MX2020004589A - Procedimiento y dispositivo para preparar una dispersión sólida. - Google Patents

Procedimiento y dispositivo para preparar una dispersión sólida.

Info

Publication number
MX2020004589A
MX2020004589A MX2020004589A MX2020004589A MX2020004589A MX 2020004589 A MX2020004589 A MX 2020004589A MX 2020004589 A MX2020004589 A MX 2020004589A MX 2020004589 A MX2020004589 A MX 2020004589A MX 2020004589 A MX2020004589 A MX 2020004589A
Authority
MX
Mexico
Prior art keywords
dispersion
polymeric binder
active ingredient
determined amount
preparing
Prior art date
Application number
MX2020004589A
Other languages
English (en)
Inventor
Tiziana Adage
Original Assignee
Bit Pharma Gmbh
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 Bit Pharma Gmbh filed Critical Bit Pharma Gmbh
Publication of MX2020004589A publication Critical patent/MX2020004589A/es

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
    • A61K9/14—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
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A61K9/204—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/022—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the choice of material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • B29K2067/04—Polyesters derived from hydroxycarboxylic acids
    • B29K2067/043—PGA, i.e. polyglycolic acid or polyglycolide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • B29K2067/04—Polyesters derived from hydroxycarboxylic acids
    • B29K2067/046—PLA, i.e. polylactic acid or polylactide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0005—Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
    • B29K2105/0035—Medical or pharmaceutical agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Processes Of Treating Macromolecular Substances (AREA)

Abstract

La presente invención se refiere a un procedimiento de extrusión por fusión para preparar una dispersión sólida que comprende un ingrediente farmacéuticamente activo, un aglutinante polimérico y, opcionalmente, uno o más agentes auxiliares, que comprende: a) en una operación en forma intermitente, poner una cantidad pre-determinada del aglutinante polimérico, una cantidad pre-determinada del ingrediente activo y, opcionalmente, una cantidad predeterminada del agente auxiliar o los agentes auxiliares en un recipiente de fusión; fundir el aglutinante polimérico con agitación para dispersar el ingrediente activo en el aglutinante polimérico hasta obtener una pre-dispersión fundida; b) alimentar la pre-dispersión en un extrusor para homogeneizar la pre-dispersión y liberar una masa fundida a través de un dado; y c) dejar que la masa fundida se solidifique.
MX2020004589A 2017-11-30 2018-11-29 Procedimiento y dispositivo para preparar una dispersión sólida. MX2020004589A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17204645.0A EP3492070A1 (en) 2017-11-30 2017-11-30 Process and device for preparing a solid dispersion
PCT/EP2018/083009 WO2019106090A1 (en) 2017-11-30 2018-11-29 Process and device for preparing a solid dispersion

Publications (1)

Publication Number Publication Date
MX2020004589A true MX2020004589A (es) 2022-08-11

Family

ID=60811754

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2020004589A MX2020004589A (es) 2017-11-30 2018-11-29 Procedimiento y dispositivo para preparar una dispersión sólida.

Country Status (17)

Country Link
US (1) US11413247B2 (es)
EP (2) EP3492070A1 (es)
JP (1) JP7250029B2 (es)
CN (1) CN111405894A (es)
AU (1) AU2018376566B2 (es)
BR (1) BR112020008646A2 (es)
CL (1) CL2020001176A1 (es)
DK (1) DK3716951T3 (es)
ES (1) ES2910012T3 (es)
HU (1) HUE058088T2 (es)
IL (1) IL274348A (es)
MX (1) MX2020004589A (es)
PL (1) PL3716951T3 (es)
PT (1) PT3716951T (es)
SG (1) SG11202004062WA (es)
SI (1) SI3716951T1 (es)
WO (1) WO2019106090A1 (es)

