GB2520779A

GB2520779A - Improvements in drug delivery inhaler devices

Info

Publication number: GB2520779A
Application number: GB1404358.2A
Authority: GB
Inventors: David Spencer; Ronald Bruin; Mark Sanders
Original assignee: Clement Clarke International Ltd
Current assignee: Clement Clarke International Ltd
Priority date: 2013-11-12
Filing date: 2014-03-12
Publication date: 2015-06-03
Anticipated expiration: 2034-03-12
Also published as: GB2520779B; GB201404358D0; GB201319924D0

Abstract

An adapter 1 for fitting to a drug delivery inhaler device, the adapter comprising: a holding chamber 2 with an inlet 3 for connection to a mouthpiece of the inhaler device; a spacer portion 4 having an outlet 5 for communication with the mouth of a user; a valve 7 positioned between the chamber and the spacer portion; an air flow path through the adapter along which air is drawn to the outlet by the user inhaling; an air flow rate indicator 6 positioned between the valve and the outlet, where the indicator is operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of a drug to the user. The indicator may generate an audible or a visible signal. The indicator may comprise at least one pressure driven mechanical oscillator. The predetermined minimum level for the rate of air-flow may be at least 15 litres/min. The predetermined maximum level for the rate of air-flow may be about 90 litres/min. The spacer-portion may be tubular. The spacer-portion may be detachable from the chamber. Also disclosed is a kit.

Description

IMPROVEMENTS IN DRUG DELIVERY INHALER DEVICES

BACKGROUND TO THE INVENTION

Field of the invention

The present invention relates to drug delivery inhaler devices, such as pressurised metered dose inhaler (pM Dl) devices and dry powder inhaler (DPI) devices and adapters for fitting to such drug delivery inhaler devices. The invention also relates to methods of operation of such devices and adapters. Of particular interest in this invention is the provision of means for improving patient compliance with such devices.

Related art Pressurised metered dose inhaler (pMDI) devices are the most popular and widely prescribed devices for respiratory drug delivery, with approximately 500 million manufactured each year.

In such devices, the active ingredient/drug is typically provided in the form of a solution or suspension held in a pressurised canister. Actuation of the canister is typically achieved by depressing the canister towards the body of the device. This causes an interaction between the canister and a valve seat that causes a metered dose to be ejected from the canister, along with a propellant gas (typically a hydrofluoroalkane (HFA) gas). The dose becomes aerosolized and available for inhalation by the patient.

Dry powder inhaler (DPI) devices are an alternative to these aerosol-based inhalers, and well known in the art, in which a powdered respiratory drug may be held within a capsule which is perforated by the device as the patient inhales. An insufficient inhalation rate will result in reduced dose delivery and incomplete de-aggregation of the powdered drug potentially leading to poor control of the respiratory problem.

The perception is that these devices are easy to use but this is far from the reality: seemingly simple steps such as coordination of actuation of the device with inhalation, and inhaling at the appropriate flow rate are often performed incorrectly.

It is known to provide a spacer or a holding chamber to assist patients, especially young and elderly patients, with their inhaler use. These adapters are known to improve the direction and deposition of medication delivered by drug delivery inhaler devices.

Spacers are relatively simple adapters (often in the form of a simple tube) which extend the mouthpiece of the drug delivery inhaler devices thus directing the medication into the patient's lungs rather than impacting and sticking to the back of their mouth.

Holding chambers are provided with a valve, typically a one-way valve allowing inhalation from but not exhalation into the chamber, and the medication is trapped within the holding chamber allowing the medication to be inhaled slowly. The use of these valved holding chambers eliminates the requirement that slow deep inhalation coincides with the actuation of the pMDI drug delivery inhaler device. An example of a valved holding chamber is the A2A Spacer1M (Clement Clarke International).

