FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(SECTION 10; RULE 13)
Title: INHALER DEVICE WITH DOSE COUNTER MEANS
Applicant
GLENMARK PHARMACEUTICALS LIMITED,
An Indian Company registered under
The Companies Act, 1956, India
and having its office at
Glenmark House, HDO - Corporate BIdg,
Wing A, B. D. Sawant Marg,
Chakala, Andheri (East),
MUMBAI-400 099
The following specification particularly describes the invention and the manner in
which it is to be performed.

INHALER DEVICE WITH DOSE COUNTER MEANS
TECHNICAL FIELD The present invention relates to an inhaler device with dose counter means. Particularly, the present invention relates to a pressurized metered dose inhaler for inhalation of medication by a patient, wherein the inhaler has dose counter means. The metered dose inhaler can be used to deliver medication for the treatment of various respiratory disorders like asthma and chronic obstructive pulmonary disease (COPD).
BACKGROUND
Traditionally, inhalation therapy has played a relatively minor role in the administration of conventional pharmaceuticals when compared to more conventional drug administration routes, such as oral and intravenous. However, oral and intravenous routes have many disadvantages, and alternative administration routes are needed. Inhalation is one such alternative administration route. The various alternatives to attain inhalation type compositions are nebulizers, pressurized metered dose inhalers (MDI) and dry powder inhalers (DPI).
A significant deficiency of MDI is the inability of the patient to precisely determine how many metered doses of medication remain in the aerosol canister. The metered dose inhaler canister is generally a metal container, and so it is not possible to tell accurately how much medicine or metered dosages are remaining. The patient, unless he or she records the information in a diary, has no real chance to remember what has been taken on any given day or how many dose of medication are remaining in the medication canister. The patient is at risk to run out at an unfortunate time, and is in medical hazard including shortness of breath, choking, respiratory discomfort, and even hospitalization.
There is currently no simple procedure to determine the number of metered doses of medication remaining in the aerosol canister. There are various recommendations given by doctors and pharmacists: one method directs the patient

to float the medication canister; the other method is to shake the canister to see if there is medication in the canister. These methods are inexact methods at best. The amount of propellant remaining in the canister will be disproportionate to the actual medication that is in the canister; and this could give the patient an incorrect assurance that there is still medication remaining in the canister when in fact only inert propellant is remaining in the canister.
European Pat. No. EP 0448204B1 discloses a MDI device with an electronic counter and timer means connected to the body of the device. The disadvantage here is in the position of sensor or advancement lever, wherein even with the slightest of the movement of the canister, the counting will be triggered. In other words it encourages to "over counting" i.e., count decremented without firing the dose physically.
U. S. Pat. No. 5,564,414 discloses MDI device with either an electronic or mechanical dose counter device.
U. S. Pat. Application No. 20040255936 discloses a disposable medication inhaler consisting of a medication canister permanently attached to a disposable housing which also encloses electronic counting and display circuitry for indicating the number of doses of medication remaining in the counter, as well as the number of doses administered in a given time period such as the current day or the previous 24 hours.
SUMMARY
The present invention relates to a metered dose inhaler device comprising a drug-containing canister (04) which is attached to canister housing that also houses a dose counter means (16).
In the context of present invention, the inhaler device comprises a tubular main body adapted to receive an inhalation canister at its back end, a spray-directing element (09), and dose counter means (16) connected to main body (02).
In an embodiment, the present invention relates to a metered dose inhaler device comprising a drug-containing canister (04) which is attached to a canister housing that also houses an electronic dose counter means (16).

The electronic dose counter means of the present invention is permanently mounted on the body of the device. The electronic dose counter means display the number of doses remaining in the canister.
The electronic dose counter means comprises a power source, a liquid crystal display (15), a tactile switch (12), a light emitting diode indicator (13) and an integrated preprogrammed microprocessor chip.
BRIEF DESCRIPTION OF DRAWINGS The present invention is more fully understood when this specification is taken in conjunction with the drawings which are appended hereto, and wherein: FIG. 1 shows side view of present invention inhaler with a drug-containing canister inserted therein.
FIG. 2 shows front view of present invention inhaler with a drug-containing canister inserted therein.
FIG. 3 shows top view of present invention inhaler with a drug-containing canister inserted therein.
DETAILED DESCRIPTION
The present invention is directed to helping the patient by providing counting means into the inhaler itself. A pressurised metered-dose inhaler consists of three major components; the canister which is produced in aluminum or stainless steel, where the formulation resides; the metering valve, which allows a metered quantity of the formulation to be dispensed with each actuation; and an actuator (or mouthpiece or canister housing) which allows the patient to operate the device and directs the aerosol into the patient's lungs. The formulation itself is made up of the drug, a liquefied gas propellant and, in many cases, pharmaceutical excipients.
To use the inhaler the patient has to press down on the top of the canister, with supporting the lower portion of the actuator. Actuation of the device releases a single metered dose of the formulation which contains the medication either dissolved or suspended in the propellant. Breakup of the volatile propellant into

