WO2002035991A3 - Spherical particles produced by a hot-melt extrusion/spheronization process - Google Patents
Spherical particles produced by a hot-melt extrusion/spheronization process Download PDFInfo
- Publication number
- WO2002035991A3 WO2002035991A3 PCT/US2001/048752 US0148752W WO0235991A3 WO 2002035991 A3 WO2002035991 A3 WO 2002035991A3 US 0148752 W US0148752 W US 0148752W WO 0235991 A3 WO0235991 A3 WO 0235991A3
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- beads
- hot
- spheronization
- pellets
- extruded
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 6
- 238000005563 spheronization Methods 0.000 title abstract 4
- 238000009474 hot melt extrusion Methods 0.000 title abstract 3
- 239000012798 spherical particle Substances 0.000 title abstract 2
- 239000011324 bead Substances 0.000 abstract 11
- 239000008188 pellet Substances 0.000 abstract 4
- 239000013543 active substance Substances 0.000 abstract 3
- 239000012943 hotmelt Substances 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 1
- 238000005469 granulation Methods 0.000 abstract 1
- 230000003179 granulation Effects 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 238000004626 scanning electron microscopy Methods 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
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
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/02—Making granules by dividing preformed material
- B29B9/06—Making granules by dividing preformed material in the form of filamentary material, e.g. combined with extrusion
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/12—Making granules characterised by structure or composition
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/001—Combinations of extrusion moulding with other shaping operations
- B29C48/0022—Combinations of extrusion moulding with other shaping operations combined with cutting
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/04—Particle-shaped
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/06—Rod-shaped
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/16—Auxiliary treatment of granules
- B29B2009/163—Coating, i.e. applying a layer of liquid or solid material on the granule
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/16—Auxiliary treatment of granules
- B29B2009/166—Deforming granules to give a special form, e.g. spheroidizing, rounding
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Glanulating (AREA)
Abstract
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2002226098A AU2002226098A1 (en) | 2000-10-30 | 2001-10-29 | Spherical particles produced by a hot-melt extrusion/spheronization process |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US24443500P | 2000-10-30 | 2000-10-30 | |
| US60/244,435 | 2000-10-30 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2002035991A2 WO2002035991A2 (en) | 2002-05-10 |
| WO2002035991A3 true WO2002035991A3 (en) | 2002-08-01 |
Family
ID=22922752
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2001/048752 WO2002035991A2 (en) | 2000-10-30 | 2001-10-29 | Spherical particles produced by a hot-melt extrusion/spheronization process |
Country Status (2)
| Country | Link |
|---|---|
| AU (1) | AU2002226098A1 (en) |
| WO (1) | WO2002035991A2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9011963B2 (en) | 2012-11-21 | 2015-04-21 | S&P Ingredient Development, Llc | Compositions of low sodium salt and methods of making and using |
Families Citing this family (52)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10026698A1 (en) | 2000-05-30 | 2001-12-06 | Basf Ag | Self-emulsifying active ingredient formulation and use of this formulation |
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| DE102005005446A1 (en) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Break-resistant dosage forms with sustained release |
| US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| US8075872B2 (en) | 2003-08-06 | 2011-12-13 | Gruenenthal Gmbh | Abuse-proofed dosage form |
| DE102004032051A1 (en) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Process for the preparation of a secured against misuse, solid dosage form |
| DE10336400A1 (en) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Anti-abuse dosage form |
| US8377952B2 (en) | 2003-08-28 | 2013-02-19 | Abbott Laboratories | Solid pharmaceutical dosage formulation |
| US8025899B2 (en) | 2003-08-28 | 2011-09-27 | Abbott Laboratories | Solid pharmaceutical dosage form |
| DE102004032049A1 (en) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Anti-abuse, oral dosage form |
| EP1817008B1 (en) * | 2004-11-09 | 2020-04-01 | Board of Regents, The University of Texas System | Stabilized hme composition with small drug particles |
| DE102005005449A1 (en) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Process for producing an anti-abuse dosage form |
| WO2007084212A2 (en) | 2006-01-19 | 2007-07-26 | Dow Global Technologies Inc. | Biologically active composition comprising ethylcellulose |
| US7771632B2 (en) | 2006-05-15 | 2010-08-10 | American Leistritz Extruder Corp. | Continuous melt spheronization apparatus and process for the production of pharmaceutical pellets |
| US20070286903A1 (en) * | 2006-06-13 | 2007-12-13 | Becicka Brian T | Composition and method for taste masking |
| DE602007008125D1 (en) | 2006-10-31 | 2010-09-09 | Surmodics Pharmaceuticals Inc | BALL-SHAPED POLYMER PARTICLES |
| DE102007009242A1 (en) * | 2007-02-22 | 2008-09-18 | Evonik Röhm Gmbh | Pellets with enteric-coated matix |
