WO2022061443A1 - Bouchons de narine analgésiques - Google Patents

Bouchons de narine analgésiques Download PDF

Info

Publication number
WO2022061443A1
WO2022061443A1 PCT/CA2020/051658 CA2020051658W WO2022061443A1 WO 2022061443 A1 WO2022061443 A1 WO 2022061443A1 CA 2020051658 W CA2020051658 W CA 2020051658W WO 2022061443 A1 WO2022061443 A1 WO 2022061443A1
Authority
WO
WIPO (PCT)
Prior art keywords
core material
deformable
nose plug
nose
phasic
Prior art date
Application number
PCT/CA2020/051658
Other languages
English (en)
Inventor
Bradford Mechor
Merle Olson
Original Assignee
Rhinoclear Nasal Care Solutions Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/031,487 external-priority patent/US20210007903A1/en
Application filed by Rhinoclear Nasal Care Solutions Inc. filed Critical Rhinoclear Nasal Care Solutions Inc.
Publication of WO2022061443A1 publication Critical patent/WO2022061443A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
    • A61F13/2002—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the use
    • A61F13/2005—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the use specially adapted for the nose cavity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • A61K31/24—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
    • A61K31/245—Amino benzoic acid types, e.g. procaine, novocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose

Definitions

  • This disclosure generally relates to non-invasive techniques for delivering medicaments.
  • the disclosure relates to hemostatic-coated nose plugs configured to deliver medicaments through intranasal pathways.
  • Intranasal pathways may be used to deliver certain medicaments to the bloodstream.
  • the nasal cavity is covered by a thin mucosa that is well-vascularized.
  • Medicaments administered via the intranasal pathways thus need only transfer across a single epithelial cell layer for systematic blood circulation.
  • the medicaments are administered via the intranasal pathways, they avoid the first pass effect, which simplifies the determination of their dosages.
  • the medicaments may also avoid the blood brain barrier.
  • Medicaments designed for intranasal delivery are typically incorporated into nasal sprays.
  • the nasal sprays produce a mist of a solution containing the medicament that coats the nostril and/or nasal passage.
  • the medicament is then transferred across the mucosa and into the bloodstream.
  • nasal sprays are not well suited for prolonged delivery of a medicament, as the coating provided by the mist is quickly degraded by a user’s breathing. As a result, several applications may be necessary. Further, it may therefore also be difficult to determine if an appropriate dose has been delivered.
  • the present disclosure relates to analgesic nose plugs for treating and/or preventing pain and optionally other ailments.
  • a deformable analgesic nose plug comprising a deformable core material comprising a multi-phasic core material.
  • the multi-phasic core material has a first phase characterized by a solid or a semisolid structure at a temperature of 35° C or less and a second phase characterized by liquefaction at a temperature of 37° C or greater.
  • the deformable analgesic nose plug also comprises one or more analgesic compounds.
  • the nose plug has a tapered distal end for insertion into a nostril and a proximal end whereby the nose plug is inserted into the nostril.
  • the analgesic nose plugs of the present disclosure may provide a number of advantages.
  • the nose plugs may provide rapid relief of pain such as head, face, and/or neck pain.
  • medicaments administered intranasally may be transferred directly to the blood stream via the mucosa.
  • most over-the-counter treatments available are for administration in the form of pills or tablets. Such treatments may, in contrast, take up to an hour to provide relief of pain or other related symptoms, depending on when the patient last ate, how much they ate, and other such events.
  • the nose plugs of the present disclosure are not affected by such factors and may consistently provide rapid administration of medicaments and thus rapid relief of pain.
  • nose plugs of the present disclosure may deliver medicaments non-invasively. As described above, treatments administered by way of pills or tablets may take a significant amount of time to take effect.
  • One alternative used by medical practitioners is to administer the treatment intravenously by way of a needle, which affords a more rapid delivery of the medicament than the pills or tablets.
  • needles are uncomfortable and may be painful.
  • the nose plugs of the present disclosure may provide similar delivery of medicaments to the bloodstream while also avoiding the discomfort and pain caused by needles.
  • the nose plugs of the present disclosure may provide prolonged administration of medicaments to a patient.
  • the nose plugs are inserted into a patient’s nose and allowed to deliver medicaments for an extended period of time, which may be particularly useful for anesthetics.
