WO2024109930A1 - Sac d'inhalation par atomisation et son utilisation dans l'administration d'inhalation par atomisation - Google Patents

Sac d'inhalation par atomisation et son utilisation dans l'administration d'inhalation par atomisation Download PDF

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Publication number
WO2024109930A1
WO2024109930A1 PCT/CN2023/133971 CN2023133971W WO2024109930A1 WO 2024109930 A1 WO2024109930 A1 WO 2024109930A1 CN 2023133971 W CN2023133971 W CN 2023133971W WO 2024109930 A1 WO2024109930 A1 WO 2024109930A1
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Prior art keywords
bag
atomizing
inhalation
inhalation bag
atomizing inhalation
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PCT/CN2023/133971
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English (en)
Chinese (zh)
Inventor
赵晓龙
苏荣尧
陈丽杰
李虎伯
司伟雪
朱涛
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康希诺生物股份公司
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Publication of WO2024109930A1 publication Critical patent/WO2024109930A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the present invention relates to the field of biomedical technology, and in particular to an atomizing inhalation bag and its application in atomizing inhalation drug administration, in particular to atomizing inhalation drug administration for preventing and/or treating respiratory diseases.
  • one treatment method for respiratory diseases is aerosol inhalation, which uses a nebulizer to disperse the drug solution into fine droplets, which are inhaled through the patient's nose or mouth.
  • the aerosolized drug directly acts on the target organ, which can increase the local concentration of the drug and achieve a therapeutic effect. Aerosol inhalation has a very good therapeutic effect on bronchiolitis, asthmatic bronchitis, bronchial asthma, acute and chronic bronchitis, acute laryngitis, acute pneumonia, etc.
  • Nebulized inhalation vaccines are vaccines that are administered through nebulized inhalation.
  • the so-called nebulized inhalation immunization refers to the use of a nebulizer to atomize the vaccine into tiny particles. These tiny particles enter the respiratory tract and lungs through inhalation, stimulating mucosal immunity.
  • the equipment and devices that realize this kind of atomized inhalation treatment and immunization are very important for the implementation and quality of treatment and immunization, and have received great attention from researchers and researchers.
  • the existing atomized drug delivery devices in the prior art mainly use a method of administering drugs by atomization and inhalation at the same time, which requires guidance to the subjects before administration. Children and even many adults often greatly affect the inhalation and absorption of drug mist due to improper control of the frequency of inhalation administration and their own breathing, which is very unfavorable for immunization.
  • the part of the device for inhalation by the subject should be disinfected or discarded after use.
  • nebulizer cup is generally used in the prior art.
  • the cost of the nebulizer cup is high, and the volume is large and not suitable for transportation; therefore, further development and use of nebulizer bags are considered, but in actual applications, it is found that when using nebulizer inhalation bags for nebulization inhalation, the nebulized drug mist is easily liquefied on the bag wall to form droplets due to electrostatic effects and cannot be normally inhaled by the human body.
  • the resistivity of the nebulizer bag will have a greater impact on the nebulization delivery rate; in addition, the bag body of different thicknesses has a greater impact on the morphology of the nebulizer bag and the changes in the bag body shape before and after nebulization.
  • the resistivity of the bag body will affect the molding, touch and effective amount of the nebulized drug mist. Therefore, it is urgent to explore the various performances of the nebulizer bag to form a suitable nebulizer bag.
  • the present invention provides an atomization inhalation bag and its application, wherein the atomization inhalation bag can be used to collect and carry the drug mist generated by the nebulizer for inhalation by a subject to achieve therapeutic or immunization effects.
  • an atomizing inhalation bag comprising a bag body and a bag cover.
  • the thickness of a single layer is 0.01-0.5 mm, preferably 0.01-0.2 mm, preferably 0.05 mm-0.15 mm, preferably 0.05-0.1 mm;
  • the surface resistivity of the inner layer of the atomizing bag body is: 10 1 -10 20 ⁇ , preferably 10 5 -10 10 ⁇ ; more preferably, 10 5 -10 9 ⁇ ; more preferably, 10 6 -10 9 ⁇ ;
  • the shape of the bag body can be any suitable shape, such as a cylindrical shape, a truncated cone shape that is wide at the top and narrow at the bottom and tapers, etc.
