MX2018001010A - Proceso no mecanico para la micronizacion de digoxina. - Google Patents

Proceso no mecanico para la micronizacion de digoxina.

Info

Publication number
MX2018001010A
MX2018001010A MX2018001010A MX2018001010A MX2018001010A MX 2018001010 A MX2018001010 A MX 2018001010A MX 2018001010 A MX2018001010 A MX 2018001010A MX 2018001010 A MX2018001010 A MX 2018001010A MX 2018001010 A MX2018001010 A MX 2018001010A
Authority
MX
Mexico
Prior art keywords
digoxin
micronization
solution
concentrated
purified
Prior art date
Application number
MX2018001010A
Other languages
English (en)
Other versions
MX365906B (es
Inventor
Mehta Raman
Original Assignee
Mehta Raman
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 Mehta Raman filed Critical Mehta Raman
Publication of MX2018001010A publication Critical patent/MX2018001010A/es
Publication of MX365906B publication Critical patent/MX365906B/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
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds 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
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Steroid Compounds (AREA)

Abstract

La presente invención describe un nuevo proceso no mecánico de micronización, capaz de reducir el tamaño de partícula de digoxina del nivel ordinario a un rango micrométrico seleccionado. La micronización se obtiene a través de un tratamiento específico, que se realizará en una solución de digoxina purificada y concentrada en un solvente o disolvente orgánico. La solución de digoxina purificada y concentrada se puede obtener a través de una secuencia de tratamientos con disolventes o solventes; luego, después de alcanzar la concentración requerida, la solución es además concentrada, obteniéndose la precipitación de la digoxina; a la mezcla de reacción luego se agrega metanol bajo agitación durante un tiempo adecuado. El precipitado recuperado consiste en una digoxina con un tamaño de partícula comprendido entre 20 y 30 micrómetros para al menos el 90% en peso de las partículas obtenidas, y está exento de productos de degradación.
MX2018001010A 2015-07-23 2016-07-21 Proceso no mecánico para la micronización de digoxina. MX365906B (es)

Applications Claiming Priority (2)

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
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
MX2018001010A true MX2018001010A (es) 2018-05-17
MX365906B MX365906B (es) 2019-06-18

Family

ID=54010825

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2018001010A MX365906B (es) 2015-07-23 2016-07-21 Proceso no mecánico para la micronización de digoxina.

Country Status (12)

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

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

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3643760A1 (de) * 1986-12-20 1988-06-23 Boehringer Mannheim Gmbh Verfahren zur anreicherung und/oder isolierung von herzglykosiden unter verwendung unpolarer adsorberharze
WO2003007968A1 (en) 2001-07-17 2003-01-30 Sun Pharmaceutical Industries Ltd. A cardiotonic composition
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
ES2765675T3 (es) 2020-06-10
WO2017013485A1 (en) 2017-01-26
JP6814522B2 (ja) 2021-01-20
AU2016296162A1 (en) 2018-02-01
EP3324942A1 (en) 2018-05-30
EP3120839A1 (en) 2017-01-25
US20180207099A1 (en) 2018-07-26
EP3120839B1 (en) 2018-12-19
MX365906B (es) 2019-06-18
KR20180032587A (ko) 2018-03-30
AU2016296162B2 (en) 2021-03-18
PT3120839T (pt) 2019-03-25
JP2018521073A (ja) 2018-08-02
BR112018001204A2 (pt) 2018-09-11
HUE042420T2 (hu) 2019-07-29
PL3120839T3 (pl) 2019-08-30
EP3324942B1 (en) 2019-10-30
ES2716681T3 (es) 2019-06-14
HUE048065T2 (hu) 2020-05-28
PL3324942T3 (pl) 2020-05-18
CN108024963A (zh) 2018-05-11
PT3324942T (pt) 2020-01-17

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