AU771799B2 - Single dose inhaler II - Google Patents

Description

AUSTRALIA

PATENTS ACT 1990 REGULATION 3.2 Name of Applicant: Actual Inventor/s: Address for Service: ASTRA AKTIEBOLAG MAGNUS JAHNSSON E.F. WELLINGTON CO., Patent and Trade Mark Attorneys, 312 St. Kilda Road, Melbourne, Southbank, Victoria, 3006.

Invention Title: "SINGLE DOSE INHALER II" Details of Associated Provisional Applications Nos: The following statement is a full description of this invention including the best method of performing it known to us.

-1- SINGLE DOSE INHALER 11 The present invention relates to a disposable inhaler, Particularly for administering powder by inhalation.

Previously, as described in W093/17728 and illustrated in Figures 1 to 3 of the accompanying drawings, there was known a disposable inhaler constructed from two parts 1 and 2. The lower part 2 includes a recesses 3 in which a dose of powder is stored and the two parts together define a channel through which a streamn of air may'be drawn by a user from an air inlet 4 to a mouthpiece 5. A tape 6 is provided to cover the recesses 3 and is additionally bent around the outside of the part 2 to cover an aperture 8 in the bottom of the recess 3. In use, the tape 6 is pulled away from the lower part 2 so as to expose both the aperture 8 and the recess 3. Projections 7 are provided to keep the loose tape out of the way of the air flow and a depression 9 directs the air flow to pick up the powder in the recess 3 more effectively. The channel defined by parts 1 and 2 also includes a deagglomeration 1s section 10 having a section inlet 11, a section outlet 12 and a divider 13. The divider 13 splits the stream of air into two flow paths and powder is caused to impact on internal *.surfaces. In this way, powder is effectively deagglomnerated.

In use, a patent inhales through the mouthpiece 5 causing an air stream to pick up the powder stored in recess 3. As the air/powder mixture flows through the inhaler, powder is deagglomerated, then passes out of the mouthpiece 5 and into the lungs of the patient.

An object of the present invention is to simplify use of the inhaler such that it is more difficult to use the inhaler incorrectly.

The present invention is based on a recognition that it is possible that a user will not insert an inhaler, such as illustrated in Figures I to 3, sufficiently far into his or her mouth.

This is in contrast to many other types of inhaler where mouthpieces are provided to give the user an indication of how far the inhaler should be inserted to thereby prevent the inhaler being inserted too far. The present invention recognises that, with small flat inhalers of the type illustrated in Figures 1 to 3, it is important that the inhaler outlet passes beyond the tongue, whereas for other larger. types of inhaler, when the mouth is opened sufficiently wide to insert the inhaler, the tongue naturally moves out of the way of the flow of air from the inhaler to the lungs.

According to the present invention, there is provided a method of indicating to a user how far to insert into the mouth an inhaler having a body extending in a first direction between an air inlet and an air/powder outlet, the outer cross-section of the body at substantially every position along the length of the body being elongate in a second direction substantially perpendicular to said first direction, the method comprising displacing the body at a predetermined distance from the air/powder outlet in a third direction perpendicular to said first and second directions.

According to the present invention there is also provided an inhaler for administering powder by inhalation, the inhaler comprising: a body extending in a first direction between an air inlet and an air/powder outlet, the outer cross-section of the body at substantially every position along the length of the body being elongate in a second direction substantially perpendicular to said first direction; s wherein at a predetermined distance from the air/powder outlet, the body is displaced in a third direction perpendicular to said first and second directions so as to provide a guide to the user as to how far the body should be inserted into the mouth of the user.

In this way, the overall construction, simplicity and effectiveness of the inhaler remains unchanged and yet it is immediately apparent to the user to what extent the inhaler should be inserted into his or her mouth. In particular, where the body of the inhaler is I displaced downwardly, it will be immediately apparent to the user that the inhaler should be inserted in to his, or her mouth until that downward displacement of the body lies immediately adjacent his or her lower lip.

In this way, it is ensured that the outlet of the inhaler is above the tongue, such that the air powder mixture will travel down into the lungs of the user, rather than be deposited on his or her tongue.

Preferably, the body is shaped such that a plane exists wholly within the body.

In this way, despite the displacement in the body, it is still possible to construct the body from two parts, each having respective portions lying in respect planes for joining together.

Preferably, at a second predetermined distance further than said first predetermined s distance from the outlet, the body is bent in a direction opposite to said third direction.

