Disposable ampoule for an aerosol generating device
11077263 · 2021-08-03
Assignee
Inventors
Cpc classification
A61M15/009
HUMAN NECESSITIES
A61M15/0028
HUMAN NECESSITIES
A61J1/067
HUMAN NECESSITIES
A61M11/00
HUMAN NECESSITIES
A61M15/0031
HUMAN NECESSITIES
A61M2207/00
HUMAN NECESSITIES
B05B17/0646
PERFORMING OPERATIONS; TRANSPORTING
International classification
A61M11/00
HUMAN NECESSITIES
Abstract
Disposable ampoule for use in an aerosol generating device, comprising: a medicament container that contains a medicament and is formed of a container body and a container bottom, and a predetermined break point that at least partly surrounds the container bottom, characterised by a collar that surrounds the predetermined break point at its outside and extends the container body over and beyond the container bottom.
Claims
1. A disposable ampoule for use in an aerosol generating device, comprising: a medicament container that contains a medicament and is formed of a container body and a container bottom extending in a plane perpendicular to a longitudinal direction of the ampoule, a predetermined break point that at least partly surrounds the container bottom, and a fixing groove formed in the container body, the fixing groove being provided centrally or closer to the container bottom in the longitudinal direction of the ampoule to absorb forces required to open the ampoule in the aerosol generating device and which arise when breaking the predetermined break point, wherein the ampoule at least at its inner contour tapers inwardly toward the container bottom in a first functional area of the container body and containing the container bottom, and a second functional area of the container body is substantially configured as a hollow cylinder, wherein the fixing groove includes an annular indentation into the container body and first and second portions of the container body located on opposite sides of the annular indentation, the first and second portions being raised with respect to a bottom part of the annular indentation and defining the annular indentation between them wherein the fixing groove is located between the first functional area and the second functional area, wherein at least one reinforcing rib is provided on the container body and wherein the reinforcing rib extends over a partial area of the container body, over and beyond the container bottom and over at least a partial area of a collar that surrounds the predetermined break point at its outside and extends the container body over and beyond the container bottom, an open end of the collar being spaced from the container body.
2. The ampoule according to claim 1, wherein the fixing groove extends in an annular manner around the container body.
3. The ampoule according to claim 1, wherein the reinforcing rib is provided on a side of the container bottom relative to the fixing groove.
4. The ampoule according to claim 1, wherein two diametrically opposed reinforcing ribs are provided.
5. The ampoule according to claim 1, wherein starting from the container bottom, the collar expands in a conical manner at least at its inner contour.
6. The ampoule according to claim 1, wherein the fixing groove is configured to mount the ampoule in the aerosol generating device and to retain the ampoule in a longitudinal direction of the ampoule.
7. The ampoule according to claim 6, wherein the fixing groove is configured to engage with catches of a translationally moveable element of the aerosol generating device.
8. The ampoule according to claim 7, wherein the fixing groove retains the ampoule in the translationally moveable element of the aerosol generating device, whereby the container bottom is pierced by a translational movement of the translationally moveable element and the retained ampoule relative to a hollow piercing element to open the ampoule and supply the medicament to the aerosol generating device.
9. The ampoule according to claim 1, wherein all parts of the ampoule are integrally formed.
10. The ampoule according to claim 9, which is produced by a blow-fill-seal process.
11. The ampoule according to claim 9, which is made of polyethylene, polypropylene or a thermoplastic copolymer.
12. The ampoule according to claim 1, wherein the medicament contains at least one active agent.
13. The ampoule according to claim 12, wherein the medicament contains at least one auxiliary agent in dissolved or suspended form.
14. The use of an ampoule according to claim 1 in an aerosol generating device, the medicament thereof being nebulized by an aerosol generator and being used for a local, nasal or pulmonary application.
15. The ampoule according to claim 1, wherein the predetermined break point at least partly surrounds the container bottom in the plane of the container bottom.
Description
(1) Further advantages and features of the present invention become apparent from the following description of a preferred embodiment, which takes place with reference to the accompanying drawings.
(2)
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(9) As is shown in
(10) Starting from the container bottom, the collar 15 is thereby designed such that the cross-section of its inner contour becomes bigger, i.e. it is configured in a conical manner, with it expanding starting from the container bottom 11 (the diameter of the annular cross-section becomes bigger starting from the container bottom 11).
(11) As is indicated in
(12) The ampoule according to the invention furthermore comprises two diametrically opposed reinforcing ribs in the first functional area 21. These provide dimensional stability to the ampoule in particular during the opening process in which the ampoule is pushed onto a needle (see below) in order to pierce the bottom 11 of the container along the predetermined break point 12. In the embodiment shown in
(13) A lug 16 is furthermore provided at the end of the container body 10 that is opposite the bottom 11 of the container. This lug, which has a substantially flat design with two opposite surface areas, enables the attachment of a labelling field 17, which can contain information about the accommodated medicament. The batch number 18 and the date of expiry can be provided on the opposite surface.
