FORM - 2
THE PATENTS ACT, 1970
(39 OF 1970)
PROVISIONAL SPECIFICATION
(See Section 10)
TITLE OF INVENTION
"A Child-safe Multifunctional Product Dispensing System "
(a) Bilcare Limited (b) a company registered under the companies Act 1956 and (c) having its registered office at 1026, Shiroli, Rajgurunagar, Khed, Pune - 410505, India
The following specification particularly describes the invention.

Field of the Invention
The present invention relates to a system for controlled unit dispensation of product/s. The invention further relates to a child-safe multifunctional device capable of providing authentication, registration, product dispensation and recording real-time product dispensation information of packaged-product, facilitating user compliance and optionally communicating product dispensation and user / product usage related information to external device/s for information processing and management.
Background of the invention
Blister packs are a common means of packaging products of various types including pharmaceuticals. An area of concern with regard to blister packs has been the uncontrolled ease with which products can be dispensed. This becomes particularly important when blister packs are handled by children. Further, establishing the authenticity and genuineness of a packaged product before use is essential as counterfeited products when consumed can cause grave harm to the consumers. Desirable aspects such as facilitating user compliance to a set consumption plan would require recording of real-time product dispensation information, automatically capturing real time product usage data and integrating the same into a healthcare system to enable on-line and off-line assistance to an user as and when necessary.
Various attempts to achieve the above objectives are reported in literature.
United States Patent Application number 2005/0199527 discloses child resistant dispensing closure package that includes a plug adapted to be fixed to the container adjacent the open end. The plug has an access opening for enabling removal of material from the container through the open end of the container. A slide is supported on the plug for sliding movement in a first direction relative to the plug between a closed position in which the slide covers the access opening and an open position in which the access opening is uncovered.


United States Patent 6874636 discloses a lock and release mechanism in a unit dose package. Lock and release mechanism of a unit dose package has a cut away formed in the second panel of an outer sleeve of the package, the cut away having a pair of legs extending therefrom and defining a node there between. A cut line and a throat region are formed in an end flap of first and second side panels, respectively, of a slide card to bifurcate each end flap into first and second engaging segments. The first and second engaging segments engage an engaging surface of a cut away formed in a second panel of the outer sleeve to prevent the slide card from unintentionally sliding within the outer sleeve. A release feature is formed in the third panel of the outer sleeve. The first and second engaging segments are disengaged from the engaging surface of the cut away by depressing the node via the release feature.
United States Patent 7093716 discloses a bend & peel medication dispenser having a blister sheet with blister pockets for medicants, a rupturable foil sealed to a back side of the blister sheet, a layer of paper secured to a back side of the rupturable foil, and a reinforcing layer of a paperboard material being adhered to the paper layer with a portion of the reinforcing layer in registry with the blister pockets not being adhered thereto. There are provided tear strips and tab members to assist in removing the tear strips which delaminate.
United States Patent 6976576 discloses child-resistant dispenser comprising a dispensing member having a dispensing cavity and a product storage cavity, the dispensing member being mounted within a sleeve movable from a first stored position to a second position wherein the dispensing cavity is exterior of the housing to permit dispensing of the product, a device having first and second locks which must be operated either sequentially or simultaneously in order to move the dispensing cavity exteriorly of the housing. The device preferably permits the dispensing of only a single tablet or product.
United States Patent 20050274643discloses a child resistant product dispenser. It includes a blister card having compartments for holding a product, a housing, and a


blister cover for use in covering the blister card compartments. The blister cover may include a dispensing area for each compartment of the blister card. To remove a product from the product dispenser the user presses a dispensing area against either a compartment thereby forcing the product through a frangible area on the blister card and through a frangible area in the housing or against a peelable area on the blister card and a frangible area in the housing. This creates an opening through which the product is removed.
It is evident from the available prior art that most of the devices are mere containers of the packaged product in blister or child resistant packages / blister packages or mere dispensing systems without the capability of real-time product dispensation sensing and recording means integrated with feedback and communication capability.
Indian Patent number 212620 discloses package-companion-user interactive system wherein an array of signal generating means and signal sensing means are provided in the companion device to receive and reflect signals generated by the signal generating means to sense presence/absence of product in the package. In this system it is essential to provide an array of signal generating means in the companion device working in conjunction with signal sensing means. This system provides a means for package authentication using the companion device but is not capable of real time recording of the product dispensation time.
The Indian Patent Application 34/MUM/2006 discloses Interactive Smart Package -Associated Device for anti-counterfeit and compliance measures wherein there is a smart system comprising product package with signal generating means and an associated device that facilitates detection of the presence or absence of product/s in the package. This system also provides for package authentication using the companion device working in conjunction with some other external devices. This system too is not capable of real time recording of the product dispensation time.