As well as providing adapters to slow and direct the flow of medication from the drug delivery inhaler device, it is also known to provide flow indicators to provide an indication of the flow rate through the adapters. The flow indicator may provide an indication when the flow rate is too high or the flow indicator may provide an indication when an optimum flow rate for drug delivery is achieved. An example of a device with a flow indicator is the FloToneTh (Clement Clarke International) which provides an audible tone to indicate when the appropriate inspired air flow rate is achieved. The Clement Clarke International Flo-ToneTM is disclosed in GB-A-2490770.

Another such device is disclosed in GB-A-2372704, wherein the device includes two reeds adapted to generate an audible signal at different air flow speeds through the device. The first reed generates an audible signal of a first pitch when the air flow reaches a predetermined minimum. The second reed generates an audible signal of a second pitch when the air flow reaches a predetermined maximum. Thus, the patient is informed when the air flow rate is within a desirable range, between the predetermined minimum and maximum.

Clement Clarke International currently market a valved holding chamber known as an Able SpacerTM which has a chamber with an inlet end for connection to the mouthpiece of a drug delivery inhaler device, a chamber, and a mouthpiece with a valve positioned between the chamber and the mouthpiece. A flow rate indicator in the form of a whistle (formed by a reed) is provided in the wall of the chamber adjacent to the inlet end of the chamber. The whistle sounds if the flow rate through the chamber is too high for optimal drug delivery. Aerochamber PlusTM (Trudell) and Optichamber DiamondTM (Philips Respironics) are also valved holding chambers having flow rate indicators which generate an audible signal.

The inventors have found that the flow rate at which the flow rate indicators (whistles) in the known valved holding chambers are actuated is highly dependent on the nature of the drug delivery inhaler device, in particular the air flow resistance of the drug delivery inhaler device. When the patient inhales from the valved holding chamber having a whistle, air will be drawn in through both the whistle and the channels surrounding the canister in the drug delivery device. The balance between these routes will dictate the flow rate at which the whistle sounds. If the drug delivery inhaler device has a fairly high resistance (e.g. Atrovent TM pMDI), it will be easier for air to enter through the whistle and therefore the whistle will sound at a lower flow rate. Conversely, if the drug delivery inhaler device has a fairly low resistance (e.g. FlutiformTM pMDI), it will be necessary to reach a high flow rate before there is sufficient negative pressure to cause air to pass through and sound the whistle.

Therefore, it now appears that using the actuation of the whistle in a valved holding chamber as an indication of an appropriate or inappropriate inhalation rate for optimum drug delivery is not appropriate and is, in fact, misleading. Doing so in certain drug delivery inhaler device/valved holding chamber combinations may well lead to erroneous use of the drug delivery device and poor respiratory symptom control.

There is a need to provide an adapter for a drug delivery inhaler device which slows and/or directs drug delivery and which provides an accurate indication of flow rate through the drug delivery inhaler device and the adapter to ensure optimal drug delivery.

SUMMARY OF THE INVENTION

Accordingly, in a first aspect, the present invention provides an adapter for fitting to a drug delivery inhaler device, said adapter comprising: a holding chamber having an inlet for connection to a mouthpiece of a drug delivery device, a spacer portion having an outlet for communication with the mouth of a patient; a valve positioned between the chamber and the spacer portion; an air flow path through the adapter along which air is drawn to the outlet by inhalation by the user; and an air flow rate indicator operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient, wherein the air flow rate indicator is positioned between the valve and the outlet of the spacer portion.

The present inventors have found that by providing an air flow rate indicator between the valve of the valved holding chamber and the outlet of the spacer portion, the flow rate at which the air flow rate indicator is actuated is independent of the air flow resistance through the drug delivery inhaler device. This means that the actuation of the flow rate indicator can be used as a reliable indication of the appropriate flow rate for any drug delivery inhaler device thus ensuring correct use of the drug delivery inhaler device and optimal drug delivery.

In some embodiments, the spacer portion is fixedly connected to or integral with the holding chamber.

