US20010002433A1 - Needleless injector drug capsule and filling method - Google Patents

Needleless injector drug capsule and filling method Download PDF

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Publication number
US20010002433A1
US20010002433A1 US09/728,662 US72866200A US2001002433A1 US 20010002433 A1 US20010002433 A1 US 20010002433A1 US 72866200 A US72866200 A US 72866200A US 2001002433 A1 US2001002433 A1 US 2001002433A1
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US
United States
Prior art keywords
capsule
adaptor
injectate
bore
combination according
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.)
Abandoned
Application number
US09/728,662
Inventor
Terence Weston
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.)
Weston Medical Ltd
Original Assignee
Weston Medical 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
Priority to GB9525757.2 priority Critical
Priority to GB9525757A priority patent/GB9525757D0/en
Priority to PCT/GB1996/003017 priority patent/WO1997022375A1/en
Priority to US09/091,320 priority patent/US6251091B1/en
Application filed by Weston Medical Ltd filed Critical Weston Medical Ltd
Priority to US09/728,662 priority patent/US20010002433A1/en
Publication of US20010002433A1 publication Critical patent/US20010002433A1/en
Application status is Abandoned legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/30Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2044Separating means having slits
    • 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00Methods of manufacture, assembly or production
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/04Tools for specific apparatus
    • A61M2209/045Tools for specific apparatus for filling, e.g. for filling reservoirs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/1782Devices aiding filling of syringes in situ

Abstract

A needleless injector capsule for a liquid medicament has a filling adapter removably, and preferably frangibly, attached thereto. The capsule has a chamber for receiving injectate, the chamber being provided with an injection orifice, and having a piston located for movement therein. The adapter has a bore which communicates with the capsule chamber via the injection orifice. The capsule is filled by introducing injectate into the capsule chamber through the injection orifice and excess injectate into the bore of the adapter, and closing the bore of the adapter to the exterior by a sealing means, leaving the bore partly filled with excess injectate.

