WO2005092413A1

WO2005092413A1 - Dispenser

Info

Publication number: WO2005092413A1
Application number: PCT/GB2005/001039
Authority: WO
Inventors: William Henry Southby; Simon James Ingram; Richard Iain Harrison
Original assignee: Bespak Plc
Priority date: 2004-03-26
Filing date: 2005-03-18
Publication date: 2005-10-06
Also published as: GB0406881D0; GB2412326A

Abstract

A hand-held pharmaceutical dispenser (1) comprising first (10) and second (20) portions moveable relative to each other and defining an air chamber with rigid internal walls (26) therebetween. The second portion has an annular seal (27) to seal against the first portion to seal a volume of air in the air chamber (26). One of the first and second portions is arranged to support or include a container (14) for a medicament (15) to be dispensed. The first and second portions are arranged such that relative movement towards each other moves the first portion relative to the annular seal of the second portion reducing the sealed internal volume of the air chamber and compressing the air in the air chamber until a shoulder (35) on the first portion encounters the annular seal on the second portion opening a flow path for the compressed air in the air chamber to be released with or after medicament dispensed from the container.

Description

Dispenser

This invention relates to a dispenser. In particular, this invention relates to a hand held pharmaceutical dispenser for discharging a pharmaceutical product in liquid or power form with or followed by a discharge of compressed air. The dispenser may be used in an inhaler, such as a nasal inhaler. Dispensers which dispense a medicament with compressed air are known. However, they can generally only produce a limited pressure of compressed air and generally cannot control the precise pressure at which the compressed air is released for each use. This makes it difficult to produce targeted medicament delivery as would be advantageous, for example, when it is desired to direct medicament to a particular part of a nasal cavity. It is an object of the present invention to reduce or overcome at least some of the disadvantages discussed above. According to a first aspect of the present invention there is provided a hand held pharmaceutical dispenser comprising first and second portions moveable relative to each other and defining an air chamber with rigid internal walls therebetween; the second portion having an annular seal to seal against the first portion to seal a volume of air in the air chamber; and one of the first and second portions being arranged to support or include a container for a medicament to be dispensed, wherein the first and second portions are arranged such that relative movement of the first and second portions towards each other moves the first portion relative to the annular seal of the second portion reducing the sealed internal volume of the air chamber and compressing the air in the air chamber until a shoulder on the first portion encounters the annular seal on the second portion opening a flow path for the compressed air in the air chamber to be released with or after medicament dispensed from the container. As the air chamber has rigid internal walls and as the flow path for the pre- compressed air is opened at a predetermined point in the movement of first and second portions towards each other at which the shoulder encounters the annular seal, the pre- compressed air is released at a predetermined pressure. Pre-compressing air in the air chamber a predetermined amount prior to releasing it with or after the medicament creates a bolas of air aiding targeted medicament delivery. Furthermore, as the air chamber has rigid internal walls, greater levels of pre-compression can be achieved than with air chambers with flexible internal walls. The pre-compressed air may also scavange medicament out through the nozzle, reducing ullage. The compressed air and medicament could be delivered from the same outlet or from different outlets, and the compressed air may be dispensed from a plurality of outlets surrounding the medicament outlet which directs the delivery of medicament. The dispenser may have one or more outlets provided on an end portion of a nozzle with a compliant or resilient seal provided around the nozzle such that, in use, the outlet of the nozzle may be inserted into a user's orifice such as a nostril or the mouth while the seal seals the orifice. The seal prevents the user varying the inhalation flow rate so that the emitted dose would be more reproducible. The resilient seal may be provided on a shoulder of the nozzle, is preferably annular and may be made from any suitable compliant or resilient material. According to a second aspect of the present invention there is provided a handheld pharmaceutical dispensing apparatus comprising an outlet for emitting medication provided on an end portion of a nozzle and a compliant or resilient seal provided around the nozzle such that, in use, the outlet of the nozzle may be inserted into an orifice of a user, such as a nostril or the mouth, while the seal seals the orifice. The seal is preferably to be used externally of the orifice to seal against its outside surface. Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a cross-sectional view of a first embodiment of a dispenser according to the present invention before actuation; Figure 2 is a cross-sectional view of the dispenser shown in Figure 1 after actuation and Figure 3 is a cross-sectional view of a second embodiment of a dispenser according to the present invention with a seal around its nozzle portion As shown in Figure 1, a dispenser 1 illustrating the present invention comprises a base 10 and an actuator 20. The base 10 includes an end portion 11 and an annular sealing portion 12, the periphery of which is arranged to seal against the inside surface of a cylindrical skirt 21 of the actuator 20. The base 10 also includes an elongate support 13 for a container or vial 14 into which, in use, a liquid or powdered medicament 15 is provided. In this example the medicament 15 is sealed in the vial 14 with a closure member 16. In this example the closure member 16 has three resilient annular projections 17 which seal against the inside surface of the vial 14 to prevent medicament 15 from leaking out. The closure member 16 also has a further seal 18 with a passage 19 therethrough having two inlets 22 and an outlet 23. However, any suitable