CA2286832A1 - Method for producing small-particle preparations of biologically active substances - Google Patents
Method for producing small-particle preparations of biologically active substances Download PDFInfo
- Publication number
- CA2286832A1 CA2286832A1 CA002286832A CA2286832A CA2286832A1 CA 2286832 A1 CA2286832 A1 CA 2286832A1 CA 002286832 A CA002286832 A CA 002286832A CA 2286832 A CA2286832 A CA 2286832A CA 2286832 A1 CA2286832 A1 CA 2286832A1
- Authority
- CA
- Canada
- Prior art keywords
- biologically active
- active substances
- zone
- additives
- matrix
- 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.)
- Granted
Links
- 239000013543 active substance Substances 0.000 title abstract 3
- 238000002360 preparation method Methods 0.000 title abstract 3
- 239000002245 particle Substances 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000000654 additive Substances 0.000 abstract 3
- 238000001816 cooling Methods 0.000 abstract 3
- 239000011159 matrix material Substances 0.000 abstract 3
- 238000000034 method Methods 0.000 abstract 2
- 238000010924 continuous production Methods 0.000 abstract 1
- 238000004898 kneading Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000007787 solid Substances 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
- B29B7/00—Mixing; Kneading
- B29B7/30—Mixing; Kneading continuous, with mechanical mixing or kneading devices
- B29B7/34—Mixing; Kneading continuous, with mechanical mixing or kneading devices with movable mixing or kneading devices
- B29B7/38—Mixing; Kneading continuous, with mechanical mixing or kneading devices with movable mixing or kneading devices rotary
- B29B7/46—Mixing; Kneading continuous, with mechanical mixing or kneading devices with movable mixing or kneading devices rotary with more than one shaft
- B29B7/48—Mixing; Kneading continuous, with mechanical mixing or kneading devices with movable mixing or kneading devices rotary with more than one shaft with intermeshing devices, e.g. screws
-
- 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
- B29B7/00—Mixing; Kneading
- B29B7/30—Mixing; Kneading continuous, with mechanical mixing or kneading devices
- B29B7/58—Component parts, details or accessories; Auxiliary operations
- B29B7/72—Measuring, controlling or regulating
- B29B7/726—Measuring properties of mixture, e.g. temperature or density
-
- 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
- B29B7/00—Mixing; Kneading
- B29B7/80—Component parts, details or accessories; Auxiliary operations
- B29B7/82—Heating or cooling
- B29B7/826—Apparatus therefor
-
- 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
- B29B7/00—Mixing; Kneading
- B29B7/80—Component parts, details or accessories; Auxiliary operations
- B29B7/88—Adding charges, i.e. additives
-
- 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
- B29B7/00—Mixing; Kneading
- B29B7/80—Component parts, details or accessories; Auxiliary operations
- B29B7/88—Adding charges, i.e. additives
- B29B7/90—Fillers or reinforcements, e.g. fibres
-
- 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
- B29C48/022—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the choice of material
-
- 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
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
- B29C48/395—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders
-
- 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
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
- B29C48/395—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders
- B29C48/40—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders
- B29C48/402—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders the screws having intermeshing parts
-
- 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
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/78—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling
- B29C48/875—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling for achieving a non-uniform temperature distribution, e.g. using barrels having both cooling and heating zones
