WO2001085242A1

WO2001085242A1 - Respiratory aid

Info

Publication number: WO2001085242A1
Application number: PCT/GB2001/001925
Authority: WO
Inventors: Brian Barney; Richard Featherstone; Esther Perea-Borobio
Original assignee: Norton Healthcare Limited
Priority date: 2000-05-08
Filing date: 2001-05-03
Publication date: 2001-11-15

Abstract

A respiratory aid adapted to combat more effectively the symptoms of a subject with a respiratory disorder, in particular to an inhaler which is capable of emitting visible radiation (e.g. light) during non-daylight hours.

Description

RESPIRATORY AID

The present invention relates to a respiratory aid adapted to combat more effectively the symptoms of a subject with a respiratory disorder, in particular to an inhaler which is capable of emitting visible radiation (eg light) in any environment in which the level of ambient lighting alone is insufficient to render the respiratory aid visible (eg during non-daylight hours) .

Various respiratory aids are now widely available to a subject wishing to self-administer therapeutip and preventative agents to combat the symptoms of a respiratory disorder such as asthma. These aids come in a range of shapes and sizes to suit the age and ability of the subject. Such respiratory aids include inhalers and auxiliary devices such as spacers, optimisation chambers, reservoirs, ^' expansion chambers and deceleration chambers.

A common example of a respiratory aid is the inhaler which is a manually operated device used to dispense into the respiratory passages a discrete amount of a therapeutic or preventative agent. These are available in principle in two types, namely an aerosol powered by a propellant (eg the metered dose inhaler) or a powder containing device (eg a metered does powder inhaler) . The therapeutic or preventative agent may be in dry powder or liquid (eg suspension) form. A particular example of an inhaler is the metered-dose inhaler which is described in inter alia GB-A- 2293110. Generally speaking, the therapeutic or preventative agent is drawn into the respiratory passages by simultaneously dispensing the agent and taking a sharp intake of breath. One of the benefits of an inhaler is that the subject is able to manage the respiratory disorder through self- administration of a preventative agent. A successful preventative regime relies on regular self-administration of the preventative agent to avert breathing difficulties and other respiratory symptoms. A second benefit of an inhaler is that sudden respiratory attacks may be treated by immediate self-administration of the desired therapeutic agent.

The preventative and therapeutic benefits of the inhaler rely on the subject being able to locate the inhaler as effortlessly as possible. Breathing difficulties may occur suddenly and indiscriminately and their onset frequently leads to a loss in co-ordination. Loss in coordination can make actuation of even the most straightforward inhaler a difficult task and furthermore makes it difficult for the subject to effectively coordinate actuation of the inhaler with a sharp intake of breath. The overall effect on the subject is cumulative distress and panic causing a sharp deterioration in their welfare. A subject is particularly vulnerable to these factors during non-daylight hours when a respiratory aid may be less effortlessly located. This is especially true of an awakened subject who may already be in a disorientated state.

A survey has revealed that these occurrences are of major concern to users of respiratory aids. Rather surprisingly, the existence and the extent of this concern has not been previously recognised in spite of the widespread use of respiratory aids over a number of years.

The present invention is based on the recognition that the welfare of a subject having a respiratory disorder (such as asthma) may be improved by assisting them to locate a respiratory aid (eg an inhaler) during hours of darkness. More particularly, the present invention provides a light emitting respiratory aid which assists regular administration in a preventative regime and which enables rapid therapeutic administration at the onset of a respiratory attack.

Thus viewed from one aspect the present invention provides a respiratory aid for use in self-administration of an agent for combatting (eg preventing or treating) the symptoms of a respiratory disorder, said respiratory aid having an external surface at least a portion of which is capable of emitting visible radiation during non-daylight hours .

In accordance with the invention, the whole or a part of the external surface of the respiratory aid may be capable of emitting visible radiation during non-daylight hours. For example, one or more components (or partial surfaces) of the respiratory aid may be selectively capable of emitting radiation during non-daylight hours (ie whilst the remaining components (or partial surfaces) are selectively incapable of emitting radiation during non-daylight hours) .

