ES2554794T3 - Procedimiento para la obtención de una composición farmacéutica a base de modafinil, la composición farmacéutica así obtenida y su aplicación - Google Patents

Procedimiento para la obtención de una composición farmacéutica a base de modafinil, la composición farmacéutica así obtenida y su aplicación Download PDF

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Publication number
ES2554794T3
ES2554794T3 ES13715262.5T ES13715262T ES2554794T3 ES 2554794 T3 ES2554794 T3 ES 2554794T3 ES 13715262 T ES13715262 T ES 13715262T ES 2554794 T3 ES2554794 T3 ES 2554794T3
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Spain
Prior art keywords
pharmaceutical composition
modafinil
procedure
obtaining
application
Prior art date
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Active
Application number
ES13715262.5T
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English (en)
Inventor
Christophe Lebon
Pascal Suplie
Fabrice Leboeuf
Jennifer Jung
Frantz Deschamps
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.)
Debregeas Et Associes Pharma SAS
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Debregeas Et Associes Pharma SAS
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Publication of ES2554794T3 publication Critical patent/ES2554794T3/es
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Classifications

    • 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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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
    • A61K9/2072—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Anesthesiology (AREA)
  • Psychiatry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Closures For Containers (AREA)

Abstract

Procedimiento para la obtención de una composición farmacéutica caracterizado porque consiste en disolver el S modafinil en un fluido en estado supercrítico, luego, después de la expansión de dicho fluido, en recuperar dicho S modafinil haciendo que se absorba en superficie por un soporte inerte que se presenta en forma de gránulos.

Description

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La formulación de S modafinil obtenida según el procedimiento del fluido supercrítico confirma bien que ésta permite a la vez una liberación muy rápida (inferior a 1 hora) y un efecto de duración limitada (entre 3 y 4 horas): es esta doble característica lo que hace interesante la formulación según la presente invención.
5 Esta formulación consiste en gránulos que constituyen un soporte, por ejemplo de manitol o de lactosa anhidra, o cualquier otro soporte inerte sobre la superficie de los cuales han sido absorbidas las partículas de S modafinil obtenidas con ayuda de la tecnología del fluido supercrítico.
Ventajosamente, los comprimidos obtenidos a partir de esta formulación se dosificarán entre 25 a 200 mg de S modafinil, y aún más ventajosamente entre 50 y 100 mg.
10 La característica anteriormente citada permite utilizar estos comprimidos en cuanto el paciente tiene necesidad de una vigilancia incrementada a corto plazo, es decir muy rápidamente (menos de una hora) durante un breve periodo (3 a 4 horas por ejemplo).
10

Claims (1)

  1. imagen1
ES13715262.5T 2012-02-28 2013-02-25 Procedimiento para la obtención de una composición farmacéutica a base de modafinil, la composición farmacéutica así obtenida y su aplicación Active ES2554794T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR1200580 2012-02-28
FR1200580A FR2987266B1 (fr) 2012-02-28 2012-02-28 Procede d'obtention d'une composition pharmaceutique a base de modafinil, composition pharmaceutique ainsi obtenue et son application
PCT/FR2013/000051 WO2013128087A1 (fr) 2012-02-28 2013-02-25 Procédé d'obtention d'une composition pharmaceutique à base de modafinil, composition pharmaceutique ainsi obtenue et son application

Publications (1)

Publication Number Publication Date
ES2554794T3 true ES2554794T3 (es) 2015-12-23

Family

ID=48083446

Family Applications (1)

Application Number Title Priority Date Filing Date
ES13715262.5T Active ES2554794T3 (es) 2012-02-28 2013-02-25 Procedimiento para la obtención de una composición farmacéutica a base de modafinil, la composición farmacéutica así obtenida y su aplicación

Country Status (31)

Country Link
US (1) US9782367B2 (es)
EP (1) EP2819654B1 (es)
JP (1) JP6026566B2 (es)
KR (1) KR101911989B1 (es)
CN (1) CN104168889B (es)
AR (1) AR090168A1 (es)
AU (1) AU2013224830B2 (es)
CA (1) CA2863042A1 (es)
CL (1) CL2014002202A1 (es)
CY (1) CY1117049T1 (es)
DK (1) DK2819654T3 (es)
EA (1) EA024459B1 (es)
ES (1) ES2554794T3 (es)
FR (1) FR2987266B1 (es)
HR (1) HRP20151280T1 (es)
HU (1) HUE027141T2 (es)
IL (1) IL234008A (es)
IN (1) IN2014DN06573A (es)
MA (1) MA37284B1 (es)
MX (1) MX349970B (es)
NZ (1) NZ628007A (es)
PH (1) PH12014501838B1 (es)
PL (1) PL2819654T3 (es)
PT (1) PT2819654E (es)
RS (1) RS54435B1 (es)
SG (1) SG11201404812QA (es)
SI (1) SI2819654T1 (es)
SM (1) SMT201600029B (es)
TW (1) TWI543779B (es)
UA (1) UA113539C2 (es)
WO (1) WO2013128087A1 (es)