  • medicaments are administered intravenously, which has a number of disadvantages such as those described above.
  • Fig. 1A is a side view of the nose plug according to one embodiment of the present disclosure
  • Fig. 1 B is a cross-sectional view of the nose plug
  • Fig. 2 is a cross -sectional side view of another embodiment of another nose plug according to of the present disclosure
  • Fig. 3 is a cross-sectional side view of another embodiment of another nose plug according to the present disclosure.
  • Fig. 4 is a cross-sectional side view of another embodiment of another nose plug according to the present disclosure. DETAILED DESCRIPTION
  • Some embodiments of the present disclosure generally pertain to nose plugs having hemostatic coatings thereon for affecting immediate cessation of nosebleeds upon insertion of the nose plugs into nasal cavities.
  • the present nose plugs comprise a core material for receiving and supporting thereon a coating comprising a compound with hemostatic properties.
  • each of the present nose plugs may additionally comprise an applicator stick engaged with the core material.
  • each of the present nose plugs may comprise a pliable material engaged with the core material wherein a portion of the pliable material extends outward from the core material.
  • nose plug refers to a device to be inserted into a nostril.
  • the nose plugs generally sized such that, when inserted into the nostril, the nose plug contacts the inner surfaces of the nostril in order to maintain its position therein.
  • core material refers to the material or materials that form the body of the nose plugs of the present disclosure.
  • the core material is deformable in that it is capable of being reshaped, which facilitates the insertion of the nose plugs into nostrils of different sizes.
  • FIGs. 1A and 1B An embodiment of a nose plug 10 according to the present disclosure is shown in Figs. 1A and 1B and comprises a multi-phasic core material 25 that has been coated with a hemostatic composition 20.
  • a suitable multi-phasic core material 25 may be formed from a mixture of materials that are solids or semi-solids at temperatures lower than about 36° C (i.e., a first phase) and that liquefy at a temperature of 37° C or higher (i.e., a second phase).
  • suitable mixtures of materials for preparing the multi- phasic core material 25 include of two or more of cocoa butter, polyethylene glycols, hydrogels, glycerin, polyglycolysed glycerides, and glycerinated gelatin.
  • Suitable polyglycolysed glycerides include but are not limited to arachidic acid, lauric acid, myristic acid, aleic acid, palmitic acid, and steric acid.
  • the core material 25 may additionally comprise an excipient exemplified by monodecanoyl-glycerol, monolauroyl-glycerol, fatty acid triglycerides, thylene glycol, triethylene glycol, propylene glycol, butylene glycols, 1 ,2-propylene glycol, and the like.
  • the multi- phasic core material 25 may additionally comprise a lubricant exemplified by mineral oil, vegetable oil, polyisobutene, polyalkyleglycol, polyolefin, diester, polymerester, vegetable stearin, magnesium stearate, hydrogenated vegetable oils, cocoa butter, theobroma oil, hydrogenated corn oil, palm oil, palm kernel oil, coconut oil, stearic acid, and the like.
  • the multi-phasic core material 25 may additionally comprise an emollient exemplified by salicylic acid, ammonium lactate, urea, dimenticone, and the like.
  • the multi-phasic core material may be prepared by mixing together the selected materials in heated water, for example, at a temperature from a range of 40° C to 90° C and anywhere therebetween, and then pouring the mixture into molds for curing and forming.
  • a suitable mixture of material for the multi-phasic core is about 14% gelatin plus about 70% glycerol plus about 16% water.
  • Another example of a suitable mixture is about 33% PEG 4000 plus about 47% PEG 6000 plus about 20 % water.
  • Suitable molds for forming the multi-phasic core material into nose plugs include metal molds, flexible rubber molds, silicone molds, and the like.
  • the multi-phasic core material may be formed into the nose plug 10 using a suppository-manufacturing device, which are known in the art.
  • Each nose plug of the present disclosure generally comprises about 0.5 g, about 0.6 g, about 0.7 g, about 0.8 g, about 0.9 g, about 1.0 g, about 1.1 g, about 1.2 g, about 1.3 g, about 1.4 g, about 1.5 g of material and therebetween. Particularly suitable is about 1.0 g of core material.
  • the nose plugs of the present disclosure generally have an elongate cylindrical shape with a tapered conical distal end 12 (i.e., the end that is inserted into a nostril). Such shapes are commonly referred to as bullet-shaped or torpedoshaped. It is optional for the distal end 12 of the nose plugs 10 to have a frusticonical taper terminating with a rounded end.
  • the proximal end 14 of a nose plug 10 of the present disclosure may be flat. Alternatively, the proximal end of the nose plug may be concave. Alternatively, the proximal end of the nose plug may be convex.