In accordance with the invention, the respiratory aid may be an inhaler or an auxiliary device. The invention is particularly advantageous where the respiratory aid .is an inhaler. Conventional inhalers are small (often pocket- sized) and therefore easily misplaced. The present invention is useful for any type of inhaler including pressurised metered dose inhalers (both manually operable and breath actuated) , aerosol inhalers and dry powder inhalers, for auxiliary devices including spacers and stands or for accessories .

Preferably, the respiratory aid is an inhaler comprising: a container for the agent (eg a pressurised cannister) ; and an actuator body adapted to permit manual dispensation of a therapeutically or preventatively effective amount of said agent through a delivery outlet directly or indirectly into the respiratory passages of a subject, said outlet being positionable in the subject's mouth or into an auxiliary device (such as a spacer or an optimisation chamber) .

If desired, the delivery outlet may be selectively capable of emitting visible radiation during non-daylight hours thereby advantageously assisting the subject to identify more effortlessly the configuration of the aid during non-daylight hours. If desired, the container (eg pressurised cannister) may be selectively capable of emitting visible radiation during non-daylight hours thereby assisting the subject to replace more effortlessly a spent container during non-daylight hours. If desired, the portions of the external surface of the actuator body upon which the subject places its fingers may be selectively capable of emitting visible radiation during non-daylight hours to assist the subject to manually dispense agent more effortlessly.

The delivery outlet may be capped with a cap. Either the cap or the body may be selectively capable of emitting visible radiation. If the cap is inseparable from the delivery outlet during use (for example in a breath actuated device) , it is preferred that the cap is selectively capable of emitting visible radiation (ie the body is incapable of emitting radiation during non-daylight hours) .

Typically, the portion of the external surface is capable of emitting visible radiation over a period of 1-12 hours, preferably at least six hours, more preferably over at least eight hours, most particularly preferably over a period of at least ten hours. In a preferred embodiment, a surface means capable of emitting visible radiation during non-daylight hours is, applied to at least a portion of the external surface of the respiratory aid. The surface means may be applied to the portion of the external surface of the respiratory aid in the form of a layer or a coating. For example, a paint, dye or ink capable of emitting radiation during non-daylight hours may be coated, printed or labelled onto at least a portion of the external surface of the respiratory aid. For example, a printed label (eg an adhesive label) capable of emitting radiation during non-daylight hours may be applied to a least a portion of the external surface.

Preferably the surface means is capable of exhibiting fluorescence, luminescence, chemiluminescence, electrochemiluininescence, bioluminescence, triboluminescence, mechanoluminescence or phosphorescence during non-daylight hours. Preferably the surface means comprises a fluorescent, luminescent, chemilu inescent, electrochemiluminescent, bioluminescent, triboluminescent, mechanoluminescent or phosphorescent material.

In a preferred embodiment, the body of the respiratory aid is intrinsically capable of emitting visible radiation during non-daylight hours. The body of the respiratory aid may be caused to emit visible radiation by a physical, biological or chemical stimulus. For example, the physical stimulus may be- electrical, thermal, mechanical or electromagnetic. For example, the chemical stimulus may be a chemical reaction or chemical interaction.

In a preferred embodiment, the body of the respiratory aid is intrinsically capable of exhibiting fluorescence, luminescence, chemiluminescence, electrochemiluminescence, bioluminescence, triboluminescence, mechanoluminescence or phosphorescence during non-daylight hours. Preferably this is achieved intrinsically by incorporating into the body of the respiratory aid a fluorescent, luminescent, chemiluminescent, electrochemilu inescent, bioluminescent, triboluminescent, mechanoluminescent or phosphorescent material (or a material capable of inducing one of these phenomena) .

