WO2003028645A2 - Nouvelles compositions de carvedilol - Google Patents
Nouvelles compositions de carvedilol Download PDFInfo
- Publication number
- WO2003028645A2 WO2003028645A2 PCT/US2002/031123 US0231123W WO03028645A2 WO 2003028645 A2 WO2003028645 A2 WO 2003028645A2 US 0231123 W US0231123 W US 0231123W WO 03028645 A2 WO03028645 A2 WO 03028645A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- carvedilol
- composition according
- spray
- pluronic
- parts
- Prior art date
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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
Definitions
- compositions of carvedilol are provided wherein carvedilol is present in a spray-dried powder.
- the compositions are prepared using a process that involves wet bead milling and spray-drying.
- Compositions are prepared by admixture and, thus, they are suitably adapted for oral, parenteral or pulmonary administration.
- the compositions may be formulated in the form of tablets, capsules, reconstitutable powders or suppositories. Orally administrable formulations are preferred.
- the chamber mill is then filled with the grinding beads and the agitator is set to run at a speed of from about 1500-2500 rpm.
- the carvedilol suspensions are circulated through the mill and the milling process is stopped after the average particle size is from about 700-500 nm.
- excipients are added into the milled carvedilol suspension and the resulting suspension is homogenized.
- Spray-drying for example using Niro Mobile Minor Spray Dryer, is then carried out.
- the carvedilol suspensions hereinbefore described are comprised of 30.0% of carvedilol and 6.0% of Pluronic F127.
- Tablets and capsules for oral administration are usually presented in a unit dose, and contain conventional excipients such as binding agents, fillers and diluents (tableting or compression aids), lubricants, disintegrants, colorants, flavorings, and wetting agents.
- excipients such as binding agents, fillers and diluents (tableting or compression aids), lubricants, disintegrants, colorants, flavorings, and wetting agents.
- the tablets may be coated according to techniques well known in the art.
- 1200 mL YTZ grinding beads 1.0 mm beads for the first in-line chamber, 0.65 mm beads for the second in-line chamber, and 0.4 mm beads for the third in-line chamber.
- the agitators were run at a speed of 1500 rpm. Approximately 5 mL suspension was collected every 30 or 60 minutes for in-process particle size analysis. The milled carvedilol suspensions were finally collected in stainless steel containers and held at 5 °C until commencing the spray-drying process.
- the spray drying was carried out with a Niro Mobile Minor 2000 Spray Dryer (two fluid 0.8 mm nozzle, co-current spraying, Nitrogen gas). Prior to spray drying, necessary excipients were added into the milled Carvedilol suspension and the resulting suspension was homogenized for approximately 30 minutes. Later in development, a PVP/cellulose solution was prepared, held at 5 °C overnight and then mixed with the milled carvedilol suspension prior to spray drying. The carvedilol suspension was then spray-dried. The spray-dried powder was collected using glass bottles.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2002341901A AU2002341901A1 (en) | 2001-10-01 | 2002-10-01 | Novel compositions of carvedilol |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US32636701P | 2001-10-01 | 2001-10-01 | |
US60/326,367 | 2001-10-01 | ||
US33023401P | 2001-10-18 | 2001-10-18 | |
US60/330,234 | 2001-10-18 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2003028645A2 true WO2003028645A2 (fr) | 2003-04-10 |
WO2003028645A3 WO2003028645A3 (fr) | 2004-03-25 |
Family
ID=26985374
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2002/031123 WO2003028645A2 (fr) | 2001-10-01 | 2002-10-01 | Nouvelles compositions de carvedilol |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU2002341901A1 (fr) |
WO (1) | WO2003028645A2 (fr) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1661558A1 (fr) * | 2004-11-30 | 2006-05-31 | Basf Aktiengesellschaft | Compositions basées sur des particules poloxamères obtenu en forme de micro goutelettes solidifiées, les méthodes de leur production |
US7268156B2 (en) | 2002-06-27 | 2007-09-11 | Sb Pharmco Puerto Rico Inc. | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment |
WO2008068731A1 (fr) * | 2006-12-06 | 2008-06-12 | Biovail Laboratories International S.R.L. | Formulations de carvedilol à libération prolongée |
US7649010B2 (en) | 2002-06-27 | 2010-01-19 | SmithKline Beechman Cork Limited | Carvedilol hydrobromide |
US7750036B2 (en) | 2003-11-25 | 2010-07-06 | Sb Pharmco Puerto Rico Inc. | Carvedilol salts, corresponding compositions, methods of delivery and/or treatment |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6224909B1 (en) * | 1996-09-12 | 2001-05-01 | Roche Diagnostics Gmbh | Fast decomposing pellets |
US6395300B1 (en) * | 1999-05-27 | 2002-05-28 | Acusphere, Inc. | Porous drug matrices and methods of manufacture thereof |
-
2002
- 2002-10-01 WO PCT/US2002/031123 patent/WO2003028645A2/fr not_active Application Discontinuation
- 2002-10-01 AU AU2002341901A patent/AU2002341901A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6224909B1 (en) * | 1996-09-12 | 2001-05-01 | Roche Diagnostics Gmbh | Fast decomposing pellets |
US6395300B1 (en) * | 1999-05-27 | 2002-05-28 | Acusphere, Inc. | Porous drug matrices and methods of manufacture thereof |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7268156B2 (en) | 2002-06-27 | 2007-09-11 | Sb Pharmco Puerto Rico Inc. | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment |
US7626041B2 (en) | 2002-06-27 | 2009-12-01 | Smithkline Beecham (Cork) Ltd | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment |
US7649010B2 (en) | 2002-06-27 | 2010-01-19 | SmithKline Beechman Cork Limited | Carvedilol hydrobromide |
US7759384B2 (en) | 2002-06-27 | 2010-07-20 | Smithkline Beecham (Cork) Limited | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment |
US7893100B2 (en) | 2002-06-27 | 2011-02-22 | Sb Pharmco Puerto Rico Inc. | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment |
US7902378B2 (en) | 2002-06-27 | 2011-03-08 | Smithkline Beecham (Cork) Limited | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment |
US7750036B2 (en) | 2003-11-25 | 2010-07-06 | Sb Pharmco Puerto Rico Inc. | Carvedilol salts, corresponding compositions, methods of delivery and/or treatment |
EP1661558A1 (fr) * | 2004-11-30 | 2006-05-31 | Basf Aktiengesellschaft | Compositions basées sur des particules poloxamères obtenu en forme de micro goutelettes solidifiées, les méthodes de leur production |
JP2006151980A (ja) * | 2004-11-30 | 2006-06-15 | Basf Ag | 微造粒ポリマーの形成方法 |
WO2008068731A1 (fr) * | 2006-12-06 | 2008-06-12 | Biovail Laboratories International S.R.L. | Formulations de carvedilol à libération prolongée |
Also Published As
Publication number | Publication date |
---|---|
AU2002341901A1 (en) | 2003-04-14 |
WO2003028645A3 (fr) | 2004-03-25 |
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