CN1193283A - sprayer - Google Patents

Abstract

A multi-dose spray applicator is disclosed for dispensing a pharmaceutical liquid from a sealed container, said applicator comprising means for holding the container, a manually operable metering pump for delivering said pharmaceutical as a nasal spray, and a hollow needle associated with said pump for penetrating a membrane sealing said container and dispensing the pharmaceutical liquid through the pump, said container having a movable wall or plug which is movable to displace the liquid from the container as it is dispensed by the pump.

Description

sprayer

The present invention relates to nebulizers, in particular nebulizers for dispensing medicaments. One established method of distributing medicaments is spraying, eg, into the nose or mouth. The advantage of this method over subcutaneous or intravenous administration is that it is easier to self-administer for patients who are cooperative or have poor muscular capacity. In the past, pump-equipped containers or aerosol-encapsulated drugs have been used. However, these methods have proven unsatisfactory for the encapsulation of pharmaceuticals that are sensitive to atmospheric substances, such as compounds that deteriorate upon exposure to water or oxygen.

SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide a sprayer for dispensing medicaments by spraying which minimizes the exposure of the medicament to atmospheric constituents prior to dispensing.

According to a feature of the present invention, there is provided a sprayer for dispensing medicament from a sealed container, said sprayer comprising: means for supporting said sealed container, a manually operated pump for outputting said medicament as a spray to the nose, and a hollow tube connected to said pump. Needle, used to penetrate the membrane of the sealed container and dispense the drug through the pump.

The nebulizer of the present invention is specifically designed to dispense oxygen- or water-sensitive medications. An example of such a compound is apomorphine hydrochloride (or other pharmaceutically acceptable salts), which is widely used in the treatment of Parkinson's disease. For this application, apomorphine is commonly used as a nasal spray and is rapidly absorbed through the nasal membranes. Of course, the nebuliser is also suitable for other uses, such as applying a spray to the mouth, and withdrawing other medicines through the mouth or nose, especially for the treatment of the mouth, nose and lungs.

The pump of the nebulizer can be made into a metered pump so that when the pump is activated, a measured dose of the drug is sprayed into the patient's nose or mouth.

Preferably, the sprayer has means for automatically moving the needle towards the membrane when or just before the pump is activated. For example, depressing the pump moves the needle toward and penetrates the membrane that holds the drug container.

To prevent inadvertent actuation of the nebulizer, the nebulizer may include a removable device, such as a clip, ring or ferrule, which prevents the needle from penetrating the membrane, or prevents the needle-containing device and the sealed container, respectively, from colliding with each other until the nebulizer is ready for use. Together.

When the needle penetrates the membrane at the top of the vial, the drug remains substantially sealed from the atmosphere so that air cannot enter the vial.

In order to expel the liquid medicine from the charge container without introducing air or other gas into the sealed vial, the charge container preferably has a removable bottom wall or bung which can be expelled when the liquid medicine is pumped out of the container potion. A spring or other mechanical device may be used to push such a movable bottom wall or plug inwardly to assist in priming of the pump, although a spring is not essential. The container can be made as a detachable container, such as a tube, using a flexible material such as a plastic sheet to form the walls of the container.

One medical use of nebulizers is to dispense medication to treat Parkinson's disease. Patients suffering from Parkinson's disease often have difficulty using a nebulizer to self-medicate. Another feature of the nebulizer of the present invention is the provision of a spray cap in which the pump outlet tube is angled obliquely, thereby providing a platform on the cap of the nebuliser for easy activation with the patient's thumb Pump.

Two embodiments of the invention will now be described with reference to the accompanying drawings, some of which are diagrammatic only.

In the attached picture there are:

Figure 1 is a longitudinal sectional view of the nebulizer in the assembled state.

Figure 2 is a perspective view of a clip preventing a needle from penetrating a sealed container.

Figure 3 shows the parts of the sprayer in a disassembled state.

Figure 4 is a diagram showing an alternative method of priming the pump.

Figure 5 is a longitudinal sectional view of a second embodiment of the nebuliser in the "use" position.

Figure 6 is a longitudinal sectional view similar to Figure 5 but in the "rest" position.

Figure 7 shows the disassembled components of the sprayer shown in Figures 5 and 6.

8A and 8B are perspective views of a modified nebulizer.