The body of the respiratory aid may comprise an organic or inorganic material capable of emitting visible radiation (or of causing visible radiation to be emitted) during non- daylight hours. For example, an inorganic or organic material ("the guest material") may be incorporated into the material of the body ("the host material''-') . Typically the host material is a polymer. The host material may be capable of emitting visible radiation (or of causing visible radiation to be emitted) during non-daylight hours. The guest material may be capable of emitting visible radiation (or of causing visible radiation to be emitted) during non-daylight hours. There may be an interaction (eg charge transfer) between the guest material and the host material which leads to emission of visible radiation during non-daylight hours.

Examples of organic materials include inter alia polyethers, polyacrylates, conjugated polymers (polyaromatics, polyvinyls or polyarylenevinylenes) and polythiophenes .

In an embodiment of the invention, the host and the guest material are polymeric (eg the body of the respiratory aid comprises a mixture of a first and second polymer) . One of the first and second polymers is capable of emitting visible radiation (or of causing visible radiation to be emitted) during non-daylight hours. Methods for manufacturing a body composed of a mixture of polymers are familiar to those skilled in the art (eg moulding techniques) . An example of an inorganic material is zinc sulphide optionally doped with a transition metal (manganese) . Other inorganic materials which may be useful may include a rare earth element selected from the group consisting of europium (EuII, EuIII, Eu²⁺ or Eu³⁺) , erbium (ErIII or Er³⁺) , ytterbium (Ybll or Yb²⁺) , cerium (Celll or Ce³⁺) , praseodymium (Prill or Pr³⁺) , gadolinium (Gdlll or Gd³⁺) and samarium (S ll or Sm²⁺) . Other inorganic materials which may be useful may include a transition metal selected from the group consisting of ruthenium (RuII, RuIII, Ru²⁺ or Ru³⁺) or chromium (CrII, CrIII, CrNI, Cr²⁺, Cr³⁺ or Cr⁶⁺) . The transition metal or rare earth metal may be complexed with an appropriate counter-ion. Other inorganic materials which may be useful include Si0₂, SiC, GaAs or Si.

Many luminescent materials suitable for use in the invention are known in the art. Such materials are disclosed inter alia in Luminescent Materials: G Blasse and B C Grab aier, 1/9/94 (Springer-Nerlag ISBΝ3540580190) and in SPIE, volume 675, 1999, page 169. Guest luminescent materials which can be incorporated into a host polymeric body (eg a plastic) are well known.

Phosphorescent materials suitable for use in the invention are typically an organic material (eg an aromatic material) optionally containing an inorganic guest material. For example, where an inorganic guest material is present, an inorganic moiety (eg an ion) with a long luminescent lifetime accepts energy from an organic (eg aromatic) chromophore.

Electrochemiluminescent suitable for use in the invention are typically organic based materials (for example see J. of Phys. D (Applied Physics), 1999, Vol 32, 24, R179- R249) . Other electrochemiluminescent materials are discussed in general in Trends in Analytical Chemistry, 1999, Vol 18, 1, 47-62.

The present invention will now be described in a non- limitative sense with reference to the accompanying Figure in which:

Figure 1 represents a respiratory aid in the form of an inhaler in accordance with an embodiment of the invention.

Figure 1 illustrates a respiratory aid in the form of an inhaler designated generally by reference numeral 1 for use by subjects with respiratory disorders. The inhaler comprises an actuator body 2 terminating in a mouth portion 3 with an outlet 5 and a container 4 from which a dose of therapeutic or preventative medicament may be dispensed. The exterior surface of the actuator body 2 and mouth piece 3 are coated with a fluorescent material which makes the device visible during hours of darkness and more effortlessly located by subjects.

It is not essential for the whole of the unit to be capable of emitting visible radiation. The body or cap may be selectively capable of emitting visible radiation, particularly if the body and cap are not separable during use (for example in a breath actuated device) . Auxiliary items such as spacers or canisters may also be selectively capable of emitting visible radiation.

