EP1883465A1 - Doppelkammer-mischvorrichtung für visköse pharmazeutische substanzen - Google Patents

Doppelkammer-mischvorrichtung für visköse pharmazeutische substanzen

Info

Publication number
EP1883465A1
EP1883465A1 EP06752699A EP06752699A EP1883465A1 EP 1883465 A1 EP1883465 A1 EP 1883465A1 EP 06752699 A EP06752699 A EP 06752699A EP 06752699 A EP06752699 A EP 06752699A EP 1883465 A1 EP1883465 A1 EP 1883465A1
Authority
EP
European Patent Office
Prior art keywords
tanks
mixing
substances
mixing element
vessel
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
Application number
EP06752699A
Other languages
English (en)
French (fr)
Other versions
EP1883465B1 (de
Inventor
Eric Bonnard
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.)
Odyssea Pharma SPRL
Original Assignee
Mithra Pharmaceuticals NV SA
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Mithra Pharmaceuticals NV SA filed Critical Mithra Pharmaceuticals NV SA
Priority to PL06752699T priority Critical patent/PL1883465T3/pl
Priority to SI200630625T priority patent/SI1883465T1/sl
Publication of EP1883465A1 publication Critical patent/EP1883465A1/de
Application granted granted Critical
Publication of EP1883465B1 publication Critical patent/EP1883465B1/de
Priority to CY20101100310T priority patent/CY1109930T1/el
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40Static mixers
    • B01F25/45Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
    • B01F25/451Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture
    • B01F25/4512Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture with reciprocating pistons
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71Feed mechanisms
    • B01F35/716Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components
    • B01F35/7161Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components the containers being connected coaxially before contacting the contents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71Feed mechanisms
    • B01F35/717Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/7174Feed mechanisms characterised by the means for feeding the components to the mixer using pistons, plungers or syringes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71Feed mechanisms
    • B01F35/717Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/71775Feed mechanisms characterised by the means for feeding the components to the mixer using helical screws
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71Feed mechanisms
    • B01F35/717Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/71805Feed mechanisms characterised by the means for feeding the components to the mixer using valves, gates, orifices or openings
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/75Discharge mechanisms
    • B01F35/754Discharge mechanisms characterised by the means for discharging the components from the mixer
    • B01F35/7547Discharge mechanisms characterised by the means for discharging the components from the mixer using valves, gates, orifices or openings
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/90Heating or cooling systems
    • B01F35/92Heating or cooling systems for heating the outside of the receptacle, e.g. heated jackets or burners
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22Mixing of ingredients for pharmaceutical or medical compositions