In this way, the inhaler is formed with a gentle S-bend along its length and retains its generally flat planar elongate shape.

Although not directly relevant to the present invention, it should be noted that medicaments suitable for administration by an inhaler using the present invention are any which may be delivered by inhalation. Suitable inhalable medicaments may include for example P2-adrenoreceptor agonists for example salbutamol, terbutaline, rimiterol, fenoterol, reproterol, adrenaline, pirbuterol, isoprenaline, orciprenaline, bitolterol, salmeterol, formoterol, clenbuterol, procaterol, broxaterol, picumeterol, TA-2005, S. mabuterol and the like, and their pharmacologically acceptable esters and salts; 15 anticholinergic bronchodilators for example ipratropium bromide and the like; glucocorticosteroids for example beclomethasone, fluticasone, budesonide, tipredane, dexamethasone, betamethasone, fluocinolone, triamcinolone acetonide, mometasone, and the like, and their pharmacologically acceptable esters and salts; anti-allergic medicaments i for example sodium cromoglycate and nedocromil sodium; expectorants; mucolytics; antihistamines; cyclooxygenase inhibitors; leukotriene synthesis inhibitors; leukotriene antagonists, phospholipase-A2 (PLA2) inhibitors, platelet aggregating factor (PAF) iantagonists and prophylactics of asthma; antiarrhythmic medicaments, tranquilisers, cardiac glycosides, hormones, antihypertensive medicaments, antidiabetic- antiparasiticand anticancer-medicaments, sedatives and analgesic medicaments, antibiotics, antirheumatic medicaments, immunotherapies, antifungal and antihypotension medicaments, vaccines, antiviral medicaments, proteins, polypeptides and peptides for example peptide hormones and growth factors, polypeptides vaccines, enzymes, endorphines, lipoproteins and polypeptides involved in the blood coagulation cascade, vitamins and others, for example cell surface receptor blockers, antioxidants, free radical scavengers and organic salts of N,N'diacetylcystine.

The present invention will be more clearly understood from the following description.

given by way of example only, with reference to the accompanying drawings in which: Figure I illustrates a previous inhaler; Figure 2 illustrates the previous inhaler of Figure 1 separated into two parts;, Figures 3a, 3b and 3c illustrate a cross-section of the inhaler of Figure 1; Figure 4 illustrates an inhaler similar to that of Figure 1 embodying the present invention; Figure 5 illustrates an embodiment of the present invention; Figure 6 illustrates an embodiment of the present invention; and Figure 7 illustrates schematically a cross-section of an embodiment of the present invention.

The inhaler illustrated in Figure 4 is similar to that illustrated in Figure 1, but at a position upstream of the inhaler outlet, the inhaler body is displaced downwardly.

***The inhaler is constructed from. a first part 20 and a second part 22. The first part and second part 22 are preferably moulded from a transparent plastics material such that the channels of the inhaler may be inspected before and after use. The first part 20 and second part 22 are joined together to form the inhaler-illustrated in Figure 4.

The inhaler has an air inlet 24 and an outlet 26. Furthermore, like the inhaler of Figure 1, the second part 22 includes a depression 28 for containing a dose of medicamnent, preferably in powdered form.

A tape 30 is provided to seal the depression 28 and extends out of the air inlet 24.

In use, the tape 30 is pulled out of the air inlet 24 so as to peel it away from the depression 28 and expose the powder contained in that depression. The outlet 26 is then placed into the mouth of the patient and the patient inhales through the inhaler. When the patient inhales, air is drawn in through the air inlet 24 and picks up the powder from the depression 28. The air powder mixture is drawn through the inhaler through a deagglomeration section 32 and out of the outlet 26.

In order to prevent the loose tape 30 from impeding the air flow into the air inlet 24, projections 34 are provided to hold the loose tape close to the inner surface of the lower part 22.

As illustrated, a restriction 36 is provided in the inhalation channel at the position of the depression 28. This is to direct the air flow down towards the depression 28 so as to assist in ensuring that the powder in the depression 28 joins the air flow through the inhaler.

The deagglomeration section 32 is provided to break down any larger powder parti ,cles into their constituent fine powder particles. In particular, the deagglomreration section 32 is provided with a divider 38 which divides the air stream into two paths and causes powder, carried by the air stream to impact with internal walls of the inhaler.