(14) As is apparent from
(15)
(16) The element 32 furthermore comprises catches 33, with which the fixing groove 13 of the ampoule according to the invention can engage in order to fix the ampoule in the element 32.
(17) The aerosol generating device furthermore comprises a needle 34 that is formed as a hollow cylinder and comprises a cutting edge 35 at its one end. The inner diameter of the needle 34 is greater than 8 mm in order to counteract the formation of air bubbles during the outflow of the medicament, which could impede the subsequent flow of the medicament. The aerosol generator, which is preferably a piezoelectrically actuated membrane, is located at the opposite end of the needle 34. A through-hole 37 is preferably also formed in the element 32 concentric to the hole 31 of the lid 30, through which the ampoule protrudes out of the aerosol generating device in the inserted state.
(18) A further sealing element in the form of an o-ring 38 is additionally provided in the upper region of the needle 34.
(19) The use of an ampoule according to the invention is explained in the following with reference to
(20) If an ampoule is to be inserted in the aerosol generating device, the lid 30 is removed from the body of the aerosol generating device, for example is unscrewed. The element 32 thereby moves upwards in a translational manner through the hole 31 of the lid 30. Once the lid has been removed, the ampoule is inserted into the element 32 from the side opposite the hole 37 of the element 32, with the lug 16 and part of the container body 10 being guided through the hole 37 of the element 32. The fixing projections 33 of the element 32 thereby engage with the fixing groove 13 of the ampoule and retain it in their longitudinal direction. The lid 30 is then placed back onto the body of the aerosol generating device. Owing to the twisting of the lid 30 and the engagement of the projections of the lid 30 with the thread grooves of the element 32, the element 32 is moved in a translational manner in the hole 31 of the lid 30. Since the ampoule is connected to the element 32, the ampoule is also moved in a translational manner. An inner surface of the collar 15 thereby first of all engages, as is shown in
(21) Furthermore, this seal is also maintained in the completely inserted state (
(22) As a result of a further rotational movement of the lid 30 and the associated further translational movement of the element 32, and thus of the ampoule, the container bottom, as shown in
(23) In the completely inserted state, the holes 37 of the element 31, 32 of the lid 30 are arranged substantially in one plane. However, the lug 16 protrudes through the hole 37 of the element 32 and out of the aerosol generating device in this position as well such that the labelling field 17 as well as the batch number 18 and the not shown expiry details are also still visible in the inserted state.
(24) In order to remove the ampoule, the lid 30 is turned in the opposite direction, as a result of which the element 32 is moved in a translational manner in the opposite direction to when opening the ampoule, and the ampoule pulls away from the needle 34 again. The seal between the ampoule (collar) and the needle (o-ring) thereby remains until the ampoule can actually be removed from the needle 34 with the lid 30 and thus contamination of the device by medicament residues can also be prevented in this manner. In order to remove the ampoule from the lid 30, the user can grip the lug 16 and push the ampoule (downwards in the figures) out of engagement with the projections 33 such that it can be removed. The user must thereby not touch the area of the ampoule that is possible wetted by a medicament, which is additionally covered by the collar 15. Pushing out of the ampoule can also be facilitated in the case of a particularly short second functional area 20 owing to the at least protruding lug 16.
(25) In summary, the present invention thus offers a plurality of advantages as compared to the ampoule of the prior art. It is, however, obvious that the described embodiment is only one possibility for carrying out the present invention and that the invention is defined by the following patent claims.
(26) The active agent classes and/or substances listed in the following can be contained in the ampoule according to the invention, however this list is not conclusive:
(27) The active compounds include, for example, substances selected from the group consisting of anti-inflammatory compounds, glucocorticoids, anti-allergy medicaments, antioxidants, vitamins, leukotrine antagonists, anti-infective agents, antibiotics, anti-fungicides, antiviral agents, mucolytic agents, decongestants, antiseptics, cyto-static agents, immunomodulators, vaccines, wound-healing agents, local anaesthetics, oligonucleotides, peptides, proteins and plant extracts.
(28) Examples of potentially useful anti-inflammatory compounds are glucocorticoids and non-steroidal anti-inflammatory agents such as, for example, betamethasone, beclomethasone, budesonide, ciclesonide, dexamethasone, desoxymethasone, fluoconolone acetonide, flucinonide, flunisolide, fluticasone, icomethasone, rofleponide, triamcinolone acetonide, fluocortinbutyl, hydrocortisone, hydroxycortisone-17-butyrate, prednicarbate, 6-methylprednisolone aceponate, mometasone furoate, dehydroepiandrosterone sulphate (DHEAS), elastane, prostaglandin, leukotriene, bradykinin antagonists, non-steroidal anti-inflammatory medicaments (NSAIDs), such as ibuprofen, including any pharmaceutically acceptable salts, esters, isomers, stereoisomers, diastereomers, epimers, solvates or other hydrates thereof, prodrugs, derivates or any other chemical or physical forms of active compounds comprising the respective active residues.