  • the diameter of the multi-phasic core material of the nose plugs 10 may be selected from a range of about 0.5 cm to about 1.75 cm and therebetween.
  • the diameter of a nose plug 10 approximate its proximal end 14 may be same as the diameter of the central body portion of the nose plug 10, i.e., the nose plug 10 may have the same diameter from its proximal end 14 until the onset of tapering to its distal end 12.
  • the diameter of a nose plug according to the present disclosure may be slightly flared outward approximate its proximal end.
  • the diameter of a nose plug according to the present disclosure may be slightly flared outward approximate its proximal end.
  • the length of the multi-phasic core material of the nose plugs may be selected from a range of about 1.5 cm to about 3.5 cm and therebetween.
  • the multi-phasic nature of the core material makes it deformable as the present nose plug is inserted into a nostril so that a large portion of the outer covering of the nose plug is in at least partial and preferably full contact with the nasal membranes lining the nostril.
  • a solution comprising one or more hemostatic compounds is coated onto the outer surface of the nose plug cores, for example, by dipping or by spraying or other suitable coating processes, after which the coated nasal plugs are dried.
  • Suitable hemostatic compounds include but are not limited to ferrous sulfate, ferric sulfate, aluminum sulfate, ammonium sulfate, aluminum potassium sulfate, aluminum chloride, tannic acid, zinc chloride, the like, and mixtures thereof.
  • Particularly suitable hemostatic compounds are ferrous sulfate, ferric sulfate, and mixtures thereof.
  • the present nose plug may be taken out of its container and simply inserted into the nostril such that some or all of the elongate outer surface of the nose plug is in contact with the nasal tissues lining the nostril and/or nasal passage.
  • the hemostatic compound in the outer coating of the nose plug will cause cessation of bleeding at a capillary source(s) within the nostril and/or nasal passage.
  • the present nose plugs will provide a compression pressure onto and about the bleeding areas within the nostril and nasal passage.
  • the core material will slowly liquefy as the nose plug is warmed to body temperature (i.e., 37° C) and will slowly flow to the back of the nasal cavity, toward the pharynx from where it may be spit out, or alternatively, pass into the esophagus and moved to the stomach where it will digested.
  • body temperature i.e. 37° C
  • the nose plug can be removed simply by blowing the nose.
  • Suitable components that may be incorporated including clotting factors such as thrombin, prothrombin, thromboplastin, fibrinogen, and the like; antibiotic compositions such as penicillin, cephalosporin, tetracycline, macrolides, and the like; antimicrobial agents such as ivermectin, thymol, benzoic acid, phenolic acid, sorbic acids, alcohols, benzethonium chloride, bronopol, butylparaben, cetrimide, chlorhexidine, chlorobutanol, chlorocresol, cresol, ethylparaben, imidurea, methylparaben, phenol, phenoxyethanol, phenylethyl alcohol, phenylmercuric acetate, phenylmercuric borate, phenylmercuric nitrate, potassium sorbate, propylparab
  • clotting factors such as thrombin, prothrombin, thromboplastin, fibr
  • emollients exemplified by mineral oil, mixtures of mineral oil and lanolin alcohols, cetyl alcohol, cetostearyl alcohol, petrolatum, petrolatum and lanolin alcohols, cetyl esters wax, cholesterol, glycerin, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lecithin, allyl caproate, althea officinalis extract, arachidyl alcohol, argobase EUC, butylene glycol, dicaprylate/dicaprate, acacia, allantoin, carrageenan, cetyl dimethicone, cyclome hicone, diethyl succinate, dihydroabietyl behenate, dioctyl adipate, ethyl laurate, ethyl palmitate, ethyl stearate, isoamyl laur
  • emollients exemplified by mineral
  • An emollient if present, is present in the compositions described herein in an amount by weight of the composition of about 1% to about 30%, about 3% to about 25%, or about 5% to about 15%.
  • one or more emollients are present in a total amount of about 1% by weight, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 1 1%, about 12%, about 13%, about 14%, about 1 %, about 16%, about 17%, about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, or about 30%, and therebetween.
  • antioxidants exemplified by citric acid, butylated hydroxytoluene (BHT), ascorbic acid, glutathione, retinol, a-tocopherol, p-carotene, a-carotene, ubiquinone, butylated hydroxyanisole, ethyl enediaminetetraacetic acid, selenium, zinc, lignan, uric acid, lipoic acid, N-acetylcysteine, and the like.
  • BHT butylated hydroxytoluene
  • an applicator stick 30 into the multi-phasic core material 25 of a nasal plug 10 as it is solidifying in a mold so that about 0.5 cm to about 1.5 cm of the applicator stick extends outward from the proximal end of the nasal plug (Fig. 2).
