AR118160A1 - Minimización de aireación de suspensiones durante la mezcla en línea - Google Patents

Minimización de aireación de suspensiones durante la mezcla en línea

Info

Publication number
AR118160A1
AR118160A1 ARP200100481A ARP200100481A AR118160A1 AR 118160 A1 AR118160 A1 AR 118160A1 AR P200100481 A ARP200100481 A AR P200100481A AR P200100481 A ARP200100481 A AR P200100481A AR 118160 A1 AR118160 A1 AR 118160A1
Authority
AR
Argentina
Prior art keywords
suspension
pharmaceutical
aeration
ifa
former
Prior art date
Application number
ARP200100481A
Other languages
English (en)
Inventor
Jonathan Whitehouse
Simon Andrew Martyn Howes
Rosalee Mlaughlin
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 AR118160A1 publication Critical patent/AR118160A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/5005Wall or coating material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5015Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Se proporcionan composiciones y métodos farmacéuticos para preparar composiciones farmacéuticas que pueden minimizar la aireación de una suspensión farmacéutica durante el proceso de producción. Las composiciones farmacéuticas incluyen una pluralidad de partículas IFA; un material de revestimiento encapsulando cada partícula IFA de la pluralidad de partículas IFA; y una solución / suspensión matriz que comprende un formador de matriz, un formador de estructura y un agente anti-aireación. Reivindicación 1: Un método para hacer una composición farmacéutica que comprende: proporcionar una solución / suspensión matriz que comprende un formador de matriz, un formador de estructura, un agente anti-aireación y un solvente; y mezclar una pluralidad de partículas hidrofóbicas en la solución / suspensión matriz para formar una suspensión farmacéutica; y dosificar la suspensión farmacéutica en envases blíster preformados, donde un peso dosificado de la suspensión farmacéutica está dentro del 10% del peso dosificado objetivo.
ARP200100481A 2019-02-22 2020-02-21 Minimización de aireación de suspensiones durante la mezcla en línea AR118160A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201962809293P 2019-02-22 2019-02-22

Publications (1)

Publication Number Publication Date
AR118160A1 true AR118160A1 (es) 2021-09-22

Family

ID=69740392

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP200100481A AR118160A1 (es) 2019-02-22 2020-02-21 Minimización de aireación de suspensiones durante la mezcla en línea

Country Status (18)

Country Link
US (1) US20200268677A1 (es)
EP (2) EP3927322B1 (es)
JP (1) JP2022521319A (es)
KR (1) KR20210130144A (es)
CN (1) CN113507923B (es)
AR (1) AR118160A1 (es)
AU (1) AU2020224375A1 (es)
BR (1) BR112021016408A2 (es)
CA (1) CA3129383A1 (es)
ES (1) ES2961850T3 (es)
GB (1) GB2585412B (es)
HU (1) HUE064524T2 (es)
IL (1) IL285652A (es)
MX (1) MX2021009681A (es)
PL (1) PL3927322T3 (es)
SG (1) SG11202108659XA (es)
TW (1) TW202045139A (es)
WO (1) WO2020169988A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2585414B (en) 2019-02-22 2023-06-14 Catalent Uk Swindon Zydis Ltd Minimizing agglomeration, aeration, and preserving the coating of pharmaceutical compositions comprising ibuprofen
KR20210130720A (ko) 2019-02-22 2021-11-01 카탈렌트 유.케이. 스윈던 지디스 리미티드 수성 현탁액에서 무용매 혼합 공정에 의해 생성된 기능적으로-코팅된 api 입자 보존
US11141380B2 (en) 2019-02-22 2021-10-12 Catalent U.K. Swindon Zydis Limited Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1183574B (it) * 1985-05-08 1987-10-22 Eurand Spa Metodo per ottenere una sospensione estemporanea omogenea di microcapsule
CA2128821A1 (en) * 1993-07-27 1995-01-28 Dilip J. Gole Freeze-dried pharmaceutical dosage form and process for separation thereof
GB9908014D0 (en) 1999-04-08 1999-06-02 Scherer Corp R P Pharmaceutical compositions
CA2449731A1 (en) * 2001-06-07 2002-12-19 Tanabe Seiyaku Co., Ltd. Functional grain-containing preparations quickly disintegrated in the oral cavity
US6509040B1 (en) * 2001-06-22 2003-01-21 R.P. Scherer Corporation Fast dispersing dosage forms essentially free of mammalian gelatin
US20040265373A1 (en) * 2003-06-27 2004-12-30 David Wynn Soft tablet containing high molecular weight cellulosics
CN101065105A (zh) * 2004-10-28 2007-10-31 潘特克股份公司 高孔隙度的速崩固体剂型及其包括生产粉末和冻干步骤的制备方法
WO2007074472A2 (en) * 2005-12-27 2007-07-05 Jubilant Organosys Limited Mouth dissolving pharmaceutical composition and process for preparing the same using a high amount of silicon dioxide
CA2664097A1 (en) * 2006-09-20 2008-03-27 Monosol Rx, Llc Edible water-soluble film containing a foam reducing flavoring agent
BRPI0718428A2 (pt) * 2006-10-25 2013-11-12 Mcneil Ppc Inc Composição de ibuprofeno
WO2013183062A2 (en) * 2012-06-05 2013-12-12 Rubicon Research Private Limited Palatable formulations of ibuprofen

Also Published As

Publication number Publication date
JP2022521319A (ja) 2022-04-06
MX2021009681A (es) 2021-09-10
EP3927322C0 (en) 2023-08-16
EP3927322A1 (en) 2021-12-29
WO2020169988A1 (en) 2020-08-27
CN113507923A (zh) 2021-10-15
CN113507923B (zh) 2024-03-26
AU2020224375A1 (en) 2021-10-14
GB2585412B (en) 2023-10-04
TW202045139A (zh) 2020-12-16
US20200268677A1 (en) 2020-08-27
HUE064524T2 (hu) 2024-03-28
EP3927322B1 (en) 2023-08-16
PL3927322T3 (pl) 2024-02-05
ES2961850T3 (es) 2024-03-14
BR112021016408A2 (pt) 2021-10-13
EP4268801A2 (en) 2023-11-01
KR20210130144A (ko) 2021-10-29
CA3129383A1 (en) 2020-08-27
EP4268801A3 (en) 2024-01-17
GB2585412A (en) 2021-01-13
IL285652A (en) 2021-09-30
GB202002475D0 (en) 2020-04-08
SG11202108659XA (en) 2021-09-29

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