FORM-2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL
Specification
(See section 10 and rule 13)
AN AEROSOL DEVICE
CIPLA LIMITED
an Indian Company
of 289, Bellasis Road, Mumbai Central, Mumbai 400 008,
Maharashtra, India,
THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION.

Technical field:
The present invention relates to an aerosol device.
Definitions:
As used in the present specification, the following words and phrases are generally intended to have the meanings as set forth below, except to the extent that the context in which they are used indicates otherwise.
The term aerosol as used herein encompasses all types of pressurized containers used for delivery of aerosolized products meant for a variety of medical and non-medical applications including but not limiting to drugs, cosmetics (deodorants, hair sprays, hair mousses, shaving creams) perfumes, air fresheners, insect repellents, cleaning agents, paints, lubricants and the like.
The delivery of the aerosolized ingredients from aerosol devices disclosed herein may be in an uniform manner delivering predetermined identical quantities (doses) per actuation, for example metered dose inhalers, or it may be in an uneven or continuous manner delivering varying quantities per actuation (e.g. perfumes and spray).
Dispenser: A container so designed that the contents of the container be used in desirable amounts.
Inhaler: A device used to introduce a powdered or misted drug into the lungs through the mouth, or through the nose.
Metered dose inhaler (MDI): A dispenser designed to deliver a specific dose of medication to the tissues of the lungs with each usage.

Crimping: It is a method of hermetically sealing the body of a container and a valve by application of pressure (from outside inwards) outside wherein thermoplastic elastomers are used as sealing material for effective sealing. Another method of sealing of a container with a valve is called clinching wherein the pressure is applied in exactly the opposite direction (from inside outwards).
In the context of this specification the term "crimping" is used in a broader sense covering both the methods wherein a container and a valve are sealed by application of pressure, ie: crimping and clinching.
Background and prior art:
A typical aerosol device known in the art consists of a unit comprising a container, a crimped cap covering the mouth of the container, and a valve fitted in the cap.
A typical assembly of a container and a valve used in pressurized aerosol devices is disclosed in US 5,775,321.
In the known aerosol devices, typically, a valve is fitted to the body of the container by crimping a valve ferrule against the body of the container with an intermediate seal made of an elastomeric material compressed between the body and the ferrule.
An intermediate seal is provided in various known aerosol devices, which can either be in the form of a ferrule gasket placed and compressed between the top edge of the body of the container and the opposing surface of the ferrule gasket, or it can be in the form of an o-ring placed around the

body of the container and compressed between the body of the container and an annular flange of the valve ferrule.
However, the conventional pressurized aerosol devices are prone to leakages resulting from improper sealing of valve and the body of the container through crimping.
Various attempts have been made to make leakage resistant aerosol devices. All the possible leakage points for a typical pressurized aerosol device have been described in detail in Fig. 3 of US 6,971,556 which disclose various sealing arrangements for leakage resistant pressurized aerosol devices.
The problems associated with sealing and leakage, have also been described in US 6254104 wherein gaskets made up of material of varying durometer values have been disclosed for effective sealing.
Following are some of the drawbacks associated with the conventional aerosol devices and method steps used in production thereof.
The drawback associated with these conventional methods of sealing the body of a container and a valve by application of pressure (crimping), is the high risk of leakage due to inefficient or improper sealing. In case of medicinal aerosol formulations, there is a need to maintain an appropriate concentration of the drug through out the usage period, leakage of the propellants in such devices causes serious problem of non-uniform and unpredictable drug delivery.

Furthermore, the conventional aerosol devices employ elastomers for
sealing purposes. In case of aerosols meant for medicinal purposes, contact
of the medication with an elastomer increases the chances of drug contamination through the process of leaching.
Still furthermore, the step of crimping involves a considerable amount of production time during the manufacture of such devices.
Another drawback associated with the method step of crimping in the production of aerosol devices is that the device has to be assembled at the site of filling station needing a machine which, adds up a step in the overall
production line thereby increasing the overall cost and time required for the production.
Yet another drawback associated with the step of crimping is that frequent testing for ensuring non-leakage of the devices is to be conducted throughout the manufacturing process, which in turn needs extra skilled man-power and machinery.
There is therefore a need for an aerosol device that is leakage-resistant, safe (without any elastomeric materials) and which is economical to produce.
Object:
An object of the present invention is to provide an integrated aerosol device, the manufacture of which does not involve the step of crimping.
Another object of the present invention is to provide a leakage resistant aerosol device.