means for sealing the medicament 15 in the vial 14 as is known to those skilled in the art will be suitable. The actuator 20 comprises the cylindrical skirt 21 with an annular shoulder 24 connecting the skirt 21 with a nozzle portion 25. The cylindrical skirt 21 of the actuator 20 defines an air chamber 26 therein which is sealed at its lower end by the outer periphery of the base's annular sealing portion 12 and at its upper end by an annular seal 27 which engages the outside of the support 13 for the vial 14. As shown in Figure 1, the support 13 and vial 14 are arranged to be fitted through the annular seal 27 to extend into the nozzle portion 25 of the actuator 20. At the top of the nozzle portion 25 there is provided an outlet 28. A plunger 29 comprising an outlet channel 30 with a mechanical break-up portion 31 therein is provided below the outlet 28 on the inside of the nozzle portion 25. The mechanical break-up portion 31 reduces the effective diameter of the outlet channel 30, through which, in use, the medicament 15 passes, creating smaller dispensed liquid droplet particles. The lower end of the mechanical break-up portion 31 has an annular conical projection 32 to engage a corresponding annular grove 33 in the top of the closure member 16 and a passage 34 to connect the outlet 23 of the closure member 16 to the outlet 28 of the nozzle portion 20. In use a user displaces the base 10 and actuator 20 towards each other. This may be done by a user placing a thumb on the end portion 11 of the base 10 and a finger over each side of the annular shoulder 24 and displacing the two towards each other. The medicament 15 may be released from the vial 14 by any method known to those skilled in the art. In this example as the base 10 and actuator 20 are displaced towards each other, the vial 14 and closure member 16 are displaced up the nozzle portion 25 until the annular groove 33 at the top of the closure member 16 engages the annular conical projection 32 at the lower end of the mechanical break-up portion 31. Further displacement of the base 10 into the actuator 20 increases the pressure of the medicament 15 in the vial 14 deflecting resilient annular projections 17 and opening a flow path from the medicament 15 to the outlet 28. As the base 10 and actuator 20 are displaced towards each other the volume of the air chamber 26 is reduced compressing the air therein. The elongate support 13 has a shoulder 35 thereon with a reduced cross-sectional area below the shoulder 35. When the base 10 is displaced into the actuator 20 to the extent that the shoulder 35 passes the seal 27, the reduced cross-sectional area below the shoulder 35 creates an air path from the air chamber 26 to the nozzle portion 25. The compressed air in the air chamber 26 is expelled from the air chamber 26, into the inside of the nozzle portion 25, up the outlet channel 30, around the mechanical break-up portion 31 and out of the outlet 28. Precompressing the discharged air a predetermined amount enables the medicament 15 to be delivered with or followed by a bolus of air to assist targeted drug delivery and deposition. Precompressing the discharged air may also assist in scavaging the medicament 15 out through the nozzle 25 reducing ullage by the passage of pre-compressed air creating low pressure to suck medicament 15 out of the vial 14 or by passing the pre-compressed air through the vial 14. One or more of the positioning of the shoulder 35 on the support 13, the length of the plunger 29 or the positioning of the vial 14 may be adjusted to vary the relative timings of the discharge of the medicament 15 and the compressed air from the air chamber 26. For example, the dispenser may be arranged such that the medicament 15 and air are mixed in the outlet channel 30 or such that air is supplied after the emitted medicament 15 depending upon which is most suitable for the particular medicament to be dispensed and the manner in which the dispenser is to be used. The volume of the air chamber 26 may be varied to any predetermined size and/or the pre-actuation pressure of the air in the air chamber 26 may be varied to produce any pre-determined level of precompression. The ability to produce a predetermined precompression enables the medicament 15 to be discharged from the dispenser in a particular manner, in this example to direct the medicament 15 to targeted portions of the nasal cavity. The dispenser may be used to deliver a liquid or a powdered medicament. If the dispenser 1 is used with powdered medicament 15, the air from the air chamber 26 may be directed through the vial 14 to entrain the powdered medicament 15 in the discharged air. This assists discharge of the powdered medicament 15. This may be achieved by any convenient method known to those skilled in the art. Figure 2 shows the dispenser 1 after the medicament 15 has been dispensed. The air path from the air chamber 26, past the seal 27 into the nozzle portion 25 can clearly be seen. As explained above, this air path is opened when, during actuation, the shoulder 35 on the elongate support 13 has passed the seal 27 such that pre- compressed air can escape from the air chamber 26, between the seal 27 and the reduced cross-sectional area section of the elongate support 13 below the shoulder 35 and into the nozzle portion 25 to be discharged with or after the discharged medicament 15. As can also be seen from Figure 2, the air from the air chamber 26 then proceeds up the nozzle portion 25 around the outside of the support 13 and vial 14. During actuation, before the base 10 has been pushed completely into the actuator 20 as shown in Figure 2, there is a space between the tops of the support 13 and vial 14 and the inside surface of the nozzle portion 25 between which the discharged air passes and then to the outlet 28 through the outlet channel 30 around the mechanical break-up portion 31. As explained above the air may be discharged with the medicament 15 and mixed together or the air could be supplied after the emitted dose of medicament 15 depending upon the particular application. The re-use of the dispenser can be prevented by the forcing of the base 10 and actuator 20 together during use to the configuration shown in Figure 2 involving the locking of the two parts, for example using a suitable snap ring and corresponding recess (not shown) as is well known in the art. Figure 3 shows a variation of the nozzle portion of the dispenser 1 shown in