Description

  • The invention relates to a disposable needleless injector and to a method for filling the same. [0001]
  • Needleless injectors are used as an alternative to hypodermic syringes to inject drugs and medicaments through a patient's skin into the underlying tissue. A typical injector comprises a high pressure piston pump which dispenses the drug through a small hole with sufficient force to pierce the epidermis and diffuse into the tissues. The present invention is directed to the filling of capsules for use in such injectors. [0002]
  • Axiomatic to the storage of the drug in the capsule is that the filling procedure is compatible with the equipment and protocols established within the pharmaceutical industry, and a number of otherwise promising ideas have failed to become commercialised because this requirement was overlooked. None of the prior art capsules have all of the features necessary for optimum storage of the drug and compatibility with filling machines. [0003]
  • The stringent requirements for ensuring optimum sterility and quality control of drug packaging means that there is a trend towards pre-filling the drug capsule. However, a prefilled capsule must be able to withstand thermal expansion and contraction due to ambient temperature fluctuations. The possible results of the latter is that increased and unacceptable outgassing of the drug could occur, or the drug could expand and leak past the seals. [0004]
  • According to the present invention there is provided a needleless injector capsule in combination with an adaptor used in filling the capsule, the capsule defining a chamber which has injectate therein and is provided with an injection orifice, a piston being located for movement within the chamber, the adapter being removably connected to the capsule and having a bore which communicates with the capsule chamber via the injection orifice and is partly filled with excess injectate, the bore being closed to the exterior by a sealing means. [0005]
  • According to another aspect of the invention there is provided a method of filling a needleless injector capsule with injectate, the capsule defining a chamber which is for receiving injectate and is provided with an injection orifice, a piston being located for movement within the chamber, the adapter being removably connected to the capsule and having a bore which communicates with the capsule chamber via the injection orifice, the method comprising the steps of: [0006]
  • (a) introducing injectate into the capsule chamber through the injection orifice and excess injectate into bore of the adaptor; and [0007]
  • (b) closing the bore of the adaptor to the exterior by a sealing means, leaving the bore partly filled with excess injectate. [0008]
  • It is necessary that the pressure induced in the drug increases very rapidly at the start of the injection, so that the liquid effectively strikes the skin to pierce it. (Conversely, if the pressure rise is too slow, the skin moves away from the jet causing the jet to splash sideways without penetration). It follows therefore that the “hydraulic circuit”—i.e. the drug capsule, its method of attachment, and the piston should be relatively rigid, otherwise much of the input energy at the start of the injection will be wasted in distorting these components. Less obvious is that any trapped air in the liquid drug will be compressed during the injection and thus absorb energy. Of course, a small quantity of entrapped air is permissible and almost inevitable, because unless rigorous de-gassing of the drug is carried out before filling, very small bubbles of air will come out of solution and coalesce within the injectate. [0009]
  • In a preferred form of the above method air is evacuated through the injection orifice before injectate is introduced into the capsule chamber and adaptor bore. [0010]
  • The invention also provides a needleless injector capsule in combination with an adaptor for use in filling the capsule, the capsule defining a chamber which is for receiving injectate and is provided with an injection orifice, a piston being located for movement within the chamber, the adaptor being removably connected to the capsule and having a bore which communicates with the capsule chamber via the injection orifice, the adaptor bore having a first portion of smaller cross-section adjacent the injection orifice and a second portion of larger cross-section remote from the said orifice. Such a construction is particularly suitable for carrying out the above filling method including evacuation of air. [0011]
  • The capsule is preferably connected frangibly to the filling adaptor, which also serves as a reservoir to accommodate expansion and contraction of the injectate. Immediately prior to use the filling adaptor is broken off the capsule to expose the injection orifice. [0012]
  • The invention is further described below with reference to the accompanying drawings which show preferred embodiments and in which: [0013]
  • FIG. 1 is a centre-line axial section view of a capsule before filling; [0014]
  • FIG. 2 shows a filling head applying a vacuum; [0015]
  • FIG. 3 shows the capsule being filled; [0016]
  • FIG. 4 shows the filled capsule with a seal attached; [0017]
  • FIG. 5 shows the filling adaptor being broken off prior to causing an injection; [0018]
  • FIG. 6 is an alternative sealing method. [0019]
  • FIG. 1 shows a capsule [0020] 1 in the form of a cylindrical elongate tube having a means of attachment 10 at a first end, and an injection orifice 5 at a second end. A piston 3 is slidingly and sealingly assembled into the capsule 1 and proximal to the injection orifice 5. The fit of the piston 3 in the capsule 1 should minimise the dead volume of air 14. A filling tube 2 has a frangible attachment 4 to the capsule 1. Tube 2 has a cylindrical bore 9 which is then reduced in diameter to form a capillary 15. Capillary 15 is connected to orifice 5 of capsule 1.
  • Referring to FIG. 2, a filling head [0021] 18 comprising vacuum connector 16 and injectate dispenser 7, is applied to filling tube 2. The vacuum connector 16 seals a rim 11 of filling tube 2, and the air contained within the cylindrical bore 9, capillary 15 and dead space 14 is evacuated. Evacuation down to 100 mbars is adequate; a lower vacuum would take longer to achieve than would normally be acceptable, and result in a very slow filling procedure. Whilst maintaining the vacuum, injectate dispenser 7 is inserted into the cylindrical bore 9, and a seal 8 on the exterior of the dispenser 7 seals with the wall of bore 9, as shown in FIG. 3. After insertion of injectate dispenser 7, the vacuum may be terminated, and the injectate 6 is pressurized to flow through cylindrical bore 9, capillary 15 and injection orifice 5 and into the capsule 1, so as to force the piston 3 towards the first end of capsule 1 to a predetermined position. On attaining this position, the flow of injectate 6 is stopped, and the filling head 18 removed from filling tube 2. The capsule is now filled, and may be sealed by a sealing cap 12, as shown in FIG. 4, or a plug 20 as shown in FIG. 6. During filling, it is important that the injectate dispenser 7 is inserted only part way into cylindrical bore 9, so that a small excess 22 of the injectate remains, and after removal of the injectate dispenser 7, an air space 21 remains.
  • Finally, as shown in FIG. 5, the filled capsule is assembled to an actuator [0022] 19. To prepare the injector, the filling tube 2 is snapped off from the capsule 1 at the frangible joint 4, together with the sealing cap 12 and excess injectate 22. This exposes the injection orifice 5, which is then placed on the patient's skin, and the injection performed in the usual manner. Thus it may be seen that the injectate is free to expand or contract during storage (i.e. between the steps of FIGS. 4 and 5) without the risk of leakage or excessive out-gassing. The dimension of the capillary bore 15 should be chosen to accommodate the maximum volumetric change through temperature variation, and also to suit the surface tension of the injectate, so that inverting the capsule does not result in migration of the injectate into the filling tube 2. However, the volume of the excess injectate 22 is not critical, and therefore the performance tolerances imposed on the filling machine are not exacting.
  • The materials for constructing the capsule [0023] 1 and filling tube 2 may be plastic or glass, and preferably transparent to permit examination of the contents. The piston 3 may be of PTFE or similar fluoropolymer or a low density polyethylene, for example. Attention is directed to our published PCT application WO 95/03844 for further details of materials which can be used for the piston. The seal 12 or 20 may be of chlorobutyl rubber or other drug-compatible seal material. An alternative to sealing the tube 2 with cap 12 or plug 20 is to thermally reform and close the opening to form a gas-tight welded seal. With some plastics, welding is difficult, and the inside surface of the tube 2 may be coated with a more suitable seal material. Again, where it is necessary to use a particular plastic in contact with the drug, for compatibility therewith, this could be a lining within a capsule, and/or filling tube, made of a plastic having the required strength and durability properties. This may be a separately made part which is then assembled to the casing, or a co-injected moulding. Even more layers of different plastic or other materials may be used to add specific properties. The frangible connection 4 may be a very thin section of material, and/or be specially treated to reduce the strength in that area to facilitate fracture of the said connection. Alternatively, the filling tube 2 may be an air tight snap fit onto the capsule 1, and preferably not be re-attachable, so as to provide tamper evidence.