In other embodiments, the spacer portion is detachable from the holding chamber. This allows for easier cleaning of the spacer portion (which comes into contact with the patient's mouth) and easier replacement of spacer in case of damage or wear. In these embodiments, the holding chamber has an outlet adjacent to the valve and the spacer portion has an inlet for connection to the outlet of the holding chamber (with the valve between the holding chamber and the spacer portion). The inlet of the spacer portion preferably includes a press-fitting connection. The press/push-fitting connection is adapted to form an interference fit with the outlet of the holding chamber.

The adapter may comprise a cap for releasable attachment to the spacer portion for covering the spacer portion when the adapter is not in use. This helps ensure that the spacer portion remains clean prior to insertion into the user's mouth. The cap may be connected to the adapter e.g. to the holding chamber.

Accordingly, in a second aspect, the present invention provides a kit comprising a holding chamber and a spacer for fitting to a drug delivery inhaler device, the holding chamber comprising: an inlet for connection to a mouthpiece of the drug delivery inhaler device; a valve; and an outlet adjacent the valve, the spacer comprising: an inlet for connection to the outlet of the holding chamber; an outlet for communication with the mouth of a patient; and an air flow rate indicator, wherein an air flow path is provided through the holding chamber and spacer along which air is drawn to the outlet of the spacer by inhalation by the user and wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.

In a third aspect, the present invention provides use of a spacer in combination with a holding chamber for fitting to a drug delivery inhaler device, the holding chamber comprising: an inlet for connection to a mouthpiece of a drug delivery device; a valve; and an outlet adjacent the valve, the spacer comprising: an inlet for connection to the outlet of the holding chamber; an outlet for communication with the mouth of a patient; and an air flow rate indicator, wherein an air flow path is provided through the holding chamber and spacer along which air is drawn to the outlet of the spacer by inhalation by the user and wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.

In a fourth aspect, the present invention provides a use of a drug delivery inhaler device to deliver a drug to a patient by inhalation, the method comprising: connecting the inlet of an adapter according to the first aspect to the mouthpiece of the drug delivery device; the patient inhaling through the outlet of the spacer portion and thereby establishing an air flow along the air flow path through the adapter and device; the air flow rate indicator in the adapter providing an indication to the patient when the air flow rate along the air flow path is at a predetermined minimum level suitable for delivery of the drug to the patient; and while the air flow rate indicator provides said indication, operating a drug reservoir seated in the device to deliver a dose of aerosolized drug into the air flow path in the device for inhalation by the patient at the spacer portion outlet.

In a fifth aspect, the present invention provides a use of a drug delivery inhaler device to deliver a drug to a patient by inhalation, the method comprising: connecting the inlet of a holding chamber to the mouthpiece of the drug delivery device, the holding chamber having a valve and an outlet adjacent the valve; connecting the inlet of a spacer to the outlet of the holding chamber, the spacer having an outlet for communication with the mouth of a patient and an air flow rate indicator; the patient inhaling through the outlet of the spacer and thereby establishing an air flow along the air flow path through the device, holding chamber and spacer; the air flow rate indicator in the spacer providing an indication to the patient when the air flow rate along the air flow path is at a predetermined minimum level suitable for delivery of the drug to the patient; and while the air flow rate indicator provides said indication, operating a drug reservoir seated in the device to deliver a dose of aerosolized drug into the air flow path in the device for inhalation by the patient at the spacer portion outlet.

The following features are applicable to all of the first to fifth aspects.

Preferably, the inlet of the holding chamber is adapted for connection to the mouthpiece of a drug delivery inhaler device by the inclusion of a press-fitting connection. The press/push-fitting connection is adapted to form an interference fit with the outlet/mouthpiece of the drug delivery inhaler device. The inlet of the holding chamber is adapted to form an air-tight seal upon connection with the mouthpiece/outlet of the drug delivery inhaler device. For example, the inlet of the holding chamber may be provided with a universal slit rubber end-piece.

This allows easy connection of the adapter to the drug delivery inhaler device.