Figures 1 and 2. A seal 110 is provided on the outside of the nozzle portion 25. When used as a nasal dispenser, the seal 110 may be used externally of the nostril and may provide an air-tight seal against the outside surface of the nostril to prevent the inhalation flow rate from being varied so that a known air flow and predetermined deposition may be achieved for a more reproducible emitted dose. The clean air from the air chamber will be discharged into the nostril and the seal will prevent the user from breathing in any additional air by preventing air from leaking in past the seal 110. The seal 110 may be provided on a shoulder 111 on the nozzle portion 25 to assist the provision of a seal with the user's nostril. The seal 110 and/or shoulder 111 could be arranged to prevent the fingers of a person operating the dispenser from coming into contact with a user's nostrils. In this example the seal 110 comprises two concentric annular resilient members 112, 113 of different outer diameters joined by a base 114. The seal 110 may be made from any compliant material such as TPEs, styrene block copolymers, thermoplastic polyurethanes, thermoplastic vulcanisates (santoprene) or elastomers including silicone rubbers. The material could have a closed or open cell structure for extra compliance. This could be created by using inorganic e.g. sodium hydrogen carbonate or organic e.g. N,N-dinitrosopenta-methylenetetramine chemical blowing agents or use of gas injection techniques. The preferred hardness of the sealing member is 20°-50°A (Shore A rubber hardness reading). TPE provides the advantage of being able to be co-moulded onto the dispenser

