Nasal dispensing head for fluid product

Abstract

A nasal dispensing head for fluid product (10) comprising a body (11) having a dispensing orifice (12), said body (11) forming a reservoir (13, 14) containing a dose of fluid product, a piston (20) sliding in a portion of said reservoir to dispense said dose of fluid product through said dispensing orifice (12), said dispensing head (10) comprising means for dispensing said dose of fluid product first as an approximately axial jet through said outlet orifice (12), and then, after a distance L from said dispensing orifice (12), as an approximately conical spray forming an angle α. (See Figure 1 for abbreviations.)

Description

Title of the invention: Nasal dispensing head for fluid product

[0001] The present invention relates to a nasal dispensing head for fluid product and a device comprising such a dispensing head.

[0002] Nasal delivery devices are well known. They generally comprise a reservoir containing one or more doses of fluid product and a delivery head that moves relative to said reservoir to dispense the fluid product, notably via a pump, a metering valve, or a piston sliding within said reservoir. When the user wishes to use the device, they insert the delivery head into the nostril and activate the device to dispense a dose of fluid product, generally in the form of a spray.

[0003] A drawback of prior art devices concerns the effectiveness of the dose delivered to the nostril, particularly when the delivered fluid is intended to act on the brain. Indeed, only a minimal portion of the dose generally reaches the target area for this type of treatment, namely the olfactory zone including the ethmoids, primarily due to the conical shape of the spray in the nostril at the device's outlet. However, it appears that this conical shape is not optimal for achieving maximum deposition in the target area.

[0004] US patents US1155608 and WO2018109409A1 describe nasal inhalation devices that use an external positioning device to correctly orient the delivery head in the user's nostril. This implementation improves the deposition of the fluid product on the target area, but this improvement remains limited due to the conical shape of the spray at the device's outlet.

[0005] The present invention aims to provide a nasal dispensing head and a device comprising such a head, which do not reproduce the aforementioned disadvantages.

[0006] The present invention aims in particular to provide a nasal delivery head and a device comprising such a head which improves the rate of deposition of active product on the olfactory area and / or the ethmoids.

[0007] The present invention also aims to provide a nasal distribution head and a device comprising such a head allowing control of the shape of the spray in the nostril.

[0008] The present invention also aims to provide a nasal dispensing head and a device comprising such a head that are simple and inexpensive to manufacture and assemble.

[0009] The present article therefore relates to a nasal dispensing head for fluid products comprising a body having a dispensing orifice, said body forming a reservoir containing a dose of fluid product, a piston sliding in a part of said reservoir to distribute said dose of fluid product through said distribution orifice, said distribution head having means for distributing said dose of fluid product first in the form of an approximately axial jet through said outlet orifice, and then after a distance L from said distribution orifice, in the form of an approximately conical spray forming an angle a.

[0010] Advantageously, said reservoir comprises a first distal cylindrical part of length 11 and diameter dl and a second proximal cylindrical part of length 12 and diameter d2, with dl > d2.

[0011] Advantageously, said second proximal cylindrical part which extends said first distal cylindrical part, and forms at its axial end said distribution orifice.

[0012] Advantageously, said second proximal cylindrical part extends said first distal cylindrical part coaxially along a longitudinal axis of said distribution head.

[0013] Advantageously, said piston slides in said first distal cylindrical part between a rest position and an actuation position.

[0014] Advantageously, said piston includes a front extension which in the actuation position occupies the volume of said second proximal cylindrical part.

[0015] Advantageously, said length 11 is between 3mm and 15mm, preferably between 4mm and 14mm.

[0016] Advantageously, said diameter dl is between 2mm and 14mm, preferably between 2.9mm and 12.5mm.

[0017] Advantageously, said length 12 is between 3mm and 18mm, preferably between 5mm and 15mm.

[0018] Advantageously, said diameter d2 is between 1mm and 7mm, preferably between 2mm and 6mm.

[0019] Advantageously, the ratio d2 / dl is between 0.3 and 0.8, preferably between 0.4 and 0.7.

[0020] Advantageously, the actuation force F of said piston is between 10N and 25N, preferably between 12N and 22N.