  • the applicator stick 30 may be a wooden stick or a plastic stick or a polymeric stick, and the like.
  • a length of a flexible material exemplified by a string, a cord, and the like may be inserted into the multi-phasic core material of a nasal plug as it is solidifying in a mold so that a portion of about 0.5 cm to about 1.5 cm of the flexible material extends outward from the proximal end of the nasal plug.
  • a flexible material it is optional to place one end of a flexible material into one core material of a nasal plug as it is solidifying in a cavity of a mold and the other end of the flexible material into an adjacent core material in and adjacent cavity of the mold so that after the multi-phasic core material has solidified, two nose plugs are joined together by the flexible material that extends into both plug cores. Once the nosebleed has stopped, the nose plug can be removed via pulling on the applicator stick or the flexible material.
  • the nose plug 50 has a core material, a distal end 52, and a proximal end 54.
  • the core material comprises a porous resiliently compressible substrate 65 into which has been imbedded an applicator stick 70 that extends outward from the proximal end 54 of the nose plug 50.
  • the porous resiliently compressible core material 65 is coated with a selected hemostatic compound 60.
  • Suitable hemostatic compounds include but are not limited to ferrous sulfate, ferric sulfate, aluminum sulfate, ammonium sulfate, aluminum potassium sulfate, aluminum chloride, tannic acid, zinc chloride, the like, and mixtures thereof.
  • Particularly suitable hemostatic compounds are ferrous sulfate, ferric sulfate, and mixtures thereof.
  • Suitable porous resiliently compressible substrates include materials that can be formed to bullet shapes or torpedo shapes or elliptical shapes or cylindrical shapes, for example man-made polymeric sponges, naturally occurring sponges, fluffy cellulosic materials, cotton, rolled gauze, the like, and mixtures thereof.
  • the porous core substrate 65 is coated with a hemostatic composition 60.
  • Suitable hemostatic compositions include but are not limited to ferrous sulfate, ferric sulfate, aluminum sulfate, ammonium sulfate, aluminum potassium sulfate, aluminum chloride, tannic acid, zinc chloride, the like, and mixtures thereof.
  • Particularly suitable hemostatic compounds are ferrous sulfate, ferric sulfate, and mixtures thereof. It is optional if so desired, to infiltrate the porous resiliently compressible substrate 65 with a multi-phasic core material prepared as previously described in reference to Figs. 1A and 1 B.
  • the applicator stick 70 may be substituted for with a length of a flexible material exemplified by a string, a cord, and the like. It is optional to place one end of a flexible material into one porous resiliently compressible core material 65 of a nasal plug 50 and the other end of the flexible material into an adjacent porous resiliently compressible core material 65 so that after the porous resiliently compressible core materials 65 have been coated with a hemostatic composition 60, two nose plugs 50 are joined together by the flexible material that extends into both plug cores.
  • the resiliently compressible nature of the porous substrate 65 makes it deformable as the present nose plug is inserted into a nostril so that a large portion of the outer covering of the nose plug 50 is in full contact with the nasal membranes lining the nostril. Once the nosebleed has stopped, the nose plug 50 can be removed via pulling on the applicator stick 70 or the flexible material.
  • a further embodiment of the present disclosure relates to nose plugs comprising one or more compounds for treating and/or preventing pain and optionally other ailments.
  • a deformable analgesic nose plug comprising: a deformable core material comprising a multi- phasic core material wherein a first phase of the multi-phasic core material is characterized by a solid or a semi-solid structure at a temperature of 35° C or less, and wherein a second phase of the multi-phasic core material is characterized by liquefaction at a temperature of 37° C or greater; and one or more analgesic compounds, wherein the nose plug has a tapered distal end for insertion into a nostril and a proximal end whereby the nose plug is inserted into the nostril.
  • an analgesic nose plug 100 comprises a deformable core material 125 and an optional outer coating of an analgesic composition 120.
  • the analgesic nose plug 100 has tapered distal end 112 and a proximal end 114.
  • an optional applicator 130 embedded into the nose plug 100.
  • the nose plug 100, the tapered distal end 112 thereof, the proximal end 114 thereof, and the optional applicator 130 may be configured in the same manner as previously described herein in relation to the nose plugs 10, 50, the tapered distal ends 12, 52, the proximal ends 14, 54, and the applicators 30, 70, respectively.
  • the core material 125 of the analgesic nose plug 100 may also be configured in the same manner as the core materials 25, 65.
