GB2196262A

GB2196262A - Nasal applicator

Info

Publication number: GB2196262A
Application number: GB8720837A
Authority: GB
Inventors: Philip Thomas Price
Original assignee: Glaxo Group Ltd
Current assignee: Glaxo Group Ltd
Priority date: 1986-09-17
Filing date: 1987-09-04
Publication date: 1988-04-27
Anticipated expiration: 2007-09-04
Also published as: GB2196262B; GB8720837D0; GB8622340D0; FR2603809B1; FR2603809A1

Abstract

An applicator for dispensing medicament into the nose from a pressurised dispensing container having a valve stem at one end thereof, comprises a body (1) to receive the container, an outlet spout (2) in the form of a nose piece leading outwards from the body (1), a stemblock (14) located in the body near its junction with the outlet spout, the stemblock having an inlet passage (15) to receive the valve stem, and an outlet member (30) located in the spout and formed integrally with the stemblock (14). The outlet member (30) has an outlet passage (8) of which the upstream end thereof communicates with the inlet passage (15) of the stemblock (14) to receive contents discharged from the container through the valve stem and of which the downstream end terminates in an outlet which is directed towards the outlet end of the spout (2) and is located a significant distance up the spout, e.g. about half way. <IMAGE>

Description

SPECIFICATION Nasal applicator This invention relates to a nasal applicator for dispensing medicaments from a pressurised dispensing container (that is to say an aerosol) to the nose of a patient.

Aerosols containing a medicament and a propellant are commonly used, for example, in the treatment of conditions of the nose (and indeed for treating conditions of the throat or mouth).

The medicament may consist of solid particles which are in suspension in the propellant. The medicament and propellant are applied in the form of spray by means of nasal applicators or dispensers containing the aerosols. The specification of UK Patent No. 1402638 describes a particularly successful known applicator. The applicator described in that specification comprises a body which is open at one end and which is arranged to receive and retain a pressurised aerosol dispensing container. An outlet spout for a mixture of medicament dispensed from the container and air leads laterally out of the body. A cover is hingedly connected to the body and is arranged to enclose the body and at the same time to enclose the outlet spout.

GB-2143283A describes a device of the type described in UK Patent No. 1402638 in which there is provided an outlet member located in the outlet spout and arranged to receive contents discharged from the dispensing container and terminating at the other end in an outlet which is located a significant distance up the spout. An object of the present invention is to provide an improved aerosol applicator device of this character.

The present invention provides an applicator for dispensing medicament into the nose from a pressurised dispensing container having a valve stem at one end thereof, the said applicator comprising a body which is adapted to receive the pressurised dispensing container, an outlet spout in the form of a nose piece leading outwards from the body, a stemblock located in the body near its junction with the outlet spout, the said stem-block having an inlet passage arranged to receive the said valve stem, and an outlet member located in the spout and formed integrally with the stemblock, the outlet member having an outlet passage of which the upstream end thereof communicates with the inlet passage of the stemblock to receive contents discharged from the dispensing container through the valve stem and of which the downstream end terminates in an outlet which is directed towards the outlet end of the spout and is located a significant distance up the spout.

In the accompanying drawings: Figure 1 is a sectional view of an embodiment of the invention, Figure 2 is a sectional view on a larger scale showing part of the embodiment of Fig. 1, and Figure 3 is a sectional view on a still larger scale showing a detail X of Fig. 2.

In the embodiment of the invention illustrated in the drawings, a nasal applicator device for dispensing medicaments from an aerosol container comprises a body 1 with an outlet spout 2 or nosepiece leading from a lower end of the body. A cover 3 is hingedly connected to the body 1 and when positioned in its closed position it will close the body 1 as well as enclosing the outlet spout 2.

A stemblock 14 is located in the body 1 of the applicator device, near its junction with the spout or nosepiece 2, and is integral therewith. The stemblock 14 has an inlet passage 15 arranged to receive the valve stem of an aerosol container. An outlet member 30 is arranged in the spout 2. The outlet member has a capillary outlet passage 8 which leads from the inlet passage 15 to an outlet end. The outlet member 30 is integral with the stemblock 14. Since the stemblock 14 is itself integral with the rest of the device, the result is a device which is entirely in one piece. The device is moulded in a plastics material.

in one example of the above embodiment the total length a of the spout 2 was 22.22 mm, the internal diameter b of the spout 2 was 7.85 mm, and the length c of the outlet member 30 was 12.25 mm, of which 2.5 mm was accounted for by the length d of a tip portion 31 thereof. The distance e from the distal end of the tip portion to the plane of the end of the spout 2 was 9.97 mm, and the angle a subtended by the interior of the end of the spout at the said distal end was therefore about 45 (in fact 43 ). The internal diameter f of the outlet passage 8 was 0.55 mm except for the portion adjoining the inlet passage 15 which tapered to a diameter g of 0.50 mm.