| DE102007009243A1 (en) * | 2007-02-22 | 2008-09-18 | Evonik Röhm Gmbh | Pellets with a drug matrix and a polymer coating, and a method for producing the pellets |
| CN101652128B (en) * | 2007-03-02 | 2012-12-19 | 法纳姆公司 | Sustained release compositions using wax-like materials |
| DE102007011485A1 (en) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Dosage form with more difficult abuse |
| DE102007025858A1 (en) * | 2007-06-01 | 2008-12-04 | Grünenthal GmbH | Process for the preparation of a medicament dosage form |
| WO2009092601A1 (en) | 2008-01-25 | 2009-07-30 | Grünenthal GmbH | Pharmaceutical dosage form |
| HRP20161307T1 (en) | 2008-05-09 | 2016-12-02 | Grünenthal GmbH | Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step |
| CN102238945B (en) * | 2008-10-07 | 2014-10-29 | 阿斯利康(英国)有限公司 | Pharmaceutical formulation 514 |
| ES2534908T3 (en) | 2009-07-22 | 2015-04-30 | Grünenthal GmbH | Hot melt extruded controlled release dosage form |
| ES2428938T3 (en) | 2009-07-22 | 2013-11-12 | Grünenthal GmbH | Dosage form resistant to manipulation and stabilized against oxidation |
| AU2011297901B2 (en) | 2010-09-02 | 2014-07-31 | Grunenthal Gmbh | Tamper resistant dosage form comprising inorganic salt |
| AU2011297892B2 (en) | 2010-09-02 | 2014-05-29 | Grunenthal Gmbh | Tamper resistant dosage form comprising an anionic polymer |
| AU2012292418B2 (en) | 2011-07-29 | 2017-02-16 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
| RS56528B1 (en) | 2011-07-29 | 2018-02-28 | Gruenenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
| EP2819656A1 (en) | 2012-02-28 | 2015-01-07 | Grünenthal GmbH | Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer |
| EP2838512B1 (en) | 2012-04-18 | 2018-08-22 | Grünenthal GmbH | Tamper resistant and dose-dumping resistant pharmaceutical dosage form |
| CA2871429C (en) | 2012-04-25 | 2018-07-31 | Spi Pharma, Inc. | Crystalline microspheres and the process for manufacturing the same |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| AU2014273227B2 (en) | 2013-05-29 | 2019-08-15 | Grunenthal Gmbh | Tamper-resistant dosage form containing one or more particles |
| BR112015029616A2 (en) | 2013-05-29 | 2017-07-25 | Gruenenthal Gmbh | tamper-resistant dosage form with bimodal release profile |
| CA2917136C (en) | 2013-07-12 | 2022-05-31 | Grunenthal Gmbh | Tamper-resistant dosage form containing ethylene-vinyl acetate polymer |
| BR112016010482B1 (en) | 2013-11-26 | 2022-11-16 | Grünenthal GmbH | PREPARATION OF A PHARMACEUTICAL COMPOSITION IN POWDER BY MEANS OF CRYOMING |
| US10406234B2 (en) | 2014-03-24 | 2019-09-10 | Kashiv Biosciences, Llc | Method of manufacturing fine particles suitable for orally disintegrating pharmaceutical dosage forms |
| JP2017518980A (en) | 2014-05-12 | 2017-07-13 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | Anti-modification immediate release capsule formulation containing tapentadol |
| CA2949422A1 (en) | 2014-05-26 | 2015-12-03 | Grunenthal Gmbh | Multiparticles safeguarded against ethanolic dose-dumping |
| CA2964068A1 (en) | 2014-09-19 | 2016-03-24 | Board Of Regents, The University Of Texas System | Methods of preparing extrudates |
| MX2017013637A (en) | 2015-04-24 | 2018-03-08 | Gruenenthal Gmbh | Tamper-resistant dosage form with immediate release and resistance against solvent extraction. |
| EP3316858A1 (en) * | 2015-07-03 | 2018-05-09 | DSM IP Assets B.V. | Novel extrudates |
| WO2017042325A1 (en) | 2015-09-10 | 2017-03-16 | Grünenthal GmbH | Protecting oral overdose with abuse deterrent immediate release formulations |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| EP3681686A1 (en) * | 2017-09-12 | 2020-07-22 | Dressler Group GmbH & Co. KG | Method and device for thermal rounding or spheronisation of powdered plastic particles |
| ES2938608T3 (en) | 2017-09-20 | 2023-04-13 | Tillotts Pharma Ag | Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization |
| CN109925290B (en) * | 2017-12-18 | 2021-03-16 | 广州白云山明兴制药有限公司 | Theophylline sustained release tablet and preparation process thereof |
| ES2907572T3 (en) | 2018-02-07 | 2022-04-25 | Daicel Corp | Cellulose acetate particles, cosmetic composition, and method of producing cellulose acetate particles |
| CN110405977B (en) * | 2019-07-19 | 2021-10-12 | 合肥智慧殿机械设计有限公司 | Lateral feeding granulator for arc cutting of elastomer prism surface of film dry material package clamp |
| WO2024263880A1 (en) * | 2023-06-22 | 2024-12-26 | Koppers Performance Chemicals, Inc. | Methods of manufacture of biocidal compositions, articles for storing biocidal compositions, wood preservative solutions, and wood products produced therefrom |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1993007859A1 (en) * | 1991-10-23 | 1993-04-29 | Warner-Lambert Company | Novel pharmaceutical pellets and process for their production |
-
2001
- 2001-10-29 WO PCT/US2001/048752 patent/WO2002035991A2/en active Application Filing
- 2001-10-29 AU AU2002226098A patent/AU2002226098A1/en not_active Abandoned
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1993007859A1 (en) * | 1991-10-23 | 1993-04-29 | Warner-Lambert Company | Novel pharmaceutical pellets and process for their production |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9011963B2 (en) | 2012-11-21 | 2015-04-21 | S&P Ingredient Development, Llc | Compositions of low sodium salt and methods of making and using |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2002226098A1 (en) | 2002-05-15 |
| WO2002035991A2 (en) | 2002-05-10 |
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