1 reducing production costs. In this example only medicament is dispensed through outlet channel 30. Precompressed air is passed through separate air channels 120 which may be one or more discrete channels or a single annular channel located around the medicament outlet channel 30. The air channel 120 leads to a series of air outlets 121 which surround the medicament outlet 122. Discharging air out of the series of air outlets 121 can be used to direct the emitted dose of medicament or deliver a bolus after the dose of medicament has been emitted. A seal as described above with reference to Figure 3 may be used with the dispenser shown in Figures 1 and 2 or with any suitable dispenser. The seal would also be suitable for other types of dispensers such as oral, anal or vaginal dispensers. Many variations may be made to the examples described above. For example, the dispenser may be arranged to dispense liquid or powder medicament. The dispenser could be arranged to require actuation of a suitable button or lever or the dispenser components may require suitable twisting prior to actuation. This could help prevent accidental actuation of the dispenser. Although the examples have been described above as being arranged to provide a single dose of medicament, they could if desired be adapted to provide a multi-dose dispenser as is well known in the art. Although the air chamber has been described as containing air, it could contain and release any suitable gas.

Claims

CLAMS

1. A hand-held pharmaceutical dispenser comprising first and second portions moveable relative to each other and defining an air chamber with rigid internal walls therebetween; the second portion having an annular seal to seal against the first portion to seal a volume of air in the air chamber; and one of the first and second portions being arranged to support or include a container for a medicament to be dispensed, wherein the first and second portions are arranged such that relative movement of the first and second portions towards each other moves the first portion relative to the annular seal of the second portion, reducing the sealed internal volume of the air chamber and compressing the air in the air chamber until a shoulder on the first portion encounters the annular seal on the second portion opening a flow path for the compressed air in the air chamber to be released with or after medicament dispensed from the container.

2. A dispenser according to claim 1, wherein the air is released from the air chamber after the first and second portions have been moved towards each other a predetermined amount.

3. A dispenser according to claim 2, wherein the first portion is arranged to support or include a container on a support and the container and support are arranged to be passed through and engage the annular seal on the second portion and the container and/or support has a shoulder leading from a wider upper portion, in use, to a narrower lower portion.

4. A dispenser according to any one of the preceding claims, wherein the air is released from the air chamber after the pressure in the air chamber has reached a predetermined level.

5. A dispenser according to any one of the preceding claims, wherein the air chamber and the container for a medicament are separate.

6. A dispenser according to any one of the preceding claims, wherein the compressed air and medicament are dispensed from the same outlet.

7. A dispenser according to any one of claims 1 to 5, wherein the compressed air and medicament are dispensed from different outlets.

8. A dispenser according to claim 7, wherein the compressed air is dispensed from a plurality of outlets surrounding the medicament outlet.

9. A dispenser according to any one of claims 6 to 8, wherein the outlet or outlets are provided on an end portion of a nozzle and a compliant or resilient seal is provided around the nozzle, such that, in use, the outlet or outlets of the nozzle may be inserted into an orifice of a user while the seal seals against the external surface of the orifice.

10. A dispenser according to claim 9, wherein the seal comprises one or more resilient annular members provided around the nozzle.

11. A dispenser according to claim 9 or claim 10, wherein the seal is made from thermoplastic elastomer, styrene block copolymer, thermoplastic polyurethane, thermoplastic vulcanisate (santoprene), an elastomer or a silicone rubber.

12. A dispenser according to any one of claims 9 to 11, wherein the seal has a hardness of 20°-50°A (Shore A rubber hardness reading).

13. A dispenser according to any one of claims 9 to 12, wherein the seal is provided on a shoulder of the nozzle.

14. A nasal dispenser according to any one of claims 9 to 13, wherein the outlet or outlets of the nozzle are arranged to be inserted into a user's nostril while the seal is arranged to seal the outside surface of the nostril.

15. An oral dispenser according to any one of claims 9 to 13, wherein the outlet or outlets of the nozzle are arranged to be inserted into a user's mouth while the seal is arranged to seal the outside surface of the mouth.

16. A dispenser substantially as hereinbefore described with reference to the accompanying drawings.