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3024416C2 (de) * 1980-06-28 1982-04-15 Gödecke AG, 1000 Berlin Verfahren zur Herstellung von Arzneimitteln mit retardierter Wirkstoff-Freisetzung
AU4316393A (en) * 1992-05-22 1993-12-30 Godecke Aktiengesellschaft Process for preparing delayed-action medicinal compositions
DE19721467A1 (de) * 1997-05-22 1998-11-26 Basf Ag Verfahren zur Herstellung kleinteiliger Zubereitungen biologisch aktiver Stoffe
WO1999021534A1 (en) 1997-10-27 1999-05-06 Merck Patent Gmbh Solid state solutions and dispersions of poorly water soluble drugs
JPH11286439A (ja) * 1998-04-01 1999-10-19 Senju Pharmaceut Co Ltd 生分解性ポリマー型薬物放出システム
US6455526B1 (en) * 1998-12-16 2002-09-24 Aventis Pharmaceuticals, Inc. Biodegradable polymer encapsulated pharmaceutical compositions and method for preparing the same
DE50210646D1 (de) 2001-05-23 2007-09-20 Hexal Ag Verfahren zur herstellung von implantaten mittels lösungsmittelfreier herstellung eines homogenisats
CN100594023C (zh) 2003-02-03 2010-03-17 诺瓦提斯公司 药物制剂
CA2618255C (en) 2005-08-08 2015-05-26 Abbott Gmbh & Co. Kg Itraconazole compositions with improved bioavailability
EP2140883B1 (en) 2007-04-20 2012-10-31 Daido Chemical Corporation Novel base for dry solid dispersion, solid dispersion containing the base, and composition containing the dispersion
EP2187968A4 (en) 2007-08-21 2013-02-20 Univ Texas THERMOKINETIC MIXING FOR PHARMACEUTICAL APPLICATIONS
CN101254180B (zh) * 2008-03-28 2010-11-10 辽宁正鑫药物研究有限公司 一种内容物为半固体组合物的尼莫地平胶囊剂及制备方法
EP2140861A1 (en) 2008-06-30 2010-01-06 Abbott GmbH & Co. KG Pharmaceutical dosage form comprising polymeric carrier composition
EP2308478A1 (en) * 2009-10-06 2011-04-13 Abbott GmbH & Co. KG Delivery system for sustained release of a calcium-channel blocking agent
FR2999081B1 (fr) 2012-12-06 2015-02-27 Hra Pharma Lab Dispersion solide d'un modulateur selectif du recepteur a la progesterone
CN103006568A (zh) * 2013-01-05 2013-04-03 中国科学院苏州纳米技术与纳米仿生研究所 非洛地平固态分散物及其制备方法
WO2016031651A1 (ja) 2014-08-29 2016-03-03 花王株式会社 難溶解性ポリフェノール類を含有する固体分散体の製造方法
JP6972623B2 (ja) 2016-04-26 2021-11-24 三菱ケミカル株式会社 固体分散体用基剤、それを用いた固体分散体の製造方法及び固体分散体

Also Published As

Publication number Publication date
HUE058088T2 (hu) 2022-06-28
WO2019106090A1 (en) 2019-06-06
PT3716951T (pt) 2022-04-06
ES2910012T3 (es) 2022-05-11
EP3492070A1 (en) 2019-06-05
CN111405894A (zh) 2020-07-10
PL3716951T3 (pl) 2022-06-06
AU2018376566B2 (en) 2023-11-30
SI3716951T1 (sl) 2022-06-30
EP3716951B1 (en) 2022-01-05
US20200368165A1 (en) 2020-11-26
BR112020008646A2 (pt) 2020-10-27
RU2020121500A (ru) 2021-12-30
AU2018376566A1 (en) 2020-04-23
JP7250029B2 (ja) 2023-03-31
IL274348A (en) 2020-06-30
DK3716951T3 (da) 2022-04-04
US11413247B2 (en) 2022-08-16
RU2020121500A3 (es) 2022-04-05
SG11202004062WA (en) 2020-06-29
CL2020001176A1 (es) 2020-10-30
JP2021504487A (ja) 2021-02-15
EP3716951A1 (en) 2020-10-07

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