Title of Invention

"MOUTHPIECE FOR USE IN AN INHALER FOR A PARTICULATE MEDICAMENT AND METHOD OF DISPERSING PARTICULATE MEDICAMENT USING SAID MOUTHPIECE"

Abstract A mouthpiece for use in an inhaler for a particulate medicament, the mouthpiece having: an inlet and an outlet for the particulate medicament; a number of abutments which extend across the mouthpiece and which are arranged in a staggered configuration such that, in use, medicament is caused to break up as the medicament passes through the mouthpiece; wherein the abutments are blades having an elongate cross section in the direction of travel of the medicament.
Full Text MOUTHPIECE FOR A PARTICULATE INHALER
This invention relates to particulate inhalers and, in particular, to a mouthpiece for such an inhaler, the mouthpiece being provided with means for ensuring that the particle size of the entrained medicament is minimised.
Mouthpieces^ for, inhalers in the prior art have used many different means for breaking up the particulate medicament which is being inhaled by the patient. Such means include the use of staggered teeth, screens, baffle plates, and filters.
In particular, as disclosed in EP 0237507, it is known to provide one or more deflector devices which are arranged in a stationary configuration within a mouthpiece of the inhaler such that the air flow is accelerated in the region of the deflector devices due to a constriction of the cross section of the mouthpiece. The air flow is caused to accelerate centripetally such that particles or aggregates of the compound are ground into smaller particles by colliding with each other and/or by impacting on the walls of the deflector devices.
A major disadvantage with such an arrangement is that, because the flow area through the mouthpiece is constricted, there is an increase in the inhalation resistance which means that it is more difficult for patients having respiratory diseases to obtain the correct dosage of the medicament.
WO 97/25086 discloses a powder inhalation device which includes a series of baffles past which the air flow with entrained medicament is caused to flow. The flow passes along one surface of each baffle until it contacts a further baffle, causing the air flow,, to change flow direction within a delivery conduit. Such changes in flow
direction reduce the flow rate of the medicament and increases the inhalation resistance.
Accordingly, the present invention is directed to providing a mouthpiece for use in an . inhaler for particulate medicament to break up agglomerations of drug particles but without creating an increased inhalation resistance during use.
According to the present invention, there is provided a mouthpiece for use in an inhaler for a particulate medicament, the mouthpiece having:
an inlet and an outlet for the particulate medicament;
a number of abutments which extend across the mouthpiece and which are arranged in a staggered configuration such that, in use, medicament agglomerations are caused to break up as the medicament passes through, the mouthpiece;
characterised in that the abutments are blades having an elongate cross section in the direction of travel of the medicament from the inlet to the outlet and around which, in use, medicament is caused to pass.
Medicament may collide with a surface of at least one of the abutments to encourage deagglomeration. Alternatively, a portion of the medicament may be deflected such that it collides with either a wall of the mouthpiece or with other agglomerates of medicament. Further, the deagglomeration may be caused by a shearing action of the air as it passes over agglomerations of medicament.
Preferably, the blades are provided with leading and/or trailing edges which are sharp. This ensures that little or no deposition of medicament is generated on either of the edges. A circular cross section of the blades was tested, but it was noted that, static zones were created in the air flow around the abutments, leading to significant deposition of medicament on the leading and
trailing edges. A further disadvantage of the circular cross-section is that the abutments are not sufficiently aerodynamically shaped so as not to affect the inhalation resistance. Accordingly, the elongate arrangement of the blades of the present invention provides the optimum solution.
—Preferably, the—blades are arranged such that the longer axes of their cross-section are parallel to the air flow through the mouthpiece.
The blades may be arranged in columns, from the inlet to the outlet.
Preferably, the longer axes of the cross-sections of adjacent blades in the same column are separated, in a direction perpendicular to the planes in which the blades lie, by between 1.5mm and 2.5mm, and more preferably by between 1.8mm and 2.2mm. The longer dimension of the
cross-section of the blades may be between 3.8mm and 4.8mm, preferably between 4.1mm and 4.5mm.
The shorter axes of the cross-sections of blades in adjacent columns may be separated, in the direction of the air flow, by between 4mm and 5mm, preferably by 4.5mm. The shorter dimension of the cross-section of the blades may be between 0.6mm and 1.2mm, preferably 0.9mm.
Preferably, particle deflectors project from the inner surface of the wall of the mouthpiece such that they act as extra blades. The provision of these additional particle deflectors ensures that there is no straight line path in the direction of the air flow through the mouthpiece for the particulate medicament such that the flow of the medicament must always be disrupted.
One embodiment of the present invention will now be described with reference to the accompanying drawings in which:
Fig. l is a cross sectional view through part of an inhaler having a mouthpiece according to the present invention;
Fig. 2 is a perspective view of the arrangement of the blades in the present invention;
Fig. 3 is a cross sectional view of a mouthpiece according to the present invention; and
Fig. 4 is a perspective view of one half of a mouthpiece.
As can be seen from Fig. 1 and Fig. 2, an inhaler 10 is provided with a mouthpiece 11 having a passageway 12 through which particulate medicament (not shown) , entrained in an air stream, is drawn in use. The passageway 12 has an inlet 13 and an outlet 14. The inlet 13 of the mouthpiece is in fluid communication with-a supply tube 15 through which the particulate medicament is drawn, entrained in an air flow. A number of blades 16 are provided extending across the passageway 12. The blades 16 are arranged in a staggered configuration such that the air flow, indicated by arrow 17 in Fig. 2, is forced to take a
tortuous path from the inlet 13 to the outlet 14 of the mouthpiece 11. The blades 16 are elongate in cross-section in the direction of air flow and have leading 18 and trailing 19 edges which are sharp.
In Fig. 3, the arrangement of the blades 16 can clearly be seen. Additional particle deflectors 20 are provided near the nominally upper and lower regions of the mouthpiece 11. These deflectors 20 may take the form of a half blade such that they have the same outer curved surface.
Fig. 4 shows a perspective view of one half of the mouthpiece 11. As can be clearly seen, the blades 16 and the particle deflectors 20 are formed so as to abut with the corresponding inner surface of the other half of the mouthpiece 11. Such an arrangement ensures that no particles entering the inlet 13 can travel to the outlet 14 without having their flow disrupted by at least one surface of either the blade 16 or the particle deflector 20.