Indian Patent Application 1386/MUM/2007 discloses a multifunctional packaged system that provides an integrated package system for dispensing a product coupled with a sensing/monitoring system, a product authentication means, and a communication capability with external devices. This system is however restricted to application involving containers and cannot be applied to blister pack systems.
The Indian Patent Application 1702/MUM/2007 discloses an interactive multifunctional system for packaged-product authentication and real-time product dispensation information that provides a comprehensive system comprising of a primary device working in conjunction with at least one other multifunctional device providing packaged-product authentication, registration, product dispensation and recording realtime product dispensation information, facilitating user compliance including appropriate patient feedback from clinical trials and / or collection of pharmaco-vigilance data and optionally communicating product dispensation and user / product usage related information including pharmaco-vigilance related information in clinical trials via the said primary device to external devices for information processing and management. This system has no provision for child locking and does not provide any construction for containing the blister packs and / or advancing the blister strips for controlled dispensing of unit dose package.
The need is felt to develop a child-safe system for controlled dispensation of a packaged-product with the capability of integrating diverse aspects such as sensing product dispensation and recording real-time product dispensation information, ensuring packaged-product authentication, registration, facilitating user compliance and optionally communicating product dispensation and user / product usage related information to external device/s for information processing in comprehensive healthcare management.
For the purposes of this invention, unit dose package includes blister packs and / or strips, plurality of unit dose forms such as pouches, sachets, pillow packs and their like, containers with unit doses, etc.


Summary of the Invention
The main object of the invention is to provide a child-safe multifunctional dispensation system for controlled dispensation of a plurality of packaged unit dose(s) with the capability of integrating diverse aspects of sensing product dispensation and recording real-time product dispensation information, ensuring packaged-product authentication, registration, facilitating user compliance and optionally communicating product dispensation and user / product usage related information to external device/s for information processing in comprehensive healthcare management.
Another object of the invention is to provide a child-safe dispensation system for products in blister packaged unit dose(s)
Another object of the invention is to provide a child-safe dispensation system for sensing product dispensation and recording real-time unit dose dispensation information of product/s in blister packs.
Yet another object of the invention is to provide a child-safe dispensation system that senses and records real-time unit dose dispensation, authenticates packaged-product, registers, facilitates user compliance and optionally communicates product dispensation and user / product usage related information to external device/s for information processing and management for product/s packed in a unit dose package.
It is yet another object of the invention to facilitate user compliance including appropriate patient feedback from clinical trials and / or collection of pharmaco-vigilance data and optionally communicating product dispensation and user / product usage related information including pharmaco-vigilance related information in clinical trials.
Thus in accordance with the invention the system comprises of dispenser housing adapted to contain packaged unit doses;


a means such as rail / path / channel/ lamina for controlled advancing of the said
packaged unit doses;
optionally a means to force the product unit dose out of the said package to dispense
the same;
an opening for guiding and dispensation of the said product unit dose or the product
a means for locking the advancement of the product unit doses in the said advancement
means
a means for unlocking the advancement of the product through the said advancement
means;
optionally unit product dose sensing means configured with communication means, user interactive means, data storage means, reader means adapted to integrate in the said housing of the system.
DETAILED DESCRIPTION OF THE INVENTION
Features and advantages of this invention will become apparent in the following detailed description and the preferred embodiments with reference to the accompanying drawings.

Figure 1 Configuration of the system (Sheet 1)
Figure 2 Configuration of the system (Sheet 2)
Figure 3 Configuration of the system (Sheet 3)
Figure 4 Configuration of the system (Sheet 4)
Figure 5 Configuration of the system (Sheet 5)
Figure 6 Configuration of the system (Sheet 6)
Figure 1 depicts one of the embodiments of the system. It comprises of a dispenser housing that is divided in a top compartment 1 and bottom compartment 5 as shown in the figure. A packaged unit dose/s controlled advancing means in the form of a rotatable lamina 4 is adapted to fit between the said compartments such that it can


rotate independently. The said lamina is provided with markings (indicated by 6), preferably time / date of product consumption etc. along the periphery. The packaged unit dose/s is disposed on the top of the said lamina 4 such that the pack also rotates upon rotation of 4. The said top compartment 1 is provided with a spring loaded pressing means 2 such that it can be aligned on the top of the individual blister. The bottom compartment is provided with an opening 8 for dispensing the product from the blister. The said two compartments and the said lamina 4 are rotated in tandem with each other. During operation the user has to align the said pressing means 2 and the said opening 8 with respect to the said marking 6. Upon pressing the said means 2, the product from the packaged unit dose/s is dispensed from the said opening. In one of the embodiments said compartments 1 and 2 are adapted to fit a unit product sensing means configured with communication means, user interactive means, data storage means, reader means adapted to integrate with the said housing.
Figure 2 depicts another embodiment of the system. It comprises of a housing 3 on which a sliding provision 1 having plurality of integrated deformable and pressable regions 6 is fitted in the said housing such that the said means 1 reciprocates in the housing to effect controlled advancing of the said packaged unit dose/s. A spring loaded pressing means 2 is attached on the side surface of the housing 3. It has to be pushed for operating / sliding the said sliding provision 1. The packaged unit dose/s 5 is disposed in the top compartment of the said housing below the said sliding provision. In one of the variants, the packaged unit dose/s is blister package in the coil form. The bottom compartment is provided with openings (not shown) corresponding to each of the product in the said packaged unit dose/s. A passage 7 is provided to collect the dispensed product from the system. The dispensation operation needs pressing of the said pressing means 2 followed by sliding the said sliding provision 1 such that the said deformable regions are on the top of the packaged unit dose/s. Pressing the said regions dispenses the product from the packaged unit dose/s. Thus the product dispensing operation is not obvious to child to operate yet is senior friendly. In one of the embodiments said compartments are adapted to fit unit product sensing means


