DEVICE FOR INTERNAL AND EXTERNAL NASAL APPLICATION

Abstract

A combination product comprising a dispensing head (10, 10′) mounted on a top of a container (20, 20′) containing a formulation for nasal administration, and a solidified skin-care balm (50) for application around the nose contained in a balm holder element (30, 30″) located on a bottom (24) of the container (20).

Claims

1. A combination product comprising a dispensing head (10, 10′) mounted on a top of a container (20, 20′) containing a formulation for nasal administration, and a solidified skin-care balm (50) for application around the nose contained in a balm holder element (30, 30″) located on a bottom (24) of the container (20).

2. A combination product according to claim 1, wherein the dispensing head (10, 10′) is a metered dose spray pump.

3. A combination product according to claim 1, wherein the balm holder element (30, 30″) comprises a base element (34, 34′, 34″) on which the balm (50) is mounted, and a balm cover (32, 32″) with a cylindrical portion (33, 33″) surrounding the balm (50), and a cover portion (36, 36″).

4. A combination product according to claim 3, wherein the cylindrical portion (33, 33″) of the balm cover (32, 32″) is aligned with a cylindrical wall (22, 22′) of the container (20, 20′) containing the formulation.

5. A combination product according to claim 3, wherein the balm cover (32) is attached to the bottom (24) of the container.

6. A combination product according to claim 5, wherein the balm cover (32) is glued to the bottom (24) of the container (20, 20′).

7. A combination product according to claim 3, wherein the cover portion (36) is dome-shaped and matches a recess in the bottom (24) of the container (20) containing the formulation.

8. A combination product according to claim 3, wherein the balm cover is clipped or snap-fitted to the bottom (24) of the container.

9. A combination product according to claim 1, wherein the base element (34″) is attached to the bottom (24) of the container (20′).

10. A combination product according to claim 1, wherein the liquid formulation comprises a saline solution and/or an active ingredient selected from the group of vasoconstrictors, antiallergic agents and corticosteroids.

11. A combination product according to claim 10, wherein the active ingredient is xylometazoline or a pharmaceutically acceptable salt thereof.

12. A combination product according to claim 1, wherein the balm comprises an active ingredient having skin soothing properties, in particular selected from the group comprising ectoin, dexpanthenol, aloe vera, calendula, bisabolol and niacinamide.

13. A combination product according to claim 1, wherein the solidified balm (50) has substantially a hemispherical shape.

14. A combination product according to claim 1, wherein the balm comprises one or several skin conditioning agents.

15. A combination product according to claim 1, wherein the balm (50) comprises an active ingredient that is a botanical extract.

16. A balm holder element (30, 30″) comprising: a base element (34, 34′, 34″) on which a balm (50) is mounted, a balm cover (32, 32″) with a cylindrical portion (33, 33″) surrounding the balm (50), and a cover portion (36, 36″), wherein the balm holder element (30, 30″) is attachable to a nasal spray dispenser.

17. A method for treating nasal discomfort whereby a cooling and soothing effect is provided to a perinasal skin area, comprising the step of using the combination product according to claim 1 by applying the balm (50) to the perinasal skin area and administering the formulation for nasal administration into a nostril.

18. A method for treating runny nose whereby irritated skin is soothed, comprising the step of using the combination product according to claim 1 by applying the balm (50) to an irritated perinasal skin area and administering the formulation for nasal administration into a nostril.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0077] FIG. 1 shows a perspective view of a combination product according to a first embodiment

[0078] FIG. 2 shows a perspective view of the combination product of FIG. 1, with a base element of a balm holder element and a balm being taken off

[0079] FIG. 3 shows a base element and a balm according to the first embodiment

[0080] FIG. 4 shows a base element and a balm according to a second embodiment

[0081] FIG. 5 shows a perspective view of a combination product according to a third embodiment

[0082] FIG. 6 shows a perspective view of a combination product according to a further embodiment, with a base element attached to a bottom of a container.

[0083] FIG. 7 shows an exploded view of the combination product of FIG. 1

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0084] The invention will now be described by way of example only with reference to the accompanying figures.