[0021] Advantageously, the volume V of the dose of fluid product distributed is between 0.3ml and 5ml.

[0022] The present also relates to a nasal fluid product distribution device comprising a distribution head as described above.

[0023] These and other features and advantages will become clearer in the following detailed description, made with reference to the accompanying drawings, given by way of non-limiting examples, and on which:

[0024] [Fig. 1] [Fig. 1] is a schematic cross-sectional view of a nasal distribution head according to a first advantageous embodiment, inserted into a nostril,

[0025] [Fig.2] [Fig.2] is a schematic cross-sectional view of the dispensing head of [Fig.1], in the actuation position, illustrating the shape of the spray downstream of the dispensing orifice,

[0026] [Fig.3] [Fig.3] is a schematic cross-sectional view of the distribution head of [Fig.2], in its rest position.

[0027] [Fig.4] [Fig.4] is a view similar to that of [Fig.3], in the actuation position,

[0028] [Fig. 5] [Fig. 5] is a schematic cross-sectional view of a nasal distribution head according to a second advantageous embodiment, and

[0029] [Fig.6] [Fig.6] is a view similar to that of [Fig.5], in the actuation position.

[0030] In the description, the terms "axial" and "radial" refer to the longitudinal axis X of the device shown in [Fig.2]. The terms "proximal" and "distal" refer to the distribution orifice.

[0031] Fig. 1 shows a cross-sectional view of a nostril. The roof P of the nasal cavity, which includes the ethmoids E, can be seen. In front of this roof P are the nasal valve and the turbinates, the presence of which makes it difficult to access the ethmoids E with a conventional spray, which extends conically at the outlet of the distribution orifice 12.

[0032] A dispensing head 10 comprising a body 11 having a dispensing orifice 12 is inserted into a nostril to dispense a dose of fluid product upon actuation. The dispensing head 10 contains a fluid product reservoir, with a piston 20 sliding axially within a portion of said reservoir to dispense the fluid product through the dispensing orifice.

[0033] The piston 20 is connected to an actuating rod 25 which can be manually operated by the user.

[0034] Alternatively, the distribution head 10 can be integrated into a distribution device comprising distribution means, for example a preloaded spring, adapted to act on the actuating rod 25, in particular on user command, for example the actuation of a suitable control button to trigger the spring.

[0035] According to the invention, the fluid product is first distributed as an approximately axial jet before transforming into an approximately conical spray after a distance L from the distribution orifice 12. As shown in [Fig. 1], this particular shape allows the fluid product to pass beyond the nasal valve and turbinates in the form of a jet, before transforming into a conical spray which will allow to reach the ethmoids E in a more significant way, both in quantity (proportion of the fluid dose that reaches the ethmoids) and in surface area (surface area S of the ethmoids touched by the fluid product).

[0036] To achieve this particular form of spray, the reservoir comprises a first distal cylindrical part 13 of length 11 and diameter dl and a second proximal cylindrical part 14 of length 12 and diameter d2, with dl > d2.

[0037] The second proximal cylindrical part 14, which extends the first distal cylindrical part 13, forms at its axial end the distribution orifice 12, which therefore also has a diameter d2.

[0038] Preferably, the second proximal cylindrical part 14 extends the first distal cylindrical part 13 coaxially along the longitudinal axis X.

[0039] The piston 20 slides in the first distal cylindrical part 13 between a rest position, visible in figures 3 and 5, and an actuation position, visible in figures 4 and 6.

[0040] In the second embodiment of figures 5 and 6, the piston 20 has a front extension 21 which in the actuation position will occupy the volume of the second proximal cylindrical part 14, thus reducing the dead volume and distributing substantially the entire dose of fluid product contained in the reservoir 13, 14 before actuation.

[0041] At the beginning of the actuation, the fluid contained in the second proximal cylindrical section 14 is expelled as a jet with a velocity VI through the distribution orifice 12. As the actuation stroke continues, the fluid contained in the first distal cylindrical section 13 passes into the second proximal cylindrical section 14, with the reduction of the diameter from dl to d2 causing an acceleration of the fluid. Thus, the fluid from the first distal cylindrical section 13 is distributed through the distribution orifice 12 also as a jet, but with a velocity V2 greater than VL. This second, faster jet catches up with the first, slower jet and strikes it at a distance L from the distribution orifice 12, generating an explosion and therefore a spray approximately in the shape of a V, as illustrated in Figures 1 and 2. This V defines an angle α.