  • a handle may be provided on the side wall of the bag body to facilitate taking the atomizing inhalation bag.
  • an antistatic agent is added into the bag body.
  • the antistatic agent is a combination of one or more of anionic antistatic agents, zwitterionic antistatic agents, nonionic antistatic agents, and polymer antistatic agents.
  • the anionic antistatic agent is a combination of one or more of alkyl sulfonates, alkyl phosphates, maleic anhydride and other monomer copolymer salts, polyacrylic acid salts, and polystyrene sulfonates.
  • the zwitterionic antistatic agent is amphoteric alkyl imidazoline salts and alkyl amino acids;
  • the nonionic antistatic agent is a combination of fatty acid polyol esters and polyethylene oxide additives;
  • the polymer antistatic agent is a combination of polyoxyethylene fatty ethers, polyoxyethylene alkylphenyl ethers, polyethylene glycol fatty acid esters, and polyacrylic acid derivatives.
  • the nonionic antistatic agent is preferably a combination of one or more fatty alcohol polyoxyethylene ether, alkylphenol polyoxyethylene ether, and glycerol monofatty acid ester;
  • the zwitterionic antistatic agent is preferably one or a combination of alkyl dicarboxymethyl ammonium ethyl lactone and dodecyl dimethyl betaine;
  • the polymer antistatic agent is preferably a combination of one or more ethylene oxide propylene oxide adducts of ethylenediamine, poly 4-vinylpyridine type polysoap, octyl styrene and styrene sulfonic acid copolymer polysoap.
  • the content of antistatic agent added to the bag is 0.01-20%; preferably, it is 0.03%-10% or 0.05-5% or 0.03%-10% or 0.02%-5% or 0.01%-15% or 0.1%-5% or 1%-10% or 2%-10% or 5%-15%.
  • the material of the bag body is plastic, selected from: one or more of polyethylene (PE), biaxially oriented polypropylene, polypropylene (PP), polyvinyl chloride (PVC), polystyrene (PS), polyester, ethylene-vinyl acetate, polyvinylidene chloride, nylon, polyvinylidene chloride, polycarbonate (PC), polyamide, polylactic acid (PLA), polyethylene cellophane, moisture-proof cellophane, moisture-proof cellophane (vinyl chloride); preferably, the polyethylene is selected from low-density polyethylene, medium-density polyethylene, and high-density polyethylene; preferably, it is low-density polyethylene; preferably, the polyvinyl chloride is selected from soft polyvinyl chloride and hard polyvinyl chloride; preferably, it is PP/K4535 and/or PP/S25.
  • PE polyethylene
  • PP polypropylene
  • PVC polyvinyl chloride
  • the inner layer material and the outer layer material of the atomizing inhalation bag are different.
  • the bag body is made of one or more of cellulose/polyethylene, stretched polypropylene/polyethylene, nylon/polyethylene, polyester/unstretched polypropylene, polyester/aluminum foil/inner layer (any one of polyethylene, polypropylene, polyvinyl chloride, and hydrochloric acid rubber).
  • the alcoholysis degree of the polyvinyl alcohol is 40-100%, preferably 60%-100%.
  • the molecular weight of the polymer is 1000-200000, preferably 9000-150000.
  • the bag cover is provided with a mist inlet and a nozzle; preferably, the inner diameter of the nozzle is 5-50mm; more preferably, the inner diameter of the nozzle is 15-25mm.
  • the suction nozzle protrudes from the bag cover and is connected to the space inside the bag. It can be in any shape suitable for the subject to inhale the mist, such as tubular or conical.
  • the suction port end of the suction nozzle can be in a circular, elliptical or other shape suitable for the subject to suck.
  • the suction port of the suction nozzle can also be provided with a closure to facilitate closing the suction nozzle before the nebulizer inhalation bag is used.
