MX2021009844A - Conservacion de particulas de ingredientes farmaceuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspension acuosa. - Google Patents

Conservacion de particulas de ingredientes farmaceuticos activos revestidas funcionalmente producidas mediante procesos de mezcla sin solvente en suspension acuosa.

Info

Publication number
MX2021009844A
MX2021009844A MX2021009844A MX2021009844A MX2021009844A MX 2021009844 A MX2021009844 A MX 2021009844A MX 2021009844 A MX2021009844 A MX 2021009844A MX 2021009844 A MX2021009844 A MX 2021009844A MX 2021009844 A MX2021009844 A MX 2021009844A
Authority
MX
Mexico
Prior art keywords
coating
preserving
functionally
aqueous suspension
particles produced
Prior art date
Application number
MX2021009844A
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 MX2021009844A publication Critical patent/MX2021009844A/es

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    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, 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
    • A—HUMAN NECESSITIES
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
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    • A—HUMAN NECESSITIES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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    • A61K47/44—Oils, 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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    • A61K9/0056—Mouth 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
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    • A61K9/1605—Excipients; Inactive ingredients
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    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • A—HUMAN NECESSITIES
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • A61K9/19—Particulate 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
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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    • A61K9/2022—Organic macromolecular compounds
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—Proteins, e.g. gelatin
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    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Landscapes

  • 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)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (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.
MX2021009844A 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. MX2021009844A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962809287P 2019-02-22 2019-02-22
PCT/GB2020/050422 WO2020169991A1 (en) 2019-02-22 2020-02-21 Preserving functionally-coated api particles produced by solventless mixing processes in aqueous suspension

Publications (1)

Publication Number Publication Date
MX2021009844A true MX2021009844A (es) 2021-09-10

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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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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.

Country Status (15)

Country Link
US (2) US11185508B2 (es)
EP (1) EP3927313A1 (es)
JP (1) JP7546581B2 (es)
KR (1) KR20210130720A (es)
CN (1) CN113438942A (es)
AR (2) AR118159A1 (es)
AU (1) AU2020225818A1 (es)
BR (1) BR112021016405A2 (es)
CA (1) CA3129404A1 (es)
GB (2) GB2597578B (es)
IL (1) IL285648A (es)
MX (2) MX2021009844A (es)
SG (1) SG11202109104XA (es)
TW (1) TWI849062B (es)
WO (1) WO2020169991A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113490486A (zh) * 2019-02-22 2021-10-08 康特伦英国斯温顿捷迪斯有限公司 最小化团聚、曝气和保持包含布洛芬的药物组合物的包衣
CA3129404A1 (en) * 2019-02-22 2020-08-27 Catalent U.K. Swindon Zydis Limited Preserving functionally-coated api particles produced by solventless mixing processes in aqueous suspension
EP3927314B1 (en) * 2019-02-22 2023-08-23 Catalent U.K. Swindon Zydis Limited Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products
BR112023001716A2 (pt) * 2020-07-31 2023-04-04 Catalent Uk Swindon Zydis Ltd Composições farmacêuticas compreendendo api revestido
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

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