The chamber may have any shape but is preferably an elongated chamber e.g. an elongated frusto-conical shape or a cylindrical shape.

The valve may be any known one-way valve which allows inhalation from the holding chamber but does not allow exhalation into the holding chamber. In some embodiments, the valve comprises a slit silicone disc seated on a valve seat, the valve seat allowing the disc to flex and the slits to open towards the spacer/spacer portion but preventing flexing of the disc and opening of the slots away from the spacer/spacer portion.

Preferably, the air flow rate indicator is adapted to generate an audible or visible signal when the flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.

In some embodiments, the air flow rate indicator generates an audible signal. For example, the air flow rate indicator may be a pressure-driven mechanical oscillator, such as a reed. Alternatively, the air flow rate indicator may be a whistle.

In some embodiments, the air flow rate indicator generates a visual signal. For example, air flow rate indicator may have a mechanically-operated signal such as a vane moveable in response to a pressure difference across it.

In some embodiments, the air flow rate indicator may operate electronically. Electronic air flow rate sensors are known, e.g. based on Venturi sensors. In the case of an electronic air flow rate indicator, the patient may be alerted to the air flow rate by a suitable signal such as an audible signal, a visual signal, or a combination of audible and visual signals. The audible and/or visual signal may be generated electronically.

By providing an audible or visible signal, the patient is given a clear indication of when the flow rate along the air flow path is at a predetermined minimum level or above a predetermined maximum level suitable for delivery of the drug to the patient.

Preferably, the predetermined minimum air flow rate through the device is at least 15 litres per minute, more preferably at least 20 litres per minute and most preferably, at least 30 litres per minute. Preferably, the predetermined maximum air flow rate through the device is at about 90 litres per minute, more preferably, at about 60 litres per minute, even more preferably, at about 50 litres per minute and most preferably at about 40 litres per minute. As will be appreciated, the preferred range of air flow through the device in order to ensure satisfactory delivery of the drug to the patient is preferably 15-90 litres per minute, more preferably 20-60 litres per minute, yet more preferably 30-60 litres per minute or 20-50 or 20-40 litres per minute. A slower air flow rate risks that the aerosol particles will settle before being delivered to the required anatomy of the patient (typically to the bronchial tubes, and/or deeper into the lungs). A higher air flow rate risks the aerosol particles simply hitting and adhering to the back of the patient's throat, without penetrating deeper into the patient's pulmonary system.

In some embodiments, the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at the predetermined minimum level and above the predetermined maximum level suitable for delivery of the drug to the patient.

For example, the air flow rate indicator may be adapted to generate a first audible or visible signal when the flow rate along the air flow path is at a predetermined minimum level and a second audible or visible signal when the flow rate along the air flow path is above a predetermined maximum level suitable for delivery of the drug to the patient.

In some embodiments, the air flow rate indicator generates a first audible signal and a second audible signal. For example, the air flow rate indicator may include two pressure-driven mechanical oscillators, such as two reeds. Alternatively, the air flow rate indicator may comprise two whistles or one oscillator and one whistle. The oscillator(s) and/or whistle(s) may be located proximal/adjacent one another or may be distal one another.

In some embodiments, the air flow rate indicator generates a first visual signal and a second visual signal. For example, air flow rate indicator may have mechanically-operated signals such as two vanes moveable in response to a pressure difference across them.

Alternatively, the air flow rate indicator may generate one visual and one audible signal and may incorporate any of the features previously identified for doing so.

In embodiments where the air flow rate indicator operates electronically, any combination of two audible/visual signals may be generated electronically.

By providing an audible or visible signal both when the air flow path is at the predetermined minimum level and above the predetermined maximum level suitable for delivery of the drug to the patient, the patient can ensure that inhalation is occurring within the optimum range for drug delivery. The patient can increase their inhalatory effort until the first signal is generated but decrease the inhalatory effort if the second signal is generated.

