FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10, Rule 13]
A CONTAINER FOR ORAL
RECONSTITUTION PRODUCTS;
PIRAMAL HEALTHCARE LTD., A COMPANY INCORPORATED UNDER THE COMPANIES ACT, 1913, WHOSE ADDRESS IS PIRAMAL TOWER, GANPATRAO KADAM MARG, LOWER PAREL, MUMBAI - 400 013, MAHARASHTRA, INDIA
THE FOLLOWING SPECIFICATION
PARTICULARLY DESCRIBES THE
INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED.

FIELD OF INVENTION:
The present invention relates to containers for oral reconstitution products and more particularly, to containers for oral pharmaceutical reconstitution products. BACKGROUND OF THE INVENTION:
Oral antimicrobial drugs in dry powder suspension formulations such as Cefixime, Cefpodoxime, Amoxycilin, Diclooxacilin, the combinations thereof and the like, need 'to be reconstituted before use1 as the ingredients or composition of the product are not stable in liquid form throughout the shelf life. Conventionally, the pharmaceutical products such as dry syrups and oral powders are packed in either plastic or glass bottle for reconstitution. Dosage preparation in such cases becomes tedious and cumbersome. For instance, in case of dry syrups, at least six steps need to be followed: boiling the water, cooling it, opening the bottle, reconstituting the powder with the cooled water, shaking the container and finally dispensing the prepared suspension. The first few steps of boiling and cooling water in itself may take about 15- 20 minutes. Further, there is a substantial probability of medical errors (under and over dosing) and contamination.
Further, a tamper-evident band of the cap of the bottle requires low tear initiation strength, therefore they are normally made up of polyethylene e.g. either low density poly ethylene, linear low density poly ethylene or high density poly ethylene. However, the use of these materials renders the cap opaque. Therefore, a separate transparent cup needs to be provided with the bottles for

measuring the dosage. The additional cup adds to the cost of packaging and
there is a chance of misplacing the measuring cup.
United States Patent 4102451 ('2451) to Clarke, et al describes a dual
compartment mixing vial having a center seal isolating one compartment from the
other which is provided with a stopper at its open end which embodies a rod that
is slidably positioned therethrough. The rod, upon being pushed downwardly,
abuts the center seal of the vial and causes it to be displaced, thereby permitting
the contents of the two compartments to intermix within the closed vial. An
activating cap is provided for preventing accidental movement of the rod and to
facilitate intentional movement of it.
However, the mixing vial of '2451 is specifically for use with a syringe. The
design is complex as the vial has to provide for insertion of the syringe needle.
Further, the rod for pushing the center seal downwards needs to be pushed with
a substantial force. The rod needs to be sufficiently strong to transmit the force
without piercing the center seal.
Therefore, there is a need for a simple, cost-effective, integrated container for
oral pharmaceutical reconstitution products which packages the medicine and
overcomes the problems stated above.
SUMMARY OF THE INVENTION
An objective of the invention is to provide a simple and cost-effective container
for oral reconstitution products, which obviates the conventional cumbersome
process of oral reconstitution dosage preparation and reduces the time required
for the same.

Accordingly, the present invention provides a container for oral reconstitution products comprising a vessel having a bottom chamber for storing a first constituent and a top chamber for storing a second constituent, a sealing plug snugly fitted at a neck of the vessel between the top and the bottom chamber for separating the first constituent from the second constituent, a cage insert for pushing the sealing plug out of the neck of the vessel, and an over cap screwed over male threads on a mouth of the vessel for sealably closing the vessel. Hence, the container is simple in construction, is cost-effective and saves time by doing away with the conventional method of reconstitution dosage preparation.
BRIEF DESCRIPTION OF THE DRAWINGS
So that the manner in which the above recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may be had by reference to various embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments.
Fig. 1 shows a container for oral reconstitution products, in accordance with an embodiment of the invention. Fig. 1a is an isometric view and Fig. 1b is a sectional view of the assembled container, and Fig. 1c is an exploded isometric view of the container.

