WO2006111690A1 - Appareil pour le remplissage de gélules et mode d'emploi - Google Patents

Appareil pour le remplissage de gélules et mode d'emploi Download PDF

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Publication number
WO2006111690A1
WO2006111690A1 PCT/GB2005/001535 GB2005001535W WO2006111690A1 WO 2006111690 A1 WO2006111690 A1 WO 2006111690A1 GB 2005001535 W GB2005001535 W GB 2005001535W WO 2006111690 A1 WO2006111690 A1 WO 2006111690A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
capsules
filler material
drum
capsule holder
Prior art date
Application number
PCT/GB2005/001535
Other languages
English (en)
Inventor
John Edward Nelson
Original Assignee
John Edward Nelson
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 John Edward Nelson filed Critical John Edward Nelson
Priority to PCT/GB2005/001535 priority Critical patent/WO2006111690A1/fr
Priority to GB0722943A priority patent/GB2441080B/en
Publication of WO2006111690A1 publication Critical patent/WO2006111690A1/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
    • 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
    • A61J3/071—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 into the form of telescopically engaged two-piece capsules
    • A61J3/074—Filling capsules; Related operations

Definitions

  • This invention relates in general to capsule filing devices, and more particularly to mechanical capsule filling devices adapted to fill small quantities of capsules, such as a single prescription, with the exact kinds and amounts of medications required to meet the needs of one particular patient.
  • Medicines and pharmaceutical substances are generally manufactured in tablet or capsule form in pre-determined dosages chosen from a relatively limited range, based on the presumptions of the manufacturer as to what dosages are likely to be prescribed by physicians for a majority of their patients. Without a flexible range of doses being available, the patient is forced to break tablets in half, or to remember complicated dosing schedules, such as having to take two tablets on Mondays, Wednesdays and Fridays, and
  • variable, continuously adjustable dose would be of benefit to both the prescribing physician and the patient include dosage adjustment based on serum or plasma concentration of drugs having a relatively narrow therapeutic window, such as (for example) theophylline, digoxin, and many anticonvulsants, including phenobarbital and dilantin, as well as drugs with a variable and unpredictable patient response such as the immunosuppressants methotrexate, prednisone and cyclosporine.
  • drugs having a relatively narrow therapeutic window such as (for example) theophylline, digoxin, and many anticonvulsants, including phenobarbital and dilantin, as well as drugs with a variable and unpredictable patient response such as the immunosuppressants methotrexate, prednisone and cyclosporine.
  • the invention is of particular benefit to the practice of veterinary medicine, in which the physician encounters wide extremes of size and species. It also benefits research pharmacists who are required to prepare small batches of capsules with various fillers for purposes of stability testing, analytical assay, reference material, clinical trials and dissolution studies.
  • the present invention provides a capsule filling device capable of filling capsules with any filler material, particularly dry flowable powdered or micro-encapsulated medication in any dosage desired.
  • any filler material particularly dry flowable powdered or micro-encapsulated medication in any dosage desired.
  • it allows for filling individual groups of capsules with specific doses of one or more medications.
  • the prior art includes a variety of capsule filling devices and methods of operation which accomplish the task of measuring and distributing dry flowable medications into individual capsules.
  • 5,797,248 which discloses a manual capsule filling device in which a known quantity of dry material, such as from a bottle in which the weight of the contents is known, is emptied into a reservoir which overlies a rotary dosage plate containing a plurality of spaced cavities, each cavity being of a known volume. The medication is allowed to flow into and fill the cavities, whereupon the dosage plate is rotated to transfer its contents into individual capsules below. The capsules are then capped and replaced by empty capsules, and the operation is repeated as many times as is necessary to fill the required number of capsules.
  • U.S. Pat. 5,660,029 Another manual capsule filling device is shown in U.S. Pat. 5,660,029 in which empty capsules are placed in cavities in a funnel-shaped tray. A known quantity of medication is placed in the tray and raked or swept into the capsule, such as by tilting or tapping the tray, after which the capsule contents are compressed by tamping before the capsule is capped. The tamping tool is also useable to remove the filled capsules from their cavities. Mentioned in U.S. Pat. 5,797,248 are other examples of similar prior art.
  • Canadian Patent 494,695 shows a capsule filling device in which a measured amount of pharmaceutical is placed on a spreader plate with wells, the depth of the wells being adjustable. The pharmaceutical is spread into the wells until it is flush with the tops of the wells, the spreader plate is covered with a funnel system and turned upside down to allow the dry medication to funnel into the capsules.
  • U.S. Pat. No. 5,321,932 shows a device to open and close capsules so that they may be filled, however, the method of filling the capsules is not described.
  • U.S. Pat. No. 4,619,336 provides a method and apparatus for weighing doses of powder in which powder is fed onto a weigh scale which stops the powder flow just below the desired weight, at which point remaining powder is allowed to run into the weighing receptacle. N
  • a principal object of the present invention is to provide an improved capsule filling device which is easily and quickly adaptable to filling small batches of capsules with predetermined quantities of medication intended to fill the needs of a specific patient and prescription.
  • a related objective is to replace the tedious and laborious task of hand measuring and filling each batch of capsules, with its resultant inconsistencies and opportunities for error, with a small scale but relatively high speed process which is adaptable to computer monitoring and control, and which permits the creation and retention of a detailed record of each batch of capsules processed.