-
- 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
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/268—Throttling of the flow, e.g. for cooperating with plasticising elements or for degassing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/0005—Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
- B29K2105/0035—Medical or pharmaceutical agents
Abstract
The invention relates to a method for the continuous production of solid, particle-based preparations of biologically active substances, in which preparations the biologically active substances are homogeneously distributed in a matrix of additives which can be thermoplastically processed, in a screw extruder divided into several zones. Said method is characterized in that the matrix additives are first melted in a healable area and the biologically active components mixed with the matrix additives. Thereafter, the mixture is cooled, pre-crushed and finely ground in a cooling zone. The screw geometry of the cooling zone is designed in such a way that the cooling zone comprises a conveyor zone, a mixing zone and a kneading zone.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19721467A DE19721467A1 (en) | 1997-05-22 | 1997-05-22 | Process for the preparation of small-scale preparations of biologically active substances |
DE19721467.3 | 1997-05-22 | ||
PCT/EP1998/002821 WO1998052684A1 (en) | 1997-05-22 | 1998-05-13 | Method for producing small-particle preparations of biologically active substances |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2286832A1 true CA2286832A1 (en) | 1998-11-26 |
CA2286832C CA2286832C (en) | 2006-03-07 |
Family
ID=7830203
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002286832A Expired - Lifetime CA2286832C (en) | 1997-05-22 | 1998-05-13 | Method for producing small-particle preparations of biologically active substances |
Country Status (12)
Country | Link |
---|---|
US (1) | US6318650B1 (en) |
EP (1) | EP0988106B1 (en) |
JP (1) | JP4173200B2 (en) |
CN (1) | CN1105596C (en) |
AT (1) | ATE204788T1 (en) |
BR (1) | BR9809860B1 (en) |
CA (1) | CA2286832C (en) |
DE (2) | DE19721467A1 (en) |
DK (1) | DK0988106T3 (en) |
ES (1) | ES2162707T3 (en) |
GR (1) | GR3036715T3 (en) |
WO (1) | WO1998052684A1 (en) |
Families Citing this family (78)
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IT1303671B1 (en) * | 1998-07-28 | 2001-02-23 | Nicox Sa | SALTS OF NITRIC ACID WITH ACTIVE DRUGS IN THE TREATMENT OF DISEASES OF THE RESPIRATORY SYSTEM |
FR2776189A1 (en) * | 1999-06-09 | 1999-09-24 | Lipha | Oral compositions having improved absorption in the gastro-intestinal tract containing a polyglycolized glyceride |
WO2001034119A2 (en) | 1999-11-12 | 2001-05-17 | Abbott Laboratories | Inhibitors of crystallization in a solid dispersion |
US7364752B1 (en) | 1999-11-12 | 2008-04-29 | Abbott Laboratories | Solid dispersion pharamaceutical formulations |
CA2393585C (en) * | 1999-12-09 | 2007-07-03 | The Boots Company Plc | Therapeutic agents |
US20010036479A1 (en) * | 2000-01-14 | 2001-11-01 | Gillian Cave | Glyburide composition |
FR2804603B1 (en) * | 2000-02-04 | 2004-01-23 | Rhodia Chimie Sa | CONTINUOUS PROCESS FOR FORMULATING IN THE FORM OF GRANULES ONE OR MORE PHARMACEUTICAL ACTIVE SUBSTANCES |
US6499984B1 (en) * | 2000-05-22 | 2002-12-31 | Warner-Lambert Company | Continuous production of pharmaceutical granulation |
DE10026698A1 (en) | 2000-05-30 | 2001-12-06 | Basf Ag | Self-emulsifying active ingredient formulation and use of this formulation |
IT1319655B1 (en) | 2000-11-15 | 2003-10-23 | Eurand Int | PANCREATIC ENZYME MICROSPHERES WITH HIGH STABILITY AND RELATIVE PREPARATION METHOD. |
GB0102342D0 (en) | 2001-01-30 | 2001-03-14 | Smithkline Beecham Plc | Pharmaceutical formulation |
US7883721B2 (en) | 2001-01-30 | 2011-02-08 | Smithkline Beecham Limited | Pharmaceutical formulation |
US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
JP3444874B1 (en) * | 2002-12-02 | 2003-09-08 | 高砂香料工業株式会社 | Granular fragrance and method for producing the same |