  • the core material 125 may comprise the previously described multi-phasic core material and/or the porous resiliently compressible core material.
  • the core material 125 is coated with the analgesic composition 120.
  • the analgesic composition 120 may be incorporated into the core material 125.
  • the analgesic composition 120 is both incorporated into the core material 125 and coated thereon.
  • the analgesic composition 120 comprises one or more analgesic compounds.
  • the one or more analgesic compounds may comprise bupivacaine, lidocaine, prilocaine, benzocaine, dibucaine, pramoxine, phenol, cocaine, tetracaine, or any combination thereof. It is noted that, in embodiments where the analgesic composition 120 is coated onto the core material 125, it may be coated onto the core material 125 using the techniques described above.
  • the core material 125 is coated using a solution comprising each of the one or more analgesic compounds in an amount of about 10 vol. % to about 30 vol. %.
  • the solution may comprise each of the one or more analgesic compounds in an amount of about 20 vol. %.
  • the analgesic composition 120 may be incorporated in a concentration of about 10% to about 30%. In a particular aspect, the analgesic composition 120 may be incorporated in a concentration of about 20%.
  • the analgesic nose plug 100 may further comprise one or more additional components.
  • the additional components may be medicaments or may be compounds that provide another non-medical benefit.
  • the one or more additional components may be incorporated into the core material 125 and/or into a coating provided on the core material 125.
  • the one or more additional components may be incorporated into the analgesic composition 120.
  • the nose plug 100 may comprise one or more of the clotting factors, antibiotics, antimicrobial agents, antihistamines, decongestants, emollients, and antioxidants described above.
  • the nose plug 100 may also comprise a corticosteroid such as hydrocortisone, mometasone, fluticasone, budesonide, betamethasone, and the like; an antidependency agent such as naloxone, naltrexone, methadone, buprenorphine, and the like; an odorant such as menthol, peppermint, salicylate, methyl salicylate, and the like; or any combination thereof.
  • a corticosteroid such as hydrocortisone, mometasone, fluticasone, budesonide, betamethasone, and the like
  • an antidependency agent such as naloxone, naltrexone, methadone, buprenorphine, and the like
  • an odorant such as menthol, peppermint, salicylate, methyl salicylate, and the like; or any combination thereof.
  • Suitable packaging for the nose plugs disclosed herein include blister packages containing multiple numbers of the present nose plugs wherein each nose plug is sealed within a single blister.
  • Such blister packages may contain one nose plug or two nose plugs or three nose plugs or four nose plugs or five nose plugs or six nose plugs or seven nose plugs or eight nose plugs or more.
  • Such blister packages may then be sealed into a cardboard container, for example one blister package per container or two blister packages per container or three blister packages per container or four blister packages per container or more.
  • multiples of the present nose plugs may be sealed in plastic bags that are then sealed in a cardboard container.
  • multiples of the present nose plugs may be sealed into a plastic bottle or composite bottle or pressed fiber bottle. The multiples of the present nose plugs may be sealed in plastic bags before being sealed in the bottles. It is optional if so desired, to sterilize the sealed and packed nose plugs prior to distribution, for example by gamma ray irradiation.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne un bouchon de narine analgésique déformable, comprenant un matériau central déformable et un revêtement externe fourni sur ledit matériau central déformable, ledit revêtement externe comprenant un ou plusieurs composés analgésiques. Le bouchon de narine présente une extrémité distale effilée destinée à être insérée dans une narine et une extrémité proximale par laquelle le bouchon de narine est inséré dans la narine. Le matériau central déformable peut comprendre un matériau central multiphasique, une première phase du matériau central multiphasique consistant en une structure solide ou semi-solide à une température de 35 °C ou moins, et une seconde phase du matériau central multiphasique étant caractérisée par une liquéfaction à une température de 37 °C ou plus. Le matériau central déformable peut également comprendre un substrat poreux élastiquement compressible. Le matériau central poreux déformable et élastiquement compressible peut être choisi parmi les éponges polymères, les éponges naturelles, les matériaux cellulosiques duveteux, le coton, la gaze roulée et leurs mélanges.
PCT/CA2020/051658 2020-09-24 2020-12-03 Bouchons de narine analgésiques WO2022061443A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/031,487 2020-09-24
US17/031,487 US20210007903A1 (en) 2016-10-27 2020-09-24 Analgesic Nose Plugs