  • Another object is to provide a capsule filling device and method of operation in which a measured quantity of medication is distributed evenly by centrifugal force from any suitable power means, such as an electric motor, into a predetermined number of capsules, so that the total amount of medication supplied to the group of capsules as a whole is accurately known, with little or no waste.
  • any suitable power means such as an electric motor
  • a related object is to provide a capsule filling device with a minimum of moving parts, all of which may be conveniently removed for cleaning or sterilizing. Thus the device can be quickly and easily prepared for filling the next batch of capsules with a different medication, or with a different dosage, to suit the individual needs of a different patient.
  • a further related object is to provide means for quickly and positively ejecting filled and covered capsules from the device by power means, such as compressed gas.
  • Another principal object is to provide a powered capsule filling device having an electronic control system for controlling, monitoring, and recording each batch of filler material and associated capsules, whereby a detailed record is created automatically to confirm and verify the filling of each such batch.
  • the present invention provides a device for filling empty medicine capsules with a filler material comprising a) a base having an enclosure and a central shaft having a vertical axis of rotation, b) a removable upper cover for said enclosure having a central inlet opening coaxial with said shaft, c) a capsule holder disk having a plurality of peripherally evenly spaced holders each adapted to receive and support an unfilled open capsule with its open end directed upward, and d) a distribution drum associated with said capsule holder disk, said distribution drum having a peripheral collection surface, and a plurality of uniformly spaced collection pockets in a peripheral array beneath said peripheral collection surface and adapted to receive and collect said filler material flowing by gravity therefrom, each said pocket being generally funnel-shaped with a downward-directed discharge opening aligned with an associated holder of said capsule holder disk, characterised by power means for rotating said shaft within said enclosure, said capsule holder disk being connectable to said shaft for rotation therewith, and said distribution drum being aligned with said capsule holder disk
  • the present invention provides the method of filling medicine capsules comprising the steps of a) placing a plurality of unfilled capsules in an evenly spaced peripheral array in a rotatable capsule holder disk with their open ends upward, b) joining said capsule holder disk with a distribution drum having an impeller plate having an impact point concentric with a shaft for receiving filler material introduced at said impact point and flinging it radially against a peripheral collection surface, said distribution drum having a plurality of uniformly spaced collection pockets in a peripheral array beneath said peripheral collection surface, and adapted to receive and collect said filler material flowing by gravity therefrom, each said pocket being generally funnel-shaped with a downward-directed discharge opening aligned with an associated capsule holder of said capsule holder disk, said capsule holder disk and distribution drum forming a rotatable assembly, c) rotating said assembly, and during rotation introducing a known quantity of filler material at the impact point of said impeller plate, whereby the material is flung by centrifugal force substantially uniformly
  • Fig. 1 is a partial sectional perspective view of a first preferred embodiment of the capsule filling device of the present;
  • Fig. 2 is a partial sectional elevation of the first embodiment of Fig. 1;
  • Fig. 3 is a fragmentary view of an alternative construction of the embodiment of Fig. 1;
  • Fig. 4 is an enlarged partial sectional perspective view of the device of Fig. 1, particularly illustrating the peripheral capsule receptacles, impeller plate and radial guide ribs;
  • Fig. 5 is an enlarged partial sectional elevation of an alternative construction of the capsule holders of the embodiment of Fig. 1;
  • Fig. 6 is a detail sectional elevation showing an alternative construction of the first embodiment of Fig. 1, and further showing the path of a dry flowable material being distributed into a receiving capsule;
  • Fig. 7 is a detail sectional perspective of the device of Fig. 1 showing the spatial arrangement of the inner cover, distribution drum, peripheral collection surface, collection pockets and capsule holders;
  • Fig. 8 is a partial sectional elevation of a second embodiment of the invention
  • Fig. 9 is a block schematic diagram showing the general relationships of a computer-controlled operating system for the device of the present invention.
  • a device for filling empty medicine capsules comprising a base 10 supporting an enclosure 11 within which is located a central shaft 12 driven by a power means 13, which in the illustrated embodiment is a variable speed electric motor.
  • the power means 13 may also be a compressed air motor, or a spring-wound mechanism, or a hand crank, or a shaft driven by a separate power unit (not shown).
  • Atop the enclosure 11 is a removable upper cover 14 having at its center, in line
  • an inlet opening 15 through which any dry flowable material, such as a medicine or pharmaceutical, may be introduced.
  • a rotating assembly consisting of a capsule holder disk 16 removably affixed to the central shaft 12 by a key means 17, or other suitable means, for rotation by the power means 13.
  • the capsule holder disk 16 contains a plurality of spaced hollow capsule holders 18, preferably but not necessarily evenly spaced around its periphery, with each holder 18 adapted to hold an unfilled capsule element 19.
  • Above the capsule holder disk 16 is a distribution drum 20, concentric with the central shaft 12 and inlet opening 15, and having an upper face serving as an impeller plate 21.
  • This plate 21 is positioned to receive material introduced through the removable upper cover 14 through a funnel-shaped receptacle 22 which directs the material onto an impact point 23 at the center of the impeller plate 21.
  • the distribution drum 20 is covered by a lid 24 having an opening concentric with the funnel receptacle 22.
  • the drum 20 is made of inexpensive lightweight injection-molded or blow-molded plastic material, to reduce expense. In practice, it is desirable to produce the drum 20 so inexpensively that it may be disposed of after a single use, to eliminate the need for washing and sterilization, and to prevent cross-contamination of the capsules being filled.