Claims (22)

1. A needleless injector capsule in combination with an adaptor used in filling the capsule, the capsule defining a chamber which has injectate therein and is provided with an injection orifice, a piston being located for movement within the chamber, the adapter being removably connected to the capsule and having a bore which communicates with the capsule chamber via the injection orifice and is partly filled with excess injectate, the bore being closed to the exterior by a sealing means.
2. A combination according to
claim 1
, wherein the adaptor is frangibly connected to the capsule.
3. A combination according to
claim 1
, wherein the adaptor is connected to the capsule by a snap-fit connection which does not permit reconnection after removal of the adaptor and capsule from one another.
4. A combination according to
claim 1
,
2
or 3, wherein the capsule and/or adaptor is of glass.
5. A combination according to any preceding claim, wherein the capsule and/or adaptor is of a plastics material.
6. A combination according to
claim 1
,
2
or 3, wherein the capsule and/or adaptor is made of more than one material.
7. A combination according to
claim 6
, wherein the capsule and/or adaptor is internally lined with a plastics material which is compatible with the injectate.
8. A combination according to any preceding claim, wherein the sealing means is a sealing cap.
9. A combination according to any one of
claims 1
to
7
, wherein the sealing means is a plug received within the said bore.
10. A combination according to any one of
claims 1
to
7
, wherein the sealing means is constituted by portions of the adaptor which have been sealed to one another after filling of the capsule.
11. A method of filling a needleless injector capsule with injectate, the capsule defining a chamber which is for receiving injectate and is provided with an injection orifice, a piston being located for movement within the chamber, the adapter being removably connected to the capsule and having a bore which communicates with the capsule chamber via the injection orifice, the method comprising the steps of:
(a) introducing injectate into the capsule chamber through the injection orifice and excess injectate into bore of the adaptor; and
(b) closing the bore of the adaptor to the exterior by a sealing means, leaving the bore partly filled with excess injectate.
12. A method according to
claim 11
, wherein step (a) is effected by an injectate dispenser which sealingly engages with the internal wall of the bore of the adaptor.
13. A method according to
claim 11
or
12
, wherein the sealing means is a sealing cap.
14. A method according to
claim 11
or
12
, wherein the sealing means is a plug received within the said bore.
15. A method according to any one of
claims 11
to
14
, wherein air is evacuated from the capsule through the injection orifice prior to step (a).
16. A needleless injector capsule in combination with an adaptor for use in filling the capsule, the capsule defining a chamber which is for receiving injectate and is provided with an injection orifice, a piston being located for movement within the chamber, the adaptor being removably connected to the capsule and having a bore which communicates with the capsule chamber via the injection orifice, the adaptor bore having a first portion of smaller cross-section adjacent the injection orifice and a second portion of larger cross-section remote from the said orifice.
17. A combination according to
claim 16
, wherein the adaptor is frangibly connected to the capsule.
18. A combination according to
claim 16
, wherein the adaptor is connected to the capsule by a snap-fit connection which does not permit reconnection after removal of the adaptor and capsule from one another.
19. A combination according to
claim 16
,
17
or 18, wherein the capsule and/or adaptor is of glass.
20. A combination according to any one of
claims 16
to
19
, wherein the capsule and/or adaptor is of a plastics material.
21. A combination according to any one of
claims 16
to
18
, wherein the capsule and/or adaptor is made of more than one material.
22. A combination according to
claim 21
, wherein the capsule and/or adaptor is internally lined with a plastics material which is compatible with the injectate.
US09/728,662 1995-12-16 2000-12-01 Needleless injector drug capsule and filling method Abandoned US20010002433A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
GB9525757.2 1995-12-16
GB9525757A GB9525757D0 (en) 1995-12-16 1995-12-16 Needleless injector drug capsule and filling method
PCT/GB1996/003017 WO1997022375A1 (en) 1995-12-16 1996-12-09 Needleless injector drug capsule and filling method
US09/091,320 US6251091B1 (en) 1995-12-16 1996-12-09 Needleless injector drug capsule and filling method
US09/728,662 US20010002433A1 (en) 1995-12-16 2000-12-01 Needleless injector drug capsule and filling method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US09/728,662 US20010002433A1 (en) 1995-12-16 2000-12-01 Needleless injector drug capsule and filling method

