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(U)PatentNomber: KE 389

(43)D•teofgnn" 22/06/2010

(51)    Int.CI.7: A61M 15/00

(21)Application Number:KE/P/2002/ 000267

(22) Filing Date: 25/09/2002

(30)    Priority data: 20020100159  29/03/2002  GR

(86)  PCT data   
PCT/GR02/00050    25/09/2002WO 03/082389 AI    09110/2003

(54)Title: DRY POWDER INHALER
 
(73)0wner:PENTAFRAGAS, Dimitrios; of Elaionon Street, GR-

190 09 Pikenni Attika, Greece

(72)    Inventor:  PENTAFRAGAS, Dimitrios;

(7 4) Agent/address for correspondence:

Hamilton Harrison & Mathews, P. 0. BOX 30333-00100
NAIROBI
 
(57)    Abstract: An inhalation device for the uptake of medicaments that are in the form of dry powder contained in the

blisters of specially designed single dose blister strips. The device is comprised of a mouthpiece (A), a strip support surface area (B), and one or more storage areas (C). Furthennore, the single dose blister strip is described. It is comprised of two sheets (17, 20) that are fixed in such a manner so that when they get separated the powder becomes available for inhalation.

Dry Powder Inhaler

The present invention refen to an inhaler for the uptake of medicaments in the form of dry powder and to specially designed single dose blister strips that are used with the said inhaler.

The inhaling devices currently used can be separated into two categories:

1.    Those where the pharmaceutical powder is stored in a container out of which a

10    measured amount of powder can be released via specific mechanisms. EP006971 S for example, describes a device in which the powder is metered in given dosages through apertures located in a rotatable disc, these a.penures being introduced into an airduct or channel through which air is inhaled, by rotating the disc.

2.    Those where measured amounts of phannaceutical powder can be stored separately in 1s   special containers. GB2242134 for example, describes a device which uses a flexible strip defining a plurality of pockets  each of which contains a dose of medicament which can

be inhaled. The device contains a chamber in which the strip is housed. an opening station which contains means for peeling the two sheets or the strip apart, and an outlet through which the user can inhale the medicament

20

The major disadvantages of these and other similar devices are that a the user cannot visually verify whether he has received the entire dose of the medicament, and b. they function through complicated internal mechanisms.

25    The advantage of the present invention is that the user can visually check the presence of the medicament in the blister of the strip prior to inhalation and verify after the inhalation that he has received the entire dose of the medicament. Additiona1ly, the device is simple to manufil.cture and easy to operate.

30    The device of the present invention is comprised of three parts: the mouthpiece, through which the powder is inhaled, the blister strip support surface and the strip storage compartrnent(s), which house(s) a large number of blister strips. The three parts are connected to each other and can be independently opened. The support surface contains
an attachment point, where the blister strip is attached with the help of an attachment

35    formation; a cavity. which accommodates the blister of the strip; and strip guides, which secure the proper and firm placement of the strip on the swface.

The single dose blister strip is comprised of two sheets that can be pealed away from each other. The base sheet has a blister which contains the powder. and an attachment
formation which fits to the attachment point of the support surface.  The cover sheet seals
40    the base sheet only in the area around the blister.

'The principle of use is that the user securely attaches the blister strip on the attachment sud'ace, pulls away the cover sheet of the blister by exercising a slight force, checlcs the content of the blister, inhales the medicament, and finaUy verifies that he has received the
entire dose.

45
Figures 1-9 depict examples of the invention.

Figure 1 shows different views of an example of an inhaler.
Figure 2 shows the mouthpiece of the device along with its component parts.

Figure 3 shows the part of the device that contains the area on which the blisters are placed.
Figure 4 shows the blister storage compartment.

Figure 5 shows a single dose blister strip and the way it is put together. Figure 6 shows the process that reveals tbe powder in the blister.
Figure 7 shows the flow of air and powder during the inhalation process.

Figures 8 and 9 are further examples of inhalers based on the principle of the present invention.

10    The inhaler (Figure 1) includes 3 basic parts, the mouthpiece A with its cover, part B with the surface on which the blister strip is placed, and the blister strip storage part C. The parts are connected to each other and can be opened independently.

The mouthpiece (Figure 2) is comprised of parts 1, land 3. Part I locks in part land part IS llocks in part 3.
Part 1 is the external part of the mouthpiece, and may have air openings at its base.

Part l is a cylinder with a w:ider base. The top of the cylinder has an opening 4, which serves as the exit of the powder from the device. Inside the cylinder there is formation 5, which may be of helical or other shape, through which the inhaled powder containing air

20    exits the device. The end of formation S at the base of part l is blocked in half with surface 6.
Part 3 is also a cylinder, which has a wider top.   The interior of part 3 is divided in
chambers 7 and 8, by an upright flat surface 9. The base of part 3 touches the blister. It has two holes, 10 and 11, one on each side of dividing part 9. Hole 11 may contain a

25    sieve, in order to block the passage of larger particles. Chamber 7 contains hole 10, and is blocked at its top with surfuce 6. Furthermore, chamber 7 contains hole ll, which serves as the air entrance.

The single dose blister strip is placed on tbe attachment surface ofpart:B (Figure 3).  This

30    swfuce has a protrusion 13 that serves as the attachment point. a cavity 14 which receives the blister of the strip, and a system of strip guides. 15 and 16 in the specific example. The protrusion, the cavity and the guides enable the correct alignment of the strip on the surfuce of part B and secure its firm placement during the use of the device.