  • the impeller plate 21 rotates, the material introduced through the funnel receptacle 22 is thrown outward by centrifugal force against a peripheral collection surface 25 at the inner periphery of the distribution drum 20.
  • the peripheral collection surface 25 is shaped with an upwardly-extending side wall to collect and retain material flung against it by centrifugal force as the distribution drum 20 is rotated by the power means 13.
  • the upper surface of the impeller plate 21 may optionally include a plurality of evenly spaced upstanding radial guide ribs 27 for urging the flowable material outwards under centrifugal force, with the conical upper surface of the drum 20 serving as a flow splitter, dividing the flowing stream of incoming material and forcing it to be distributed in a relatively uniform manner as it is directed by centrifugal force against the peripheral collection surface 25.
  • the peripheral collection surface may optionally have grooves, ribs, indentations or roughened surfaces to prevent filler material from migrating from the impact point.
  • the invention of the first embodiment (Fig. 1) is utilized by first removing the upper cover 14 and lifting the distribution drum 20 and lid 24 from the shaft 12 to expose the holders 18 in the capsule holder disk 16. An individual unfilled capsule 19 is placed in each holder 18. The distribution drum 20 and lid 24 and upper cover 14 is replaced and the power means 13 energized to start the rotatable assembly (shaft 12 and capsule holder disk 16 and distribution drum 20 and Hd 24) rotating.
  • a measured quantity of dry flowable pharmaceutical or other material is introduced into the screened opening of the inlet funnel 22.
  • the filter screen 29 prevents clumps of material from dropping onto the impeller plate 21.
  • the material flows by gravity onto the impact point 23 of the impeller plate where it is flung by centrifugal force (and assisted by the radial guide ribs 27 if used) against the
  • peripheral collection surface 25 in a substantially even circumferential distribution.
  • the power means 13 is de-energized and the rotational assembly is allowed to slow and stop. As it does so, the centrifugal forces of rotation are overcome by the forces of gravity, and the material commences to flow, slowly and evenly, out of the collection pockets 26 and through the funnel-shaped collection pockets 26 into the empty capsules 19, thus assuring that each capsule is filled with substantially the same amount of material.
  • the cover 14 and lid 24 and distribution drum 20 are removed. At this point the operator may place closures (not shown) on the filled capsules.
  • a channel 28 is provided in the base of each capsule holder 18.
  • a vacuum source (not shown) may be connected to the channel 28 to draw the unfilled capsules firmly into the capsule holder disk 16.
  • the channel 28 may either be subject to positive gas pressure or a blunt ejector pin (Fig 5) may be passed upward through the channel 28 to serve as an ejection means to eject the filled capsules.
  • FIGs 6 and 1 An alternative version of this first embodiment is shown in Figs 6 and 1, where the distribution drum and capsule holder disk and capsule holders are incorporated in a single unit.
  • FIG. 8 A second embodiment of the invention is shown in Fig. 8, in which the distribution drum 20a is physically separate from the impeller plate 22a, and driven through a separate inner concentric drive shaft 12a which is separately rotatable with respect to the outer drive shaft 12b, and can be driven by the power means 13a through a selectable ratio transmission means (not shown).
  • a selectable ratio transmission means (not shown).
  • the impeller plate to be driven faster, slower, or at the same speed relative to the distribution drum, or (if desired) in a different direction.
  • the device is able to fill capsules with a wider range of sizes and weights of particle sizes.
  • the device of the present invention may be combined with a microprocessor controller or central processing unit 30 (Fig.
  • a keyboards and/or mouse 31 with which are associated various data input and output means such as a keyboards and/or mouse 31, barcode reader 32, digital weigh scale 33, capsule counter 34, drum speed and position sensor 35, safety interlocks 36 (to prevent opening during rotation), motor speed and position control 37, a memory unit 38 (to store individual formulation recipes), a network interface 39 (for remote operation), a capsule eject mechanism 40 (associated with an ejection means as previously described), a visual display 41, an audible alert 42 (to signal malfunctions) and a printer 43 for making a hard-copy record of the capsule filling process.
  • various data input and output means such as a keyboards and/or mouse 31, barcode reader 32, digital weigh scale 33, capsule counter 34, drum speed and position sensor 35, safety interlocks 36 (to prevent opening during rotation), motor speed and position control 37, a memory unit 38 (to store individual formulation recipes), a network interface 39 (for remote operation), a capsule eject mechanism 40 (associated with an ejection means as previously described), a visual
  • prescription information is received via the various data input means and recognized and recorded by the central processing unit 30.
  • the operator takes note of the information and gathers together the required number of capsules and amount of filler material (or materials) with which to fill the capsules.
  • the controller may require the operator to scan bottle labels and/or weigh out the prescribed amount of material on a recording scale (not shown), all of which information is recorded by the
  • controller 30 in association with this particular batch of capsules.
  • the controller then ' permits the operator to energize the power means 13 and fill the capsules, after which it causes a suitable label for the batch of medication to be created by the printer 42.
  • the emptying of a measured quantity of pharmaceutical material into a predetermined quantity of unfilled capsules insures that the total quantity of medication supplied by that batch of capsules, in response to a single prescription, is in the aggregate exactly the amount specified for that patient for that number of doses and inadvertent double filling of capsules is prevented.
  • the filler material for the capsules need not be of a single medication, but can be a combination of various medications in predetermined proportions, to insure that the patient gets exactly the mix of pharmaceuticals prescribed by his or her physician, and without risk that by missing one pill or another the therapeutic mixture of medications will be inadvertently upset or skewed.

