringe. The "D" thumb cut pockets on the inner surface of the top panel comprises of one or more of product information leaflet and one or more alcohol swabs.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
24 June 2010
Publication Number
42/2013
Publication Type
INA
Invention Field
PHARMACEUTICALS
Status
Email
Parent Application

Applicants

RANBAXY LABORATORIES LIMITED
HEAD OFFICE AT 12TH FLOOR, DEVIKA TOWER, 6, NEHRU PLACE, NEW DELHI-110019, INDIA

Inventors

1. SANTOSH JOSHI
RANBAXY LABORATORIES LIMITED, PLOT NO. 20, SECTOR - 18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001, HARYANA, INDIA.
2. SANTANU CHOWDHURY
RANBAXY LABORATORIES LIMITED, PLOT NO. 20, SECTOR - 18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON-122001, HARYANA, INDIA.

Specification

Technical Field of Invention
The present invention relates to a tamper evident kit packaging system for injectable products.
Background of the Invention
One of the essential requirements of any packaging system is to safeguard the product throughout its route from manufacture to final point of use. Particularly, parenteral packaging demands high standards in terms of user safety, convenience, attractiveness and avoidance of any misuse of the packed products. Therefore, there has always been a need for a parenteral packaging system that delivers a combination of product protection, tamper evidence, patient comfort and security needs for the injectable products being packaged. As per the conventional practice, injectable products are packaged in conventional vials and ampoules. The injectable products packaged in a conventional pack requires one or more of additional components such as sterile water for injection, alcohol swabs etc. and other relevant delivery devices such as appropriate needle and syringe for drug delivery to patients. In the existing marketing practice, the conventional product packs, additional component packs and other relevant delivery devices are made available in separate package units. This practice presents several inconveniences at the end of both final consumers, which includes the need for gathering or purchasing each component separately at the time of emergency and retailers, which includes higher space requirement for the storage of all individual components and delivery devices separately, which at times may also create inventory handling issues. Hence it would be advantageous to design a packaging system where the all the individual components such as the injectable product, other additional components and other relevant delivery devices are contained in a single pack to ensure an absolute delivery of the complete product kit to the ultimate user. Further, the single pack can be designed to have an additional tamper evident feature which will ensure complete safety and reliability to the product and other components packed in it.
There are few references in the art which describes a kit packaging system where two
or more individual components are packed in a single pack. The US patent no. 7097038
describes a packaging system for food products such as meal kits which contain a variety of ready to eat food items chosen to provide an essentially complete meal. There are also few references in the art which describes tamper evident packaging systems for injectable products. The US patent no. 5230429 describes a tamper evident injectable pharmaceutical vial. In this case, the task of making the vial tamper evident is solved by covering one surface of the vial stopper with a stretched or elongated elastic element which will rupture or break when pierced by the needle so as to reveal the surface of the stopper previously covered by the elastic element. When the stopper surface so revealed is of a distinctive color or contains a design or logo, the tampering by introducing the needle will be readily apparent to the eye. However, none of the prior arts teach a tamper evident kit packaging for injectable products which is designed to hold all individual components in independent tamper evident compartments of the packaging system which would not only simplify handling issues of the individual components, but would also offer safety against any misuse before final use by consumer and also avoid any point of purchase issues.
Summary of the Invention
In accordance with the present invention, there is provided a tamper evident kit packaging system for injectable products comprising a top panel, a bottom panel, a spine panel, a front closing panel and two side closing panels to form a box type kit pack, wherein the said box type kit pack comprises of one or more independent compartments on the inner side of the bottom panel and one or more "D" thumb cut pockets on the inner side of the top panel; and said box type kit pack is made tamper evident by providing series of perforations on front closing panel and on each compartments for tear opening and/or by placing a tamper evident holographic sticker at the final closing position. The unique box type kit packaging system can be used to contain all individual components needed for dispensing injectable products to patients, which may include one or more of product pack along with product information leaflet, sterile water for injection and/or alcohol swabs and other relevant delivery devices like appropriate needle and syringe. The kit packaging system provided with tamper evident features ensure absolute safety and reliability to the individual components contained in the package. In the box type kit packaging system, the top panel on its
outer side can be used as a principal display panel which contains important information about the product being packed. One or more "D" thumb cut pockets provided on the inner side of the top panel are for holding product information leaflet or any other promotional material and/or one or more alcohol swabs. The bottom panel on its outer side can be used to provide relevant labeling information. The plurality of compartments on the inner side of the bottom panel are created by folding a cardboard sheet or other similar materials, such that the folds are arranged perpendicular to each other and may be glued at certain folds onto the inner side of the bottom panel to form a plurality of compartments. One or more of the individual components like product pack, sterile water for injection, appropriate needle and syringe may be easily placed in each of the independent compartments thus formed. Each independent compartment is made tamper evident by providing a series of perforations on the closure flap which can be opened by tearing away along the perforation lines such that the compartments cannot be resealed without showing the evidence of being opened previously. The top panel is connected to the bottom panel by a spine panel of sufficient width, so that once the box is formed, the compartments on the bottom panel are not crushed or damaged. The spine panel comprises of dust flaps attached to both ends. The bottom panel is attached with two side closing panels on either side which comprises of tuck flaps. The top panel is attached with a front closing panel which comprises of dust flaps attached to both ends. The front closing panel comprises of a tuck flap, a slit cut and a series of perforation to tear open the package. The front closing panel is used to seal close the package and a tamper evident sticker is applied to form a complete tamper evident kit packaging system.
The unique containment feature and the tamper evident feature provided in the kit pack ensure safe delivery of the product to the ultimate user. The design also does not affect any inventory handling issues as it can be sent in a collapsed form to the shop floor. Further features and advantages of the tamper evident kit packaging system of the present invention will be described in more details with specific reference to the preferred embodiment as illustrated in the accompanying drawings.
Brief Description of the Drawings
FIG. 1 is a plan view of the outer surface of a blank of foldable sheet material from
which the kit packaging system in accordance with the present invention may be
formed.
FIG. 2 is a plan view of the inner surface of a blank showing the individual
compartments and the "d" thumb cut pockets.
FIG. 3 is a perspective view of the kit packaging system showing the inner side of the
bottom panel.
Detailed Description of the Invention
A tamper evident kit packaging system in accordance with the invention is illustrated in FIG. 1-3. The main portion or body of the tamper evident kit packaging system comprises of six panels which includes a top panel 1, a bottom panel 2, a spine panel 3, a front closing panel 4 and two side closing panels 5 and 6. Referring to FIG. 1, the top panel 1, bottom panel 2, spine panel 3 and front closing panel 4 are foldably joined to each other along the parallel fold lines 19, 20 and 21 respectively, to form a box type kit packaging system open at ends. A tuck flap 15 is further foldably joined to the front closing panel 4 along the fold line 30, and is inserted into the slit cut 17, by folding the tuck flap 11, along the fold line 18, onto the bottom panel 2, to seal close the box type kit package. The dust flaps 7, 8, 9 and 10 are folded along the fold lines 26, 27, 28 and 29 respectively. The tuck flaps 12 and 13 are foldably joined along the fold lines 22 and 24 respectively, to the side closing panels 5 and 6 which are further folded along the fold lines 23 and 25 respectively, to close the open ends of the box type kit package. The seal closed box type kit packaging system is made tamper evident by placing a tamper evident holographic sticker at the final closing position 14. The front closing panel 4 is provided with a series of perforations 16 for tear opening the pack such that once the perforations are tear opened, the pack cannot be resealed again without showing the evidence of being opened previously, thereby giving a tamper evident feature to the kit packaging system. The packaging system according to the present invention can be formed from any material that is sufficiently rigid to safeguard the product and provide tamper evident feature to the
package. The preferred material includes a moderately rigid material such as cardboard or reinforced paper. The material may optionally be wax coated or coated with a moisture barrier layer.
The tamper evident kit packaging system may optionally be printed with logos identifying the product, pasted with holographic stickers incorporating tamper evident feature and with instructions or directions in the form of written texts and/or graphics to instruct the user about the steps to tear open the package along the perforations to obtain the product contained therein. The tamper evident kit packaging system may be designed from a single sheet, which is die-cut and scored or may be formed by affixing separate sheets for each feature.
Referring to FIG. 2, the kit packaging system comprises of one or more of "D" thumb cut pockets 33, on the inner side of the top panel 1, for holding product information leaflet and/or one or more alcohol swabs. The individual components such as injectable product, additional components like sterile water for injection and one or more of the other relevant delivery devices such as appropriate needle and syringe are placed in the independent compartments 31, formed on the inner side of the bottom panel 2 as illustrated in FIG. 3. Each independent compartment is provided with a series of perforation 32, for tear opening the compartments to obtain the individual components contained therein, thereby giving tamper evident feature to the independent compartments.

