WO2007113551A1

WO2007113551A1 - Nasal spray device

Info

Publication number: WO2007113551A1
Application number: PCT/GB2007/001224
Authority: WO
Inventors: Stephen England
Original assignee: Norton Healthcare Limited
Priority date: 2006-04-04
Filing date: 2007-04-03
Publication date: 2007-10-11
Also published as: GB0606872D0

Abstract

A nasal spray device comprising a reservoir for a medicament, said reservoir having a neck portion disposed at an angle in relation to a vertical plane and a base portion; a spray pump dispenser having a dip tube; a means for attaching the spray pump dispenser to the neck portion; the spray pump dispenser and the reservoir are arranged so that the dip tube extends to the base portion and allows consistent dosing throughout the dosage regime up to exhaustion of the medicament volume.

Description

NASAL SPRAY DEVICE

The present invention relates to a nasal spray device for consistently dispensing a predetermined volume of medicament throughout a dosage regime up to exhaustion of the medicament volume.

BACKGROUND OF THE INVENTION

WO 2004/0221 discloses a nasal spray having an open mouthed bottle containing a preparation of sesame oil and a spray pump dispenser mounted to close the open top of the bottle. A dip tube extends down into the preparation. The pump body is provided with a mounting collar which seals the top of the bottle in an airtight manner.

FR2578426 discloses a flat-bottomed bottle, characterised in that the useful internal volume is between 2 and 15 ml and its corresponding external volume is between 7 and 30 ml and in that the lower internal part of the bottle narrows progressively in a concentric manner so that the lower walls of the bottle are regularly thicker and thicker and form a rounded cone, the ratio of the useful internal volume to the corresponding external volume necessarily being between 1 :2 and 1 :4. The disclosure also relates to a spray device constituted by such a bottle and by a spray system disposed on the neck of the bottle, the immersed tube of the spray system extending along the whole length of the bottle. The device is said to allow a controlled dose of medicine in solution to be sprayed nasally.

US design patent 447419 discloses a dispenser bottle (hereinafter called the "Astelin 30 ml bottle") that the inventor has used for the purposes of comparative tests. The Astelin 30 ml bottle has a cone-shaped base portion onto which a snap on skirt may be attached so that the dispenser bottle may stand upright on a flat surface. When in use the dispenser bottle is combined with a spray pump dispenser having a dip tube that extends towards the apex of the inverted cone. Our study (Example 1 hereinafter) has shown that this arrangement allows consistent dosing throughout the dosage regime up to exhaustion of the medicament. However this arrangement, with the nasal spray dispenser extending along the same vertical axis as the dispenser bottle, has been found to be difficult for some patients to use because if the container is tilted slightly the medicament does not collect at the apex of the inverted cone but rather along the side of the cone. This can give rise to inconsistency in dosage in the later stages of the dosage regime i.e. when there is only a small volume of medicament left in the bottle.

Consequently there is a need for a nasal spray dispenser that allows consistent dosing throughout the dosage regime up to exhaustion of the medicament and that is ergonomically shaped so mat it is easy to use by patients.

SUMMARY OF THE INVENTION

The present invention provides a nasal spray device comprising a reservoir for a medicament, said reservoir having a neck portion disposed at an angle (theta) in relation to a vertical plane and a base portion; a spray pump dispenser having a dip tube; a means for attaching the spray pump portion to the neck portion; the spray pump dispenser and the reservoir portion are arranged so that the dip tube extends to the base portion and allows consistent dosing throughout the dosage regime up to exhaustion of the medicament volume.

Further preferred features and advantages of the invention are recited in the detailed description and in the claims.

BRIEF DESCRIPTION OF THE DRAWING

An embodiment of the invention will now be described, by way of example, with reference to the accompanying figure.

Figure 1 shows a cross-sectional view of a representation of the nasal spray dispenser according to the invention. DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a nasal spray device that is easy to use by patients and allows consistent dosing throughout the dosage regime up to exhaustion of the medicament volume.