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5618845A (en) 1994-10-06 1997-04-08 Cephalon, Inc. Acetamide derivative having defined particle size
CN1249932A (zh) * 1999-09-29 2000-04-12 付俊昌 一种莫达芬尼及其光学对映体l及d异构体的新用途
DK1263413T3 (da) * 2000-03-09 2006-09-11 Univ Ohio State Res Found Fremgangsmåde til fremstilling af faste dispersioner
US6919378B2 (en) 2000-10-11 2005-07-19 Cephalon, Inc. Pharmaceutical solutions of modafinil compounds
US6489363B2 (en) 2000-10-11 2002-12-03 Cephalon, Inc. Pharmaceutical solutions of modafinil compounds
US7297346B2 (en) 2001-05-25 2007-11-20 Cephalon Inc. Pharmaceutical formulations of modafinil
US20040048931A1 (en) 2002-07-12 2004-03-11 Craig Heacock Modafinil pharmaceutical compositions
US20040121003A1 (en) 2002-12-19 2004-06-24 Acusphere, Inc. Methods for making pharmaceutical formulations comprising deagglomerated microparticles
US20060024370A1 (en) * 2004-07-29 2006-02-02 Cephalon France Modafinil oral lyophilizate
GB0523653D0 (en) * 2005-11-21 2005-12-28 Novartis Ag Organic compounds
WO2007011707A2 (en) * 2005-07-15 2007-01-25 Micell Technologies, Inc. Polymer coatings containing drug powder of controlled morphology
AU2006272874B2 (en) * 2005-07-21 2010-03-11 Neurohealing Pharmaceuticals, Inc. Rapid onset and short term modafinil compositions and methods of use thereof
AU2007272501A1 (en) * 2006-07-12 2008-01-17 Elan Pharma International Limited Nanoparticulate formulations of modafinil
US8173169B2 (en) * 2007-07-11 2012-05-08 Hikma Pharmaceuticals Formulation and process for the preparation of modafinil
FR2943543B1 (fr) 2009-03-31 2013-02-08 Separex Sa Procede de preparation de compositions pharmaceutiques comprenant des particules fines de substance active.
KR100924236B1 (ko) * 2009-06-23 2009-10-29 충남대학교산학협력단 균일한 입도분포를 가지는 초미세입자의 신규한 제조방법 및 장치

Also Published As

Publication number Publication date
AR090168A1 (es) 2014-10-22
PL2819654T3 (pl) 2016-02-29
US9782367B2 (en) 2017-10-10
SI2819654T1 (sl) 2015-12-31
IL234008A (en) 2017-02-28
US20150105470A1 (en) 2015-04-16
PH12014501838A1 (en) 2014-11-10
JP2015508804A (ja) 2015-03-23
UA113539C2 (xx) 2017-02-10
IL234008A0 (en) 2014-09-30
NZ628007A (en) 2015-07-31
MA20150242A2 (fr) 2015-07-31
PT2819654E (pt) 2015-12-21
AU2013224830A1 (en) 2014-08-21
TWI543779B (zh) 2016-08-01
CA2863042A1 (fr) 2013-09-06
FR2987266A1 (fr) 2013-08-30
AU2013224830B2 (en) 2017-02-02
CL2014002202A1 (es) 2015-03-13
IN2014DN06573A (es) 2015-06-26
EP2819654B1 (fr) 2015-09-09
HRP20151280T1 (hr) 2016-01-01
HK1198931A1 (en) 2015-06-19
CN104168889B (zh) 2016-10-26
DK2819654T3 (en) 2015-12-21
KR101911989B1 (ko) 2018-10-25
MX349970B (es) 2017-08-23
JP6026566B2 (ja) 2016-11-16
SG11201404812QA (en) 2014-10-30
CN104168889A (zh) 2014-11-26
RS54435B1 (sr) 2016-06-30
HUE027141T2 (hu) 2016-08-29
EA024459B1 (ru) 2016-09-30
TW201340995A (zh) 2013-10-16
KR20140129035A (ko) 2014-11-06
WO2013128087A1 (fr) 2013-09-06
FR2987266B1 (fr) 2014-12-19
SMT201600029B (it) 2016-02-25
EP2819654A1 (fr) 2015-01-07
PH12014501838B1 (en) 2014-11-10
MA37284B1 (fr) 2016-06-30
MX2014010236A (es) 2015-04-09
CY1117049T1 (el) 2017-04-05
EA201400962A1 (ru) 2014-12-30

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