As illustrated, the inhaler of Figure 4 has a generally flat elongate form. This makes it easy to store and pleasing to patients. It may be constructed with a relatively small overall size which is advantageous to patients, particularly those who have to carry a number of such inhalers with them on a day to day basis. However, although the elongate crosssection and outlet are very pleasing and advantageous to the user, since they may very easily be inserted to the mouth, it is important that the outlet 26 of the inhaler extends beyond the tongue.

With an inhaler of this form, i.e. one which extends in a generally first direction *.*between the air inlet 24 and the outlet 28 and has a generally flat construction such that it extends in an elongate manner in a direction perpendicular to the first direction, a patient does not open his or her mouth to any great extent, such that the tongue is not naturally moved down away from the flow of air between the mouth and the lungs. Thus, as illustrated in Figure 4, unlike previous inhalers of this general form, the inhaler is not completely flat along its length, but, at position 40, is deflected downwards, such that it is displaced in a third direction perpendicular to both the first and second directions. This deflection or displacement provides a downwardly extending wal 42, which, in use, may be pressed against the lower lip of the user. In this way, the user can assuredly insert the inhaler into his or her mouth by the correct amount. Indeed, because of the shape of the inhaler, it will feel strange to insert the inhaler by less than the correct amount.

Thus, in use, the inhaler will be inserted with the outlet 26 over and clear of the user's tQngue, rather than a position where-the user's tongue could still impede the flow of air/Powder from the outlet 26 into his or her lungs.

Since it is desirable that the inhaler retains its generally flat form, at position 44, the inhaler is deflected back upwardly such that it is displaced or bent in a direction opposite to the third direction. In this way, the inhaler may have the required function and yet retain a pleasing gentle s S-bend form.

Clearly, as described above, the present invention applies to any inhaler having the generally flat form described above, in particular inhalers where the portion to be inserted into the mouth is generally flat with a shallow elongate cross-section. It is not essential to the invention how medicament is stored or released into the inhalation channel of the inhaler, nor is it essential to the invention that, where the medicament is in powdered form, it is deagglomerated as described above. Nevertheless, it is particularly advantageous with dry powder inhalers of the general form discussed above.

Figures 5 and 6 illustrate two other inhalers embodying the present invention.

Figure 7 illustrates a cross-section of an inhaler according to the present invention. As S 15 illustrated, a plane 46 exists which passes within the inhaler. Shaping the inhaler with such a plane is highly advantageous, since, as illustrated, the inhaler can be formed from first and second 22 parts which can still be joined at a flat surface. This makes the moulding and construction steps much more straightforward.

Figure 7 also illustrates some preferred dimensions or inhalers of this type. In general, such inhalers should be between 50mm and 120mm in length, 3mm and 20mm in height :and 10mm and 40mm in width. More preferably, they should be between 60mm and in length, 3mm and 12mm in height and 12mm and 30mm in width or in the region or more preferably still, they should be in the region of 80mm in length, 5mm in height and 20mm in width. Of course, the width to height ratio is of some importance and should be between 2 to 13, 3 to 10 or preferably in the region of 4. Preferably, at position 40, there is an inner radius of curvature 48 of approximately 5mm and an outer radius of curvature of approximately 8mm. Similarly, at position 44, there is an inner radius of curvature 52 of approximately 5mm and an outer radius of curvature 54 of approximately 8mm.

To obtain the correction length of insertion of the outlet 26 into the mouth of a patient, the downwardly extending wall 42 should occur at approximately 30mm from the outlet 26. It may be sufficient to have the downward deflection at a position in the region of to 60mm, with increasing preference for the ranges 20mm to 50mm, 25mm to and 25mm to With reference to the use of the word(s) "comprise" or "comprises" or "comprising" in the foregoing description and/or in the following claims, unless the context requires otherwise, those words are used on the basis and clear understanding that they are to be interpreted inclusively, rather than exclusively, and that each of those words is to be so interpreted in construing the foregoing description and/or the following claims.

Claims (16)

1. An inhaler for administering powder by inhalation, the inhaler comprising: a body extending in a first direction between an air inlet and an air/powder outlet, an outer cross-section of the body at substantially every position along a length of the body being elongate in a second direction perpendicular to said first direction; wherein, at a first predetermined distance from the air/powder outlet, the body is displaced in a third direction perpendicular to said first and second directions, forming a wall, the wall in use contacting a lip of the user so as to provide a guide to the user as to how far the body should be inserted into a mouth of the user wherein, at a second predetermined distance further than said first predetermined distance from the outlet, the body is displaced in a direction opposite to said third direction.

