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WO2023059210A1 - Procédé de préparation de particules par atomisation - Google Patents

Procédé de préparation de particules par atomisation Download PDF

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Publication number
WO2023059210A1
WO2023059210A1 PCT/PT2022/050026 PT2022050026W WO2023059210A1 WO 2023059210 A1 WO2023059210 A1 WO 2023059210A1 PT 2022050026 W PT2022050026 W PT 2022050026W WO 2023059210 A1 WO2023059210 A1 WO 2023059210A1
Authority
WO
WIPO (PCT)
Prior art keywords
mixture
solution
particles
frozen
liquid solution
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/PT2022/050026
Other languages
English (en)
Portuguese (pt)
Inventor
Miguel ÂNGELO JOAQUIM RODRIGUES
Sara RAQUEL FERNANDES SARAIVA
Mónica FILIPA DA SILVA ROSA
Vítor MANUEL GERALDES FERNANDES
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Universidade de Lisboa
Original Assignee
Universidade de Lisboa
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
Application filed by Universidade de Lisboa filed Critical Universidade de Lisboa
Publication of WO2023059210A1 publication Critical patent/WO2023059210A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5192—Processes
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D1/00—Evaporating
    • B01D1/16—Evaporating by spraying
    • B01D1/18—Evaporating by spraying to obtain dry solids

Definitions

  • the depressurization takes place at the sublimation temperature of the dry ice under the existing pressure conditions, and the depressurization temperature is controlled by the depressurization of the supercritical CO 2 fluid itself, which leads to the cooling of the system.
  • the depressurization takes place at a temperature of at least -80°C; preferably -78.5 ° C,
  • the liquid solution/mixture and the supercritical CO 2 fluid are depressurized separately. [0030] In one embodiment, the liquid solution/mixture and the supercritical CO 2 fluid are depressurized in separate injectors. In another embodiment, the liquid solution/mixture and the supercritical CO 2 fluid are depressurized in separate injectors, where the solution/mixture is atomized by an ultrasonic injector.
  • freeze-drying takes place at a pressure ranging from 1 to 1000 Pa, preferably from 10 to 100 Pa. In one embodiment, freeze-drying takes place at a temperature ranging from -80°C to 25°C, preferably from -40 to 20°C; in yet another embodiment, lyophilization takes place for 24 to 120 hours, preferably for 72 hours. Preferably, lyophilization takes place at 10 Pa and -40 °C for 12 h followed by a heating ramp to -10 °C (1 °C/min) followed by a hold at -10 °C for 20 h, followed by a heating ramp of 0.15 °C/min to 25 °C, followed by 12 h at 25 °C.
  • the present disclosure also describes a nebulizer, tablets or suspension characterized by comprising the described nanoparticle.
  • the suspension is parenterally administrable.
  • the supercritical CO 2 fluid can be depressurized in an injector different from the injector in which the liquid solution/mixture is depressurized.
  • the supercritical CO 2 fluid can be depressurized in co-current, in which both injectors are located at the top of the precipitator, or in counter-current, with, for example, the supercritical CO 2 fluid being depressurized through an injector located at the bottom of the precipitator and the solution/mixture depressurized through an injector located at the top of the precipitator.
  • the depressurization of the supercritical CO 2 fluid or the mixture of the supercritical CO 2 fluid with the liquid solution should preferably be greater than 12 MPa so that the cooling causes the sublimation of the CO 2 to the state solid and form a macrostructure that surrounds and captures the droplets resulting from the solution/mixture after its atomization.
  • depressurisations lower than 12 MPa and higher than 8 MPa, using higher ratios of CO 2 flow per solution flow, preferably between 20 and 50.
  • Supercritical CO 2 from a pressure of 12 MPa to atmospheric pressure, through an injector with a channel 0.15 mm in diameter and 0.25 mm in length.
  • the solution and the supercritical CO 2 were mixed immediately before the injector at a temperature of 40°C, in a volume of less than 0.1 ml.
  • the supercritical CO 2 fluid flow rate was 35 g/min and the solution flow rate was 2.2 g/min.
  • the solid was captured in a cylindrical precipitator of 0.2 L volume and 50 mm diameter.

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Optics & Photonics (AREA)
  • Nanotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)
  • Glanulating (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un procédé pour obtenir des particules ayant des dimensions inférieures à 1 micromètre par atomisation à partir d'une solution/d'un mélange liquide. Ledit procédé est caractérisé en ce qu'il comprend les étapes suivantes consistant à atomiser la solution/le mélange liquide et un fluide de CO2 supercritique par élimination de la pression au moyen d'au moins un injecteur, avec au moins un canal, et à refroidir la solution/le mélange liquide et le fluide à pression éliminée jusqu'à la congélation de la solution et la solidification d'au moins 10% en poids de CO2; pour obtenir des particules atomisées de la solution/du mélange congelé dans lequel le CO2 à pression éliminée implique les particules atomisées de la solution/du mélange congelé; séparer les particules atomisées de la solution/du mélange congelé et le CO2 solide du CO2 gazeux au moyen de la séparation gravitationnelle, d'un cyclone et/ou d'un filtre; séparer le CO2 solide des particules atomisées de la solution/du mélange congelé par sublimation du CO2; et sécher les particules atomisées de la solution/du mélange congelé par lyophilisation.
PCT/PT2022/050026 2021-10-07 2022-10-06 Procédé de préparation de particules par atomisation Ceased WO2023059210A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PT117503 2021-10-07
PT117503A PT117503B (pt) 2021-10-07 2021-10-07 Método de preparação de particulas por atomização

Publications (1)

Publication Number Publication Date
WO2023059210A1 true WO2023059210A1 (fr) 2023-04-13

Family

ID=84365724

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/PT2022/050026 Ceased WO2023059210A1 (fr) 2021-10-07 2022-10-06 Procédé de préparation de particules par atomisation

Country Status (2)

Country Link
PT (1) PT117503B (fr)
WO (1) WO2023059210A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101869282A (zh) * 2010-06-12 2010-10-27 嘉吉烯王生物工程（武汉）有限公司 一种喷雾冷冻干燥制备多不饱和脂肪酸油脂微胶囊的方法
WO2013139384A1 (fr) * 2012-03-21 2013-09-26 Dorkoosh, Farid Abedin Congélation de solutions en aérosol (fas): système de production continue de particules
WO2016184576A2 (fr) * 2015-05-20 2016-11-24 Curevac Ag Composition de poudre sèche comprenant de l'arn à chaîne longue

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101869282A (zh) * 2010-06-12 2010-10-27 嘉吉烯王生物工程（武汉）有限公司 一种喷雾冷冻干燥制备多不饱和脂肪酸油脂微胶囊的方法
WO2013139384A1 (fr) * 2012-03-21 2013-09-26 Dorkoosh, Farid Abedin Congélation de solutions en aérosol (fas): système de production continue de particules
WO2016184576A2 (fr) * 2015-05-20 2016-11-24 Curevac Ag Composition de poudre sèche comprenant de l'arn à chaîne longue

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SHOYELE S A ET AL: "Particle engineering techniques for inhaled biopharmaceuticals", ADVANCED DRUG DELIVERY REVIEWS, ELSEVIER, AMSTERDAM , NL, vol. 58, no. 9-10, 31 October 2006 (2006-10-31), pages 1009 - 1029, XP024892116, ISSN: 0169-409X, [retrieved on 20061031], DOI: 10.1016/J.ADDR.2006.07.010 *

Also Published As

Publication number Publication date
PT117503B (pt) 2024-03-20
PT117503A (pt) 2023-04-10

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