EP0829341A2 - Verfahren und Vorrichtung zum Herstellen von Tabletten aus medizinischem Pulver - Google Patents

Verfahren und Vorrichtung zum Herstellen von Tabletten aus medizinischem Pulver Download PDF

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Publication number
EP0829341A2
EP0829341A2 EP97102534A EP97102534A EP0829341A2 EP 0829341 A2 EP0829341 A2 EP 0829341A2 EP 97102534 A EP97102534 A EP 97102534A EP 97102534 A EP97102534 A EP 97102534A EP 0829341 A2 EP0829341 A2 EP 0829341A2
Authority
EP
European Patent Office
Prior art keywords
medicinal powder
tablets
die
machine
forming
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Withdrawn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
EP97102534A
Other languages
English (en)
French (fr)
Other versions
EP0829341A3 (de
Inventor
Angelo Ansalino
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.)
MG 2 SpA
MG2 SpA
Biovail Technologies Ltd
Original Assignee
MG 2 SpA
MG2 SpA
Fuisz Technologies 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 MG 2 SpA, MG2 SpA, Fuisz Technologies Ltd filed Critical MG 2 SpA
Publication of EP0829341A2 publication Critical patent/EP0829341A2/de
Publication of EP0829341A3 publication Critical patent/EP0829341A3/de
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B30PRESSES
    • B30BPRESSES IN GENERAL
    • B30B11/00Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/027Particular press methods or systems
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B30PRESSES
    • B30BPRESSES IN GENERAL
    • B30B15/00Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/30Feeding material to presses
    • B30B15/302Feeding material in particulate or plastic state to moulding presses
    • B30B15/304Feeding material in particulate or plastic state to moulding presses by using feed frames or shoes with relative movement with regard to the mould or moulds