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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)
  • Basic Packing Technique (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Appareil et mode d'emploi pour le remplissage de gélules de médicament permettant de maintenir une quantité fixe de gélules ouvertes (19) à remplir en arrangement circulaire par une plaque de maintient (16) se trouvant sous la périphérie d'un tambour de distribution rotatif (20, 20a). Lorsqu'il est en service, une quantité mesurée de médicament de remplissage sous forme granulaire sèche est introduite dans le centre du tambour rotatif (20, 20a), où elle est distribuée équitablement sous l'effet de la force centrifuge à la périphérie du tambour. Lorsque le tambour (20, 20a) cesse de tourner, le médicament tombe alors dans les gélules sous l'effet de la gravité; les gélules sont ensuite inspectées, fermées et emballées. La distribution du médicament de remplissage est plus régulière que lors d'un remplissage manuel des gélules; de plus, la quantité moyenne (par volume et par poids) de médicament de remplissage par gélule dans le lot peut varier pour répondre aux besoins particuliers d'un patient, et elle est toujours connue de façon très précise. enfin, il est possible de mélanger deux médicaments de remplissage compatibles ou plus pour répondre aux besoins spécifiques d'un utilisateur particulier. Comme la quantité de médicament fournie est complètement distribuée dans chaque lot de gélules, les doubles remplissages accidentel sont évités.
PCT/GB2005/001535 2005-04-22 2005-04-22 Appareil pour le remplissage de gélules et mode d'emploi WO2006111690A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/GB2005/001535 WO2006111690A1 (fr) 2005-04-22 2005-04-22 Appareil pour le remplissage de gélules et mode d'emploi
GB0722943A GB2441080B (en) 2005-04-22 2005-04-22 Capsule filling device and method of operation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/GB2005/001535 WO2006111690A1 (fr) 2005-04-22 2005-04-22 Appareil pour le remplissage de gélules et mode d'emploi