Referring to Figures 1 to 4, the nose sprayer includes a housing (1) designed to accommodate a medicine bottle (2) for encapsulating medicine. The medicine bottle (2) adopts the type used for encapsulating injection medicine in the pharmaceutical industry at present. The medicine bottle has a glass or plastic tube (3) closed at its lower end with a rubber or plastic stopper or stopper (4). The upper end of the medicine bottle has a membrane (5), which is designed to be penetrated by a hypodermic needle to take out the medicine solution. After the membrane has been penetrated, the membrane is elastic enough to close around the needle and seal itself against inadvertent spillage of the drug solution, or spillage caused by the pressure build up when the drug solution is pumped out of the container. Film preferably adopts rubber or rubber-like plastics. The medicine bottle (2) is designed as a container that can use multiple doses, so when the medicine liquid is taken out from the medicine bottle (2), the stopper (4) moves upwards to drain the medicine liquid that needs to be taken out. A spring (6) can be used to assist this action and/or prime the pump, but this is not required. On the upper end of the casing (1), a cap (7) is screwed, and a pump support (8) is installed, and the pump support (8) can be used as an axial direction on the neck (9) of the casing (1). slide. A pump (11) is pressed into the neck (10) of the pump support (8), and a nasal spray (12) and cap (13) are respectively housed on the upper end of the pump. Pump (11) adopts the common pump type that extracts medicine from closed container. The pump may be a vacuum mechanical pump with or without a dose measuring device, such as the "VP7" pump manufactured by the company Perfect-Valois or its parent company, Valois Step. An example of such a metering pump is also described in WO95/09054.

The lower end of the pump (11) has a tubular part (14), and the hollow needle (15) is connected with the pump from the inside or the outside, such as adopting a suction connection.

The sprayer works as follows. Remove the cap (13) that is press fitted on the nasal spray (12), and place your fingers on the flange (16) to depress the nasal spray. This causes the pump support (8) to move down until the needle (15) penetrates the membrane (5) and penetrates deep into the liquid medicine enclosed in the vial (2). Continue to press down, make the pump inhale the medicinal liquid of a dose, and spray medicinal liquid by nasal sprayer (12). After the finger pressure is released, the needle (15) can Remains in the vial, and the membrane sealing around the needle prevents the spillage of the drug solution between the outer surface of the needle and the membrane. The piston (not shown) in the pump (11) is returned to its original position by means of a return spring in the housing of the pump (11). This draws the liquid medicine into the pump, ready to dispense the next dose from the vial. Additional doses of medical fluid can be withdrawn from the vial by depressing the flange (16) by the patient if desired.

In order to prevent accidentally starting the sprayer, a removable clip (20) can be fitted in the groove (21) of the neck (9) of the housing (1). The clip (20) can be made of resilient plastic so that it can be easily pulled off with a hoop or ring attached to it. However, when the clip is in place, due to its thickness or its protruding support surface, it prevents the pump mount from moving down the neck (9), making the hollow needle far less able to penetrate the membrane (5).

Figure 4 shows another way of depressing the nasal spray (12), which is suitable for patients with very poor medical or muscular abilities. In this modification, the casing (1) can be clamped by a bracket (30) on which a lever (31) is mounted. The lever (31) has an arm (32) designed to bear on the shoulder (16) of the nasal spray (12). By manipulating the lever arm (33), the patient can activate the nebulizer with minimal mechanical force.

It should be understood that various modifications can be made to the nebulizer of the present invention. For example, a detachable screwed base can be used to make a pump support for loading medicine bottles, and the neck (7) can be integrated with the body (1). The pump can be pressed down on the neck of the holder and is designed to move down to allow the needle to enter the membrane (5).

Most parts of the sprayer are suitably made of plastic. For example, the holder (1) can be made of transparent plastic so that the patient can see whether the medicine bottle is empty or not. In the case of apomorphine, the solution will turn green after exposure to atmospheric oxygen. Once you see that the liquid in the vial has turned a sufficiently strong green (indicated by the tint chart on the nebulizer or its packaging), the liquid is no longer effective. An important feature of the application of the present invention is that the drug in the vial remains sealed from the atmosphere until the patient uses the nebulizer for the first time.

Figures 5, 6, 7, 8A and 8B show a sprayer which has been modified in a number of ways but still operates similarly to the sprayer shown in Figures 1 to 4.

Referring to Figures 5, 6 and 7, the modified sprayer includes a hollow outer part (101) which forms part of the housing and is preferably molded from plastic. In the embodiment shown in these Figures, the pump (105) is of the same metering pump type as described in Figures 1-4. In addition, the vial (111) is basically as described in the embodiment of Figs. 1 to 4 as well. The difference lies in the casing of the vial and the nozzle that dispenses the medicine. The part (101) is open at one end (102) and forms an open throat (104) at the other end (103) for mounting a metering pump (105). The pump (105) is preferably pressed into the opening (104) of the part (101) using an aluminum sheath. A hollow needle (106) fits in the pump (105).

The second part (107) of the housing is slidably received in the tubular hollow portion of the part (101). Likewise, the second part is suitably molded from plastic. Part (107) has two longitudinally spaced grooves (108) and (109) and inside part (101) there is a corresponding circumferential ring or protrusion (110).

The part (107) forms a tubular cavity for receiving the vial (111) and has a closed bottom (112) and neck (113). The vial (111) is retained in the part (107) due to the threaded cap (114) engaging the threads inside the neck of the part (107). Alternatively, the cap (114) could be friction fit on the neck of the part (107), or one of the parts could have lugs that fit into grooves or notches. In actual use, the shoulder of the vial (111) will abut against the cap (114), or its neck will abut against the flange (115). However, for the sake of clarity, there are some gaps in the representation in the figure. The medicine bottle (111) is a tube open at the lower end, but has a sealing plug (116) (preferably elastic rubber material). The stopper (116) is preferably in contact with a spring (117) to push the stopper towards the neck of the vial.

