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WO2013091006A1 - Procédé de mélange de poudre sèche - Google Patents

Procédé de mélange de poudre sèche Download PDF

Info

Publication number
WO2013091006A1
WO2013091006A1 PCT/AU2012/001572 AU2012001572W WO2013091006A1 WO 2013091006 A1 WO2013091006 A1 WO 2013091006A1 AU 2012001572 W AU2012001572 W AU 2012001572W WO 2013091006 A1 WO2013091006 A1 WO 2013091006A1
Authority
WO
WIPO (PCT)
Prior art keywords
micronised
process according
drug
lactose
blending
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/AU2012/001572
Other languages
English (en)
Inventor
David Morton
David BARLING
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.)
Monash University
Original Assignee
Monash University
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 AU2011905415A external-priority patent/AU2011905415A0/en
Application filed by Monash University filed Critical Monash University
Publication of WO2013091006A1 publication Critical patent/WO2013091006A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/60—Mixing solids with solids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/40—Mixers using gas or liquid agitation, e.g. with air supply tubes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2215/00—Auxiliary or complementary information in relation with mixing
    • B01F2215/04—Technical information in relation with mixing
    • B01F2215/0413—Numerical information
    • B01F2215/0418—Geometrical information
    • B01F2215/0431—Numerical size values, e.g. diameter of a hole or conduit, area, volume, length, width, or ratios thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2215/00—Auxiliary or complementary information in relation with mixing
    • B01F2215/04—Technical information in relation with mixing
    • B01F2215/0413—Numerical information
    • B01F2215/0436—Operational information
    • B01F2215/0468—Numerical pressure values

Definitions

  • de-agglomerated particles may easily and rapidly exit the vessel, after one or a small number of spiral trajectories, and after, for example, a few hundredths of a second residence, but with the large particles remaining in the vessel until they become sufficiently de-agglomerated to be small enough to exit.
  • the process may therefore advantageously lend itself to a continuous feed/exit process.
  • the feed rate can be optimised to be within a range, which can be identified by trial evaluation, such that the particle concentration within the vessel is high enough to provide sufficient numbers of collisions, but is not so high that the particle concentration over-saturates the chamber, such that particles have inadequate space between each other to allow acceleration, development of shear forces and effective collisions to occur.
  • a minimum free path in the flow is desired to effect such forces and collisions, as can be determined by the skilled person.
  • Pharmaceutically acceptable carriers and micronised excipients contemplated herein include, mono, di- and polysaccharides, for example, sugars such as glucose, lactose fructose, sucrose, mannitol, xylitol, sorbitol, dextran, and trehalose, starches, such as corn starch, and cellulose and derivatives thereof, such as ethyl cellulose. It will be appreciated that the carrier and excipient are independently chosen, that is to say, the carrier and excipient may be the same compound or different.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Otolaryngology (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention porte sur des procédés pour un mélange de poudre sèche de microparticules, et sur des mélanges de poudre sèche à usage en tant que produits pharmaceutiques. En particulier, la présente invention concerne un procédé pour préparer un mélange de poudre de microparticules sèche comprenant un médicament micronisé et un excipient pharmaceutiquement acceptable micronisé, le procédé comprenant l'étape de mélange fluidisé du médicament micronisé et de l'excipient pharmaceutiquement acceptable micronisé. Ledit mélange de poudre peut en outre être mélangé avec un véhicule pharmaceutiquement acceptable. Le mélange de poudre de microparticules sèche est destiné à être utilisé dans des systèmes d'inhalation portatifs.
PCT/AU2012/001572 2011-12-23 2012-12-21 Procédé de mélange de poudre sèche Ceased WO2013091006A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2011905415A AU2011905415A0 (en) 2011-12-23 Process for dry powder blending
AU2011905415 2011-12-23

Publications (1)

Publication Number Publication Date
WO2013091006A1 true WO2013091006A1 (fr) 2013-06-27

Family

ID=48667510

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2012/001572 Ceased WO2013091006A1 (fr) 2011-12-23 2012-12-21 Procédé de mélange de poudre sèche

Country Status (1)

Country Link
WO (1) WO2013091006A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016156970A1 (fr) * 2015-04-01 2016-10-06 Lupin Pharmaceuticals Inc. Procédé pour la fabrication de mélanges de poudres sèches
WO2021126829A1 (fr) * 2019-12-16 2021-06-24 Rutgers, The State University Of New Jersey Procédés continus de fabrication de supports poreux imprégnés et de fabrication de supports poreux imprégnés contenant des produits pharmaceutiques
US11344494B2 (en) 2010-08-24 2022-05-31 Rutgers, The State University Of New Jersey Formulation and manufacture of pharmaceuticals by impregnation onto porous carriers
WO2023128918A1 (fr) * 2021-12-31 2023-07-06 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Procédé comprenant un système de gaz d'alimentation pour préparer des compositions d'inhalation en poudre sèche

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001089492A1 (fr) * 2000-05-19 2001-11-29 Astrazeneca Ab Nouvelle composition
US20040121003A1 (en) * 2002-12-19 2004-06-24 Acusphere, Inc. Methods for making pharmaceutical formulations comprising deagglomerated microparticles
WO2007068443A1 (fr) * 2005-12-12 2007-06-21 Jagotec Ag Préparations de poudre pour inhalation
WO2007070851A2 (fr) * 2005-12-15 2007-06-21 Acusphere, Inc. Procedes d'elaboration de preparations pharmaceutiques a base de particules pour administration pulmonaire ou nasale

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001089492A1 (fr) * 2000-05-19 2001-11-29 Astrazeneca Ab Nouvelle composition
US20040121003A1 (en) * 2002-12-19 2004-06-24 Acusphere, Inc. Methods for making pharmaceutical formulations comprising deagglomerated microparticles
WO2007068443A1 (fr) * 2005-12-12 2007-06-21 Jagotec Ag Préparations de poudre pour inhalation
WO2007070851A2 (fr) * 2005-12-15 2007-06-21 Acusphere, Inc. Procedes d'elaboration de preparations pharmaceutiques a base de particules pour administration pulmonaire ou nasale

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11344494B2 (en) 2010-08-24 2022-05-31 Rutgers, The State University Of New Jersey Formulation and manufacture of pharmaceuticals by impregnation onto porous carriers
WO2016156970A1 (fr) * 2015-04-01 2016-10-06 Lupin Pharmaceuticals Inc. Procédé pour la fabrication de mélanges de poudres sèches
CN107864622A (zh) * 2015-04-01 2018-03-30 鲁平亚特兰蒂斯控股股份公司 用于制造干粉末共混物的方法
US10617646B2 (en) 2015-04-01 2020-04-14 Lupin Atlantis Holdings Sa Process for manufacturing dry powder blends
WO2021126829A1 (fr) * 2019-12-16 2021-06-24 Rutgers, The State University Of New Jersey Procédés continus de fabrication de supports poreux imprégnés et de fabrication de supports poreux imprégnés contenant des produits pharmaceutiques
US20230000776A1 (en) * 2019-12-16 2023-01-05 Rutgers,The State University Of New Jersey Continuous Processes for Manufacturing Impregnated Porous Carriers and for Manufacturing Pharmaceuticals Containing Impregnated Porous Carriers
WO2023128918A1 (fr) * 2021-12-31 2023-07-06 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Procédé comprenant un système de gaz d'alimentation pour préparer des compositions d'inhalation en poudre sèche

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