  • the mist inlet can be opened at any suitable position of the bag cover, such as the edge, the center, especially the edge of the bag cover; a closure member can also be provided at the mist inlet to facilitate closing the mist inlet before the atomization inhalation bag is used.
  • the volume of the atomizing inhalation bag is 100-1000 ml, preferably 300-800 ml, and preferably 200 ml-500 ml.
  • the volume of the atomizing inhalation bag can be 300-800 ml (e.g., 300, 350, 400, 450, 500, 550, 600, 700, 800 ml), in particular 500 ml.
  • the invention provides a method for preparing an atomizing inhalation bag, comprising the following steps: mixing raw materials and auxiliary materials and adding them into a stirrer, mixing them uniformly to obtain a mixture, stirring them uniformly, and heating them with an extruder to obtain a tube-packed plastic film, that is, the atomizing inhalation bag.
  • the method further comprises a molding step, such as molding by extrusion, blow molding, etc.
  • the application is the use of the above-mentioned atomization inhalation bag in the preparation of a device for atomization inhalation administration of drugs for the prevention and/or treatment of respiratory diseases.
  • the drug is a vaccine.
  • the drug is a vaccine, such as pneumococcal vaccine, influenza vaccine, coronavirus vaccine, varicella vaccine, Newcastle virus vaccine, measles vaccine, tuberculosis vaccine, dust mite allergy vaccine, etc.
  • an atomization inhalation drug delivery device which comprises the atomization inhalation bag described in the first aspect of the present invention, and a nebulizer.
  • the nebulizer can be an ultrasonic nebulizer, a compression nebulizer, a vibrating mesh nebulizer or other suitable nebulizers, especially a vibrating mesh nebulizer.
  • a method for drug administration by aerosol inhalation comprises the step of administering the drug to a subject through the aerosol inhalation bag described in the first aspect.
  • the method is an aerosol inhalation immunization method, wherein the drug is a vaccine, such as pneumococcal vaccine, influenza vaccine, coronavirus vaccine, varicella vaccine, Newcastle virus vaccine, measles vaccine, tuberculosis vaccine, dust mite allergy vaccine, etc.; in some embodiments of the present invention, the vaccine is a coronavirus vaccine, in particular a SARS-CoV-2 vaccine.
  • a vaccine such as pneumococcal vaccine, influenza vaccine, coronavirus vaccine, varicella vaccine, Newcastle virus vaccine, measles vaccine, tuberculosis vaccine, dust mite allergy vaccine, etc.
  • the vaccine is a coronavirus vaccine, in particular a SARS-CoV-2 vaccine.
  • the method comprises the following steps:
  • step (2) collecting the drug mist generated in step (1) through the atomization inhalation bag;
  • step (3) is performed within 30 seconds (s) (e.g., 20s, 15s, 10s, 5s) after completing the mist collection, and in particular, step (3) is performed within 10s after completing the mist collection.
  • s e.g., 20s, 15s, 10s, 5s
  • the nebulizer in step (1) can be a suitable nebulizer such as a vibrating mesh nebulizer, a metered pressure aerosol dosing device, a soft mist dosing device, etc., in particular a vibrating mesh nebulizer.
  • a suitable nebulizer such as a vibrating mesh nebulizer, a metered pressure aerosol dosing device, a soft mist dosing device, etc., in particular a vibrating mesh nebulizer.
  • the mist will enter the bag through the atomizer port, and the subject can inhale the mist through the atomizer nozzle to achieve vaccination.
  • the lid can be screwed on to ensure that the residual mist in the bag will not overflow into the air, protecting the environment from being contaminated by biological products.
  • the atomization inhalation bag is disposable to avoid cross infection.
  • the atomizing inhalation bag provided by the present invention can be used for atomizing inhalation administration of drugs for the prevention and/or treatment of respiratory diseases.
  • Atomizing therapy mainly refers to aerosol inhalation therapy.
  • aerosol refers to tiny solid or liquid particles suspended in the air. Therefore, atomizing inhalation therapy is to use an atomizing device to disperse the drug into tiny droplets or particles, so that it is suspended in the gas and enters the respiratory tract and lungs.
