EP2135666B1 - Seringues pour fabrication de suspensions de médicaments, et système correspondant - Google Patents

Seringues pour fabrication de suspensions de médicaments, et système correspondant Download PDF

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Publication number
EP2135666B1
EP2135666B1 EP08011309A EP08011309A EP2135666B1 EP 2135666 B1 EP2135666 B1 EP 2135666B1 EP 08011309 A EP08011309 A EP 08011309A EP 08011309 A EP08011309 A EP 08011309A EP 2135666 B1 EP2135666 B1 EP 2135666B1
Authority
EP
European Patent Office
Prior art keywords
syringe
medicament
ultrasonic bath
syringes
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.)
Active
Application number
EP08011309A
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German (de)
English (en)
Other versions
EP2135666A1 (fr
Inventor
Jürgen Göbel
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Individual
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Individual
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Publication date
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Priority to AT08011309T priority Critical patent/ATE547167T1/de
Priority to EP08011309A priority patent/EP2135666B1/fr
Publication of EP2135666A1 publication Critical patent/EP2135666A1/fr
Application granted granted Critical
Publication of EP2135666B1 publication Critical patent/EP2135666B1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0053—Syringes, pipettes or oral dispensers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/50—Mixing liquids with solids
    • B01F23/55—Mixing liquids with solids the mixture being submitted to electrical, sonic or similar energy
    • B01F23/551—Mixing liquids with solids the mixture being submitted to electrical, sonic or similar energy using vibrations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F31/00—Mixers with shaking, oscillating, or vibrating mechanisms
    • B01F31/80—Mixing by means of high-frequency vibrations above one kHz, e.g. ultrasonic vibrations
    • B01F31/87—Mixing by means of high-frequency vibrations above one kHz, e.g. ultrasonic vibrations transmitting the vibratory energy by means of a fluid, e.g. by means of air shock waves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • B01F33/50112—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held of the syringe or cartridge type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80—Mixing plants; Combinations of mixers
    • B01F33/836—Mixing plants; Combinations of mixers combining mixing with other treatments
    • B01F33/8361—Mixing plants; Combinations of mixers combining mixing with other treatments with disintegrating
    • B01F33/83612—Mixing plants; Combinations of mixers combining mixing with other treatments with disintegrating by crushing or breaking
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held

Definitions

  • Food probes can become clogged by particles that are too large. This may lead to the need for hospitalization and replacement of the probe. When given orally, the risk of aspiration of particles and / or mucosal irritation is given. Micropellet-based tablets must not be rubbed, as this may lead to rapid release or loss of efficacy.
  • the present invention seeks to provide a syringe, which improves and accelerates the comminution process for the drug.
  • the drug to be applied and the application liquid or a part thereof are exposed to an ultrasonic bath in a syringe whose walls are permeable to ultrasonic waves.
  • a syringe whose walls are permeable to ultrasonic waves.
  • commercial syringes esp. Luer-lock syringes.
  • Usually a capacity of 10 to 20 ml is used.
  • the soft plastic wall of commercial syringes allows the effective in the ultrasonic bath Waves through. They are transferred from the liquid contained therein to the drug so that it is gently crushed and suspended in the application liquid.
  • the method is suitable for those drugs which are pressed or granulated from fine-grained or powdery starting material (tablets).
  • the effect of the ultrasound triggers the bond between the particles - if necessary promoted by the dissolving forces of the liquid.
  • unsuitable are soft gelatin capsules; Hard gelatin capsules must be opened.
  • syringes are particularly advantageous because if desired they can be connected directly to a feeding probe. They are always cost-effective in the field of application with the required closures available, and the staff has practice in dealing with it.
  • the tablet to be applied is filled into a disposable syringe.
  • the syringe plunger is then replaced and the syringe is vented, ie the plunger is pushed in as far as the size of the medicament permits. The amount of trapped air is thus reduced (reduction of oxidation and humidity).
  • the syringe is closed with a commercially available combination stopper. It can then be easily stored for long periods, for example, for the daily or weekly needs ("drug centers"). Physical or chemical properties of the medicinal product may be taken into account, for example storage until application in the absence of light or air (shielding gas).
  • the syringes can be labeled patient specific or drug specific.
  • a spike stopper This consists of a commercially available combination stopper, in which a stainless steel mandrel or impact body is used, the bottom of which has the same diameter as the inner diameter of the combination stopper opening.
  • the stainless steel mandrel has the diameter of the syringe opening and protrudes depending on the make about 5 mm into the syringe chamber.
  • the protruding part is edged and acts as a mechanical impact surface, which improves and accelerates the crushing process.
  • the spike may also be used as a means that couples the ultrasonic vibration into the syringe space.
  • the mandrel closes off the syringe opening from the syringe space and thus prevents sedimentation of the drug in the syringe opening.
  • the syringe After insertion of the spike stopper, the syringe is filled to 30 to 50% with application liquid and sealed with the syringe plunger. Full filling is possible but inconvenient for shaking up the resulting suspension.
  • the medicine should be at least covered.
  • the application liquid is usually water, but can also be, for example, artificial gastric or intestinal juice.
  • the pH can be adjusted depending on the site of application or the drug.
  • the syringe is then immersed in an ultrasonic bath.
  • Commercially available equipment with water can be used. The most suitable one can easily be determined by trial and error. Successfully used was a commercial device with a frequency of 25 kHz, as it is also used by opticians to clean glasses.
  • the water level of the device should be higher than the area occupied by the drug in the syringe so that it is fully detected by the vibration transmitted by the ultrasonic bath. in the In general, this means that the water level in the device is at least as high as the liquid level in the syringe, better higher than this.
  • a holding device To hold the syringe or multiple syringes in the ultrasonic bath is conveniently used a holding device.
  • This may be formed by the lid of the ultrasonic bath, which has a corresponding number of holes for receiving a number of syringes whose diameter is slightly larger than that of the syringes so that they are guided.
  • the holes are inclined according to the invention with respect to the vertical direction, usefully with an inclination angle of 25 - 40 °, esp. 30 °. As a result, the syringes tilt in the holes and do not float on.
  • the lid is suitably locked in relation to the vessel of the ultrasonic bath.
  • the syringe By commissioning the ultrasound machine, a gentle wet grinding is performed. A possible second grinding is possible without refilling.
  • the syringe is removed from the holding device and shaken vigorously. The obtained suspension can now be applied directly to the feeding probe after removal of the plug. Alternatively, the suspension can be filled into a collection tube. The syringe is rinsed again with liquid in order to quantitatively remove any residues of the drug and to apply them as well. At the same time the food probe is rinsed.
  • the use of a syringe has decisive advantages: The preparation of the suspension takes place directly in the dispersion medium. The mechanical and thermal load on the drug is low. A quantitative application is possible. Contamination by other drugs does not occur. Micropellets are preserved. The grind takes place in a closed system without endangering the nursing staff. The galenics of the finished drug does not matter (exception: soft gelatin capsule). The dispersant can be chosen freely. Physical and chemical properties of the drug can be taken into account. Since the syringe opening in the diameter is much smaller than the feeding tube, the latter can not clog. The procedure is simple and can also be done by laymen. It is much more economical than the traditional one; the required working time is at least halved.
  • the attached drawing shows schematically a section through an ultrasound device with lid and inserted syringe.
  • the device 1 forms a vessel for a water bath 2, whose wall is equipped with an ultrasonic sonotrode, not shown.
  • the bath is closed with a removable lid 3, which is fixed by a bordering in the edge of the bath rim 4. It contains a series of bores 5, which are inclined at an angle of 30 ° with respect to the vertical direction and whose diameter is adapted to the outer diameter of the syringes to be absorbed by them.
  • a syringe is shown, which is secured by the tendency to float in the water bath.
  • syringe body 6 and a piston 7 and is closed by a combination stopper 8, the opening channel of which is filled by a removable pin 9 whose angular end projects into the interior of the syringe.
  • a tablet 10 is located together with an application liquid 11 in the interior of the syringe.
  • the water level of the bath 2 is higher than that in the interior of the syringe.

Claims (9)

  1. Seringue comprenant une paroi souple destinée à la réalisation d'un procédé pour fabriquer des suspensions de médicaments destinées à la prise par voie orale ou à l'administration par sonde, pour laquelle le médicament (10) est introduit sous forme pilée dans la seringue et dispersé dans une solution à administrer (11), et la seringue contenant le médicament (10) et au moins une partie de la solution à administrer (11), dont les parois sont perméables aux ultrasons, est exposée à un bain à ultrasons (2), caractérisée en ce que la seringue comporte un corps de rebondissement (9).
  2. Seringue comprenant une paroi souple destinée à la réalisation d'un procédé pour fabriquer des suspensions de médicaments destinées à la prise par voie orale ou à l'administration par sonde, pour laquelle le médicament (10) est introduit sous forme pilée dans la seringue et dispersé dans une solution à administrer (11), et la seringue contenant le médicament (10) et au moins une partie de la solution à administrer (11), dont les parois sont perméables aux ultrasons, est exposée à un bain à ultrasons (2), caractérisée en ce que le capuchon de la seringue comporte une tige fabriquée à partir de matériaux durs en tant que coupleur d'oscillation entre une partie de la paroi du bain qui se déplace en fonction des ultrasons et la partie interne de la seringue, la tige étant façonnée en tant que corps de rebondissement (9).
  3. Seringue selon la revendication 1 ou 2, caractérisée en ce qu'elle est une seringue Luer-Lock.
  4. Seringue selon l'une des revendications 1 à 3, caractérisée en ce qu'elle est une seringue à usage unique d'un volume allant de 10 à 20 ml.
  5. Seringue selon l'une des revendications 1 à 4, caractérisée en ce que le médicament (10) sous forme solide peut être conservé en seringue.
  6. Seringue selon la revendication 5, caractérisée en ce que l'air est éliminé complètement ou partiellement de la seringue avant de l'obturer.
  7. Seringue selon l'une des revendications 1 à 6, caractérisée en ce que 30 à 50 % du volume de la seringue peut être rempli par une solution à administrer (11).
  8. Système de fabrication de suspensions de médicaments à l'aide d'un bain à ultrasons et une seringue selon l'une des revendications 1 à 7, caractérisé en ce que le bain à ultrasons (2) comporte un couvercle (3) muni d'une multitude d'orifices de branchement (5) pour les seringues, qui sont réalisés pour être favorables à l'orientation restant en position verticale.
  9. Système selon la revendication 8, caractérisé en ce que le bain à ultrasons (2) peut être rempli jusqu'à un niveau d'eau, qui est plus élevé que celui de la seringue utilisée.
EP08011309A 2008-06-21 2008-06-21 Seringues pour fabrication de suspensions de médicaments, et système correspondant Active EP2135666B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AT08011309T ATE547167T1 (de) 2008-06-21 2008-06-21 Spritzen zur herstellung von arzneimittelsuspensionen sowie darauf bezogenes system
EP08011309A EP2135666B1 (fr) 2008-06-21 2008-06-21 Seringues pour fabrication de suspensions de médicaments, et système correspondant

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP08011309A EP2135666B1 (fr) 2008-06-21 2008-06-21 Seringues pour fabrication de suspensions de médicaments, et système correspondant

Publications (2)

Publication Number Publication Date
EP2135666A1 EP2135666A1 (fr) 2009-12-23
EP2135666B1 true EP2135666B1 (fr) 2012-02-29

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP08011309A Active EP2135666B1 (fr) 2008-06-21 2008-06-21 Seringues pour fabrication de suspensions de médicaments, et système correspondant

Country Status (2)

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EP (1) EP2135666B1 (fr)
AT (1) ATE547167T1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060093644A1 (en) * 2004-08-20 2006-05-04 Gerhard Quelle Methods of administering microparticles combined with autologous body components

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE935726C (de) * 1942-04-23 1955-11-24 Siemens Ag Verfahren zum Aufloesen von Stoffen in Fluessigkeiten mittels Ultraschall
US5376072A (en) 1993-12-15 1994-12-27 Lake Medical Products, Inc. Apparatus for and method of, crushing a pill and administering the pill ingredients
ZA9811087B (en) * 1997-12-04 1999-06-03 Bracco Research Sa Automatic liquid injection system and method
JP3642713B2 (ja) * 2000-02-29 2005-04-27 株式会社日立製作所 自動分析装置
EP1128185B8 (fr) * 2000-02-25 2009-08-19 Hitachi, Ltd. Dispositif de mélange pour analyseur automatique
US20040054286A1 (en) * 2001-11-05 2004-03-18 Audain Vaughn A Ultrasonic transducing probe with liquid flow-through capability and related automated workstation and methods of using same
US9174176B2 (en) 2003-01-09 2015-11-03 Disperse Systems, Inc. Ultrasonic dispersion apparatus, system, and method

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060093644A1 (en) * 2004-08-20 2006-05-04 Gerhard Quelle Methods of administering microparticles combined with autologous body components

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EP2135666A1 (fr) 2009-12-23
ATE547167T1 (de) 2012-03-15

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