[0042] Thus, the spray generated by the present invention has two important characteristics for the effectiveness of the device: the length L and the angle a.

[0043] By varying the characteristics of the dispensing head 10, such as the lengths 11 and / or 12, the diameters d1 and / or d2, and / or those of the piston actuation, such as the piston actuation force 20 and / or its actuation speed, and / or the volume of the dispensed dose, these two parameters L and a can be varied, and thus adapted to different morphologies, sizes, or shapes of nostrils. In particular, the length L can be chosen to generate the conical spray in the correct location, which varies This necessarily depends on the individual being treated: adult / child, male / female, ethnic origin, etc. Similarly, varying the angle α allows for modulation of the surface area S to be treated, which also varies depending on the individual. Adjusting the parameters L and α also allows, when desired, targeting an area of ​​the nasal cavity other than the ethmoids, for example, the turbinates.

[0044] Another advantage of the present invention is that it is no longer necessary to insert the dispensing head 10 deeply into the nostril; depending on the length L, positioning the dispensing orifice 12 at the entrance of the nostril may be sufficient. Advantageously, in this case, the dispensing head 10 could include insertion-limiting means, for example, a radial projection disposed around the body 11 of the dispensing head 10, near the outlet orifice 12, which could cooperate with the walls of the nostril to limit insertion.

[0045] The distribution head advantageously comprises the following characteristics: - the length 11 is between 3mm and 15mm, preferably between 4mm and 14mm; - the diameter dl is between 2mm and 14mm, preferably between 2.9mm and 12.5mm; - the length 12 is between 3mm and 18mm, preferably between 5mm and 15mm; - the diameter d2 is between 1mm and 7mm, preferably between 2mm and 6mm.

[0046] Tests have shown that an important parameter for obtaining a spray as desired is the ratio of diameters d2 / dl. Advantageously, this ratio d2 / dl is between 0.3 and 0.8, preferably between 0.4 and 0.7.

[0047] The actuation force F of the piston 20 is advantageously between 10N and 25N, preferably between 12N and 22N. Tests have shown that with constant characteristics of the distribution head 10 (11, dl, 12, d2), the greater the force F, the smaller the angle a.

[0048] The volume V of the dose of fluid product distributed is advantageously between 0.3ml and 5ml.

[0049] Thus, the length L can advantageously vary between 5mm and 50mm, and the angle a can advantageously vary between 15° and 125°.

[0050] The table below shows different configurations tested (with water as the fluid): V (ml) F (N) dl (mm) 11 (mm) d2 (mm) 12 (mm) d2 / dl L (mm) a(°) 1 12 4.69 14 2 5 0.43 47.21 32.05 3 12 8.95 14 4 5 0.45 30.21 121.58 3 12 8.95 14 6 15 0.67 15.22 31.68 0.3 17 2.90 9 2 10 0.69 34.95 18.16 3 17 8.95 9 6 15 0.67 12.81 48.49 3 17 8.95 14 6 10 0.67 5.17 60.00 5 17 12.44 4 6 10 0.48 20.00 25.15 3 22 8.95 14 6 5 0.67 24.79 55.34

[0051] The present invention is particularly suitable for treating neurodegenerative diseases, such as Parkinson's or Alzheimer's, which require the drug to cross the nose-brain barrier. Targeting the area, especially the ethmoids, via the nasal cavity is a simplified and non-invasive way to administer treatment to the brain.