The lower portion of part B can be used as a storage compartment for the blister strips.

JS

The strip storage part C (Figure 4) can be of various shapes. and may contain a grid, depending on the number of strips it accommodates, e.g. 30 or 60.

The blister strip (Figure 5) consists of two sheets (Figure 5A) made of suitable material

40    e.g. PVC. aluminium, polyamide, paper. polyester, vinyl gwn. One of the two sheets is the base sheet 17, which has the blister 18 that contains the powder, and the attachment
hole 19. The other is the cover sheet lO that is fixed to the base sheet, e.g. by heat adhesion, and air-tightly seals only the area around blister 18, as shown in the drawing (Figure 5B, darkened area). Sheet 10 is theo folded by a 180-degn:e rotatinn around axis
45    DE, revealing hole 19 and covering the flat surface of blister 18 (Figure SC).

The process by which the blister~contained powder is exposed takes place in two stages (Figure 6).
 
During the first stage {Figure 6A) and while the mouthpiece is open, the user secures the strip on the support surfilce of part B by placing hole 19 atoWld protrusion 13. Blister 18 is then placed in cavity 14 with the assistance of guides IS and 16.

During the second stage (Figure 68). the user closes the mouthpiece and puJls cover sheet 20 towards the direction of the arrow until it is completely detached.

At this point and after lifting the mouthpiece, the user can verify that the powder contained in blister 18 has been revealed and is available for inhalation (Figure 6C). The user then just closes the mouthpiece and inhales. Finally, by opening again the
10    mouthpiece, he can visually check whether he has inhaled the medicament

During the process of inhalation (Figure 7) the air that is breathed-in enters the mouthpiece via the air openings, and thel'lenters chamber 7 through hole 12. From there
on and passing through hole 10, the air canies along the powder which is located in

15    blister 18 and passing through hole 11 brings it to chamber 8. From there and through formation S, the powder exits the device.

Another example of the invention is shown in Figure 8.  The attachment point for the

blister strip on surfu.ce B is cavity 11.  The mouthpiece A contains projection ll which,

20    when said mouthpiece is closed, enters cavity 11 and in this way secun:s the blister. In this case, the blister is placed on surfilce B with hole 19 above cavity 11. Alternatively, blister strip hole 19 could be replaced by a cavity.

Figure  9 shows  another  embodiment  of the  invention.   In this  case,  the  attaching

25    component of the blister strip is formation 13 that is placed in the openings 14 of guides IS and 16 of surliwe B.

It is obvious that there may be variations relating to the shape and the positions of the attachment point, the cavity and the guides on surface B, which can achieve appropriate

30    and secure attachment of the blister. All these different embodiments are also included in the scope of the present invention.

A funher embodiment of the inhaler would include its use through the nose. This could be achieved by substituting the mouthpiece with the appropriate attachment

CLAIMS

I. An inhalation device for the uptalc.e of medicaments in the form of dry powder, which is characterized by the we of single dose blister strips, and in that it includes a mouthpiece (A) through which the powder is inhaled, a part (B) with a support surface on which the blister strip is placed in such a manner as to remain securely attached, and a strip stomge comparttnent (C).

10    2. An inhalation device according to claim 1, characterised in that the mouthpiece is comprised of three parts (1, 2, 3) which are lockable to each other.

3. An inhalation device according to claim 1 characterised in that the mouthpiece contains a projection (22).

15
4. An inhalation device according to claim I characterised in that the blister strip support surface includes an attachment point (13, 21, 24), a cavity (14) which accommodates the blister and strip guides (15, 16).

20    5. An inhalation device according to claim I, chamcterised in that the single dose blister strip is comprised of a base sheet (17) and a cover sheet (20), which can be separated from each other.

6.    An inhalation device according to claim 5, characterised in that the base sheet (17)

25    defines a blister (18) that contains the powder and an attachment fbnnation (19, 23), and in that the cover sheet (20) air-tightly seals the base sheet only in the area of the blister
(18).

7.    An inhalation device according to claim 5, characterized in that the exposure of

30 the powder takes place by pulling away the cover sheet (20) from the base sheet (17).

8.    A single dose medicament pack for use with a dry powder inhalation device, which is characterized by a base sheet (17) and a cover sheet (20). said sheets being air tightly sealed to one another, in that said base sheet (17) defines a powder containing

35    blister (18) and an """chment formation (19, 23), and in that the cover sheet (20) covers the base sheet around the blister and can be detached from the base sheet

9. A blister strip support surface (B) for a dry powder inhalation device, cheracterized by an attachment point (13, 21, 24), a cavity (14) which accommodates the

40    blister and strip guides (15, 16).

INTERNATIONAL SEARCH REPORT    ,~., ........... ..   
       
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C. DOCUMENT$ caGIOE.fiED TO BE REl~ANT

EP  0  129  985    A    (GLAXO    GROUP  LTD)    1,3-5,9
2 January  !985    (1985-01-02)   
page    5,  line  20    -page    6,  line  12;    figure  7
page    5,  line    29-  11ne  33    6, 7

WO 00 64779 A (BONNEY STANLEY GEORGE ;DAVIES MICHAEL BIRSHA (GB); GODFREY JAMES W) 2 November 2000 (2000-11-02)
page  10,  line  II  -  line  24;  figure  I
page 12, line 12 - line 18; figures 6,7 3C,4A,48

WO 98 34663 A (WIDERSTROEM CARIN ;ASTRA AB (SE)) 13 August 1998 (1998-08-13)
page  7,  line  4 -  line  19;  figure  8


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