Fig. 2 shows a container for oral reconstitution products, in accordance with
another embodiment of the invention. Fig. 2a is an isometric view and Fig. 2b is a
sectional view of assembled container, and Fig. 2c is an exploded isometric view
of the container.
Figs. 3a-6a illustrate the process of using the container for preparing an oral
dosage, in accordance with an embodiment of the invention.
Figs. 3b-6b illustrate the process of using the container for preparing an oral
dosage, in accordance with another embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
Various embodiments of the invention provide a simple and cost-effective
container for oral pharmaceutical reconstitution products.
Figure 1 shows container 100, in accordance with an embodiment of the
invention. Referring to figs. 1b and 1c, container 100 includes a vessel 102
having a bottom chamber 104 and a top chamber 106, a sealing plug 108, a
cage insert 112, and an over cap 114 screwed over male threads on a mouth
116 of vessel 102 for sealably closing vessel 102.
Vessel 102 creates two different chambers for two different constituents of drug
products. The material of construction of vessel may be one of poleolefins,
polypropylene, polyvinyl chloride, polyethylene terepthalate, poly carbonate,
acrylic, vinyl acetate, polystyrene and the like.
Bottom chamber 104 is a base of container 100 and stores a first constituent.
Top chamber 106 stores a second constituent. The first and the second
constituent intermix to form a desired reconstitution composition.

Sealing plug 108 is snugly fitted at a neck 110 of vessel 102 between top chamber 106 and bottom chamber 104 and separates the first constituent from the second constituent. Sealing plug 108 seals the opening of the bottom chamber 104 where the first constituent is filled and does not allow the second constituent to get mixed unless pushed by cage insert 112. Sealing plug 108 provides a perfect sealing (or leak proof partition) between the two chambers and also minimizes the moisture transmission rate. The material of construction of sealing plug 108 is one of thermoplastic elastomer (such as styrene, polycarbonate, polyethylene, polypropylene, polyvinylchloride, pofyurethane, polyesters, polyamides and the like), thermosetting elastomer (such as butyi rubber, ethylene propylene diene monomer, silicone, natural rubber, neoprene, polybutadiene, flouroelastomer, styrene butadiene rubber and the like) and the like.
Cage insert 112 is for pushing sealing plug out of the neck of the vessel so that the first constituent can mix with the second constituent. Cage insert tip 112b has a hollow circular section which allows exerting an even force on the periphery of the sealing plug 108. Further, a steady movement of cage insert 108 is enables by tight interference of its outer surface with the inside surface of vessel 102. The material of construction of cage insert 108 may be one of polyolefins, polystyrene, polyvinyl chloride, polyethylene terepthalate and the like. In an embodiment, over cap 114 has a tamper evident tear band 118. Tamper evident tear band 118 of over cap 114 acts as a stopper to the downward movement of cage insert 112. Tamper evident tear band 118 needs to be

removed before screwing over cap 114. Only after removing tamper evident tear band 118, over cap 114 can be rotated. The material used for over cap 114 (along with tamper evident tear band 118) is one of low density poly ethylene, linear low density poly ethylene, high density poly ethylene, and the like and preferably polypropylene or by mixing with other additives. Polypropylene allows transparency and additional cup is not required.
It may be apparent to a person skilled in the art that polypropylene has very high tear initiation strength but low tear propagation strength. Therefore, for tear initiation a cut, tamper evident band puller 118a, has been provided at the opening of tamper evident tear band 118 to facilitate easy opening. Fig. 2 shows container 200, in accordance with another embodiment of the invention. Here, sealing plug 108 and cage insert 112 are replaced with a sealing plug 208 and a cage insert 212, repectively. Sealing plug 208 is in the form of a ring and is attached to cage insert 212 or is a part thereof so that the sealing plug does not fad on the bottom of container 200 once it is intentionally pushed by a user (figure 6). Cage insert 212 has grooves for sealing plug 208 to snugly fit into. The length or the height of cage insert 212 is adapted so that sealing plug 208 is snugly fit into neck 110.
Assembly of container 100 will be explained with reference to Fig. 1 (c). Bottom chamber 104 is filled with the first constituent and sealing plug 108 is inserted into vessel 102 and is snugly fitted at neck 110 of vessel 102. Cage insert 112 is then inserted into vessel 102 so that cage insert tip 112b is just above sealing