Yet another object of the present invention is to provide an aerosol device that uses very less elastomeric material thereby ensuring contaminant free
delivery of the ingredients.
Yet another object of this invention is to provide an aerosol device the production of which is safe, efficient, economical and speedy.
Summary of the invention
The present invention provides an aerosol device wherein the valve assembly and the body of the container are assembled in such a way that the need for the method step of crimping during the production is obviated.
The present invention further provides a leakage resistant aerosol device, which uses very less elastomeric materials in its assembly thereby ensuring the contaminant-free delivery of contents.
Brief Description of the accompanying Drawings:
Fig 1: Cross sectional view of an aerosol device;
Fig 2: Tubular container and a base;
Fig 3: Exploded view of a valve chamber;
Fig 4: Valve assembly mounted on a stalk;
Fig 5: Sealed aerosol device with over-molding.
Description
The aerosol device of the present invention overcomes the drawbacks in the prior art in that there is neither any problem of leakage nor does it require any crimping and hence minimizes the use of elastomer.

Fig 1 illustrates an integrated aerosol device (10) consisting of a tubular container (12) a valve assembly (14), a base (16) and a stalk (18).
The words "top" and "bottom" as used herein below are used for the particular orientation of an aerosol device as shown in Figures 1 to 5, in its operative configuration and are interchangeable.
Fig. 2 illustrates the tubular container with a slender neck (20). The neck is provided with an opening at one end (22). Unlike the conventional aerosol devices, the end 24 of the tubular container (12) is open . An annular ridge (26) integral with outer surface of the bottom (24) is provided. Just above the annular ridge (26)), at least one more outward annular locking ridge (30) is provided on the outer surface of the bottom (24).
The base (16) is corrugated and it has an annular groove (32) on the periphery. A furrow (34) is provided on the inner surface of the outer wall of the groove from inside. The depth of the furrow (34) of the base and the height of annular ridge (26) of the bottom are such that when the base (16) along with the stalk (18) is inserted into the bottom (24) of the tubular container (12) they snap-fit each other forming a leakage resistant sealing engagement.
Figure 3 illustrates the valve assembly (14) consisting of a valve chamber (36) with a seat gasket (38). A valve stem (40), with an orifice (42) is provided on the valve stem (40) in such a way that it can be displaced along the longitudinal axis inside the valve chamber (36).

Also provided with a valve stem (40) is an integrated annular stopper (44),
which limits the vertical movement of the valve stem (40) within the valve chamber (36).
In one embodiment of the invention, the valve stem (40) is partially solid and partially hollow, typically tubular and the orifice (42) is typically formed in the hollow tubular region.
The seat gasket (38) has an aperture through which the valve stem (40) extends along the longitudinal axis outside the valve assembly (14) and also out of the tubular container (12) passing through the opening.
In continuation with the valve chamber (36), towards the bottom (24), there is a valve body (46), which contains a spring element (48). The spring element (48) is attached to valve stem (40) and whenever the spring is compressed (during actuation) the valve stem enters inside the valve body (46).
Figure 4 illustrates the Stalk (18), which extends vertically upwards from the base (16), preferably from the center of the base (16).
In one embodiment the stalk is integral with the valve body (46) of the valve assembly as shown in Figure 4.
In another embodiment, the valve assembly is mounted on a stalk (18).
The combination of stalk (18) with a mounted valve assembly (14) attached
to the base (16), are fitted inside the tubular container (12) and the base (16) is hermetically sealed using a snap fit arrangement (54). Once this

sealing is done the snap-fit joint may be typically, jacketed by over-molding. This is illustrated in Figure 5.
The sealing may be done by any one of the means including but not limiting to fusing, molding, welding, ultra sound welding, shrink sleeve and the like.
The base (16) may comprise a support for the valve that may be provided as a separate part or as an integral part.
When the stem is pressed, the fluid inside the container comes in the valve chamber through small apertures and it is expelled through the stem in the form of a fine mist or spray.
A suitable nipple or other actuating devices may be mounted on the mouth of the annular space at the extremity of the valve stem distal from the spring element for directing the pressurized contents of the container as desired by the user.
In another embodiment of the present invention the device may be vaccuumised prior to assembly.
Thus the present invention provides a pre-assembled, hermetically sealed device, wherein the only task that needs to be done is filling the device with the required amount of medicament. As a result it reduces the production time considerably as there is no need of crimping.
In another embodiment, when metal is used as the material of construction an elastomer may be required to snap fit the base to the main body.