2. An inhaler according to claim 1 wherein the body forms a generally S-shaped bend along its length.

3. An inhaler according to claim 1 or 2, wherein the body is shaped such that a plane exists 000 wholly within the body. S: 0 o 0

4. An inhaler according to any preceding claim wherein, where the body is displaced in the third direction, the outer surface of the body bends with an inner radius of curvature of approximately 5 mm and an outer radius of curvature of approximately 8 mm. .i

5. An inhaler according to any preceding claim, wherein said first predetermined distance 000 from the outlet is 20 mm to 60 mm. •ooVo•

6. An inhaler according to claim 5 wherein said first predetermined distance from said outlet is about 30 mm.

7. The inhaler of claim 5 wherein said first predetermined distance from the outlet is 20 mm to 50 mm.

8. The inhaler of claim 7 wherein said first predetermined distance is 25 mm to 45 mm.

9. The inhaler of any preceding claim wherein the body includes a first part and a second part, the first and second parts defining an inhalation channel therebetween. An inhaler for administering powder by inhalation, the inhaler comprising: a body extending in a first direction between an air inlet and an air/powder outlet, an outer cross- section of the body at substantially every position along a length of the body being elongate in a second direction perpendicular to said first direction; wherein, at a predetermined distance from the air/powder outlet, the body is displaced in a third direction perpendicular to said first and second directions, forming a wall, the wall in use contacting a lip of the user so as to provide a guide to the user as to how far the body should be inserted into a mouth of the user; wherein the body includes a first part and a second part, the first and second parts defining an inhalation channel therebetween; .o. e wherein either the first part or the second part defines a recess that contains a dose of powder, the dose of powder comprising a pharmaceutically active substance.

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11. The inhaler of claim 10 wherein the substance is systemically active.

12. An inhaler for administering powder by inhalation, the inhaler comprising: *ooo a body extending in a first direction between an air inlet and an air/powder outlet, an outer e. cross-section of the body at substantially every position along a length of the body being elongate in a second direction perpendicular to said first direction; wherein, at a predetermined distance from the air/powder outlet, the body is displaced in a third direction perpendicular to said first and second directions, forming a wall, the wall in use contacting a lip of the user so as to provide a guide to the user as to how far the body should be inserted into a mouth of the user wherein the body defines an inhalation channel extending from the air inlet to the air/powder outlet, the inhalation channel having an upper wall and a lower wall, the upper and lower walls extending in both said first and said second directions, wherein a plane defined by said first and second directions passes through said channel without contacting the upper or the lower wall.

13. An inhaler for administering powder by inhalation, the inhaler comprising: a body extending in a first direction between an air inlet and an air/powder outlet, an outer cross- section of the body at substantially every position along a length of the body being elongate in a second direction perpendicular to said first direction; wherein, at a predetermined distance from the air/powder outlet, the body is displaced in a third direction perpendicular to said first and second directions, forming a wall, the wall in use contacting a lip of the user so as to provide a guide to the user as to how far the body should be inserted into a mouth of the user; wherein said predetermined distance is 25 mmn to 35 mm.

14. A method of indicating to a user how far to insert into a mouth of the user an inhaler having a body extending in a first direction between an air inlet and an air/powder outlet, an outer cross-section of the body at substantially every position along a length of the body being elongate in a second direction substantially perpendicular to said first direction, the method comprising: displacing the body at a predetermined distance from the air/powder outlet in a third direction perpendicular to said first and second directions so as to form a wall, the wall during use contacting a lip of the user thereby indicating to the user how far the body should be inserted into the user's mouth further comprising inserting the body into the user's mouth such that the wall contacts a lip of the user, and the outlet is located beyond a tongue of the user.

An inhaler for administering powder by inhalation the inhaler comprising: 11 11 a first end sized and shaped to fit within a user's mouth, the first end defining an air/powder outlet; a second end defining an air inlet; a generally flat, elongate body that defines an inhalation channel between the inlet and the outlet, the body including a projection spaced a predetermined distance from the outlet, the predetermined distance being sufficiently long such that inserting the first end into a user's mouth until the projection contacts the user's lip locates the outlet beyond the user's tongue, thereby preventing the user's tongue from blocking delivery of the powder.

16. The inhaler of claim 15 wherein the predetermined distance is 20-50 mm. DATED this 9 day of February 2004 ASTRA AKTIEBOLAG, By its Patent Attorneys, F. WELLINGTON CO., (Bruce Wellington) *ee s*