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MX2024000819A - Conservación de partículas de ingredientes farmacéuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspensión acuosa. - Google Patents

Conservación de partículas de ingredientes farmacéuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspensión acuosa.

Info

Publication number
MX2024000819A
MX2024000819A MX2024000819A MX2024000819A MX2024000819A MX 2024000819 A MX2024000819 A MX 2024000819A MX 2024000819 A MX2024000819 A MX 2024000819A MX 2024000819 A MX2024000819 A MX 2024000819A MX 2024000819 A MX2024000819 A MX 2024000819A
Authority
MX
Mexico
Prior art keywords
coating
preserving
functionally
aqueous suspension
particles produced
Prior art date
Application number
MX2024000819A
Other languages
English (en)
Inventor
Rosaleen Mclaughlin
Jonathon Whitehouse
Adam Parker
Original Assignee
Catalent Uk Swindon Zydis Ltd
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 Catalent Uk Swindon Zydis Ltd filed Critical Catalent Uk Swindon Zydis Ltd
Publication of MX2024000819A publication Critical patent/MX2024000819A/es

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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    • A61K9/0012Galenical forms characterised by the site of application
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    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
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    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
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    • A61K9/1629Organic macromolecular compounds
    • A61K9/1658Proteins, e.g. albumin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/1682Processes
    • AHUMAN NECESSITIES
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    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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    • A61K9/2806Coating materials
    • A61K9/288Compounds of unknown constitution, e.g. material from plants or animals
    • AHUMAN NECESSITIES
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    • A61K9/5005Wall or coating material
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    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Se proporcionan composiciones y métodos farmacéuticos para preparar composiciones farmacéuticas que conservan el revestimiento de partículas de IFA revestidas en una suspensión farmacéutica. Las composiciones farmacéuticas incluyen partículas de ingrediente farmacéutico activo (IFA) revestidas que comprende: una partícula de IFA; un primer revestimiento que comprende uno o más componentes deformados revistiendo la partícula de IFA; un segundo revestimiento que comprende sílice rodeando y/o parcial o totalmente insertado en el primer revestimiento, un formador de matriz y un formador de estructura.
MX2024000819A 2019-02-22 2021-08-16 Conservación de partículas de ingredientes farmacéuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspensión acuosa. MX2024000819A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201962809287P 2019-02-22 2019-02-22

Publications (1)

Publication Number Publication Date
MX2024000819A true MX2024000819A (es) 2024-03-15

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ID=69740394

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2021009844A MX2021009844A (es) 2019-02-22 2020-02-21 Conservacion de particulas de ingredientes farmaceuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspension acuosa.
MX2024000819A MX2024000819A (es) 2019-02-22 2021-08-16 Conservación de partículas de ingredientes farmacéuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspensión acuosa.

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MX2021009844A MX2021009844A (es) 2019-02-22 2020-02-21 Conservacion de particulas de ingredientes farmaceuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspension acuosa.

Country Status (16)

Country Link
US (2) US11185508B2 (es)
EP (1) EP3927313B1 (es)
JP (1) JP7546581B2 (es)
KR (1) KR20210130720A (es)
CN (1) CN113438942A (es)
AR (2) AR118418A1 (es)
AU (1) AU2020225818B2 (es)
BR (1) BR112021016405A2 (es)
CA (1) CA3129404A1 (es)
GB (2) GB2597578B (es)
IL (1) IL285648A (es)
MX (2) MX2021009844A (es)
PH (1) PH12021552022A1 (es)
SG (1) SG11202109104XA (es)
TW (1) TWI849062B (es)
WO (1) WO2020169991A1 (es)

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BR112021016421A2 (pt) 2019-02-22 2021-10-13 Catalent U.K. Swindon Zydis Limited Minimização de aglomeração, aeração e preservação do revestimento de composições farmacêuticas que compreendem ibuprofeno
GB2597578B (en) * 2019-02-22 2023-04-26 Catalent Uk Swindon Zydis Ltd Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension
BR112021016485A2 (pt) 2019-02-22 2021-10-13 Catalent U.K. Swindon Zydis Limited Minimização de aglomeração de material de revestimento de partícula de fármaco durante armazenamento para estabilizar tempos de desintegração de produtos farmacêuticos
JP7681511B2 (ja) 2019-02-22 2025-05-22 キャタレント・ユーケー・スウィンドン・ザイディス・リミテッド インライン混合中の懸濁液の通気の最小化
AR123109A1 (es) * 2020-07-31 2022-10-26 Catalent Uk Swindon Zydis Ltd Composiciones farmacéuticas que comprenden ifa
WO2022103639A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Methods of treating autoimmune or inflammatory conditions with cannabidiol or its derivatives/analogs
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

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