The air flow rate indicator is preferably provided on and is preferably integral with a wall of the spacer portion/spacer.

The spacer portion/spacer is preferably tubular. It may have any cross-sectional profile e.g. a circular cross-sectional profile such that the spacer portion/spacer is cylindrical.

Alternatively, the cross-sectional profile of the spacer portion/spacer may be an oval, a truncated oval (barrel-shaped), an elongated oval, a mandorla or any other shape.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will now be described by way of example with reference to the accompanying drawings in which: Figure 1 shows an adapter according to a first preferred embodiment of the present invention.

Figure 2 shows a holding chamber and spacer according to a second preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Figure 1 shows an adapter 1 according to a first embodiment of the present invention.

The adapter 1 comprises a holding chamber 2 having an inlet 3 for connection to a mouthpiece of a drug delivery device (not shown) and a spacer portion 4 having an outlet for communication with the mouth of a patient. A valve 7 is positioned between the chamber 2 and the spacer portion 4. The adapter further comprises a flow rate indicator 6 which is operable to indicate when the air flow rate along the air flow path (through the adapter along which air is drawn to the outlet 5 by inhalation by the user) is at a predetermined minimum level suitable for delivery of the drug to the patient.

The air flow rate indicator 6 is positioned between the valve 7 and the outlet 5 of the spacer portion 4.

The air flow rate indicatorS is adapted to generate an audible signal when the flow rate along the air flow path is at a predetermined minimum level. The air flow rate indicator is a pressure-driven mechanical oscillator, such as a reed.

Preferably, the predetermined minimum air flow rate through the device is at least 30 litres per minute. A slower air flow rate risks that the aerosol particles will settle before being delivered to the required anatomy of the patient (typically to the bronchial tubes, and/or deeper into the lungs).

The air flow rate indicatorS is formed in a wall of the spacer portion 4.

The spacer portion 4 is a tubular portion with a pinched oval shape. The adapter comprises a cap 8 for releasable attachment to the spacer portion 6 for covering the outlet 5 of the spacer portion 4 when the adapter 1 is not in use. This helps ensure that the spacer portion 4 remains clean prior to insertion into the user's mouth. The cap 8 is connected to the holding chamber 2 by a tab 9 (extending behind the spacer portion in Figure 1).

The spacer portion 4 is fixedly connected to the holding chamber 2 in the first embodiment.

The inlet 3 of the holding chamber 2 is adapted for connection to the mouthpiece of a drug delivery inhaler device (not shown) by the inclusion of a press-fitting connection which forms an air-tight interference fit with the mouthpiece of the drug delivery inhaler device.

The chamber 2 is an elongated frusto-conical shape.

The valve 7 comprises a slit silicone disc seated on a valve seat, the valve seat allowing the disc to flex and the slits to open towards the spacer portion 5 but preventing flexing of the disc and opening of the slots away from the spacer portion 5.

Figures 2a and 2b show an embodiment according to the second aspect of the present invention.

Figure 2a shows a holding chamber 2 comprising an inlet 3 for connection to a mouthpiece of the drug delivery inhaler device (not shown). The holding chamber includes a valve 7 comprising a slit silicone disc seated on a valve seat, the valve seat allowing the disc to flex and the slits to open towards an outlet 10 of the holding chamber 2 but preventing flexing of the disc and opening of the slots away from outlet 10 of the holding chamber 2.

Figure 2b shows a spacer 4' comprising an inlet 11 for connection to the outlet 10 of the holding chamber 2, an outlet 5' for communication with the mouth of a patient and an air flow rate indicator6.

In use, the spacer 4' is connected to outlet 10 of the holding chamber and the inlet of the holding chamber is connected to the mouthpiece of a drug delivery inhaler device. An air flow path is provided through the holding chamber 2 and spacer 4' along which air is drawn to the outlet 5' of the spacer 4' by inhalation by the user. The air flow rate indicator 6 is operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and above a predetermined maximum level suitable for delivery of the drug to the patient.

This is achieved by providing a flow rate indicator 6 having two reeds 12, 12' set to oscillate at different flow rates. The air flow rate indicator 6 generates a first audible signal when the air flow rate along the air flow path is at a predetermined minimum level (e.g. around 30 litres a minute) and a second audible signal when the air flow rate along the air flow path is above a predetermined maximum level suitable for delivery of the drug to the patient (e.g. above around 60 litres per minute).

To use the first embodiment, the inlet 3 of the holding chamber 2 is connected to the mouthpiece of a drug delivery inhaler device. The patient then inhales through the outlet of the spacer portion 4 thereby establishing an air flow along the air flow path through the holding chamber 2, spacer portion 4 and device. The air flow rate indicator 6 in the adapter 1 provides an indication to the patient when the air flow rate along the air flow path is at a predetermined minimum level. Mien the air flow rate indicator 6 provides an indication that the air flow rate is at the predetermined minimum level, the patient can operate a drug reservoir seated in the device to deliver a dose of aerosolized drug into the air flow path in the device for inhalation by the patient at the spacer portion outlet 5.

In the case of the second embodiment, the inlet 11 of the spacer 4' is fitted onto the outlet 10 of the holding chamber 2 either before or after the holding chamber 2 is fitted to the drug delivery inhaler device. The patient then inhales through the outlet 5' of the spacer 4' thereby establishing an air flow along the air flow path through the holding chamber 2, spacer 4' and device. The first reed 12 in the air flow rate indicator 6 provides an indication to the patient when the air flow rate along the air flow path is at a predetermined minimum level. When the air flow rate indicator 6 provides an indication that the air flow rate is at the predetermined minimum level, the patient can operate a drug reservoir seated in the device to deliver a dose of aerosolized drug into the air flow path in the device for inhalation by the patient at the spacer outlet 5'. If the patient exerts too great an inhalatory effort, the second reed 12' in the air flow rate indicator will provide an indication that inhalatory effort needs to be reduced.

EXPERIMENTAL

Three valved holding chambers were selected: AeroChamber PIu5TM (TrudelD; EasiVentTM (Mylan Speciality LP); and OptichamberTM (Diamond, Philips Healthcare).

These valved holding chambers all include a coaching whistle for indicating when an optimal inspiratory flow rate is exceeded.

The three valved holding chambers were each fitted, in turn with four pMDls: VentolinTM HFA (GSK); ProAirTM HFA (Teva Respiratory LLC); AtroventlM (Boehringer Ingelheim); and SeretideTM (GSK).

Using a standardized vacuum force pulmonary waveform generator (1 litre per minute (1pm) increments; MH Custom Design & Mfg. L.C., Utah, US) each combination was tested three times until the whistle sound(s) were agreed by two observers.

The experiment was repeated using the four pMDls with an A2A SpacerTM (Clement Clarke International) (similar to the holding chamber shown in Figure 2a) fitted (on the user side) with a spacer having flow rate indicator with two reeds set to oscillate at two different flow rates (as shown in Figure 2b).

The results are shown in Table 1.

pMDI Atrovent Seretide Ventolin Pro Air VHC L.min AeroChamber 30/39/30 60/66/60 96/102/96 105/114/108 Plus 33 62 98 109 * n=3 30/27/30 48/48/48 96/78/78 90/84/88 EasiVent _____________ mean 29 48 84 87 27/27/24 42/42/42 78/75/75 84/78/78 Optichamber 26 42 76 80 A2A + spacer * 17/17/17 17/17/17 17/18/17 18/17/17 lstsignal n=3 17 17 18 17 * mean 29/29/29 30/30/30 31/30/31 31/32/31 2nd signal 29 30 31 31 Table 1 -Vacuum force (1pm) at which the coaching whistle is first audible for four valved holding chambers combined with four pMDls.

Inspiratory effort draws air through both the coaching whistle and the channels around a pMDI canister. The results show that there is a variation in performance of commercial valved holding chambers with whistles as a function of the pMDI to which they are attached.

For a high resistance pMDI (e.g. AtroventTM and SeretideTM) plus valved holding chamber with whistle, inspired air preferentially enters via the whistle, resulting in signalling at a lower inspiratory flow rate. The opposite situation occurs with a low resistance pMDI (e.g. VentolinTM and Pro AirTM) plus valved holding chamber with whistle, with a high inspiratory flow rate being reached before the signal is heard.

This may represent a clinical problem if training is conducted by titrating back from the whistle signal. For example, a patient using a low resistance pMDI may exert an excessive inspiratory flow rate with no alerting whistle thus causing the patient to believe that the device is being used correctly when, in fact, it is being used in a manner that is sub-optimal.

When the whistle is external to the valved holding chamber i.e. between the valve and the outlet for communication with the patient's mouth (as in the combination of the A2A SpacerlM valved holding chamber plus the dual-whistle spacer which forms an embodiment according to the second aspect of the present invention), the effect of pMDI resistance is minimized and the signal is a more correct indicator of a desirable inspiratory flow rate.

The above embodiments are given by way of example only and various modifications will be apparent to the person skilled in the art.