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US09/091,320 Division US6251091B1 (en) 1995-12-16 1996-12-09 Needleless injector drug capsule and filling method

Publications (1)

Publication Number Publication Date
US20010002433A1 true US20010002433A1 (en) 2001-05-31

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Application Number Title Priority Date Filing Date
US09/091,320 Expired - Lifetime US6251091B1 (en) 1995-12-16 1996-12-09 Needleless injector drug capsule and filling method
US09/728,662 Abandoned US20010002433A1 (en) 1995-12-16 2000-12-01 Needleless injector drug capsule and filling method

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US09/091,320 Expired - Lifetime US6251091B1 (en) 1995-12-16 1996-12-09 Needleless injector drug capsule and filling method

Country Status (17)

Country Link
US (2) US6251091B1 (en)
EP (2) EP1097727A3 (en)
JP (1) JP2000501967A (en)
KR (1) KR20000064372A (en)
AT (1) AT204772T (en)
AU (1) AU1102397A (en)
BR (1) BR9612003A (en)
CA (1) CA2240581A1 (en)
DE (2) DE69614881D1 (en)
DK (1) DK0876175T3 (en)
ES (1) ES2159768T3 (en)
GB (1) GB9525757D0 (en)
MX (1) MX9804618A (en)
NO (2) NO982756D0 (en)
RU (1) RU2161512C2 (en)
WO (1) WO1997022375A1 (en)
ZA (1) ZA9610344B (en)

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US20090234276A1 (en) * 2004-12-01 2009-09-17 Toles Warren L Needle-free injector
US20090292239A1 (en) * 2006-04-06 2009-11-26 Novo Nordisk A/S Injector System for Needleless, High Pressure Delivery of a Medicament
US20090247940A1 (en) * 2006-10-06 2009-10-01 Bioject, Inc. Triggering mechanism for a needle-free injector
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US7744563B2 (en) 2007-02-23 2010-06-29 Bioject, Inc. Needle-free injection devices and drug delivery systems therefor
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DK876175T3 (en)
NO20016382L (en) 1998-06-15
NO982756D0 (en) 1998-06-15
MX9804618A (en) 1998-10-31
NO20016382D0 (en) 2001-12-27
ES2159768T3 (en) 2001-10-16
US6251091B1 (en) 2001-06-26
ZA9610344B (en) 1997-09-18
CA2240581A1 (en) 1997-06-26
EP1097727A2 (en) 2001-05-09
EP0876175A1 (en) 1998-11-11
WO1997022375A1 (en) 1997-06-26
KR20000064372A (en) 2000-11-06
DE69614881T2 (en) 2002-03-28
BR9612003A (en) 1999-02-09
JP2000501967A (en) 2000-02-22
AU1102397A (en) 1997-07-14
AT204772T (en) 2001-09-15
DE69614881D1 (en) 2001-10-04
RU2161512C2 (en) 2001-01-10
NO982756L (en) 1998-06-15
DK0876175T3 (en) 2001-11-12
EP0876175B1 (en) 2001-08-29
GB9525757D0 (en) 1996-02-14
EP1097727A3 (en) 2002-04-10

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