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WO2006111690A1 true WO2006111690A1 (fr) 2006-10-26

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WO (1) WO2006111690A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101991503A (zh) * 2009-08-11 2011-03-30 通辽东北六药业有限公司 一种硬胶囊粥状物料灌装方法及设备
IT201700094206A1 (it) * 2017-08-17 2019-02-17 Mg 2 Srl Sistema di tenuta per una macchina rotativa per il riempimento di capsule con prodotti farmaceutici

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4619336A (en) 1983-04-18 1986-10-28 Manufacture De Machines Due Haut-Rhin Method of and apparatus for weighing doses of powder
US4731979A (en) * 1985-02-27 1988-03-22 Nippon Elanco Kabushiki Kaisha Capsule filling apparatus
US4964262A (en) 1988-09-03 1990-10-23 Robert Bosch Gmbh Machine for filling and closing two-piece capsules
US5018335A (en) 1988-12-28 1991-05-28 Nippon Elanco Kabushiki Kaisha Capsule charging apparatus
US5321932A (en) 1992-02-26 1994-06-21 Professional Compounding Centers Of America, Inc. Capsule handling system
US5490702A (en) 1995-01-24 1996-02-13 Fleming; Thomas E. Fastening tool for engaging in a channel of a concrete block
US5660029A (en) 1995-11-21 1997-08-26 King; Sidney E. Capsule filler
US5797248A (en) 1996-05-07 1998-08-25 Willem Wassenaar Manual capsule filling device
US6170226B1 (en) 1998-07-15 2001-01-09 William Chang Capsule filling apparatus

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4619336A (en) 1983-04-18 1986-10-28 Manufacture De Machines Due Haut-Rhin Method of and apparatus for weighing doses of powder
US4731979A (en) * 1985-02-27 1988-03-22 Nippon Elanco Kabushiki Kaisha Capsule filling apparatus
US4964262A (en) 1988-09-03 1990-10-23 Robert Bosch Gmbh Machine for filling and closing two-piece capsules
US5018335A (en) 1988-12-28 1991-05-28 Nippon Elanco Kabushiki Kaisha Capsule charging apparatus
US5321932A (en) 1992-02-26 1994-06-21 Professional Compounding Centers Of America, Inc. Capsule handling system
US5490702A (en) 1995-01-24 1996-02-13 Fleming; Thomas E. Fastening tool for engaging in a channel of a concrete block
US5660029A (en) 1995-11-21 1997-08-26 King; Sidney E. Capsule filler
US5797248A (en) 1996-05-07 1998-08-25 Willem Wassenaar Manual capsule filling device
US6170226B1 (en) 1998-07-15 2001-01-09 William Chang Capsule filling apparatus

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101991503A (zh) * 2009-08-11 2011-03-30 通辽东北六药业有限公司 一种硬胶囊粥状物料灌装方法及设备
IT201700094206A1 (it) * 2017-08-17 2019-02-17 Mg 2 Srl Sistema di tenuta per una macchina rotativa per il riempimento di capsule con prodotti farmaceutici

Also Published As

Publication number Publication date
GB0722943D0 (en) 2008-01-02
GB2441080B (en) 2008-10-01
GB2441080A (en) 2008-02-20

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