In yet another embodiment of the present invention the inner surface of the container may optionally be anodized, lacquer-coated and/or plastic-coated with suitable coating materials, so as to render it anti-adherent.
Various materials used for coating the inner surface of a container may be epoxyphenolic, PFA, FEP/PES, Teflon, Silicon, ethylene, and xylan.
The present invention may comprise a body capable of withstanding the vapor pressure of the propellant used such as a plastic or plastic-coated glass bottle or metal can, for example aluminum. The present invention may be made by different materials of construction known in the art but not limited to metals (aluminum, stainless steel) polycarbonate, polysulphone, Polymers/Plastics ( polyethylene terephthalate (PET), thermoplastic polycarbonates, copolymers of ethylene and CI C6 mono- or di-unsaturated monomers, ethylene based polymers, including ethylene/vinyl acetate, ethylene acrylate, ethylene methacrylate, ethylene methyl acrylate, ethylene methyl methacrylate, ethylene vinyl acetate carbon monoxide, and ethylene N-butyl acrylate carbon monoxide, polybutene-1, high and low density polyethylene, polyethylene blends and chemically modified polyethylene, polybutadiene rubber, polyamides, polyesters such as polyethylene terephthalate, polyethylene naphthalate, polybutylene terephthalate;, atactic polyalphaolefms, including atactic polypropylene, polyvinylmethylether and others; thermoplastic polyacrylamides, polyacrylonitriles, copolymers of acrylonitrile and other monomers such as butadiene styrene; polymethyl pentene, polyphenylene sulfide, aromatic polyurethanes; styrene-acrylonitrile, acrylonitrile-butadiene-styrene) and glass.

The container may be provided with markings (etchings) indicative of the number of doses of the formulation remaining in the container. In accordance with one aspect of the invention, the container including the base are transparent or translucent. The contents of the container are therefore visible giving an indication of the quantity remaining after periodic use.
The valve or valve assembly may be selected from the different types valves/valve assemblies including but not limiting to vertical valve assemblies, toggle action aerosol valve, the female aerosol valve, ferrule type aerosol valve, one-shot valve and the like.
The material for making valve may be at least one selected from a group of materials consisting of Metals, glass, thermoplastics materials including but not limiting to polymers such as PET, polycarbonates and the like and any combinations thereof. Alternatively, the valve assembly may be made of acetyl or polyester, hydral, and the like .
The elastomers used may be at least one of nitrile, butyl, chloroprene,EPDM,TPE,HNBR,POE,chlorobutyl, and bromobuty/.
The body made from the aforementioned materials may be transparent, opaque or translucent. And may be made up of materials like polycarbonate, polysulphone.
Because of the minimum use of elastomers and high leakage resistance wide variety of propellants including but not limited to CFC Propellants
(for example: dichlorodifluoromethane, monofluorotrichloromethane ,dichlorotetrafluoroethane & combinations thereof, propane, butane,

isobutene, isopropane, LPG, HFA Propellants (for example: Tetrafluoroethane ( HFA 134a) , Heptafluoropropane (HFA227) & combinations thereof with or without any polar or non polar co solvents & / or surface active agent/s may be used.
The body may be made by any conventional molding techniques including but not limited to injection molding, blow molding, two stage blow molding, compression molding, transfer molding, extrusion molding, rotational molding or thermoforming.
The present invention may be of any suitable shape, preferably the shape as per the present invention because it ensures that even the last drop of medicament is delivered which was not possible in the existing cans.
It is appreciated that certain features of the invention, which are for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Also various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in suitable combination.
Dated this 20th day of November, 2006.
MOHAN DEWAN
OF R. K. DEWAN & COMPANY
APPLICANTS' PATENT ATTORNEY