configured with communication means, user interactive means, data storage means, reader means adapted to integrate with the said housing..
Figure 3 depicts yet another embodiment of the system. It comprises of housing 2 provided with markings on the top corresponding to individual packaged unit dose/s. In one of the embodiments packaged unit dose/s is a blister stripe. A roller 3 is disposed vertically in the said housing wherein a rotatable provision 1 in the form of a disc / dial is adapted to fit on the said roller outside the housing such that it engages with the said roller upon pressing / pushing down. The said roller is the controlled advancing means and the locking / unlocking is effected with the said disc / dial. The packaged unit dose/s 2 in the form of a strip is rolled over the said roller 3 as shown in the figure. The part of the packaged unit dose/s is dispensed from the opening 4 provided in the said housing. In operation one has to press the said rotatable provision 1 and further rotate the same to transmit the force to the roller and in turn to the said blister strip so as to dispense the packed-product from the said housing. Thus the product dispensing operation is not obvious to child to operate yet is senior friendly. In one of the embodiments said compartments are adapted to fit unit product sensing means configured with communication means, user interactive means, data storage means, reader means adapted to integrate with the said housing..
Figure 4 depicts yet another embodiment of the system. It comprises of housing with compartment 1 adapted to receive a rotatable provision 2 on the top surface. A rotatable spindle 3 is disposed vertically between the said top compartment 1 and the bottom compartment 5 of the housing. The said rotatable provision has to be pressed to engage with the said spindle. The packaged unit dose/s 4 in the form of a ring is mounted on the said spindle 3 as shown in the figure. In one of the embodiments the packaged unit dose/s is a blister stripe. The said top compartment 1 is adapted to fit a pressing means 6. The said bottom compartment 5 is provided with openings corresponding to each of the product in the packaged unit dose/s. According to the markings the user has to rotate the said top compartment, press the said provision 1 to engage it with the said spindle , rotate the same and then press the said pressing


means 6 to dispense the product from the packaged unit dose/s. Thus the product dispensing operation is not obvious to child to operate yet is senior friendly. In one of the embodiments said compartments are adapted to fit unit product sensing means configured with communication means, user interactive means, data storage means, reader means adapted to integrate with the said housing.
Figure 5 depicts yet another embodiment of the system. It comprises of housing having top compartment and bottom compartment. The first pressing means 2 is adapted to fit on the top compartment and is in connection with the sliding provision 3 that is housed between the said two compartments. The blister pack is mounted on the said means 3. The second pressing means 2 is provided on the bottom compartment and engaged with the said sliding means 3 such that user has to push both the pressing means to enable sliding of the said sliding provision and in turn packaged unit dose/s to dispense the packaged-product from the opening 6. Thus the product dispensing operation is not obvious to child to operate yet is senior friendly. In one of the embodiments said compartments are adapted to fit unit product sensing means configured with communication means, user interactive means, data storage means, reader means adapted to integrate with the said housing..
Figure 6 depicts yet another embodiment of the system. It comprises of housing having first compartment 1 and second compartment 2 adapted to mount guide 9 for the packaged unit dose/s so as to coil the same around 9. In one of the embodiments the said packaged unit dose/s is blister package in stripe form. The packaged unit dose/s, in particular blister pack 3 shown as representation in the figure is coiled around the said guide 9. The means for advancing packaged unit dose/s comprises of a gear 5, roller 7 and ratchet 6 coaxially mounted on the shaft 8. The said gear 5 is engaged with a pressing means 4 wherein one of the ends of the said pressing means is pivoted at 10 in the said compartment 1 The other end of the said pressing means is provided with gear teeth wherein the pressing means is disposed so as to engage the said gear teeth with the said gear 5. From the end that is pivoted there is a concavely outwards surface 12 that is limited by the lower geared surface as shown in the figure. Part of the


said protrudes out of the said compartment 1 and 2. The opening 13 is provide at the bottom portion of the said compartments. The free end of the said blister package rotatably engaged with the said roller wherein in operation pressing the said means 4, causes rotation of the said gear 5 thereby effecting the rotation of the said roller 7 resulting in advancement of the blister stripe to dispense from the said opening 13. The ratchet 6 restricts the rotation of the said gear in opposite direction. In one of the embodiments said compartments are adapted to fit unit product sensing means configured with communication means, user interactive means, data storage means, reader means adapted to integrate with the said housing..
It is evident that the synergistic combination of the system components such as dispenser housing with compartment/s adapted to fit holding / mounting means for the said unit dose package; a means for controlled displacement of the said pack and product/s therein and optionally means to peel off / remove product/s from the package along with the capability of integrating unit product sensing means configured with communication means, user interactive means, data storage means, reader means adapted to integrate in the said housing of the system provides a unique child-safe multifunctional dispensing system for product /s in unit dose package/s.