Definitions

  • the present invention relates to a method of producing tablets of medicinal powder.
  • the present invention also relates to a machine for producing tablets of medicinal powder.
  • the method whereby currently marketed tablets of medicinal powder are produced comprises the steps of withdrawing a predetermined quantity of medicinal powder from a vessel; compressing said quantity of medicinal powder into a predetermined volume to form a tablet of compressed medicinal powder; and, finally, depositing and preserving said tablet of medicinal powder inside a container.
  • Tablets of medicinal powder formed using the above method present the drawback of being poorly identifiable as regards the medicinal product of which the tablet is formed, whereas the present demand among drug companies is for greater characterization to make the products easily identifiable by the user.
  • a method of producing tablets of medicinal powder comprising, for each cycle, the steps of withdrawing a number of quantities of medicinal powder from a vessel by means of a metering device; compressing each said quantity of medicinal powder, by means of said metering device, to form a respective tablet of compressed medicinal powder; and, finally, depositing each said tablet of compressed medicinal powder inside a container; the method being characterized in that said compression step comprises a precompression step wherein each said quantity of medicinal powder is compressed by the metering device inside said vessel, and a compacting step wherein each said quantity of medicinal powder is compressed by said metering device outside the vessel; each said quantity of medicinal powder being subjected to die forming action in the course of said compacting step.
  • a machine for producing tablets of medicinal powder comprising a storage unit for storing the medicinal powder; a supply unit for supplying containers; and a tablet forming and conveying unit; said forming unit successively withdrawing a given quantity of medicinal powder from said storage unit, forming a number of tablets, and transferring said tablets into at least one of the containers of said supply unit; the machine being characterized in that said forming unit comprises die forming means movable between said storage unit and said supply unit, and die means located in a fixed position between said storage unit and said supply unit; said die forming means contacting said die means to compress said tablets on the die means.
  • Number 1 in Figure 1 indicates a machine for forming a number of tablets composed of one or more powdered pharmaceutical products 3.
  • Machine 1 comprises a supporting frame 4; a storage unit 5 for storing powdered pharmaceutical product 3; a supply unit 6 for supplying a number of medicinal containers 7; and a metering unit 8 interposed between storage unit 5 and supply unit 6.
  • Metering unit 8 provides for withdrawing powdered pharmaceutical product 3 from storage unit 5, for successively compressing the withdrawn pharmaceutical product into a number of tablets 9 of powdered pharmaceutical product 3, and finally, for transferring tablets 9 into respective containers 7 carried on supply unit 6 and for preserving tablets 9.
  • Storage unit 5 is of known type, and comprises a vessel 10 fitted to frame 4, rotating about a vertical axis 11, and supplied constantly with powdered pharmaceutical product 3; a drive unit (not shown) for rotating vessel 10 in predetermined manner about axis 11; and a supply device 12 for supplying and homogenizing powdered pharmaceutical product 3, and for skimming over the upper surface of powdered pharmaceutical product 3 to keep it at a given level L.
  • Supply unit 6 comprises a horizontal supporting plate 13 fitted to frame 4 coaxially with an axis 14 parallel to axis 11, and which is rotated in predetermined manner about axis 14; and the upper surface 15 of plate 13 comprises a number of equally spaced seats 16, each for housing one or more medicinal containers 7.
  • Metering unit 8 comprises at least one operating head 17 located over units 5 and 6 and connected by a connecting arm 19 to an upright 18 extending from frame 4. Arm 19 is hinged at one end to upright 18, and is rotated, at said end, in predetermined manner about an axis 20 parallel to axis 11, so as to feed head 17 along a circular path P.
  • metering unit 8 also comprises, for each head 17, a device 21 for forming tablets 9, and which is fitted to head 17, facing units 5 and 6, and is movable in relation to head 17 along an axis 22 parallel to axis 20. More specifically, device 21 is connected to head 17 by a hollow shaft 23 coaxial with axis 22 and housing a second shaft 24 also coaxial with axis 22; and both shafts 23 and 24 of head 17 are movable axially in predetermined manner by actuating devices (not shown) housed inside head 17.
  • Tablet forming device 21 comprises a first substantially parallelepiped box 25 having a horizontal top wall 26 integral with a free end of hollow shaft 23, two lateral walls 27 facing each other and extending vertically downwards, and a bottom wall 28 parallel to and facing top wall 26.
  • device 21 comprises a second box 29 in turn comprising a top wall 30 integral with a free end of shaft 24, and a bottom wall 31 facing and parallel to bottom wall 28 of first box 25.
  • Device 21 also comprises a number of nozzles 32 arranged, in the example shown, in a number of rows and columns and fitted to bottom walls 28 and 31.
  • Each nozzle 32 has an axis 32a parallel to axis 22, and comprises a hollow body 33 fitted to bottom wall 28 coaxially with axis 32a, and a pin 34 housed movably inside body 33 and fitted to bottom wall 31 coaxially with axis 32a.
  • Body 33 comprises an externally-threaded top end 35 screwed inside a threaded hole 36 formed through bottom wall 28 of first box 25; while pin 34 extends vertically beyond bottom wall 28, engages in sliding manner a respective hole 37 formed through bottom wall 31, and comprises, at the top end, a head 34a simultaneously contacting walls 30 and 31, and of such a size as to prevent pin 34 from withdrawing from through hole 37.
  • metering unit 8 also comprises a horizontal plate 50 fitted to frame 4 and over which operating head 17 is positioned as it travels along path P.
  • the surface 51 of plate 50 facing head 17 comprises a number of seats 52, each housing a respective die 53 of appropriate shape; and seats 52 are so arranged that, when operating head 17 positions device 21 over plate 50, each die 53 is aligned with a respective nozzle 32, and more specifically with the bottom end 34b of a respective pin 34 fitted integral with a respective die 54.
  • operating head 17 rotates about axis 20 and along path P into a position over vessel 10 of storage unit 5; at which point, shafts 23 and 24 are extended simultaneously downwards to move tablet forming device 21 along axis 22 and bring the bottom ends of nozzles 32 into contact with powdered pharmaceutical product 3.
  • each body 33 penetrates powdered pharmaceutical product 3, while the bottom end of respective pin 34 remains substantially at level L, thus defining, inside body 33, a chamber 33a, which is filled with a given quantity of powdered pharmaceutical product 3.
  • the withdrawal step terminates upon the bottom end of body 33 contacting the bottom wall of vessel 10 ( Figure 2), and each of chambers 33a being filled with said quantity of powdered pharmaceutical product 3.
  • the precompression step commences, wherein shaft 24 moves down along axis 22 to gradually lower pins 34, reduce the volume of chambers 33a, compress the quantity of powdered pharmaceutical product 3 contained inside chambers 33a, and so form tablets 9.
  • operating head 17 withdraws device 21 - inside which tablets 9 are retained - from vessel 10, and rotates about axis 20 to position device 21 over plate 50.
  • the compacting step commences, wherein shafts 23 and 24 move axially downwards to bring the bottom end of hollow body 33 of each nozzle 32 into contact with plate 50, in which position, the tablet 9 inside each body 33 simultaneously contacts a respective die 54 and a respective die 53 ( Figures 3 and 4).
  • shaft 24 exerts a given pressure to complete the formation of and simultaneously impart a given shape to tablets 9.
  • operating head 17 lifts device 21 - which retains respective tablet 9 inside each nozzle 32 - off plate 50, and rotates about axis 20 into a position over unit 6 and in which device 21 is aligned with a seat 16 on supporting plate 13. At which point, head 17 lowers device 21 to deposit tablets 9 inside container/s 7.
  • vessel 10 rotates by a given angle about axis 11; and, similarly, upon tablets 9 being deposited, plate 13 rotates by a given angle about axis 14 to position a seat 16 with empty containers 7, or one empty container 7, along path P.
  • operating head 17 Upon tablets 9 being deposited, operating head 17 is once again positioned over vessel 10 of storage unit 5, and the operating cycle is repeated.
  • tablets 9 may be characterized by forming, on substantially any surface portion of tablets 9, letters or symbols enabling the pharmaceutical product and the maker to be more clearly identified.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Basic Packing Technique (AREA)
EP97102534A 1996-09-11 1997-02-17 Verfahren und Vorrichtung zum Herstellen von Tabletten aus medizinischem Pulver Withdrawn EP0829341A3 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBO960453 1996-09-11
IT96BO000453A IT1286212B1 (it) 1996-09-11 1996-09-11 Metodo e macchina per la produzione di pastiglie di polvere medicinale