[0085] FIGS. 1 and 7 show a combination product which comprises a conventional nasal spray device comprising a HDPE container 20 containing a liquid formulation for nasal administration, and a dispensing head 10, here a metered dose spray pump, with a nozzle 12 to be introduced into a nostril, covered by a cap 40, as well as a balm holder element 30 containing a solidified skin-care balm 50. The balm holder element 30 comprises a balm cover 32 and a base element 34 holding the balm 50.

[0086] FIG. 2 shows the same combination product, where the base element 34 carrying the balm 50 has been taken off. FIG. 3 shows the base element 34 of the embodiment of FIG. 1, together with the balm, separately and ready to be used. The base element 34 is moulded in one piece and has a circular base plate 37, with a circumferential rim 52 on that base plate 37 surrounding the solidified balm 50. Protrusions protruding inwardly from the circumferential rim 52 can be used to hold the solidified balm 50 in place, once it has been pressed on the base plate 37 and on same protrusions. Alternatively, the base element 34 and the balm 50 may be assembled upon moulding of the balm whereby a molten balm formulation solidifies on the base element 34. In the first embodiment shown in FIGS. 1 and 3, the base element 34 is provided with circumferential ribs 38 running along parts of the circumference of the base plate 37 and making it easier to grip the base plate 37 and thus the base element 34 with the balm 50.

[0087] The balm 50 has a substantially hemispherical shape, and an example for a formulation is given in Table 1.

[0088] The balm cover 32 consists of a cylindrical portion 33 surrounding the balm 50, and a cover portion 36 which has a domed shape, as it can be seen in FIG. 7. The cover portion 36 with its domed shape matches a corresponding recess in the bottom 24 of the container 20, and it is glued on the bottom 24 using a primer and cyano-acrylate glue. Both the balm cover 32 and the base element 34 are made of Polypropylene (PP).

[0089] On the outer surface of the rim 52, several protrusions 56 are foreseen, which make a snap-fit connection with the cylindrical portion 33 of the balm cover 32 and help to keep the base element 34 connected to the balm cover 32, and thus to the container 20.

[0090] FIG. 4 shows an alternative embodiment of a base element 34′ carrying the same solidified balm 50. While the overall shape of the base plate 37′ and the circumferential rim 52′ are the same as for the first embodiment shown in FIGS. 1 and 3, the rim 52′ is in this embodiment provided with a thread 54 which matches a thread at the inner circumference of the cylindrical portion of the balm cover (not shown in the figures). Furthermore, in the embodiment shown in FIG. 4, the base element 34′ also has ribs 39 on the outer circumference of the circular base plate 37′, but these are perpendicular to the circumference of the base plate 37′.

[0091] FIG. 5 shows an embodiment of a combination product according to the disclosure, differing from the embodiment shown in FIG. 1 in the choice of the container 20′ and the metered dose spray pump 10′. Here, a laterally actuated pump 10′ as for example described in WO2017191205A1 is used. The balm holder element 30 is the same as in the embodiment shown in FIGS. 1 and 3.

[0092] FIG. 6 shows another embodiment of a combination product according to the disclosure, using the same container 20′ and the same laterally actuated metered dose spray pump 10′, but a different balm holder element 30″. As it can be seen when comparing FIGS. 5 and 6, the orientation of the balm holder element 30″ is inverted in the embodiment of FIG. 6, with the base element 34″ being attached to the bottom of the container 20′, and the balm cover 32″ being removable. In this embodiment, the base element 34″ is not glued on a base surface at the bottom of the container, but it comprises a cylindrical portion extending around the lowest part of the cylindrical wall 22′ of the container 20′, and can either be glued thereto, or fixed in another way, e.g. via a snap-fit or clip connection. The cover portion 36″ of the balm cover 32″ is flat, so that the combination product can stand on it.

Example 1

[0093] An example for a balm formulation is given below in Table 1.