Figure 1 shows a cross-sectional view of a representation of a nasal spray device 10 having a reservoir 20 for a medicament 30, said reservoir 20 having a neck portion 22 disposed at an angle (theta) in relation to a vertical plane (A-A') and a base portion 24. A spray pump dispenser 40 having a dip tube 42 and a means for attaching the spray pump dispenser 40 to the neck portion 44. The spray pump dispenser 40 and the reservoir 20 are arranged so that the dip tube 42 extends to the base portion 24 and allows consistent dosing throughout the dosage regime up to exhaustion of the medicament volume.

Typically the reservoir 20 is manufactured by a blow moulding method. The blow moulding method may be a blow fill seal method or other such method as is known to the person skilled in the art as appropriate for the manufacture of the reservoir 20. For ease of storage and use the reservoir 20 maybe manufactured as a hermetically sealed reservoir 20 that has a twist off top 26 (not shown). After twisting off the top 26 the neck portion 22 is opened and a spray pump dispenser 40 may be attached.

Conveniently the reservoir 20 is manufactured from a polymeric material having thermoplastic properties that allow them to be moulded into an appropriate shape for a container. Examples of such materials are polyethylene, polypropylene, polyester or high density polyethylene or other such materials that are known to the person skilled in the art to be appropriate for the manufacture of a reservoir 20 according to the invention. Alternatively the reservoir 20 may be made of a glass.

The plastic or glass may be treated to avoid degradation of the medicament. Degradation of the medicament maybe UV-induced degradation. For example the plastic or glass may be coloured or treated to reduce passage of UV radiation through the wall of the reservoir.

^■ Typically the volume of the reservoir 20 will be between 5 and 50 ml, preferably between 10 and 40 ml and more preferably 30 ml.

Typically the medicament 30 is selected from the group of medicaments 30 consisting of nasal irrigation solutions, decongestants, allergy treatments, systemic treatments and vaccines. Examples of nasal irrigation solutions include saline; examples of decongestants include oxymetalozone; examples of allergy treatments include glucocorticoids, corticosteroids such as fluticasone, budesonide, beclomethasone, azalastine; examples of antihistamines include setirazine; examples of systemic treatments include insulin and calcitonin; examples of vaccines include vaccines to viruses such as influenza virus and HIV virus. The medicament 30 is commonly used for nasal administration and in particular for targeted nasal administration. The inventor does not intend to limit the medicament 30 that may be used in the nasal spray device 10 but intends that all medicaments 30 known by the person skilled in the art to be suitable for nasal administration and in particular targeted nasal administration should be included in this group.

Typically the nasal spray device 10 has the neck portion 22 disposed at an angle (theta) of about 20° to 70° from the vertical axis (A-A'), preferably angle theta is 30° to 60°, more preferably angle theta is 40° to 50° from the vertical axis A-A'. In Figure 1 angle theta is 45° from the vertical axis A-A'.

Typically the base portion 24 has a raised central portion 26 that causes the medicament 30 to occupy the internal circumferential part 28 of the base portion 24. Preferably, for ease of manufacture, the raised central portion 26 is dome shaped but it may be any shape that is suitable to displace the medicament 30 into the internal circumferential part 28 of the base portion 24.

Typically the end 46 of the dip tube 42 that is proximal to the base portion 24 has a notch 48 in it. The notch 48 allows the dip tube 42 to continue to act as a conduit for the medicament 30 even if the spray pump dispenser 40 is over tightened by the user. The notch 48 in the end 46 of the dip tube 42 ensures that even when only a small volume of medicament 30 is remaining in the reservoir 20 the medicament 30 is still dispensed consistently. Preferably the notch 48 is V-shaped but may be any shape suitable for the purpose.

Typically the spray pump dispenser 40 is attached to the neck portion 22 with a screw fit or with a push fit. Alternatively the spray pump dispenser 40 may be attached to the neck portion 22 by any means known to be suitable by the person skilled in the art.

