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WO2001060340A1 - Capsule d'administration de substance - Google Patents

Capsule d'administration de substance Download PDF

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Publication number
WO2001060340A1
WO2001060340A1 PCT/GB2001/000558 GB0100558W WO0160340A1 WO 2001060340 A1 WO2001060340 A1 WO 2001060340A1 GB 0100558 W GB0100558 W GB 0100558W WO 0160340 A1 WO0160340 A1 WO 0160340A1
Authority
WO
WIPO (PCT)
Prior art keywords
inner layer
capsule
outer layer
capsule according
layer
Prior art date
Application number
PCT/GB2001/000558
Other languages
English (en)
Inventor
Malcolm David Brown
Original Assignee
Bioprogress Technology International Inc.
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 claimed from GB0003424A external-priority patent/GB0003424D0/en
Application filed by Bioprogress Technology International Inc. filed Critical Bioprogress Technology International Inc.
Priority to AU2001232068A priority Critical patent/AU2001232068A1/en
Publication of WO2001060340A1 publication Critical patent/WO2001060340A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells

Definitions

  • the present invention relates to a delivery capsule, that is, a capsule designed to retain and protect its contents until an intended site of delivery or conditions of delivery are encountered, at which point the capsule contents are released.
  • Delivery capsules are well known as a convenient means for conveying doses of a substance. As such, they find particular application in numerous and disparate fields including the delivery of accurately metered doses of pharmaceutical and dietary supplements, and doses of cosmetic preparations e.g. fragranced oils encapsulated within a soft water soluble film material.
  • the capsule walls of delivery capsules have been formed from animal derived gelatin.
  • animal derived gelatin In view of animal welfare concerns and the fear of animal related diseases such as Bovine Spongiform Encephalopathy (BSE), the popularity of water-soluble gelatin substitute materials, which are non-animal derived, is increasing.
  • BSE Bovine Spongiform Encephalopathy
  • WO 97/35537 describes capsules produced from non- animal derived materials including water soluble films such as polyvinyl alcohol (PVA).
  • PVA polyvinyl alcohol
  • the capsules described in this document dissolve and release their contents according to the solubility of the film material of the capsule wall i.e. if a hot water soluble film is used, the capsules will only dissolve and release their contents in hot water.
  • the capsules of WO 97/35537 are formed from two films of like material with each film forming a capsule half, and with two halves being sealed together to form a complete capsule.
  • a delivery capsule comprising an enclosing wall, the enclosing wall comprising an inner layer of a first material and an outer layer of a second material, the first and second materials having different solubility properties, with one or more portions of the inner layer constituting part of the outer surface of the capsule.
  • the inner layer and the outer layer of the enclosing wall together form a complete enclosure around the contents of the capsule.
  • the capsule may contain a wide range of materials in the form of gels, liquids, solids (e.g. particulates, powders etc.), and mixtures thereof e.g. slurries.
  • suitable materials for use in the capsules described herein include drugs, vitamins, powders, oils, cosmetic preparations, drug delivery systems, domestic and household preparations etc.
  • the outer surface of the capsule is comprised in part by the inner layer of the first material and in part by the outer layer of the second material, the two materials having different solubility properties.
  • One or more portions of the inner layer thus constitute part of the outer surface of the capsule. This means that the outer layer of the enclosing wall is incomplete. Therefore, regions of the inner layer are exposed to the external environmental conditions experienced by the capsule.
  • capsules in accordance with the present invention are brought into contact with an appropriate solvent (e.g. by being added to an appropriate solvent), typically water (although other solvents may be usefully employed e.g. alcohols, aqueous alcoholic mixtures, digestive juices etc.), the solvent contacts both the inner layer and the outer layer of the enclosing wall of the capsule.
  • an appropriate solvent typically water
  • other solvents may be usefully employed e.g. alcohols, aqueous alcoholic mixtures, digestive juices etc.
  • the solvent contacts both the inner layer and the outer layer of the enclosing wall of the capsule.
  • the first and second materials of the inner layer and the outer layer respectively may behave differently under the same conditions due to their different solubility properties.
  • the outer surface of the capsule is comprised in part by the inner layer of the
  • the outer layer of the enclosing wall is incomplete.