WE CLAIM:
1. A tamper evident kit packaging system for injectable products comprising:
a top panel, a bottom panel, a spine panel, a front closing panel and two side closing panels to form a box type kit pack, wherein the said box type kit pack comprises of one or more independent compartments on the inner side of the bottom panel and one or more "D" thumb cut pockets on the inner side of the top panel; and said box type kit pack is made tamper evident by providing series of perforations on front closing panel and on each compartments for tear opening and/or by placing a tamper evident holographic sticker at the final closing position.
2. The kit packaging system as in claim 1, wherein the individual compartments on
the inner side of the bottom panel comprises of one or more of product pack,
sterile water for injection and one or more of other relevant delivery devices like
appropriate needle and syringe.
3. The kit packaging system as in claim 1, wherein the "D" thumb cut pockets on
the inner surface of the top panel comprises of one or more of product
information leaflet and one or more alcohol swabs.
4. The kit packaging system as in claim 1, wherein the kit pack is formed from
cardboard or reinforced paper.

Documents

Application Documents

# Name Date
1 1478-del-2010-abstract.pdf 2011-08-21
1 1478-del-2010-form-2.pdf 2011-08-21
2 1478-del-2010-claims.pdf 2011-08-21
2 1478-del-2010-form-1.pdf 2011-08-21
3 1478-del-2010-correspondence-others.pdf 2011-08-21
3 1478-del-2010-drawings.pdf 2011-08-21
4 1478-del-2010-description (complete).pdf 2011-08-21
5 1478-del-2010-correspondence-others.pdf 2011-08-21
5 1478-del-2010-drawings.pdf 2011-08-21
6 1478-del-2010-claims.pdf 2011-08-21
6 1478-del-2010-form-1.pdf 2011-08-21
7 1478-del-2010-abstract.pdf 2011-08-21
7 1478-del-2010-form-2.pdf 2011-08-21