[0052] The present invention can advantageously be used with the following drugs: - neurotransmitters and neuromodulators, for example: acetylcholine (ACH), anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbidopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors, noradrenaline, nitric oxide, Substance P; - general anesthetics, for example: alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, lorazepam, diazepam, morphine, nitrous oxide (N2O), propofol, sevoflurane, sufentanil, sublimase, thiopental; - local anesthetics, for example: benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine; - opioid analgesics, agonist-antagonists and antitussives, for example: agonists, codeine, diphenoxylate, fentanyl, heroin and other opioids, hydrocodone, 1-alpha-acetylmethadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, tramadol; - agonists / antagonists and antagonists, for example: buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, hydrocodone; - medications used in the treatment of Parkinson's disease and motor disorders, for example: amantadine, apomorphine, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, en- tacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, monoamine oxidase inhibitor, COMT inhibitor; - antiepileptics, for example: acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, vigabatrin, midazolam; - medications used in affective disorders, for example: antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, flu-voxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tra-nylcypromine, venlafaxine, antimanic medications, carbamazepine, lithium carbonate, valproic acid; - antipsychotics (neuroleptics), for example: chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone; - sedative-hypnotics, anxiolytics and centrally acting muscle relaxants, for example: alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, zolpidem; - drugs used in anxiety disorders and skeletal muscle relaxants, for example: alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam; - treatments for Alzheimer's disease, for example: donepezil, galantamine, riva-stigmine, tacrine, detemir, novolin, humulin, insulin, insulin analogue hormone, insulin analogue such as NPH insulin, lispro, aspart, insulin detemir, glulisine, insulin glargin, insulin degludec, BDNF, GDNF, MIBG, anticancer agents, anticancer drugs, dopamine agonists, dopamine antagonists; - other drugs, for example: amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylenedioxymethyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana / THC, organic solvents, nicotine, pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, da-vunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, entacopone, anti-ADHD agents, anti-ADHD drugs such as methylphenidrate (ritalin), drugs for autism and autism symptoms.

[0053] The present invention has been described with reference to two advantageous embodiments, but it is understood that a person skilled in the art can make any modifications to them. fications, without departing from the scope of the present invention as defined by the attached claims.

Claims

Demands

1. Nasal fluid product dispensing head (10) comprising a body (11) having a dispensing orifice (12), said body (11) forming a reservoir (13, 14) containing a dose of fluid product, a piston (20) sliding in a portion of said reservoir to dispense said dose of fluid product through said dispensing orifice (12), said dispensing head (10) comprising means for dispensing said dose of fluid product first in the form of an approximately axial jet through said outlet orifice (12), then after a distance L from said dispensing orifice (12), in the form of an approximately conical spray forming an angle α, said reservoir comprising a first distal cylindrical portion (13) of length 11 and diameter dl and a second proximal cylindrical portion (14) of length 12 and diameter d2, with dl > d2,characterized in that said piston (20) comprises a frontal extension (21) which, in the actuation position, occupies the volume of said second proximal cylindrical part (14).

2. Head according to claim 1, wherein said second proximal cylindrical part (14) extends said first distal cylindrical part (13), and forms at its axial end said distribution orifice (12).

3. Head according to claim 2, wherein said second proximal cylindrical part (14) extends said first distal cylindrical part (13) coaxially along a longitudinal axis (X) of said distribution head (10).

4. Head according to any one of the preceding claims, wherein said piston (20) is configured to slide in said first distal cylindrical portion (13) between a rest position and an actuation position.

5. Head according to any one of the preceding claims, wherein said length 11 is between 3mm and 15mm, preferably between 4mm and 14mm.

6. Head according to any one of the preceding claims, wherein said diameter dl is between 2mm and 14mm, preferably between 2.9mm and 12.5mm.

7. Head according to any one of the preceding claims, wherein said length 12 is between 3mm and 18mm, preferably between 5mm and 15mm.

8. Head according to any one of the preceding claims, wherein said diameter d2 is between 1mm and 7mm, preferably between 2mm and 6mm.

9. Head according to any one of the preceding claims, wherein the ratio d2 / dl is between 0.3 and 0.8, preferably between 0.4 and 0.

7.

10. Head according to any one of the preceding claims, wherein the actuation force F of said piston (20) is between 10N and 25N, preferably between 12N and 22N.

11. Head according to any one of the preceding claims, wherein the volume V of the dispensed dose of fluid product is between 0.3ml and 5ml.

12. A nasal dispensing device for fluid products, characterized in that it comprises a dispensing head according to any one of the preceding claims.

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