droplets, followed by rapid evaporation of these droplets, results in the generation of an aerosol consisting of micrometer-sized medication particles that are then inhaled.
The dose counter means (16) is integrated with MDI actuator. The sensor switch or lever (05) of dose counter detects the movement of the canister during release of the medicine from the canister through the mouthpiece of the actuator. During each operation of the actuator, the sensor switch or lever (05) will provide a signal to the dose counter, which processes the signal, and then the number of remaining available doses in the canister will be displayed on the Liquid Crystal Display (LCD) screen (15). Every time the inhaler is used this count is decremented by one and is displayed. The display on the LCD is on for 30 seconds, which reduces a lot of power consumption. The sensor switch or lever (05) is in contact with the collar portion of drug-containing canister (04). The dose counter means (16) is advanceable by contact of the drug-containing canister (04) with lever (05) which is connected to said dose counter means (16).
A tactile switch (12) is provided for the user who only intends to check the available number of dosages left in the inhaler. Every time the tactile switch (12) is pressed it will provide a signal to the microcontroller of dose counter. The microcontroller processes the signal and the LCD (15) is lit on for the next 30 seconds displaying the available number of dosages. The main purpose of tactile switch (12) is to facilitate the user to know the remaining number of dosages without practically firing the dose. This feature is also implemented as a power saving feature.
A Light Emitting Diode (LED) (13) is also provided to indicate the end user when the count value reaches the last pre defined available dose count (e.g 20 doses). This indication is done after every use of the Inhaler once the inhaler has reached the minimum number of dosages available. Once the canister has reached the end of the dosage, The LCD only displays "End" to indicate the end user that the canister is empty.
The particular internal mechanism is now within the purview of the artisan and not discussed in detail. In other words, electronic stop watches and counting

mechanisms are known and available. It is the particular application to the inhaler that constitutes the critical features herein.
Referring to FIG. 1, there is shown a side view of inhaler 1, having a hollow main body (02), with back end (03) adapted to receive an inhalation canister (04), and a front end (mouthpiece) (10) adapted for placement to or in a mouth (although, without exceeding the scope of the invention, it could be for placement relative to the mouth and nostrils or nostrils). Spray-directing element (09) is fixedly located within main body (02), as shown, and includes a continuous opening (08). The opening (08) has an insert end (07) for receiving a spray stem (06) of an inhalation canister valve, and has a spray end (11) for directing sprays or puffs of medicine through and out of the front end (10) of main body (02) when canister (04) is activated by a user.
Referring to both FIG. 1 and FIG. 2, like parts are like numbered as FIG. 2 shows a full front view of the inhaler (01) of FIG. 1. Unit (16) includes electronic dose counter means with a long-life power source (not shown) which is activated by downward movement of canister (04) against lever (05), which is connected to unit (16). Lever (05) is located so as to pass through orifice (17) and is movable therein. Each time the user depresses canister (04), lever (05) swings downward and ticks off one more count, which is displayed at LCD (15). Tactile switch (12) is provided for the user who only intends to check the available number of dosages left in the inhaler. An LED (13) is provided to indicate the end user when the count value reaches the last pre defined available dose count e.g last 20 doses. LCD (15) will display the number of doses remaining in the inhaler. The advantage of the positioning of lever (05) is that there is minimal or no scope for over counting. The counting mechanism won't be triggered unless the dose is fired physically.
While FIG. 1 and FIG. 2 show an inhaler having no moving parts other than the lever, the present invention could include a pump or a push button or have other features used in available inhalers without exceeding the present invention scope.
FIG. 3 shows top view of the inhaler, which shows dose counter means (16), drug-containing canister (04) and mouthpiece or front end (10). After

actuating drug- containing canister (04) downwards and subsequently inhaling the drug by the patient via front end (10) of the inhaler, the dose counter means (16) will show the number of doses remaining in the canister.
The metered dose inhaler of the present invention may have additional feature like, lock to prevent accidental actuation of the inhaler, and the like.
Since manufacturers today sell or provide inhalers with the medication which are disposable, the present invention inhaler may include a counter unit which is detachable and is usable with many inhalers which are adapted to have the counter unit removably attached thereto. However it is preferred that the dose counter unit is not removable from main body. Such embodiments would be included within the scope of the invention.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and application of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments of the present invention as described.
All publications, patents, and patent applications cited in this application are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference.

CLAIMS We claim:
1. A metered dose inhaler device (01) comprising a drug-containing canister (04) which is attached to a canister housing that also houses a dose counter means (16), characterized in that the device (01) further comprises lever (05) which is in contact with collar portion of drug-containing canister (04).
2. The metered dose inhaler device according to claim 1, wherein the dose counter means (16) is an electronic dose counter means.
3. The metered dose inhaler device according to claim 1, wherein the dose counter means (16) is advanceable by contact of the drug-containing canister (04) with lever (05) which is connected to said dose counter means (16).
4. The metered dose inhaler device according to claim 2, wherein the electronic dose counter means (16) displays the number of doses remaining in the canister.
5. The metered dose inhaler device according to claim 2, wherein the electronic dose counter means (16) comprises a power source, a liquid crystal display (15), a tactile switch (12), a light emitting diode indicator (13) and an integrated preprogrammed microprocessor chip.
6. The metered dose inhaler device according to claim 1, wherein the dose counter means (16) is not removable from main body (02).

7. The metered dose inhaler device according to claim 1, wherein the dose counter means (16) minimizes over counting.
8. The metered dose inhaler device according to claim 1, wherein the dose counter means (16) has power saving feature.
9. The metered dose inhaler device according to claim 8, wherein the power saving feature is a tactile switch (12) which lightens LCD (15) in dose counter for the next at least 30 seconds displaying the available number of dosages.
10. The metered dose inhaler device according to claim 2, wherein the electronic dose counter means (16) displays by LED (13) when the count value reaches the last 20 available dose counts.