It will be appreciated the term "an external surface at least a portion of which is capable of emitting visible radiation during non-daylight hours" as used herein is intended to include a surface which is capable of emitting visible radiation in any environment in which the level of ambient lighting alone is insufficient to render the respiratory aid visible.

Claims

1. A respiratory aid for use in self-administration of an agent for combatting the symptoms of a respiratory disorder, said respiratory aid having an external surface at least a portion of which is capable of emitting visible radiation during non-daylight hours.

2. A respiratory aid as claimed in claim 1 wherein the whole or a part of the external surface of the respiratory aid is capable of emitting visible radiation during non-daylight hours .

3. A respiratory aid as claimed in claim 1 or 2 of which one or more components or partial surfaces are selectively capable of emitting visible radiation during non-daylight hours whilst the remaining components or partial surfaces are selectively incapable of emitting visible radiation during non-daylight hours.

4. A respiratory aid as claimed in any preceding claim being an inhaler or an auxiliary inhalation device.

5. A respiratory aid as claimed in claim 4 being an inhaler.

6. A respiratory aid as claimed in claim 4 or 5 wherein the inhaler is selected from the group consisting of a metered dose inhaler, a breath actuated inhaler, a pressurised metered dose inhaler, an aerosol inhaler and a dry powder inhaler, and the auxiliary inhalation device is selected from the group consisting of a spacer, an optimisation chamber and a stand.

7. A respiratory aid as claimed in any preceding claim being an inhaler comprising: a container for the agent; and an actuator body adapted to permit manual dispensation of a therapeutically or prophylactically effective amount of said agent through a delivery outlet directly or indirectly into the respiratory passages of a subject, said delivery outlet being positionable in the subject's mouth or into an auxiliary inhalation device.

8. A respiratory aid as claimed in claim 7 wherein the portion of the external surface is on the actuator body.

9. A respiratory aid as claimed in claim 7 or 8 wherein the delivery outlet is selectively capable of emitting visible radiation during non-daylight hours .

10. A respiratory aid as claimed in claim 7 wherein the container is selectively capable of emitting visible radiation during non-daylight hours.

11. A respiratory aid as claimed in claim 7 or 8 wherein the portion of the external surface of the actuator body upon which the subject places its fingers is selectively capable of emitting visible radiation during non-daylight hours.

12. A respiratory aid as claimed in claim 7 wherein the delivery outlet is capped with a cap and either the cap or the actuator body is selectively capable of emitting visible radiation.

13. A respiratory aid as claimed in claim 12 wherein the cap is inseparable from the delivery outlet during use and is selectively capable of emitting visible radiation.

14. A respiratory aid as claimed in any preceding claim wherein the portion of the external surface is capable of emitting visible radiation over a period of 1-12 hours.

15. A respiratory aid as claimed in any preceding claim wherein the portion of the external surface is capable of emitting visible radiation over at least six hours.

16. A respiratory aid as claimed in any preceding claim wherein the portion of the external surface is capable of emitting visible radiation over at least eight hours.

17. A respiratory aid as claimed in any preceding claim wherein the portion of the external surface is capable of emitting visible radiation over at least ten hours.

18. A respiratory aid as claimed in any preceding claim wherein a surface means capable of emitting visible radiation during non-daylight hours is applied to the portion of the external surface.

19. A respiratory aid as claimed in claim 18 wherein the surface means is applied to the portion of the external surface in- the form of a layer or a coating.

20. A respiratory aid as claimed in claim 18 wherein the surface means is a paint, dye or ink capable of emitting visible radiation during non-daylight hours, said paint, dye or ink being coated, printed or labelled onto the portion of the -external surface.

21. A respiratory aid as claimed in claim 18, 19 or 20 wherein the surface means is a printed label capable of emitting radiation during non-daylight hours, wherein the printed label is applied to the portion of the external surface.

22. A respiratory aid as claimed in any of claims 18 to 21 wherein the surface means is capable of exhibiting fluorescence, luminescence, chemiluminescence, electrochemiluminescence, bioluminescence, triboluminescence, mechanoluminescence or phosphorescence during non-daylight hours .