plug 108. Subsequently, the second constituent is filled in top chamber 106 and over cap 114 is put over mouth 116 to close and seal vessel 102. An o-ring 120 is already fitted on a groove 120a on cage insert 112, which arrests the movement of cage insert 112. A liner 122 is provided in over cap 114 for sealing over cap with a top 112a of cage insert 112.
Use and operation of container 100 will be explained with reference to figures 3 to 6. To use container 100 for administering the composition therein, tamper-evident tear band 118 is removed by tearing it apart by pulling away tamper evident puller 118a. As a result, over cap 114 is screwed clock-wise as shown in figure 4. Over cap 114 moves downwards and pushes cage insert 112 downwards, which in turn pushes sealing plug 108 out of neck 110 and opens up a channel for the first and second constituents to intermix so that the reconstitution takes place and the desired composition is formed. Container 100 may be shaken well before dispensing the composition.
In accordance with an embodiment of the invention, over cap 114 is made of polypropylene and has graduation marks and is used as a measuring cup. Subsequently, over cap 114 is unscrewed from vessel 102 and may be filled with the desired dispensing quantity of the composition formed. In various embodiments of the invention, vessel 102 is a dual-chambered single container body and is manufactured using known methods such as injection molded, injection blow moulded or extrusion blow moulded or injection stretch blow molded.

In various embodiments, the first and second constituents may be in liquid, solid or powdered form. Further, in various embodiments, it may be apparent that any of the constituents may be kept in either of the top or bottom chambers. Following is an example of the constituents in case of a preparation of a typical drug - Cefixime (oral suspension): First constituent (powdered):
Material No. Material Name mg/5 ml
1 Cefixime trihydrate 50
2 Sugar 2500
3 Xanthan Gum 15
4 Sod Benzoate 10
5 Orange Flavour 5
First, material 1 and material 2 are mixed. Subsequently, material 3-5 are added and mixed and passed through 0.5mm screen. The first constituent is then ready to be filled into one of the chambers of the container. Second constituent (diluent):
Material No. Material mg/5m(
1 Methyl Paraben 2.5
2 Propyl Paraben 0.5
3 Water 4000
Material 1 and material 2 are dissolved in hot water (material 3) to form the second constituent which is then filled in the other chamber of the container. Other examples are oral antimicrobial drugs in dry powder such as cefodoxine, dry powder suspension formulations such as cefixime, cefpodoxime, amoxycilin, diclooxacilin, combinations thereof and the like.

It may be apparent to persons skilled in the art that various sealing means such as o-rings, liners, and the like may be provided at appropriate locations in the construction of the various embodiments described above to save the constituents from getting exposed to the atmosphere before the means for sealing is broken and during the process of administration. While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow.

We Claim :
1. A container for an oral reconstitution product, the container comprising:
a. a vessel, the vessel having a bottom chamber for storing a first constituent
and a top chamber for storing a second constituent of the oral
reconstitution product;
b. a sealing plug for separating the first constituent from the second
constituent, the sealing plug being snugly fitted at a neck of the vessel
between the top and the bottom chamber;
c. a cage insert for pushing the sealing plug out of the neck of the vessel;
and
d. an over cap for sealably closing the vessel, the over cap being screwed
over male threads on a mouth of the vessel.
2. The container according to claim 1 further comprising a tamper-evident tear band, the tamper evident tear band being formed on the over cap, the tamper-evident tear band being removable before screwing the over cap.
3. The container according to claim 2, where in the over cap and the tamper evident tear band are made of polypropylene.
4. The container according to claim 1, wherein the sealing plug is attached to the cage insert.
5. The container according to claim 1, wherein the over cap has graduation marks for measuring the reconstitution product formed.

6. The container according to claim 1, wherein the oral reconstitution product is an oral reconstitution pharmaceutical product, the oral reconstitution pharmaceutical product being at least one selected from the group comprising of cefixime, cefpodoxime, amoxycilin, and diclooxacilin.