(29) Examples of anti-infective agents whose class or therapeutic category is understood herein as including compounds that are effective against bacterial, fungal and viral infections, i.e. including the classes of microbicides, antibiotics, fungicides, antiseptics and anti-viral agents, are penicillins, including benzylpenicillins (penicillin-G-sodium, clemizone penicillin, benzathine penicillin G), phenoxypenicillins (penicillin V, propicillin), amino-benzylpenicillins (ampicillin, amoxicillin, bacampicillin), acylaminopenicillins (azlocillin, mezlocillin, piperacillin, apalcillin), carboxypenicillins (carbenicillin, ticarcillin, temocillin), isoxazolylpenicillins (oxacillin, cloxacillin, dicloxacillin, flucloxacillin), and amiidine penicillins (mecillinam); cephalosporins, including cefazolins (cefazolin, cefazedone); cefuroximes (cerufoxime, cefamdole, cefotiam); cefoxitins (cefoxitin, cefotetan, latamoxef, flomoxef); cefotaximes (cefotaxime, ceftriaxone, ceftizoxime, cefmenoxime); ceftazidimes (ceftadzidime, cefpirome, cefepime); cefalexins (cefalexin, cefaclor, cefadroxil, cefradine, loracarbef, cefprozil), and cefiximes (cefixime, cefpodoxime proxetil, cefuroxime axetil, cefetamet pivoxil, cefotiam hexetil), loracarbef, cefepime, clavulanic acid/amoxicillin, ceftobiprole; synergists, including beta-lactamase inhibitors, such as clavulanic acid, sulbactam and tazobactam; carbapenems, including imipenem, cilastin, meropenem, doripenem, tebipenem, ertapenem, ritipenam and biapenem; monobactams, including aztreonam; aminoglycosides such as apramycin, gentamicin, amikacin, isepamicin, arbekacin, tobramycin, netilmicin, spectinomycin, streptomycin, capreomycin, neomycin, paromoycin and kanamycin; macrolides, including erythromycin, clarithromycin, roxithromycin, azithromycin, dithromycin, josamycin, spiramycin and telithromycin; gyrase inhibitors or fluroquinolones, including ciprofloxacin, gatifloxacin, norfloxacin, ofloxacin, levofloxacin, perfloxacin, lomefloxacin, garenoxacin, clinafloxacin, sitafloxacin, prulifloxacin, olamufloxacin, caderofloxacin, gemifloxacin, balofloxacin, trovafloxacin and moxifloxacin; tetracyclines, including tetracycline, oxytetracycline, rolitetracycline, minocycline, doxycycline, tigecycline and aminocycline; glycopeptides, including vancomycin, teicoplanin, ristocetin, avoparcin, oritavancin, ramoplanin and Peptide 4; polypeptides, including plectasin, dalbavancin, daptomycin, oritavancin, ramoplanin, dalbavancin, telavancin, bacitracin, tyrothricin, neomycin, kanamycin, mupirocin, paromomycin, polymyxin B and colistin; sulfonamides, including sulfadiazine, sulfamethoxazole, sulfalene, co-trimoxazole, co-trimetrol, co-trimoxazine, co-tetraxazine; azoles, including clotrimazole, oxiconazole, miconazole, ketoconazole, itraconazole, fluconazole, metronidazole, tinidazole, bifonazole, ravuconazole, posaconazole, voriconazole and ornidazole and other anti-fungicides including flucytosine, griseofluvine, tonoftal, naftifine, terbinafine, amorolfine, ciclopiroxolamine, echinocandin, such as micafungin, caspofungin, anidulafungin; nitrofuranes, including nitrofurantoin and nitrofuranzone; polyenes, including amphotericin B, natamycin, nystatin, flucocytosine; other antibiotics, including tithromycin, lincomycin, clindamycin, oxazolidinones (linezolids), ranbezolid, streptogramin A+B, pristinamycin aA+B, virginiamycin A+B, dalfopristin/quinupristin (synercid), chloramphenicol, ethambutol, pyrazinamide, terizidone, dapsone, prothionamide, fosfomycin, fucidin acid, rifampicin, isoniazid, cycloserine, terizidone, ansamycin, lysostaphin, iclaprim, mirocin B17, clerocidin, filgrastim and pentamidine; antiviral agents, including aziclovir, ganciclovir, brivudin, valaciclovir, zidovudine, didanosine, thiacytidine, stavudine, lamivudine, zalcitabine, ribavirine, nevirapirine, delaviridine, trifluridine, ritonavir, saquinavir, indinavir, foscarnet, amantadine, podophyllotoxin, vidarabine, tromantadine and proteinase inhibitors; antiseptics, including acridine derivatives, iodine providon, benzoates, rivanol, chlorhexidine, quaternary ammonium compounds, cetrimides, biphenylol, chlorophen and octenidine; plant