23. A respiratory aid as claimed in claim 22 wherein the surface means comprises a fluorescent, luminescent, che iluminescent, electrochemiluminescent, bioluminescent, triboluminescent, mechanoluminescent or phosphorescent material.

24. A respiratory aid as claimed in any of claims 1 to 17 wherein the portion of the external surface is intrinsically capable of emitting visible radiation during non-daylight hours.

25. A respiratory aid as claimed in claim 24 wherein the portion of the external surface is caused to emit visible radiation by a physical, biological or chemical stimulus.

26. A respiratory aid as claimed in claim 25 wherein the physical stimulus is an electrical, thermal, mechanical or electromagnetic stimulus.

27. A respiratory aid as claimed in claim 25 wherein the chemical stimulus is a chemical reaction or chemical interaction.

28. A respiratory aid as claimed in claim 24 wherein the portion of the external surface is intrinsically capable of fluorescing, luminescing, chemiluminescing, electrochemiluminescing, bioluminescing, triboluminescing, mechanoluminescing or phosphorescing during non-daylight hours .

29. A respiratory aid as claimed in claim 28 wherein the portion of the external surface comprises a fluorescent, luminescent, chemiluminescent, electrochemiluminescent, bioluminescent, triboluminescent, mechanoluminescent or phosphorescent material or a material capable of inducing fluorescence, luminescence, chemiluminescence, electrochemiluminescence, bioluminescence, triboluminescence, mechanoluminescence or phosphorescence.

30. A respiratory aid as claimed in claim 1 wherein the portion of the external surface comprises an organic or inorganic material capable of emitting visible radiation or of causing visible radiation to be emitted during non- daylight hours.

31. A respiratory aid as claimed in claim 30 wherein the portion of the external surface is a portion of the external surface of an actuator body.

32. A respiratory aid as claimed in claim 31 wherein the inorganic or organic material is incorporated into the material of the actuator body.

33. A respiratory aid as claimed in claim 31 or 32 wherein the material of the actuator body is a polymer.

34. A respiratory aid as claimed in claim 32 or 33 wherein an interaction between the organic or inorganic material and the material of the body leads to emission of visible radiation during non-daylight hours.

35. A respiratory aid as claimed in claim 34 wherein the interaction is a charge transfer.

36. A respiratory aid as claimed in claim 30 wherein the organic material is selected from the group consisting of polyethers, polyacrylates, conjugated polymers and polythiophenes .

37. A respiratory aid as claimed in claim 36 wherein the conjugated polymer is selected from the group consisting of polyaromatics, polyvinyls and polyarylenevinylenes.

38. A respiratory aid as claimed in claim 30 wherein the inorganic material is zinc sulphide optionally doped with a transition metal.

39. A respiratory aid as claimed in claim 38 wherein the transition metal is manganese.

40. A respiratory aid as claimed in claim 30 wherein the inorganic material is selected from the group consisting of rare earth elements and transition metals.

41. A respiratory aid as claimed in claim 40 wherein the inorganic material is selected from the group consisting of europium (EuII, EuIII, Eu²⁺ or Eu³⁺) , erbium (ErIII or Er³⁺) , ytterbium (Ybll or Yb²⁺) , cerium (Celll or Ce³⁺) , praseodymium (Prill or Pr³⁺) , gadolinium (Gdlll or Gd³⁺) , samarium (Smll or Sm²⁺) , ruthenium (RuII, RuIII, Ru²⁺ or Ru³⁺) and chromium (CrII, CrIII, CrNI , Cr²⁺, Cr³⁺ or Cr⁶⁺) .

42. A respiratory aid as claimed in claim 40 wherein the inorganic material is complexed with an appropriate counter- ion.

43. A respiratory aid as claimed in claim 30 wherein the inorganic material is selected from the group consisting of Si0₂, SiC, GaAs or Si.