Definitions

  • the present invention relates to a dual chamber mixing device for obtaining a very good homogeneity in the case of a mixture of viscous substances, particularly in the pharmaceutical field.
  • the invention also relates to the method of implementation of the device.
  • the present invention aims to provide a solution that makes it possible to overcome the drawbacks of the state of the art.
  • the present invention aims to provide a device and a mixing process that allow to obtain a perfectly homogeneous mixture of viscous pharmaceutical substances.
  • the invention also aims to provide a device and a fully automated mixing process.
  • the invention has the additional object of providing a mixing process whose result is satisfactory in less than 10 to 15 minutes.
  • the invention also aims to allow the mixture of heat-sensitive pharmaceutical substances. Finally, the invention aims to provide a mixing device for the complete emptying of the tanks used.
  • a first object of the present invention is to propose a device for mixing at least two viscous substances, with a double chamber, comprising: a first and a second cylindrical coaxial tank, each closed at a first end in a sealed manner by a movable piston and provided at its second end with a slightly conical bottom, the two tanks being arranged, preferably vertically, symmetrically in a mirror with respect to a plane perpendicular to their common axis;
  • a second object of the present invention is to provide a method of mixing at least two viscous substances, preferably pharmaceutical, by means of the aforementioned device, characterized by the following steps:
  • the substances to be mixed are injected into the first tank by withdrawing the piston or by screw injection;
  • a predetermined number of successive mixing cycles are carried out by pumping from the first tank to the second tank, passing through the central static mixer, and vice versa; the final mixture is transferred to one of the two tanks which is then emptied.
  • Figure 1 shows a sectional view of the mixing device according to a preferred embodiment of the present invention.
  • FIG. 2 diagrammatically represents the different steps of the implementation method of the device according to FIG. 1.
  • Figure 3 shows schematically the emptying step of the mixing device of the invention, which occurs once achieved the desired homogeneity.
  • the present invention relates to a mixing unit which allows the incorporation and the automated and closed-loop mixing of pharmaceutical products for obtaining a mixture. final high viscosity.
  • the invented mixing unit generally consists of two communicating tanks, vertical cylindrical, of the same axis and symmetrical with respect to a median horizontal plane (image of the tanks one of the other as in a mirror). These tanks are equipped with sealed pistons whose actuation by a hydraulic system allows the passage in successive cycles of the components to be mixed through a baffle mixing device.
  • the assembly is fully automated using a PLC and can be thermostatically controlled for mixtures of heat-sensitive substances that require it.
  • the mixing unit consists of the following elements:
  • a high pressure hydraulic device for the automatic activation of the lid / piston (not shown);
  • connections 4 possibly equipped with valves, for temperature measurement, evacuation or putting in an inert gas, sampling during mixing, injection or removal of substances, etc. ;
  • a mixing element 5 also made of stainless steel connecting the two tanks 1, 2 equipped with: a double jacket 3 in which a cooling fluid or heating can circulate;
  • a stainless steel element provided with baffles (static mixer) allowing the creation of a turbulent flow of mixture at the level of the components to be mixed;
  • FIG. 2 is carried out by pumping, in the form of successive cycles, components to be mixed from the upper tank 1 to the lower tank 2 through the static mixer 5 and vice versa.
  • the number of cycles required is set by the type and viscosity of the components to be mixed.
  • this process is carried out between 5 and 10 cycles of about 30 seconds, which corresponds to a total process time of between 2 minutes and 5 minutes. According to the state of the art, a typical mixing time is 60 minutes.
  • the components of the mixture are introduced into the upper tank 1 before starting the mixing process by removing the cover 12 or are injected into the system being mixed using a sealed worm gear (not shown in the figures) which can be positioned indifferently on the upper tank 1 or on the central mixing element 5.
  • a sealed worm gear not shown in the figures
  • the system allows complete emptying of the latter as shown in FIG. 3.
  • the mixture is transferred for this purpose completely into the upper tank 1 or lower 2 and then drained outwards.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Accessories For Mixers (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Nozzles (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Mixers Of The Rotary Stirring Type (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Processing And Handling Of Plastics And Other Materials For Molding In General (AREA)
EP06752699A 2005-05-24 2006-05-23 Doppelkammer-mischvorrichtung für visköse pharmazeutische substanzen und verfahren Active EP1883465B1 (de)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PL06752699T PL1883465T3 (pl) 2005-05-24 2006-05-23 Dwukomorowe urządzenie mieszające do lepkich substancji farmaceutycznych oraz sposób
SI200630625T SI1883465T1 (sl) 2005-05-24 2006-05-23 Dvokomorna mešalna naprava za viskozne farmacevtske snovi in postopek
CY20101100310T CY1109930T1 (el) 2005-05-24 2010-03-31 Διαταξη αναμιξης διπλου θαλαμου για πυκνορρευστες φαρμακευτικες ουσιες και μεθοδος

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US68433805P 2005-05-24 2005-05-24
PCT/BE2006/000058 WO2006125284A1 (fr) 2005-05-24 2006-05-23 Dispositif de melange a double chambre pour substances pharmaceutiques visqueuses

Publications (2)

Publication Number Publication Date
EP1883465A1 true EP1883465A1 (de) 2008-02-06
EP1883465B1 EP1883465B1 (de) 2010-01-20

Family

ID=36747276

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06752699A Active EP1883465B1 (de) 2005-05-24 2006-05-23 Doppelkammer-mischvorrichtung für visköse pharmazeutische substanzen und verfahren

Country Status (13)

