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1. WO2021111149 - NEW PROCESS FOR THE MANUFACTURE OF PHARMACEUTICAL COMPOSITIONS

Publication Number WO/2021/111149
Publication Date 10.06.2021
International Application No. PCT/GB2020/053129
International Filing Date 04.12.2020
IPC
A61K 9/14 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
A61K 9/50 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules
A61K 9/51 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules
51Nanocapsules
A61K 31/706 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7042Compounds having saccharide radicals and heterocyclic rings
7052having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
706containing six-membered rings with nitrogen as a ring hetero atom
A61P 35/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
CPC
A61K 31/706
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7042Compounds having saccharide radicals and heterocyclic rings
7052having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
706containing six-membered rings with nitrogen as a ring hetero atom
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
A61K 9/06
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
06Ointments; Bases therefor; ; Other semi-solid forms, e.g. creams, sticks, gels
A61K 9/143
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
143with inorganic compounds
A61K 9/145
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
145with organic compounds
A61K 9/4858
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
4841Filling excipients; Inactive ingredients
4858Organic compounds
Applicants
  • NANEXA AB [SE]/[SE]
Inventors
  • JOHANSSON, Anders
  • ROOTH, Mårten
  • HELLRUP, Joel
Agents
  • MCNEENEY, Stephen Phillip
Priority Data
1917899.506.12.2019GB
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) NEW PROCESS FOR THE MANUFACTURE OF PHARMACEUTICAL COMPOSITIONS
(FR) NOUVEAU PROCÉDÉ DE FABRICATION DE COMPOSITIONS PHARMACEUTIQUES
Abstract
(EN)
There is provided a process for the preparation of composition in the form of a plurality of particles having a weight-, number-, and/or volume-based mean diameter that is between amount 10 nm and about 700 µm, which particles comprise: (a) solid cores, preferably comprising a biologically active agent; and (b) two or more sequentially applied, discrete layers, each of which comprises at least one separately applied coating material, and which two or more layers together surround, enclose and/or encapsulate said cores, which process comprises the sequential steps of: (1) applying an initial layer of at least one coating material to said solid cores by way of a gas phase deposition technique; (2) discharging the coated particles from the gas phase deposition reactor and subjecting the coated particles to agitation to disaggregate particle aggregates formed during step (1) by way of mechanical sieving technique; (3) reintroducing the disaggregated, coated particles from step (2) into the gas phase deposition reactor and applying a further layer of at least one coating material to the reintroduced particles; and (1) optionally repeating steps (2) and (3) one or more times to increase the total thickness of the at least one coating material that enclose(s) said solid core. The gas phase deposition technique is preferably atomic layer deposition. When the cores comprise biologically active agent, the compositions may provide for the delayed or sustained release of said active agent without a burst effect.
(FR)
L'invention concerne un procédé pour la préparation d'une composition sous la forme d'une pluralité de particules ayant un diamètre moyen basé sur le poids, le nombre et/ou le volume qui est compris entre 10 nm et environ 700 µm, lesquelles particules comprenant : (a) des noyaux solides, contenant de préférence un agent biologiquement actif ; et (b) deux ou plusieurs couches distinctes appliquées de manière séquentielle, chacune d'entre elles étant constituée d'au moins un matériau d'enrobage appliqué séparément, et ces deux ou plusieurs couches entourant, enfermant et/ou encapsulant ensemble lesdits noyaux, lequel procédé comprenant les étapes séquentielles suivantes : (1) l'application d'une couche initiale d'au moins un matériau d'enrobage sur lesdits noyaux solides au moyen d'une technique de dépôt en phase gazeuse ; (2) l'évacuation des particules enrobées du réacteur de dépôt en phase gazeuse et la soumission des particules enrobées à une agitation pour désagréger les agrégats de particules formés pendant l'étape (1) au moyen d'une technique de tamisage mécanique ; (3) la réintroduction des particules désagrégées et enrobées de l'étape (2) dans le réacteur de dépôt en phase gazeuse et l'application d'une autre couche d'au moins un matériau d'enrobage sur les particules réintroduites ; et (1) la répétition facultative des étapes (2) et (3) une ou plusieurs fois pour augmenter l'épaisseur totale dudit au moins un matériau d'enrobage qui enferme ledit noyau solide. La technique de dépôt en phase gazeuse est de préférence un dépôt de couche atomique. Lorsque les noyaux comprennent un agent biologiquement actif, les compositions peuvent permettre la libération retardée ou prolongée dudit agent actif sans effet de libération immédiate.
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