As shown in Figure 6, the cap (114) has an oblong hole (118) in which the protective strip (119) can slide. The protective strip (119) passes through the oblong holes (118A and 118B) on the parts (101 and 107) aligned with the oblong holes (118). The width and toughness of the band (119) make it difficult for a needle to penetrate it and to touch the film lying across the neck of the vial (111).

The pump (105) has an output tube (120) which is depressed to activate the pump. The tube (120) fits inside the nasal spray head (121) which has a nozzle (122) connected to the tube (120). The nozzle (122) extends obliquely to the centerline of the nebuliser, thereby providing a suitable protrusion (123) for the patient to activate the nebuliser with finger pressure.

The sprayers shown in Figures 5, 6 and 7 work in the following manner. In the position shown in Figure 6, the protrusion (110) cooperates with the groove (108) and releasably maintains the relationship between the inner part (107) and the outer part (101) in the position shown in Figure 6 .

When the sprayer needs to be used more, the ring (120) is pulled, so that the protective band (119) is pulled out. The bottom (112) can then be pressed down on a flat surface and the sprayer can be activated by pressing on the protrusion (123) with the thumb. It causes the inner part (107) to be pressed into the outer part (101), while the needle penetrates the membrane (124) lying across the neck of the vial. At the same time, the circumferential projection (110) cooperates with the groove (109), thereby keeping the part (107) inside the part (101). For this purpose, the projection (110) can be made to fit better in the groove (109) than in the groove (108), so that it is easier to remove from the groove (108) than in the groove (109) Raised (110).

It has been found that needles with little or no taper work best. This is because a needle with a long taper allows the liquid in the vial to be ejected as the needle begins to penetrate the membrane. Of course, conventional needles can also be used.

The walls of the parts (101, 107) can be transparent or have windows. This setting can check the liquid medicine in the medicine bottle, that is, to see if the medicine liquid in the medicine bottle is enough for more than one course of treatment, or for some medicines, the appearance of the medicine liquid can be observed, so that the indication failure can be checked color change.

A boss can be molded on the bottom (108) to replace the spring (6) as shown in the embodiment of Figs. 1-3. The boss presses over the plug (112) so that when the sprayer is initially primed, the plug is pushed up and the pump is activated.

8A and 8B show perspective views of the appearance of a modified nebulizer. In this embodiment, the vial (not visible) is housed in a housing (400), which may be composed of inner and outer parts similar to parts (101, 107) of Figs. 5 and 6 . The protective band (401) is contained in the rectangular hole (402) to prevent the sprayer from starting accidentally. The spray head (403) fits over the output tube of the pump and provides a platform (404) for actuating the pump with finger or thumb pressure. The nozzle is at the end of the output tube, which can be combined with various outlet designs to change the spray pattern. A closure cap (405) can be fitted over the nozzle to protect the nozzle during storage and transport.

Claims (10)

1. A multi-dose nebulizer for dispensing medicament from a sealed container, said nebulizer comprising: means for supporting said sealed container, a manually operated pump for outputting said medicament as a spray to the nose, and a hollow needle connected to said pump , used to penetrate the membrane of a sealed container and dispense the drug through a pump. The above-mentioned container has a movable bottom wall or a plug, which can be moved to discharge the liquid medicine in the container when the pump sprays the liquid medicine. 2. A sprayer as claimed in claim 1 which includes means for moving the needle towards the membrane when the pump is initially activated. 3. A nebulizer as claimed in claim 2 which includes a movable means for preventing the needle from penetrating the membrane until the nebulizer is ready for use. 4. A nebuliser as claimed in claim 3, wherein the safety means comprises a shield between the membrane and the needle, said shield being movable to an inoperative position when the nebuliser is ready for use. 5. A nebuliser as claimed in claim 3, wherein the safety means comprises a locking means which, in its operative position, prevents the member supporting the pump from moving towards the container to allow the needle to penetrate the membrane. 6. A sprayer as claimed in any one of the preceding claims, wherein the bung is movable within the container under the action of a spring. 7. The nebulizer of any one of the preceding claims, wherein actuation of the pump is caused by movement of the needle in the container. 8. The sprayer of any one of the preceding claims, wherein: the means for supporting the container comprises a housing comprising a bottom supporting the container and a top supporting the pump, the top and the bottom being movable relative to each other so that the needle penetrates the membrane . 9. A sprayer as claimed in claim 8, wherein the base is slidable in the top, the two parts include a cooperating means joining them together, and the needle end and membrane in the container form a seal around the needle. 10. A sprayer as claimed in claim 9, wherein the engaging means has at least one resilient pin on one part which engages a notch in the other part.

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