Publications (2)

Publication Number Publication Date
EP0829341A2 true EP0829341A2 (de) 1998-03-18
EP0829341A3 EP0829341A3 (de) 1998-04-15

Family

ID=11341588

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97102534A Withdrawn EP0829341A3 (de) 1996-09-11 1997-02-17 Verfahren und Vorrichtung zum Herstellen von Tabletten aus medizinischem Pulver

Country Status (2)

Country Link
EP (1) EP0829341A3 (de)
IT (1) IT1286212B1 (de)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000024381A1 (de) * 1998-10-27 2000-05-04 Alpharma-Isis Gmbh & Co. Kg Teilbare tablette
WO2003066437A1 (en) * 2002-02-07 2003-08-14 Meridica Limited Method and apparatus for introducing powder into a pocket
WO2013166138A1 (en) * 2012-05-01 2013-11-07 Mcneil-Ppc, Inc. Machine for production of solid dosage forms
US8784781B2 (en) 2009-09-24 2014-07-22 Mcneil-Ppc, Inc. Manufacture of chewing gum product with radiofrequency
US8858210B2 (en) 2009-09-24 2014-10-14 Mcneil-Ppc, Inc. Manufacture of variable density dosage forms utilizing radiofrequency energy
US8968769B2 (en) 2007-10-31 2015-03-03 Mcneil-Ppc, Inc. Orally disintegrative dosage form
US9445971B2 (en) 2012-05-01 2016-09-20 Johnson & Johnson Consumer Inc. Method of manufacturing solid dosage form
US9789066B2 (en) 2014-01-10 2017-10-17 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
US10493026B2 (en) 2017-03-20 2019-12-03 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
CN112121919A (zh) * 2020-09-17 2020-12-25 浙江省中医药研究院 一种治疗肝纤维化的中药制剂的制取成型装置
IT202300021411A1 (it) * 2023-10-13 2025-04-13 Sasib Spa Unita' e metodo di alimentazione per alimentare dosi di un prodotto incoerente in una macchina confezionatrice per la produzione di bustine contenenti ciascuna una dose del prodotto incoerente