  • the atomizing inhalation bag of the present invention comprehensively considers various mechanisms causing the deposition of fog particles, including but not limited to impact deposition, gravity deposition, dispersion deposition, electrostatic attraction deposition and interception deposition, etc., to provide an atomizing inhalation bag with stable and excellent atomization performance.
  • the atomization inhalation bag of the present invention is suitable for large-scale inoculation, solves the problem that the atomization cup is inconvenient to transport, can prevent cross infection and reduce costs at the same time, and has high inhalation inoculation efficiency.
  • subject refers to a human being who receives the administration method (especially the aerosol inhalation immunization method) of the present invention.
  • Example 1 Effect of different bag resistivity on atomization effect
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15L/min by TSI gas flow meter; 0.1ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) was added to the nebulizer cup and atomized into the atomizer bag.
  • the atomizer bag was made of PE with a single layer thickness of 0.1mm. The atomizer bag was treated with antistatic agents.
  • the resistivity is shown in Table 1 below; after the nebulization is completed, the bag is allowed to stand for 10 seconds, and the vacuum pump and the nebulization bag are connected to extract the gas in the nebulization bag; 20 ml of eluent is added to the nebulization bag to fully moisten the inner wall of the nebulization bag; the type 5 adenovirus vector in the eluent is quantified using the qPCR method.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • the PE material used has a resistivity greater than 10 9 ⁇ , and the mist condenses rapidly on the bag wall, leaving a large amount of mist in the bag.
  • the resistivity is 10 5 -10 9
  • the amount of mist remaining in the atomization bag is relatively low 10 seconds after the atomization is completed, and the residual rate is less than 50%.
  • Example 2 Effect of different bag thickness on atomization effect
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15 L/min by TSI gas flow meter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer cup and atomized into the atomizer bag.
  • the atomizer bag was made of PE with a resistivity of 10 9 . Leave it in the air for 10 seconds, connect the vacuum pump and the nebulizer bag, and extract the gas in the nebulizer bag; add 20 ml of eluent to the nebulizer bag to fully wash the inner wall of the nebulizer bag; use the qPCR method to quantify the type 5 adenovirus vector in the eluent.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • the vaccine residue results in the atomizer bags with a bag thickness of 0.05 mm to 0.15 mm were low, and the residue rate was less than 50%.
  • the bag thickness was less than 0.05 mm, the atomizer bag had poor formability, and a large amount of mist was deposited during the 10-second standing time.
  • the bag thickness was greater than 0.15 mm, a large number of droplets gathered at the pleats, and the residue rate increased.
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15 L/min using the TSI gas flowmeter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer medicine cup and atomized into the atomizer bag.
  • the atomizer bag was made of PE, and the resistivity and bag thickness were shown in Table 3.
  • the bag was allowed to stand for 10 seconds, and the vacuum pump and the atomizer bag were connected to extract the gas in the atomizer bag; 20 ml of eluent was added to the atomizer bag to fully moisten the inner wall of the atomizer bag; the adenovirus type 5 vector in the eluent was quantified using the qPCR method.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • the vaccine residue in the atomizing bag with a bag resistivity of 10 5 -10 9 ⁇ and a bag thickness of 0.05mm-0.15mm is low and the results are stable.
  • the more preferred range is the atomizing bag with a resistivity of 10 6 -10 9 ⁇ and a bag thickness of 0.05mm to 0.1mm.
  • Example 4 Effect of different bag materials on atomization effect
  • the atomization effect is best when the resistivity is 10 6 -10 9 ⁇ and the bag thickness is 0.05-0.1 mm. Based on this, the influence of different bag materials on the atomization effect is further verified.
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15 L/min using a TSI gas flowmeter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer medicine cup, the bag thickness was 0.1 mm, the bag resistivity was 10 9 , and the bag material was shown in Table 4 below.