WE CLAIM:

1. A mouthpiece for use in an inhaler for a particulate medicament,
the mouthpiece having:

an inlet and an outlet for the particulate medicament;
a number of abutments which extend across the mouthpiece and
which are arranged in a staggered configuration such that, in use,
medicament agglomerations are caused to break up as the medicament
passes through the mouthpiece;
characterised in that the abutments are blades having an elongate cross section in the direction of travel of the medicament from the inlet to the outlet and around which, in use, medicament is caused to pass.
2. A mouthpiece as claimed in claim 1, wherein the blades are
provided with leading and/or trailing edges which are sharp.
3. A mouthpiece as claimed in claim 1 or claim 2, wherein the
blades are arrranged in columns, from the inlet towards the outlet.
4. A mouthpiece as claimed in any one of claims 1 to 3, wherein the
longer axes of the cross-sections of the blades are parallel to the air
flow through the mouthpiece.
5. A mouthpiece as claimed in any one of claims 1 to 4, wherein the
longer axes of the cross-sections of adjacent blades in the same
column are separated, in a direction perpendicular to the planes in
which the blades lie, by between 1.5mm and 2.5mm.
6. A mouthpiece as claimed in claim 5, wherein the longer axes of the blades are separated by between 1.8mm and 2.2mm.
7. A mouthpiece as claimed in any one of claims 1 to 6, wherein the longer dimension of the cross-sections of the blades is between 3.8mm and 4.8mm.
8. A mouthpiece as claimed in claim 7, wherein the longer dimension of the blades is between 4.1mm and 4.5mm.
9. A mouthpiece as claimed in any one of claims 1 to 8, wherein the shorter axes of the cross-sections of blades in adjacent columns are separated, in the direction of the air flow, by between 4mm and 5mm.
10. A mouthpiece as claimed in claim 9, wherein the shorter axes of the blades are separated by 4.5mm.

11. A mouthpiece as claimed in any one of claims 1 to 10, wherein the shorter dimension of the cross-sections of the blades is between 0.6mm and 1.2mm.
12. A mouthpiece as claimed in claim 11, wherein the shorter dimension of the blades is 0.9mm.
13. A mouthpiece as claimed in any one of claims 1 to 12, wherein particle deflectors project from the inner surface of the wall of the mouthpiece.
14. A method of dispersing particulate medicament using a
mouthpiece as claimed in any one of claims 1 to 13, wherein deagglomeration is caused by one or more of the following: medicament collision with one or more blades, medicament collision with a wall of the mouthpiece, collisions between medicament particles and a shearing action of the air as it passes over agglomerations of medicament.

Documents:

abstract.jpg

in-pct-2002-822-del-abstract.pdf

in-pct-2002-822-del-claims.pdf

in-pct-2002-822-del-complete specification(as filed).pdf

in-pct-2002-822-del-complete specification(granted).pdf

in-pct-2002-822-del-correspondence-others.pdf

in-pct-2002-822-del-correspondence-po.pdf

in-pct-2002-822-del-description (complete).pdf

in-pct-2002-822-del-drawings.pdf

in-pct-2002-822-del-form-1.pdf

in-pct-2002-822-del-form-19.pdf

in-pct-2002-822-del-form-2.pdf

in-pct-2002-822-del-form-3.pdf

in-pct-2002-822-del-form-5.pdf

in-pct-2002-822-del-gpa.pdf

in-pct-2002-822-del-pct-210.pdf

in-pct-2002-822-del-pct-408.pdf

in-pct-2002-822-del-pct-409.pdf

in-pct-2002-822-del-pct-416.pdf


Patent Number 199563
Indian Patent Application Number IN/PCT/2002/00822/DEL
PG Journal Number 33/2007
Publication Date 17-Aug-2007
Grant Date 06-Apr-2007
Date of Filing 20-Aug-2002
Name of Patentee ANDI-VENTIS LIMITED
Applicant Address FORTUNA COURT, BLOCK B, 284 MAKARIOS AVENUE, LIMASSOL, CYPRUS,
Inventors:
# Inventor's Name Inventor's Address
1 MCDERMENT, IAIN GRIERSON 2 MORTLOCK STREET, MELBOURN, ROYSTON, HERTS SG8 6DB, U.K.
2 MORTON, DAVID ALEXANDER VODDEN 2ND FLOOR FLAT, LINSLEY HOUSE, BEECHEN CLIFF ROAD, BATH BA2 4QR, U.K.
3 STANIFORTH, JOHN NICHOLAS HIGH TREES, 170 BLOOMFIELD ROAD, BATH BA2 2AT, U.K.
PCT International Classification Number A61M 15/00
PCT International Application Number PCT/GB01/01215
PCT International Filing date 2001-03-20
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 00302979.0 2000-04-07 EUROPEAN UNION