extracts or components, such as plant extracts of camomile, hamamelis, Echinacea, calendula, thyme, papain, pelargonium, pine trees, essential oils, myrtol, pinene, limonene, cineole, thymol, menthol, camphor, tannin, alpha-hederin, bisabolol, lycopodine, vitapherol; wound-treating compounds, including dexpanthenol, allantoin, vitamins, hyaluronic acid, alpha-antitrypsin, inorganic and organic zinc salts/compounds, bismuth salts and selenium salts; interferons (alpha, beta, gamma), tumour necrosis factors, cytokines, interleukins, immunomodulators, including methotrexate, azathioprine, cyclosporine, tacrolismus, sirolismus, rapamycin, mofetil, mofetil-mycophenolate; cytostatic agents and metastase inhibitors; alkylating agents, such as nimustin, melphalan, carmustine, lomustine, cyclophosphamide, ifosfamide, trofosfamide, chloroambucil, busulfan, treosulfan, prednimustine, thiotepa; anti-metabolites, for example cytarabine, fluorouracil, methotrexate, mercaptopurine, thioguanine; alkaloids such as vinblastine, vincristine, vindesine; antibiotics such as, for example, alcarubicin, bleomycin, dactinomycin, daunorubicin, doxorubicin, epirubicin, idarubicin, mitomycin, plicamycin; complexes of transitional elements (for example, Ti, Zr, V, Nb, Ta, Mo, W, Pt) such as carboplatinim, cis-platinum and metallocene compounds such as, for example, titanocene dichloride; amsacrine, dacarbazine, estramustine, etoposide, beraprost, hydroxycarbamide, mitoxanthrone, procarbazine, temiposide; paclitaxel, iressa, zactima, poly-ADP-ribose-polymerase (PRAP) enzyme inhibitors, banoxantrone, gemcitabine, pemetrexed, bevacizumab, ranibizumab.
(30) Examples of potentially useful mucolytic agents are DNase, P2Y2-agonists (denufosol), medicaments that affect the penetration of chlorine and sodium, such as, for example, N-(3,5-diamino-6-chloropyrazine-2-carbonyl)-N′-{4-[4-(2,3-dihydroxypropoxy)-phenyl]butyl}guanidine-methane sulfonate (PARION 552-02) heparinoids, guaifenesine, acetylcysteine, carbocysteine, ambroxol, bromhexine, tyloxapol, lecithine, myrtol and recombinant surfactant proteins.
(31) Examples of potentially useful vasoconstrictors and decongestants that may be useful for reducing swelling of the mucous membrane are phenylephrine, naphazoline, tramazoline, tetryzoline, oxymetazoline, fenoxazoline, xylometazoline, epinephrine, isoprenaline, hexoprenaline and ephedrine.
(32) Examples of potentially useful local anaesthetics include benzocaine, tetracaine, procaine, lidocaine and bupivacaine.
(33) Examples of potentially useful anti-allergy agents include the aforementioned glucocorticoids, cromolyn sodium, nedocromil, cetrizine, loratidine, montelukast, roflumilast, ziluton, omalizumab, heparinoids and other antihistamines, including azelastine, cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine.
(34) Antisense oligonucleotides are short synthetic strands of DNA (or analogues) which are complementary or opposite to the target sequence (DNA, RNA) and which are designed such that they stop a biological process such as transcription, translation or splicing. The inhibition of gene expression hereby caused makes oligonucleotides useful for the treatment of many illnesses, depending on their composition, and numerous compounds are currently being clinically tested, such as, for example, ALN-RSV01 for the treatment of respiratory syncytial virus, AVE-7279 for the treatment of asthma and allergies, TPI-ASM8 for the treatment of allergic asthma and 1018-ISS for the treatment of cancer.
(35) Examples of potentially useful peptides and proteins include amino acids, such as, for example, L-arginine, L-lysine, antibodies to toxins produced from microorganisms, antimicrobial peptides such as cecropins, defensins, thionins and cathelicidins.
(36) For each of these and other explicitly mentioned examples of medicament substances that are potentially useful for carrying out the invention, the compound names specified herein should be understood as also including any pharmaceutically acceptable salts, solvates or other hydrates, prodrugs, isomers or any other chemical or physical forms of the relevant compounds which contain the corresponding active residues.