  • the bag was allowed to stand for 10 s, and the vacuum pump and nebulization bag were connected to extract the gas in the nebulization bag; 20 ml of eluent was added to the nebulization bag to fully moisten the inner wall of the nebulization bag; the adenovirus type 5 vector in the eluent was quantified using the qPCR method.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the flow rate of the inhalation preparation particle size detector (Helos inhaler, sympatec GmbH) was calibrated to 15 L/min by the TSI gas flowmeter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer medicine cup, the bag thickness was 0.05 mm, the bag resistivity was 10 8 , and the bag material was shown in Table 4 below. After nebulization, the bag was left to stand for 10 seconds, and after 10 seconds, the nebulizer bag was placed in the inhalation preparation particle size detector to detect the aerosol particle size in the nebulizer:

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Abstract

L'invention concerne un sac d'inhalation par atomisation et son utilisation dans l'administration d'inhalation par atomisation, et en particulier, son utilisation dans l'administration d'inhalation par atomisation d'un médicament pour la prévention et/ou le traitement d'une maladie du système respiratoire. Le sac d'inhalation d'atomisation peut assurer efficacement la stabilité d'un aérosol de médicament pendant une certaine période de temps, dans un état de taille de particule stable, et avec une quantité moindre de médicament laissé dans le sac, de sorte qu'une quantité d'inhalation efficace du médicament est assurée, et qu'une opération d'administration est simple et pratique, de sorte que l'efficacité d'inoculation est considérablement améliorée, et que le sac d'inhalation par atomisation peut ainsi être utilisé pour une inoculation à grande échelle.
PCT/CN2023/133971 2022-11-24 2023-11-24 Sac d'inhalation par atomisation et son utilisation dans l'administration d'inhalation par atomisation WO2024109930A1 (fr)

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1213975A (zh) * 1996-03-22 1999-04-14 阿斯特拉公司 吸入装置的构件
CN104640589A (zh) * 2012-04-20 2015-05-20 Fsc实验室有限公司 吸入装置和系统以及包括该装置和系统的方法
CN109310834A (zh) * 2016-04-18 2019-02-05 励志私人有限公司 用于吸入器的间隔装置
CN110730674A (zh) * 2017-04-18 2020-01-24 励志私人有限公司 干粉吸入器和用于干粉吸入器的间隔装置
CN110831647A (zh) * 2017-04-18 2020-02-21 励志私人有限公司 用于雾化器的间隔装置
US20210244896A1 (en) * 2018-06-13 2021-08-12 Puff-Ah Pty Ltd Apparatus for use in delivering respiratory drugs
CN114522152A (zh) * 2015-03-11 2022-05-24 艾利斯达医药品公司 气道中的防静电材料用于热气溶胶凝结方法的用途
CN116173358A (zh) * 2021-11-29 2023-05-30 康希诺生物股份公司 一种雾化杯及其在雾化吸入给药中的应用
CN219814705U (zh) * 2022-08-04 2023-10-13 康希诺生物股份公司 一种具有双层结构的雾化吸入给药用自立袋

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1213975A (zh) * 1996-03-22 1999-04-14 阿斯特拉公司 吸入装置的构件
CN104640589A (zh) * 2012-04-20 2015-05-20 Fsc实验室有限公司 吸入装置和系统以及包括该装置和系统的方法
CN114522152A (zh) * 2015-03-11 2022-05-24 艾利斯达医药品公司 气道中的防静电材料用于热气溶胶凝结方法的用途
CN109310834A (zh) * 2016-04-18 2019-02-05 励志私人有限公司 用于吸入器的间隔装置
CN110730674A (zh) * 2017-04-18 2020-01-24 励志私人有限公司 干粉吸入器和用于干粉吸入器的间隔装置
CN110831647A (zh) * 2017-04-18 2020-02-21 励志私人有限公司 用于雾化器的间隔装置
US20210244896A1 (en) * 2018-06-13 2021-08-12 Puff-Ah Pty Ltd Apparatus for use in delivering respiratory drugs
CN116173358A (zh) * 2021-11-29 2023-05-30 康希诺生物股份公司 一种雾化杯及其在雾化吸入给药中的应用
CN219814705U (zh) * 2022-08-04 2023-10-13 康希诺生物股份公司 一种具有双层结构的雾化吸入给药用自立袋

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