DE10300325A1 (en) | 2003-01-09 | 2004-07-22 | Hexal Ag | Granules with oily substance, manufacturing process and tablet |
EP1638527B1 (en) * | 2003-06-27 | 2006-10-25 | BIOPROGRESS S.p.A. | Composite product obtainable by cogrinding of an active principle with a copolymer n-vinyl-2-pyrrolidone/vinyl-acetate |
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DE10336400A1 (en) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Anti-abuse dosage form |
DE10361596A1 (en) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Process for producing an anti-abuse dosage form |
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US8075872B2 (en) | 2003-08-06 | 2011-12-13 | Gruenenthal Gmbh | Abuse-proofed dosage form |
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WO2005023215A2 (en) * | 2003-09-10 | 2005-03-17 | Janssen Pharmaceutica N.V. | Particles shaped as platelets |
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DK1748762T3 (en) * | 2004-05-28 | 2014-03-17 | Abbvie Deutschland | Dosage form which can be obtained from a powder mixture comprising an inorganic pigment |
DE102004032049A1 (en) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Anti-abuse, oral dosage form |
JP2006176461A (en) * | 2004-12-24 | 2006-07-06 | Dai Ichi Seiyaku Co Ltd | Granulated material |
DE102005005449A1 (en) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Process for producing an anti-abuse dosage form |
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AU2011224098B2 (en) * | 2005-05-10 | 2013-10-31 | Novartis Ag | Extrusion process for making compositions with poorly compressible therapeutic compounds |
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US20070249572A1 (en) * | 2005-12-20 | 2007-10-25 | Verus Pharmaceuticals, Inc. | Systems and methods for the delivery of corticosteroids |
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CN103933555B (en) | 2007-02-20 | 2018-06-01 | 阿普塔利斯制药有限公司 | Stable digestive enzyme compositions |
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ATE176618T1 (en) * | 1993-06-16 | 1999-02-15 | Union Carbide Chem Plastic | DEVICE AND METHOD FOR CONTINUOUS PELLETIZING THERMOPLASTIC PLASTICS |
DE4418837A1 (en) | 1994-05-30 | 1995-12-07 | Bayer Ag | Thermal granulation process |
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-
1997
- 1997-05-22 DE DE19721467A patent/DE19721467A1/en not_active Withdrawn
-
1998
- 1998-05-13 CN CN98805101A patent/CN1105596C/en not_active Expired - Fee Related
- 1998-05-13 DK DK98930687T patent/DK0988106T3/en active
- 1998-05-13 WO PCT/EP1998/002821 patent/WO1998052684A1/en active IP Right Grant
- 1998-05-13 US US09/424,513 patent/US6318650B1/en not_active Expired - Lifetime
- 1998-05-13 EP EP98930687A patent/EP0988106B1/en not_active Expired - Lifetime
- 1998-05-13 CA CA002286832A patent/CA2286832C/en not_active Expired - Lifetime
- 1998-05-13 DE DE59801326T patent/DE59801326D1/en not_active Expired - Lifetime
- 1998-05-13 JP JP54990598A patent/JP4173200B2/en not_active Expired - Lifetime
- 1998-05-13 BR BRPI9809860-8A patent/BR9809860B1/en not_active IP Right Cessation
- 1998-05-13 AT AT98930687T patent/ATE204788T1/en active
- 1998-05-13 ES ES98930687T patent/ES2162707T3/en not_active Expired - Lifetime
-
2001
- 2001-09-26 GR GR20010401572T patent/GR3036715T3/en unknown
Also Published As
Publication number | Publication date |
---|---|
BR9809860A (en) | 2000-06-27 |
EP0988106A1 (en) | 2000-03-29 |
DE19721467A1 (en) | 1998-11-26 |
US6318650B1 (en) | 2001-11-20 |
DE59801326D1 (en) | 2001-10-04 |
CN1255877A (en) | 2000-06-07 |
GR3036715T3 (en) | 2001-12-31 |
EP0988106B1 (en) | 2001-08-29 |
CA2286832C (en) | 2006-03-07 |
JP4173200B2 (en) | 2008-10-29 |
DK0988106T3 (en) | 2001-10-08 |
BR9809860B1 (en) | 2009-01-13 |
ATE204788T1 (en) | 2001-09-15 |
ES2162707T3 (en) | 2002-01-01 |
JP2001527464A (en) | 2001-12-25 |
WO1998052684A1 (en) | 1998-11-26 |
CN1105596C (en) | 2003-04-16 |
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MKEX | Expiry |
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