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2050885C3 (de) * 1969-10-21 1974-02-28 Fratelli Zanasi S.P.A., Ozzano Emilia, Bologna (Italien) Verfahren zur Dosierung von pulverformigen Stoffen mit Hilfe eines Stechheberdosiergeräts
FR2038932A5 (de) * 1970-03-13 1971-01-08 Perry Ind Inc
US3847191A (en) * 1971-08-23 1974-11-12 T Aronson Means and methods for measuring and dispensing equal amounts of powdered material
US3893492A (en) * 1973-08-06 1975-07-08 John E Nohren Apparatus and method for accurately dispensing and consolidating powdered material into receptacles
IT1156553B (it) * 1982-03-03 1987-02-04 Mg 2 Spa Procedimento per prelevare una quantita' prefissata di polvere dall'interno di un recipiente rotante e per depositare tale quantita' all'interno di un fondello di un contenitore di forma qualsiasi e macchina ch attui tale procedimento
IT1245757B (it) * 1991-01-15 1994-10-14 Mg 2 Spa Macchina per il dosaggio di prodotti farmaceutici in polvere.
IT1254529B (it) * 1992-03-18 1995-09-25 Procedimento e macchina per il riempimento di contenitori con prodotti cosmetici
US5662849A (en) * 1993-09-10 1997-09-02 Fulsz Technologies Ltd. Method and apparatus for forming compression dosage units within the product package
US5653926A (en) * 1993-09-10 1997-08-05 Fuisz Technologies, Ltd. Method and apparatus for forming compression dosage units
DE29619278U1 (de) * 1996-11-06 1996-12-12 Propharm Apotheker Koch GmbH, 83646 Bad Tölz Vorrichtung zur Herstellung von Tabletten

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000024381A1 (de) * 1998-10-27 2000-05-04 Alpharma-Isis Gmbh & Co. Kg Teilbare tablette
WO2003066437A1 (en) * 2002-02-07 2003-08-14 Meridica Limited Method and apparatus for introducing powder into a pocket
US7051771B2 (en) 2002-02-07 2006-05-30 Pfizer Limited Method and apparatus for introducing powder into a pocket
US8968769B2 (en) 2007-10-31 2015-03-03 Mcneil-Ppc, Inc. Orally disintegrative dosage form
US8871263B2 (en) 2009-09-24 2014-10-28 Mcneil-Ppc, Inc. Manufacture of tablet in a die utilizing radiofrequency energy and meltable binder
US8807979B2 (en) 2009-09-24 2014-08-19 Mcneil-Ppc, Inc. Machine for the manufacture of dosage forms utilizing radiofrequency energy
US8858210B2 (en) 2009-09-24 2014-10-14 Mcneil-Ppc, Inc. Manufacture of variable density dosage forms utilizing radiofrequency energy
US8865204B2 (en) 2009-09-24 2014-10-21 Mcneil-Ppc, Inc. Manufacture of lozenge product with radiofrequency
US8784781B2 (en) 2009-09-24 2014-07-22 Mcneil-Ppc, Inc. Manufacture of chewing gum product with radiofrequency
US9610224B2 (en) 2009-09-24 2017-04-04 Johnson & Johnson Consumer Inc. Manufacture of tablet in a die utilizing powder blend containing water-containing material
US9445971B2 (en) 2012-05-01 2016-09-20 Johnson & Johnson Consumer Inc. Method of manufacturing solid dosage form
US9233491B2 (en) 2012-05-01 2016-01-12 Johnson & Johnson Consumer Inc. Machine for production of solid dosage forms
WO2013166138A1 (en) * 2012-05-01 2013-11-07 Mcneil-Ppc, Inc. Machine for production of solid dosage forms
US9789066B2 (en) 2014-01-10 2017-10-17 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
US10493026B2 (en) 2017-03-20 2019-12-03 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
CN112121919A (zh) * 2020-09-17 2020-12-25 浙江省中医药研究院 一种治疗肝纤维化的中药制剂的制取成型装置
IT202300021411A1 (it) * 2023-10-13 2025-04-13 Sasib Spa Unita' e metodo di alimentazione per alimentare dosi di un prodotto incoerente in una macchina confezionatrice per la produzione di bustine contenenti ciascuna una dose del prodotto incoerente
EP4563475A1 (de) 2023-10-13 2025-06-04 Sasib S.p.A. Herstellungsmaschine und herstellungsverfahren zur herstellung von beuteln mit jeweils einer menge loser produkte

Also Published As

Publication number Publication date
ITBO960453A0 (it) 1996-09-11
IT1286212B1 (it) 1998-07-08
ITBO960453A1 (it) 1998-03-11
EP0829341A3 (de) 1998-04-15

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