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 PDFInfo
- 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
- Authority
- ES
- Spain
- Prior art keywords
- pharmaceutical composition
- modafinil
- procedure
- obtaining
- application
- 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.)
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Links
- YFGHCGITMMYXAQ-UHFFFAOYSA-N 2-[(diphenylmethyl)sulfinyl]acetamide Chemical compound C=1C=CC=CC=1C(S(=O)CC(=O)N)C1=CC=CC=C1 YFGHCGITMMYXAQ-UHFFFAOYSA-N 0.000 title abstract description 6
- 229960001165 modafinil Drugs 0.000 title abstract description 6
- 238000000034 method Methods 0.000 title abstract description 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 239000012530 fluid Substances 0.000 abstract description 4
- 239000008187 granular material Substances 0.000 abstract description 2
- 238000009472 formulation Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 229960004977 anhydrous lactose Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
Classifications
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- 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)
- Psychiatry (AREA)
- Anesthesiology (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
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)
-
imagen1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
| FR1200580 | 2012-02-28 | ||
| 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) | PH12014501838A1 (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)
| 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 |
| EP1263413B1 (en) * | 2000-03-09 | 2006-05-24 | Ohio State University Research Foundation | Method of preparing solid dispersions |
| 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 |
| PL1909973T3 (pl) * | 2005-07-15 | 2019-01-31 | Micell Technologies, Inc. | Polimerowe powłoki zawierające proszek leku o kontrolowanej morfologii |
| WO2007013962A2 (en) * | 2005-07-21 | 2007-02-01 | Neurohealing Pharmaceuticals, Inc. | Rapid onset and short term modafinil compositions and methods of use thereof |
| MX2009000391A (es) * | 2006-07-12 | 2009-06-30 | Elan Pharma Int Ltd | Formulación de modafinilo en forma de nano-partículas. |
| 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 |
-
2012
- 2012-02-28 FR FR1200580A patent/FR2987266B1/fr not_active Expired - Fee Related
-
2013
- 2013-02-25 NZ NZ628007A patent/NZ628007A/en not_active IP Right Cessation
- 2013-02-25 US US14/381,699 patent/US9782367B2/en not_active Expired - Fee Related
- 2013-02-25 EA EA201400962A patent/EA024459B1/ru not_active IP Right Cessation
- 2013-02-25 IN IN6573DEN2014 patent/IN2014DN06573A/en unknown
- 2013-02-25 MA MA37284A patent/MA37284B1/fr unknown
- 2013-02-25 CA CA 2863042 patent/CA2863042A1/fr not_active Abandoned
- 2013-02-25 CN CN201380011313.0A patent/CN104168889B/zh not_active Expired - Fee Related
- 2013-02-25 UA UAA201409665A patent/UA113539C2/uk unknown
- 2013-02-25 HR HRP20151280TT patent/HRP20151280T1/hr unknown
- 2013-02-25 KR KR1020147023178A patent/KR101911989B1/ko not_active Expired - Fee Related
- 2013-02-25 JP JP2014559269A patent/JP6026566B2/ja not_active Expired - Fee Related
- 2013-02-25 SG SG11201404812QA patent/SG11201404812QA/en unknown
- 2013-02-25 PL PL13715262T patent/PL2819654T3/pl unknown
- 2013-02-25 HU HUE13715262A patent/HUE027141T2/hu unknown
- 2013-02-25 RS RS20150789A patent/RS54435B1/sr unknown
- 2013-02-25 DK DK13715262.5T patent/DK2819654T3/en active
- 2013-02-25 MX MX2014010236A patent/MX349970B/es active IP Right Grant
- 2013-02-25 EP EP13715262.5A patent/EP2819654B1/fr active Active
- 2013-02-25 AU AU2013224830A patent/AU2013224830B2/en not_active Ceased
- 2013-02-25 ES ES13715262.5T patent/ES2554794T3/es active Active
- 2013-02-25 SI SI201330097T patent/SI2819654T1/sl unknown
- 2013-02-25 PT PT137152625T patent/PT2819654E/pt unknown
- 2013-02-25 WO PCT/FR2013/000051 patent/WO2013128087A1/fr not_active Ceased
- 2013-02-26 TW TW102106626A patent/TWI543779B/zh not_active IP Right Cessation
- 2013-02-27 AR ARP130100595 patent/AR090168A1/es unknown
-
2014
- 2014-08-07 IL IL234008A patent/IL234008A/en active IP Right Grant
- 2014-08-14 PH PH12014501838A patent/PH12014501838A1/en unknown
- 2014-08-19 CL CL2014002202A patent/CL2014002202A1/es unknown
-
2015
- 2015-12-09 CY CY20151101120T patent/CY1117049T1/el unknown
-
2016
- 2016-01-29 SM SM201600029T patent/SMT201600029B/it unknown
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