Claims

CLAIMS1. An adapter for fitting to a drug delivery inhaler device, said adapter comprising: a holding chamber having an inlet for connection to a mouthpiece of a drug delivery device, a spacer portion having an outlet for communication with the mouth of a patient; a valve positioned between the chamber and the spacer portion; an air flow path through the adapter along which air is drawn to the outlet by inhalation by the user; and an air flow rate indicator operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient, wherein the air flow rate indicator is positioned between the valve and the outlet of the spacer portion.
2. An adapter according to claim 1 wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at the predetermined minimum level and above the predetermined maximum level suitable for delivery of the drug to the patient.
3. An adapter according to claim 1 or 2 wherein the air flow rate indicator is adapted to generate an audible or visible signal when the flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.
4. An adapter according to any one of claims 1 to 3 wherein the air flow rate indicator comprises at least one pressure-driven mechanical oscillator.
5. An adapter according to any one of the preceding claims wherein the predetermined minimum air flow rate is at least 15 litres per minute.
6. An adapter according to any one of the preceding claims wherein the predetermined maximum air flow rate is about 90 litres per minute.
7. An adapter according to any one of the preceding claims wherein the air flow rate indicator is integral with a wall of the spacer portion.
8. An adapter according to any one of the preceding claims wherein the spacer portion is a tubular portion.
9. An adapter according to any one of the preceding claims wherein the spacer portion is fixedly connected to or integral with the holding chamber.
10. An adapter according to any one of claims 1 to 8 wherein the spacer portion is detachable from the holding chamber.
11. A kit comprising a holding chamber and a spacer for fitting to a drug delivery inhaler device, the holding chamber comprising: an inlet for connection to a mouthpiece of the drug delivery inhaler device; a valve; and an outlet adjacent the valve, the spacer comprising: an inlet for connection to the outlet of the holding chamber; an outlet for communication with the mouth of a patient; and an air flow rate indicator, wherein an air flow path is provided through the holding chamber and spacer along which air is drawn to the outlet of the spacer by inhalation by the user and wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.
12. A kit according to claim 11 wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at the predetermined minimum level and above the predetermined maximum level suitable for delivery of the drug to the patient.
13. A kit according to claim 11 or 12 wherein the air flow rate indicator is adapted to generate an audible or visible signal when the flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.
14. A kit according to any one of claims 11 to 13 wherein the air flow rate indicator comprises at least one pressure-driven mechanical oscillator.
15. A kit according to any one of claims 11 to 14 wherein the predetermined minimum air flow rate is at least 15 litres per minute.
16. A kit according to any one of claims 11 to 15 wherein the predetermined maximum air flow rate is about 90 litres per minute.
17. A kit according to any one of claims 11 to 16 wherein the air flow rate indicator is integral with a wall of the spacer.
18. Use of a spacer in combination with a holding chamber for fitting to a drug delivery inhaler device, the holding chamber comprising: an inlet for connection to a mouthpiece of a drug delivery device; a valve; and an outlet adjacent the valve, the spacer comprising: an inlet for connection to the outlet of the holding chamber; an outlet for communication with the mouth of a patient; and an air flow rate indicator, wherein an air flow path is provided through the holding chamber and spacer along which air is drawn to the outlet of the spacer by inhalation by the user and wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.
19. Use according to claim 18 wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at the predetermined minimum level and above the predetermined maximum level suitable for delivery of the drug to the patient.
20. Use according to claim 18 or 19 wherein the air flow rate indicator is adapted to generate an audible or visible signal when the flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.
21. Use according to any one of claims 18 to 20 wherein the air flow rate indicator comprises at least one pressure-driven mechanical oscillator.
22. Use according to any one of claims 18 to 21 wherein the predetermined minimum air flow rate is at least 15 litres per minute.
23. Use according to any one of claims 18 to 22 wherein the predetermined maximum air flow rate is about 90 litres per minute.
24. Use according to any one of claims 18 to 23 wherein the air flow rate indicator is integral with a wall of the spacer.
25. A method of using of a drug delivery inhaler device to deliver a drug to a patient by inhalation, the method comprising: connecting the inlet of an adapter according to any one of claims 1 to 10 to the mouthpiece of the drug delivery device; the patient inhaling through the outlet of the spacer portion and thereby establishing an air flow along the air flow path through the adapter and device; the air flow rate indicator in the adapter providing an indication to the patient when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient; and while the air flow rate indicator provides said indication, operating a drug reservoir seated in the device to deliver a dose of aerosolized drug into the air flow path in the device for inhalation by the patient at the spacer portion outlet.
26. A method of using of a drug delivery inhaler device to deliver a drug to a patient by inhalation, the method comprising: connecting the inlet of a holding chamber to the mouthpiece of the drug delivery device, the holding chamber having a valve and an outlet adjacent the valve; connecting the inlet of a spacer to the outlet of the holding chamber, the spacer having an outlet for communication with the mouth of a patient and an air flow rate indicator; the patient inhaling through the outlet of the spacer and thereby establishing an air flow along the air flow path through the device, holding chamber and spacer; the air flow rate indicator in the spacer providing an indication to the patient when the air flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient; and while the air flow rate indicator provides said indication, operating a drug reservoir seated in the device to deliver a dose of aerosolized drug into the air flow path in the device for inhalation by the patient at the spacer portion outlet.
27. Method according to claim 26 wherein the air flow rate indicator is operable to indicate when the air flow rate along the air flow path is at the predetermined minimum level and above the predetermined maximum level suitable for delivery of the drug to the patient.
28. Method according to claim 26 or 27 wherein the air flow rate indicator is adapted to generate an audible or visible signal when the flow rate along the air flow path is at a predetermined minimum level and/or above a predetermined maximum level suitable for delivery of the drug to the patient.
29. Method according to any one of claims 26 to 28 wherein the air flow rate indicator comprises at least one pressure-driven mechanical oscillator.
30. Method according to any one of claims 26 to 29 wherein the predetermined minimum air flow rate is at least 15 litres per minute.
31. Method according to any one of claims 26 to 30 wherein the predetermined maximum air flow rate is about 90 litres per minute.
32. Method according to any one of claims 26 to 31 wherein the air flow rate indicator is integral with a wall of the spacer.
33. Adapter substantially as any one embodiment herein described with reference to the accompanying Figures.
34. Kit substantially as any one embodiment herein described with reference to the accompanying Figures.
35. Use substantially as any one embodiment herein described with reference to the accompanying Figures.
36. Method substantially as any one embodiment herein described with reference to the accompanying Figures.