Typically the dip tube 42 extends to the internal circumferential part 28 of the base portion 24. Preferably the end 46 of the dip tube 42 is in contact with the internal circumferential part 28 of the base portion 24.

EXAMPLE

Comparison Testing of Astelin 30ml Bottle and Nasal Spray Device 10 (TVAX 30 ml Bottle).

Introduction

This investigation compares the tail off characteristics of the Astelin bottle and the nasal spray device 10 at exhaustion. The spray weight and droplet size measurement was performed after each actuation. Analysis of droplet size and spray weight were performed at the same time using 16 actuations per bottle.

Components used

o Empty Astelin 30ml bottle (no spray pump) lot no 0000002572 exρ07/2007 o Astelin dip tube 40.6mm o Nasal spray device 10 (no spray pump) o Dip tube 50.0mm (cut to fit) o Valois spray pump type 100VP3/140 18/415; lot no 8PH 17546.

Sum _pee mary of results

Spray weight

Both the Astelin 30ml bottle and nasal spray device 10 (IVAX 30 ml bottle) gave similar tail off profiles. The nasal spray device 10 showed slightly better performance characteristics than the Astelin bottle

Comparison of Tail off profile

-IVAX 30ml Bottle - Astelin 30ml Bottle

Actuation number

Droplet Size Distribution

Both the Astelin 30ml bottle and nasal spray device 10 (IVAX 30 ml bottle) gave similar tail off profiles. Unfortunately the 12^th actuation was not collected for the Astelin bottle due to a software/PC problem.

Comparison of Tail off profile

-♦- IVAX 30ml Bottle -±-Asteltn 30ml Bottle

Actuation number

Conclusion

The tail off profiles between the Astelin 30ml bottle and nasal spray device 10 are similar and show good correlation.

Claims

1. A nasal spray device 10 comprising a reservoir 20 for a medicament 30, said reservoir 20 having a neck portion 22 disposed at an angle (theta) in relation to a vertical plane (A-A') and a base portion 24; a spray pump dispenser 40 having a dip tube 42; a means for attaching the spray pump dispenser 40 to the neck portion 22; the spray pump dispenser 40 and the reservoir 20 are arranged so that the dip tube 42 extends to the base portion 24 and allows consistent dosing throughout the dosage regime up to exhaustion of the medicament volume.

2. A nasal spray device 10 according to claim 1 wherein the reservoir 20 is manufactured by a blow moulding method.

3. A nasal spray device 10 according to claim 1 or claim 2 wherein the reservoir 20 is manufactured from polypropylene or high density polyethylene.

4. A nasal spray device 10 according to any of claims 1 to 3 wherein the reservoir 20 is treated to reduce UV degradation of the medicament 30.

5. A nasal spray device 10 according to any preceding claim wherein the medicament 30 is used for nasal administration.

6. A nasal spray device 10 according to any preceding claim wherein the medicament 30 is a nasal irrigation solution, a decongestant, an allergy treatment, a systemic treatment or a vaccine.

7. A nasal spray device 10 according to any preceding claim wherein the neck portion 22 is disposed at an angle of about 30° to 60° from the vertical axis.

8. A nasal spray device 10 according to any preceding claim wherein the neck portion 22 is disposed at an angle of about 45° from the vertical axis.

9. A nasal spray device 10 according to any preceding claim wherein the base portion 24 comprises a raised central portion 26.

10. A nasal spray device 10 according to any preceding claim wherein the end of the dip tube 42 that is proximal to the base portion has a notch 48 in it.

11. A nasal spray device 10 according to any preceding claim wherein the spray pump dispenser 40 is attached to the neck portion 22 with a screw fit.

12. A nasal spray device 10 according to any preceding claim wherein the spray pump dispenser 40 is attached to the neck portion 22 with a push fit.

13. A nasal spray device 10 according to any preceding claim wherein the dip tube 42 extends to a circumferential part 28 of the base portion 24.

14. A nasal spray device 10 according to any preceding claim wherein the dip tube 42 is in contact with the circumferential part 28 of the base portion 24.