The operation of the illustrated embodiment was tested using a pressurised dispensing container at a pressure of 55psi (3.8 bar). Comparative tests were done with the devices after their outlet members had been shortened. All these results are set out in the following Table. In each case the dose (medicament) which the valve of the container was intended to dispense in a single actuation was 50,ug. In each test the container was depressed to dispense a dose, and the weight of medicament emerging from the spout was measured and also the weight of medicament deposited in the actuator. The total of these two weights gave the total weight of medicament dispensed and the weight of medicament deposited in the actuator was then calculated as a percentage of the total weight.

TABLE

Batch No. Percentage Deposition of Medicament in Actuator.

c = 12.25mm c = 9.75mm c = 5.00mm c = 2.50mm box I a 9.9 - 20,8 26.4 b 10.0 - 25.2 31.0 c 11.3 - 37 37.4 26.5 d 12.7 e 13.3 Box II a 13.0 - 44.5 31.7 b 10.6 - 35.8 28.2 c 12.5 5 38.6 36.6 d 17.6 e ~ 18.2 - Box III a 13.3 3 29.3 25.1 b 12.4 4 18.0 21.2 c 12.9 - 25.1 26.7 d ~ 16.5 - Box IV a 12.9 - 26.8 32.9 b 16.1 - 27.8 29.5 c 13.0 - 22.5 21.7 standard 1.71 2.41 8.06 4.51 deviation c is the length of the. outlet member 17 (see Fig 2) As can be- seen from the Table, increasing the length of outlet member from 2.5 to 5 mm gave no improvement in terms of reducing the amount of medicament deposited in the actuator.

Further increasing the length to 9.75 mm gave a substantial improvement, and increasing to 12.25 mm gave still more improvement. It might be thought that still better results could be obtained by lengthening the outlet member 30 still further. However, apart from making the device more difficult to mould (an important practical consideration), the nearer the end of the outlet member is to the outlet end of the spout 2 the more intensely will the spray of medicament impinge on the interior surface of the patient's nose. If the spray is too intense it is possible that damage to the nose could result and in any case the sensation is unpleansant.

Although the outlet member could be somewhat longer (as in the preceding embodiments, it is believed that the length of outlet member represented by the first column in the table (i.e.

c=12.25 mm) is a good compromise between the various competing factors which bear on the selection of outlet member length. The angle a is then 43 .

The use of an integral outlet member, as opposed to an outlet member which is a separate component, as in the illustrated embodiments of GB 2143283A, has a number of advantages.

One advantage is that of greater safety in that it avoids any possibility of the outlet member becoming detached from the remainder of the device during use, which could be hazardous to the patient, or indeed at any other time. Another advantage is that elimination of the junction at the upstream end of the outlet member helps to improve the extent to which the flow of the medicament after it leaves the dispensing container is laminar. Any junction such as that just mentioned gives rise to a certain degree of turbulence in the flow, and some of the medicament is deposited in the region of turbulence. This of course is undesirable as it reduces the amount of medicament which reaches the patient.

Claims

1. An applicator for dispensing medicament into the nose from a pressurised dispensng container having a valve stem at one end thereof, the said applicator comprising a body which is adapted to receive the pressurized dispensing container, an outlet spout in the form of a nose piece leading outwards from the body, a stemblock located in thebody near its junction with the outlet spout, the said stemblock having an inlet passage arranged to receive the said valve stem, and an outlet member located in the spout and formed integrally with the stemblock, the outlet member having an outlet passage of which the upstream end thereof communicates with the inlet passage of the stemblock to receive contents discharged from the disperising container through the valve stem and of which the downstream end terminates in an outlet which is directed towards the outlet end of the spout and is located a significant distance up the spout.

2. An applicator according to claim 1, wherein the interior of the outlet end of the spout subtends an angle of about 450 at the outlet of the outlet member.

3. An applicator according to claim 1, wherein the interior of the outlet end of the spout subtends an angle of from about 300 to about 1000 at the outlet of the outlet member.

4. An applicator according to any preceding claim, wherein the outlet of the outlet member is located approximately half way up the spout.

5. An applicator according to any preceding claim, wherein the outlet of the outlet member is located about 10mm from the outlet end of the spout.

6. An applicator for dispensing medicament into the nose, substantially as herein described with reference to the accompanying drawings.