AU2016296162B2 - Non-mechanical process for the micronization of digoxin - Google Patents

Non-mechanical process for the micronization of digoxin Download PDF

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Publication number
AU2016296162B2
AU2016296162B2 AU2016296162A AU2016296162A AU2016296162B2 AU 2016296162 B2 AU2016296162 B2 AU 2016296162B2 AU 2016296162 A AU2016296162 A AU 2016296162A AU 2016296162 A AU2016296162 A AU 2016296162A AU 2016296162 B2 AU2016296162 B2 AU 2016296162B2
Authority
AU
Australia
Prior art keywords
digoxin
solution
concentrated
methanol
added
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2016296162A
Other languages
English (en)
Other versions
AU2016296162A1 (en
Inventor
Raman Mehta
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of AU2016296162A1 publication Critical patent/AU2016296162A1/en
Application granted granted Critical
Publication of AU2016296162B2 publication Critical patent/AU2016296162B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/1682Processes
    • A61K9/1688Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • 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
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Steroid Compounds (AREA)
AU2016296162A 2015-07-23 2016-07-21 Non-mechanical process for the micronization of digoxin Ceased AU2016296162B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15178009.5A EP3120839B1 (en) 2015-07-23 2015-07-23 Non-mechanical process for the micronization of digoxin
EP15178009.5 2015-07-23
PCT/IB2016/001035 WO2017013485A1 (en) 2015-07-23 2016-07-21 Non-mechanical process for the micronization of digoxin

Publications (2)

Publication Number Publication Date
AU2016296162A1 AU2016296162A1 (en) 2018-02-01
AU2016296162B2 true AU2016296162B2 (en) 2021-03-18

Family

ID=54010825

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016296162A Ceased AU2016296162B2 (en) 2015-07-23 2016-07-21 Non-mechanical process for the micronization of digoxin

Country Status (12)

Country Link
US (1) US20180207099A1 (enExample)
EP (2) EP3120839B1 (enExample)
JP (1) JP6814522B2 (enExample)
KR (1) KR20180032587A (enExample)
CN (1) CN108024963A (enExample)
AU (1) AU2016296162B2 (enExample)
ES (2) ES2716681T3 (enExample)
HU (2) HUE042420T2 (enExample)
MX (1) MX365906B (enExample)
PL (2) PL3120839T3 (enExample)
PT (2) PT3120839T (enExample)
WO (1) WO2017013485A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111110632B (zh) * 2018-10-31 2023-01-20 上海上药信谊药厂有限公司 一种地高辛气雾剂及其制备方法和应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5062959A (en) * 1986-12-20 1991-11-05 Boehringer Mannheim Gmbh Process for the enrichment and/or isolation of heart glycosides with the use of non-polar absorber resins
CN101390838A (zh) * 2008-10-10 2009-03-25 北京工业大学 一种制备微粉化药物的方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003007968A1 (en) 2001-07-17 2003-01-30 Sun Pharmaceutical Industries Ltd. A cardiotonic composition

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5062959A (en) * 1986-12-20 1991-11-05 Boehringer Mannheim Gmbh Process for the enrichment and/or isolation of heart glycosides with the use of non-polar absorber resins
CN101390838A (zh) * 2008-10-10 2009-03-25 北京工业大学 一种制备微粉化药物的方法

Also Published As

Publication number Publication date
MX2018001010A (es) 2018-05-17
CN108024963A (zh) 2018-05-11
AU2016296162A1 (en) 2018-02-01
PL3120839T3 (pl) 2019-08-30
JP2018521073A (ja) 2018-08-02
HUE042420T2 (hu) 2019-07-29
PT3120839T (pt) 2019-03-25
BR112018001204A2 (pt) 2018-09-11
HUE048065T2 (hu) 2020-05-28
JP6814522B2 (ja) 2021-01-20
PL3324942T3 (pl) 2020-05-18
ES2765675T3 (es) 2020-06-10
MX365906B (es) 2019-06-18
US20180207099A1 (en) 2018-07-26
PT3324942T (pt) 2020-01-17
EP3120839B1 (en) 2018-12-19
EP3324942A1 (en) 2018-05-30
KR20180032587A (ko) 2018-03-30
WO2017013485A1 (en) 2017-01-26
EP3120839A1 (en) 2017-01-25
EP3324942B1 (en) 2019-10-30
ES2716681T3 (es) 2019-06-14

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FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired