EP1639986A1 - Installation pour la réalisation de préparations magistrales - Google Patents

Installation pour la réalisation de préparations magistrales Download PDF

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Publication number
EP1639986A1
EP1639986A1 EP04022875A EP04022875A EP1639986A1 EP 1639986 A1 EP1639986 A1 EP 1639986A1 EP 04022875 A EP04022875 A EP 04022875A EP 04022875 A EP04022875 A EP 04022875A EP 1639986 A1 EP1639986 A1 EP 1639986A1
Authority
EP
European Patent Office
Prior art keywords
installation
reservoirs
ingredients
ingredient
magistral
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.)
Withdrawn
Application number
EP04022875A
Other languages
German (de)
English (en)
Inventor
Nadine Vertommen-Billene
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.)
Preventest Ltd
Original Assignee
Preventest Ltd
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 Preventest Ltd filed Critical Preventest Ltd
Priority to EP04022875A priority Critical patent/EP1639986A1/fr
Publication of EP1639986A1 publication Critical patent/EP1639986A1/fr
Withdrawn legal-status Critical Current

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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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/74—Device provided with specific sensor or indicating means for weight
    • 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
    • A61J2205/00—General identification or selection means
    • A61J2205/10—Bar codes

Definitions

  • the present invention relates to an installation for the realization of magistral preparations.
  • This type of installation is more particularly for public pharmacies for the fabrication of magistral preparations, especially vitamin and / or mineral compositions or containing any other substance having beneficial effect for health prescribed by physician for his or her patients.
  • compositions containing different active principles and combined to combat relatively rare pathologies are not or are no longer prepared industrially by pharmaceutical manufacturers considering their low distribution.
  • a certain number of deficits or misregulations shown by biological tests may be overcome by an adequate and personalized composition.
  • a problem that occurs and which the present invention seeks to solve is thus that of proposing an installation for the realization of magistral preparations that makes it possible not only to realize them under irreproachable sanitary conditions but also to be able to repeat doing so with considerable precision and with a minimum of operator intervention.
  • each magistral preparation contains determined weights in a reservoir which has an identification mark for the ingredient it contains
  • said installation comprising means for weighing the ingredients and receiving means adapted for being mounted on said weighing means, the ingredients being capable of being delivered into said receiving means from said reservoirs, said weighing means being adapted for providing a weight of the ingredient delivered, and which comprises according to the inventions:
  • a characteristic of the invention resides in the utilization of distribution means, transfer means and identification means by suitable control means. making it possible to sequentially and automatically control the means for identifying the reservoirs containing the given ingredients of said preparation into which the ingredients are going to be dispensed, then the distribution means for dispensing said ingredients until the respective determined weight values are attained.
  • the installation for the realization of magistral preparations according to the invention makes it possible to produce the magistral preparation completely automatically.
  • the installation for the realization of magistral preparations comprises means for mixing the ingredients contained in said receiving means and said mixing means are capable of being controlled by said control means.
  • the mixing means comprising, for example, a mechanical agitator, are also used automatically by said control means.
  • the installation for the realization of magistral preparations comprises an automatic transfer mean for transferring the recipient by translation or by pendular guided motion from the reception/weighting zone to the upright of the mixing system.
  • the installation for the realization of magistral preparations comprises means for encapsulation into unit doses, said encapsulation means being capable of being controlled by said control means.
  • the installation makes it possible not only to realize the magistral preparations but it also makes it possible to automatically package them.
  • the risk of contamination with any microbe or a substance not foreseen in the formulation is practically zero.
  • said identification mark are constituted of a barcode, said identification means comprising a barcode reader.
  • each of the reservoirs has a barcode or barcodes determined as a function of the ingredient it contains, the reading of the barcode is suitable for reading the barcode of each of said reservoirs, in order to transmit information to said control means.
  • said transfer means comprises a rotating magazine, wherein said reservoirs are installed.
  • the rotating magazine comprises a plate on which the reservoirs are installed in a circular arrangement; it is suitable by rotating to carry each of said reservoirs at the receiving means.
  • said distribution means comprise at least one endless screw suitable for extending into said distribution position between said tank and a point situated plumb with said receiving means.
  • Said reservoir is adapted to open into a discharge spout that extends over the receiving means, said spout is crossed by an endless screw making it possible to carry along the ingredients from the tank to the receiving means.
  • said control means comprise a computer, said computer comprising a computer program specifically adapted for controlling said installation.
  • the computer that also comprises a memory suitable for recording each of the determined weights of a plurality of given ingredients of a magistral preparation is suitable, in virtue of its specific program, so that said magazine comprises all of the reservoirs of the given ingredients of said plurality and does so in sufficient quantities for automatically controlling the identification means, the transfer means, the weighting means and the distribution means in order to deliver into the receiving means all of the ingredients of said preparation.
  • the invention proposes a method for formulating magistral preparations utilizing an installation such as the one described hereinbefore.
  • the invention proposes a software product comprising a user interface, characterized in that it comprises said aforementioned specific computer program.
  • a software product is suitable for being installed into said computer, said software product comprising at least one computer program corresponding to a magistral preparation.
  • the software product comprises a plurality of computer programs suitable respectively for carrying out a plurality of magistral preparations.
  • the user interface comprises a formulation editor suitable for editing the formulated preparations.
  • a formulation editor suitable for editing the formulated preparations.
  • FIG. 1 diagrammatically represents an installation 10 according to the invention, suitable for automatically realizing magistral or extemporaneous preparations.
  • This installation 10 comprises, in top view, a scales 12 on whose platform the receiving means 14 are placed, said means being formed by a container open at its top, and a circular magazine 16 in which a plurality of reservoirs 18 are arranged.
  • the circular magazine 16 is capable of being rotated by driving means (not shown), about a central axis A kept at a fixed distance from the scales 12 and the container 14 in order to bring each of the reservoirs 18 of said plurality of reservoirs to overhang said container 14.
  • the circular magazine 16 has in this case 22 cavities each suitable for receiving 22 reservoirs.
  • the circular magazine 16 is suitable for being moved in steps of 1/22ths of a rotation in order to be able to successively carry all of the reservoirs 18 at said container 14.
  • each of the reservoirs 18 bears an identification marking formed by a barcode, this barcode being capable of being read by a contact less reading device 20, equipped with laser means or a suitable optical measurement apparatus disposed tangentially relative to the circular magazine 16.
  • the reading device 20 is in this case suitable for reading an identification marking on a reservoir, scaled in 7/20ths of a rotation relative to the position of a reservoir situated at the recipient 14.
  • Each of the reservoirs 18 contains a given and single ingredient and has an identification marking formed by said barcode and corresponding to the given ingredient.
  • the barcode for each of the reservoirs 18 is composed of a six-figure code, the four first figures designate the type of ingredient, the three following figures correspond to the batch number of said ingredient and the three following figures correspond to the order in the series of the batch. These last figures serve only in distinguishing one given reservoir relative to another in the same batch of the given ingredient.
  • control means 22 comprising a microcomputer equipped with a central unit 24, a data entry peripheral device 26 in the form of a keyboard and a viewing peripheral device 28 in the form of a monitor.
  • the central unit 24 is connected to the scales by means of a link 30; for example, a RS232 type link, so that said scales 12 can transmit to the central unit 24 signals representing the weight value that it measures and this, advantageously, to the nearest milligram.
  • the central unit 24 is also connected to a reading device 20 by appropriate connection means 32, the reading device 20 being suitable for transmitting to it signals representing each of the barcodes read and consequently of the ingredients contained in each of said reservoirs.
  • the central unit 24 is connected at once to the circular magazine driving means 16 by a first electrical link 34 and to distribution means 36 by means of a second electrical link 38; said distribution means 36 will be described hereinafter with reference to Fig. 2.
  • the installation has a communications interface (not shown) between the central unit 24 and the actuators themselves: the distribution means 36 and the circular magazine driving means 16. This communications interface makes it possible to control the inputs/outputs and to run automated sub-routines in order not to saturate the computer in its serial scanning phases.
  • the circular magazine 16 is shown together with a representation of a single reservoir 18 for the sake of clarity.
  • the circular magazine 16 is capable of being driven in rotation in a plane perpendicular to the plane of Fig. 2 and about the axis
  • distribution means 36 comprising opening means (not shown) make it possible to drive said traps in translation in order to free the openings when they are situated plumb with said spout 42.
  • the control means 22 of installation for realizing magistral preparations 10 as represented in Fig. 1 comprise a specific computer program suitable for controlling said installation 10.
  • the reservoirs 18 are mounted in the circular magazine 16, they are first filled with the ingredient corresponding to their barcode and a corresponding weight value of said ingredient contained in the reservoir is saved in the computer memory. Thus, the weight of each of the ingredients contained in said reservoirs 18 is saved in memory.
  • magistral preparations is also stored in the computer memory.
  • Each of the magistral preparations comprises information on the ingredients that it contains and on the required weight of each of these ingredients.
  • a first step 50 of utilization upon starting the control means 22, the microcomputer launches the program that then displays on the screen 28 a choice of magistral preparations. After a choice of magistral preparation has been made, on the one hand a list of the ingredients of said selected magistral preparation is displayed on the screen 28 and on the other hand, in a second step 52, the computer program at once controls the rotation of the circular magazine 16 and the sequential reading of the barcodes of all of the reservoirs 18 mounted on said circular magazine so that each of the ingredients of said list is available and to record its position relative to all of the other reservoirs.
  • the computer program subtracts, for each of the ingredients, the weight required for formulating said magistral preparation from the weight value previously stored in the computer memory from the weight of the product contained in the reservoir 18. Obviously, after the reservoirs 18 have been filled, this subtraction is positive for all of the ingredients.
  • the computer program carries out a first test 54 making it possible to verify if the aforementioned subtraction is positive and if, consequently, the quantity of each of the ingredients of the magistral preparation selected is sufficient for compounding it. If this is not the case, the computer program stops and displays an error message 56; if not, it continues with normal operation.
  • the computer program controls the driving means of the circular magazine 16 in order to bring the reservoir 18 corresponding to the first ingredient of said list, in front of the open container 14.
  • the program stops the circular magazine 16 when the reading device 20 identifies the reservoir that is scaled at 7/22ths of a rotation relative to the reservoir of the first ingredient of said list, in the counter clockwise direction. This is made possible in virtue of the prior calibration of the reservoirs 18 each one relative to the others.
  • the computer program controls, in a fourth step 60, the opening means for driving said trap and allowing the corresponding ingredient to flow through the opening 40 and into the spout 42.
  • the program controls the driving means 46 in a first direction of rotation, so as to drive the endless screw 44 in the same direction of rotation so that it carries ingredient along which then arrives in the spout 42, towards the first end 43 and further, into the bottom of the container 14 situated further down.
  • the scales 12 transmits to the central unit 24 signals representing a variation in weight that corresponds to the weight of the ingredient delivered into the container 14.
  • the computer program checks, if the determined weight of the first ingredient of said list is attained. As long as said weight has not been reached, the driving means 46 continue to drive the endless screw 44. In contrast, once the computer program identifies that a weight value transmitted by the scales 12 is equal to that of the determined weight of the first ingredient, in a sixth step 66, it commands the stop of the driving means 46, the closure of the opening 40 and then, again, the driving means 46, but in a reverse direction of rotation. In this fashion, the endless screw 44 carries the ingredients remaining in the spout 42 towards the recovery receptacle 47. Thus, the spout 42 is cleared of any ingredient and it can receive the ingredient of another reservoir 18.
  • the computer program stores the actual weight value of the preceding ingredient delivered and which is measured by the scales 12.
  • the computer program verifies that all of the ingredients of said list have been delivered into the container 14, and in the negative case, returns to the third step 58 and controls the circular magazine 16 in rotation, in order to bring the reservoir of the second ingredient of said list in front of the container 14. In the same fashion and for this second ingredient, the computer program commands the installation to run the third test 70.
  • the computer program is suited to control the dispensing of all of the ingredients of said list in their respective weights and to do so entirely automatically, until the third test 70 indicates that all of the ingredients of said list have been delivered into the container 14.
  • the computer program then commands means that will be described hereinafter with reference to Fig. 3 and which make possible the mixing together of the ingredients.
  • FIG. 3 diagrammatically represents in part the circular magazine 16 over which the reservoirs 18 are mounted.
  • the reservoirs 18 For the purpose of illustration and in order to simplify the drawing, only two reservoirs have bar codes 17 and 19. However, all of the reservoirs have a barcode representative of the ingredients they contain, respectively.
  • the scales 12 and the container 14 positioned on its plate, said container 14 now being between two parallel belts 74, 76. These two parallel belts 74, 76 are suitable for being held in extension between two supports 78, 80 and being driven parallel in translation in the direction of an agitator 82, arranged in the vicinity of the scales 12. In this fashion, the container 14, held locked between the two belts 74, 76 can be carried to be plumb with the agitator 82.
  • this transfer system of the container 14 can be replaced advantageously by pendulum guiding means that make it possible to raise the container 14 from the scales, in order to transfer it in line with the agitation system.
  • the agitator 82 is controlled so as to be introduced into the container 14, closure means being provided for simultaneously closing said container 14 so as to prevent any contamination of said preparation and to confine it in the container 14 during agitation. Then the agitator is controlled in rotation in order to homogenize all of the ingredients of the preparation so formulated.
  • ingredients homogenized in this fashion can be automatically encapsulated or placed into gelatin capsules in virtue of encapsulation means known per se.
  • the supports 78, 80 are equipped with driving means in translation of the belts 74, 76; these driving means in translation being capable of being controlled via a connection 84 connected to the central unit 24 by the computer program.
  • the agitator 82 is also connected to the central unit 24 via another connection 86.
  • the computer program is suitable for controlling the driving means in translation for carrying the container 14 to the agitator 82 and then for controlling said agitator 82 and mixing the ingredients of said preparation.
  • the computer program is suitable for controlling said aforementioned encapsulation means.
  • the computer program is capable of controlling the printing means (not shown), in a final step 90, so as to provide the list and the proportion of ingredients of the preparation so formulated and the actual weights of the ingredients it contains.
  • the circular magazine or table is vertically mobile in order to assure the connection of the reservoirs or bottles to the spout equipped with the endless screw or pump.
  • the reservoirs are equipped with a coupling end.
  • the circular magazine is driven in translation downwards in order to connect the reservoir and the spout.
  • the reservoir has a neck, which is closed off by a lateral hatch, which is brought into a position opposite to a mobile piston when the circular magazine moves down. Accordingly, the mobile piston can be driven in translation and is capable of operating the hatch and effecting the evacuation of the product contained in the reservoir towards the spout. After the quantity of material has been dispensed, the hatch is closed again and the circular magazine raised.
  • the bar code reader is advantageously mounted overhanging the spout and gently moved upstream relative to the direction of rotation of the circular magazine, so as to compensate for the inertia of reaction due to the rotation of the circular magazine.
  • locking means for the circular magazine are provided, which make it possible not only to block rotation during the product dispensing operations but also to bring it into a position, wherein the receptacle is precisely in line with the spout.
  • the circular magazine has two circular concentric rows of reservoirs, the respective reservoirs of the two circular rows being angularly offset.
  • two spouts are required; the one for the first inner circular row and one for the second circular peripheral row.
  • the inner circular row makes it possible to receive the larger-volume containers containing the excipients, for example.
  • the spout that is adapted to connect with said inner circular row and the container is on the one hand of a greater diameter than the other spout and it is equipped with a larger endless screw so as to dispense the products with a greater throughput.
  • the speed of distribution of the products into the container 14 is modulated as a function of the mass already delivered.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nutrition Science (AREA)
  • Devices For Dispensing Beverages (AREA)
EP04022875A 2004-09-24 2004-09-24 Installation pour la réalisation de préparations magistrales Withdrawn EP1639986A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04022875A EP1639986A1 (fr) 2004-09-24 2004-09-24 Installation pour la réalisation de préparations magistrales

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP04022875A EP1639986A1 (fr) 2004-09-24 2004-09-24 Installation pour la réalisation de préparations magistrales

Publications (1)

Publication Number Publication Date
EP1639986A1 true EP1639986A1 (fr) 2006-03-29

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EP04022875A Withdrawn EP1639986A1 (fr) 2004-09-24 2004-09-24 Installation pour la réalisation de préparations magistrales

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021112666A (ja) * 2015-12-04 2021-08-05 ケアフュージョン ３０３、インコーポレイテッド 自動薬物調合器のためのラベルリーダ

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3933272A (en) * 1973-10-25 1976-01-20 Stauffer Chemical Company Apparatus for dispensing liquids
EP0348077A1 (fr) * 1988-06-20 1989-12-27 Yamato Scale Company, Limited Dispositif automatique pour remplir et empaqueter un produit de poids prédéterminé dans des récipients
US5111855A (en) * 1988-07-21 1992-05-12 Henkel Kommanditgesellschaft Auf Aktien Plant and apparatus for producing perfumes
WO1998031322A1 (fr) * 1997-01-15 1998-07-23 Teeple Edward Jr Procede et dispositif ameliores pour preparer et administrer des perfusions d'anesthesie intraveineuse
US5938080A (en) * 1997-02-21 1999-08-17 The Geon Company System and apparatus for dispensing high-viscosity pigments
EP1093842A1 (fr) * 1999-10-19 2001-04-25 Maria Jesus Esmoris Rodriguez Machine de melange pour teintures et cremes

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3933272A (en) * 1973-10-25 1976-01-20 Stauffer Chemical Company Apparatus for dispensing liquids
EP0348077A1 (fr) * 1988-06-20 1989-12-27 Yamato Scale Company, Limited Dispositif automatique pour remplir et empaqueter un produit de poids prédéterminé dans des récipients
US5111855A (en) * 1988-07-21 1992-05-12 Henkel Kommanditgesellschaft Auf Aktien Plant and apparatus for producing perfumes
WO1998031322A1 (fr) * 1997-01-15 1998-07-23 Teeple Edward Jr Procede et dispositif ameliores pour preparer et administrer des perfusions d'anesthesie intraveineuse
US5938080A (en) * 1997-02-21 1999-08-17 The Geon Company System and apparatus for dispensing high-viscosity pigments
EP1093842A1 (fr) * 1999-10-19 2001-04-25 Maria Jesus Esmoris Rodriguez Machine de melange pour teintures et cremes

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021112666A (ja) * 2015-12-04 2021-08-05 ケアフュージョン ３０３、インコーポレイテッド 自動薬物調合器のためのラベルリーダ

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