Country Link
US (1) US7878704B2 (de)
EP (1) EP1883465B1 (de)
AT (1) ATE455588T1 (de)
CA (1) CA2609438C (de)
CY (1) CY1109930T1 (de)
DE (1) DE602006011876D1 (de)
DK (1) DK1883465T3 (de)
EA (1) EA012125B1 (de)
ES (1) ES2339384T3 (de)
PL (1) PL1883465T3 (de)
PT (1) PT1883465E (de)
SI (1) SI1883465T1 (de)
WO (1) WO2006125284A1 (de)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010027107A1 (ja) * 2008-09-05 2010-03-11 オンコセラピー・サイエンス株式会社 エマルジョン製剤を自動調整するための装置及び調整方法
ITMI20090102A1 (it) * 2009-01-29 2010-07-30 Marina Scremin Miscelatore
GB2513675A (en) * 2011-04-05 2014-11-05 Edge Therapeutics Intraventricular drug delivery system for improving outcome after a brain injury affecting cerebral blood flow
NL2006787C2 (en) * 2011-05-16 2012-11-19 Avantium Holding B V COMPOUNDER AND METHOD FOR MIXING ONE OR MORE VISCOUS FLUIDS.
US9604184B2 (en) 2013-03-06 2017-03-28 Orthovita, Inc. Mixing system and valve assembly
US10596069B2 (en) * 2015-12-22 2020-03-24 Ethicon, Inc. Syringes with mixing chamber in a removable cap
RU2656319C2 (ru) * 2016-11-25 2018-06-04 Общество с ограниченной ответственностью "Тунег" Способ смешения сыпучих материалов и автоматическое устройство для его осуществления
RU170178U1 (ru) * 2016-11-25 2017-04-18 Общество с ограниченной ответственностью "Тунег" Смеситель для приготовления смесей из сыпучих материалов
CN111729532B (zh) * 2020-08-03 2020-12-18 山东明福染业有限公司 一种天然植物染料混匀装置
CN113230958A (zh) * 2021-05-10 2021-08-10 深圳杰明纳微电子科技有限公司 一种均匀混合氧化铈泥浆的装置

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US2477598A (en) * 1948-02-16 1949-08-02 George M Hain Microworker for lubricating greases
US2724383A (en) * 1951-06-28 1955-11-22 Compule Corp Combined mixing container structure and hypodermic syringe for segregated ingredients of hypodermically injectable preparations
US2798488A (en) * 1954-09-15 1957-07-09 Merck & Co Inc Syringe unit
US3035820A (en) * 1960-03-23 1962-05-22 Allergy Section Of The Res Fou Emulsification apparatus
US3010705A (en) * 1960-09-26 1961-11-28 Brown Ethan Allan Emulsifiers
GB1052971A (de) * 1962-10-25
US3190619A (en) * 1963-05-27 1965-06-22 Union Carbide Corp Fluid mixing container assembly
US3700215A (en) * 1970-10-21 1972-10-24 Hardman Inc Mixing and dispensing device
CH542699A (de) * 1972-02-18 1973-10-15 P Huerlimann Hans Vorrichtung zum Behandeln von Stoffen
US4350650A (en) * 1979-01-09 1982-09-21 Euro-Linea S.N.C. Di Colombo & C. Method for admixing at least two liquids and feeding them to a shaping mould
SU895160A1 (ru) * 1979-01-16 1983-12-23 Среднеазиатский научно-исследовательский институт природного газа Устройство дл приготовлени бурового раствора
US4463875A (en) * 1982-06-14 1984-08-07 Robert W. Mann Method and apparatus for preparing and applying a two-component cement
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Also Published As

Publication number Publication date
WO2006125284A1 (fr) 2006-11-30
EP1883465B1 (de) 2010-01-20
CA2609438A1 (en) 2006-11-30
CY1109930T1 (el) 2014-04-09
ES2339384T3 (es) 2010-05-19
DK1883465T3 (da) 2010-05-17
PT1883465E (pt) 2010-04-14
US7878704B2 (en) 2011-02-01
SI1883465T1 (sl) 2010-05-31
CA2609438C (en) 2014-07-08
US20080212399A1 (en) 2008-09-04
ATE455588T1 (de) 2010-02-15
EA200702272A1 (ru) 2008-04-28
DE602006011876D1 (de) 2010-03-11
EA012125B1 (ru) 2009-08-28
PL1883465T3 (pl) 2010-06-30

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