TABLE-US-00001 TABLE 1 Example of a balm formulation % of component in INCI name of the final Function of component formulation the component OCTYLDODECANOL 17.00 EMOLLIENT CAPRYLIC/CAPRIC 14.70 SKIN CONDITIONING TRIGLYCERIDE RICINUS COMMUNIS 14.30 SKIN CONDITIONING SEED OIL ORYZA SATIVA 14.00 SKIN CONDITIONING CERA SKIN PROTECTING SMOOTHING RHUS VERNICIFLUA 13.40 EMOLLIENT PEEL CERA/RHUS STABILISING/ SUCCEDANEA BINDING FRUIT CERA EMOLLIENT THEOBROMA CACAO 7.00 EMOLLIENT SEED BUTTER SKIN CONDITIONING PERSEA GRATISSIMA 5.00 SKIN CONDITIONING OIL CETEARYL ALCOHOL 3.00 EMOLLIENT EMULSIFYING EMULSION STABILISING MYRISTYL MYRISTATE 3.00 EMOLLIENT SKIN CONDITIONING POLYGLYCERYL-3 2.50 EMULSIFYING DIISOSTEARATE CETYL ESTERS 2.00 EMOLLIENT SKIN CONDITIONING BUTYROSPERMUM 2.00 SKIN CONDITIONING PARKII BUTTER OLEYL ALCOHOL 0.48 EMOLLIENT MASKING ZANTHOXYLUM 0.12 SKIN CONDITIONING BUNGEANUM FRUIT EXTRACT TOCOPHERYL ACETATE 0.50 ANTIOXIDANT MENTHYL ETHYLAMIDO 0.50 SKIN CONDITIONING OXALATE Eucalyptol Nat 0.2 PERFUMING SKIN CONDITIONING MENTHOL 0.20 REFRESHING SOOTHING BHT 0.10 ANTIOXIDANT The names of the raw materials are given using the International Nomenclature of Cosmetic Ingredients (INCI). The % are indicated by weight.

[0094] The balm may be prepared by a conventional method. For the example, it was prepared by melting of the solid components in a water bath at a temperature sufficiently high to melt all ingredients, about 60° C.-70° C. Subsequently, the liquid ingredients were added, and the mixture was stirred to form a bulk. Any volatile ingredients were added after letting the bulk cool under stirring, but whilst the bulk was still fluid. The fluid bulk was poured into a stainless steel mould with an array of recesses of hemispheric shape. Excess bulk was scraped off. The mould filled with the bulk was let cool down at 5° C. for 20 minutes. The solidified balm hemispheres were removed from the mould by turning it upside down and placing it on a hard surface. To produce the combination product, the balm was pressed on the base element (34, 34′) and the base element was assembled with the remaining parts of the balm holder element (30, 30″) and the container containing the formulation for nasal administration.

TABLE-US-00002 TABLE 2 Examples of formulations for nasal administration Amount Ingredient Function (% w/w) Example for a liquid formulation comprising a corticosteroid Fluticasone Propionate Active 0.05 Micronised Dextrose Anhydrous Osmolarity agent 5 Phenylethyl Alcohol USP Preservative 0.25 Avicel RC591 (GI) Suspending agent 1.50 Benzalkonium Chloride Preservative 0.02 EP/USNF/JP Polysorbate 80 (GI) Wetting agent 0.005 Purified Water Vehicle Ad 100.0 Example for a liquid formulation comprising a vasoconstrictor Xylometazoline Hydrochloride Active Ingredient 0.1 Sodium dihydrogen phosphate Buffering Agent 0.28 dihydrate Disodium phosphate Buffering Agent 0.3 dodecahydrate Disodium edetate Chelating agent 0.05 Benzalkonium Chloride Preservative 0.01 Sodium Chloride Isotonicity regulator 0.7 Purified water Vehicle Ad 100 Example for a liquid formulation comprising a vasoconstrictor and a moisturizing agent Oxymetazoline Hydrochloride Active Ingredient 0.05 Sodium dihydrogen phosphate Buffering Agent 0.2 dihydrate Disodium phosphate dodecahydrate Buffering Agent 0.28 Disodium edetate Chelating agent 0.05 Benzalkonium Chloride Preservative 0.01 Sorbitol 70% (non-crystallising) Moisturizing Agent 1.4 Sodium Chloride Isotonicity regulator 0.5 Levomenthol Aroma 0.03 Cineol Aroma 0.02 Castor oil, polyoxyl hydrogenated Solubiliser 0.275 Purified water Vehicle ad 100