Publications (1)

Publication Number Publication Date
WO2022061443A1 true WO2022061443A1 (fr) 2022-03-31

Family

ID=80844496

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2020/051658 WO2022061443A1 (fr) 2020-09-24 2020-12-03 Bouchons de narine analgésiques

Country Status (1)

Country Link
WO (1) WO2022061443A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190254961A1 (en) * 2016-10-27 2019-08-22 Rhinoclear Nasal Care Solutions Inc. Hemostatic Nose Plugs
US20200197338A1 (en) * 2018-12-19 2020-06-25 Nortic Holdings Inc. Therapeutic composition of intranasal lidocaine

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190254961A1 (en) * 2016-10-27 2019-08-22 Rhinoclear Nasal Care Solutions Inc. Hemostatic Nose Plugs
US20200197338A1 (en) * 2018-12-19 2020-06-25 Nortic Holdings Inc. Therapeutic composition of intranasal lidocaine

Similar Documents

Publication Publication Date Title
EP2485720B1 (fr) Composition à faible teneur en éther et appareil d'administration
JP5632284B2 (ja) 経口経粘膜剤形を使用する処置時の鎮静および無痛のための組成物および方法
Maunuksela et al. Double-blind evaluation of a lignocaine-prilocaine cream (EMLA) in children: effect on the pain associated with venous cannulation
US20090304812A1 (en) Topical Pharmaceutical Compositions
WO2009040595A1 (fr) Composition pharmaceutique à multiples doses d'un analgésique pour administration nasale
KR20030041871A (ko) 국소 약학 제제 및 치료 방법
CA3041921C (fr) Bouchons de nez hemostatiques
WO2020051117A1 (fr) Compositions de gel au menthol et aux cannabinoïdes, patchs et méthodes
KR20120104543A (ko) 시술 환경에서 경도의 진정, 불안해소 및 진통을 위한 조성물 및 방법
US20040131665A1 (en) Topical anesthetic formulation
CN114144224A (zh) 药物合成物输送器械和方法
EP2560614B1 (fr) Compositions pharmaceutiques et procédés d'administration de celles-ci
US20220288366A1 (en) Drug delivery device and methods for using same
US20210007903A1 (en) Analgesic Nose Plugs
WO2022061443A1 (fr) Bouchons de narine analgésiques
CA3214511A1 (en) Analgesic nose plugs
US11147775B2 (en) Cannabinoid and menthol gel compositions, patches and methods
US20160051494A1 (en) Multi-dose medication kit for treating anaphylaxis
US11229610B2 (en) Cannabinoid and menthol gel compositions, patches and methods
US11071717B2 (en) Anesthetic bandage
WO2021177940A1 (fr) Compositions à base de gel de menthol et de cannabinoïdes, timbres et procédés
AU2022234780A1 (en) Naloxone for use in the treatment of a opioid overdose administered by a drug delivery device
US20090215753A1 (en) Topical Compositions for Paediatric Use
WO2024035832A1 (fr) Système d'administration de médicament applicateur mains libres de produit topique et ses méthodes de fabrication et d'utilisation
Winfield et al. Routes of administration and dosage forms

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20954333

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20954333

Country of ref document: EP

Kind code of ref document: A1