  • the inner layer of the enclosing wall may be incomplete or complete, and preferably is complete.
  • the inner layer is approximately spherical or ovoid, and may be formed from two similar halves of an appropriate shape conveniently joined together by a circumferential flange at their periphery.
  • the capsule is of a generally spherical or oval shape, having a circumferential flange extending from its outer surface.
  • the capsule thus comprises two similar hemispherical or hemiovoid halves having at their periphery a circumferential flange, each half including a superimposed inner layer and outer layer with the two halves being sealed together via the flanges to form the complete capsule.
  • the inner layer constitutes part of the outer surface of the capsule at the inner or central region of the flange periphery.
  • Such capsules may be conveniently made by the technique and apparatus described in WO 97/35537 with possible minor modification.
  • the materials of the inner layer and/or outer layer may be supplied in the form of ribbon-like films, or alternatively can be readily manufactured e.g. by extrusion from solution.
  • the inner layer of a first material is applied to the outer layer formed from two ribbon-like films in the form of a viscous solution via extrusion, generally employing extruder bars modified with fine applicator controls for accuracy.
  • the viscous solution should be applied to the outer layer in an appropriate amount.
  • the amount of viscous solution applied is generally controlled to prevent complete dissolution of the outer layer and/or the formation of a film of insufficient strength to process into a complete capsule: this amount can be readily determined by experiment.
  • the amount of viscous solution applied to the outer layer is such that the outer layer softens and partial dissolution thereof is effected. Conveniently, this effect also facilitates the formation of a capsule of a desirable shape.
  • the first material of the inner layer is applied as a 12% solution in water to each film forming the outer layer at a thickness of about 25 to about 50 g/m , preferably 35 g/m .
  • the outer layer generally absorbs a proportion of the solvent, typically water, from the solution. Additionally, some of the solvent will evaporate under manufacturing conditions. This results in the formation of a discrete, superimposed inner layer.
  • the solvent typically water
  • means for applying solvent described in WO 97/35537 are replaced with means for applying a solution of an inner layer of a first material to the upper surface presented by the outer layer of a second material, preferably at an appropriate location upstream of the encapsulation unit.
  • the capsule comprises a complete inner layer of a first material bearing an incomplete outer layer comprising one or more portions of a second material including one or more apertures, gaps or spaces.
  • the inner layer thus constitutes part of the outer surface of the capsule in the region of the apertures, gaps or spaces.
  • the inner layer of the first material and the outer layer of the second material may be chemically alike but may not be identical in terms of grade, or alternatively, the materials may be chemically different.
  • the thickness of the outer layer of the enclosing wall may depend upon a number of factors including the nature of the contents, the intended use and purpose of a particular capsule and its size. Typically, the thickness of the outer layer may vary between the range 50 microns to about 150 microns, and is preferably about 100 microns. Typically, the thickness of the inner layer will be chosen so as to control the rate at which the contents of the capsule are released, but generally varies between about 5 microns to about 30 microns.
  • the first and second materials of the inner layer and the outer layer respectively have different solubility properties from one another in an appropriate solvent, generally water, although for certain applications other solvents e.g. alcohols may be appropriate.
  • an appropriate solvent generally water, although for certain applications other solvents e.g. alcohols may be appropriate.
  • Preferred materials for the first material and second material of the enclosing wall herein are cold water soluble, warm water soluble or hot water soluble.
  • cold water soluble as used herein means a material which dissolves at a temperature in the range from about 0°C to about 30°C.
  • warm water soluble as used herein means a material which dissolves at a temperature in the range from about 30°C to about 60°C and the term “hot water soluble” as used herein means a material which dissolves at a temperature greater than 60°C.
  • Suitable examples of materials soluble in water include polyvinyl alcohol (PVA), alginates, hydroxypropyl methyl cellulose and polyethylene oxide, or mixtures thereof.
  • PVA polyvinyl alcohol
  • alginates hydroxypropyl methyl cellulose
  • polyethylene oxide or mixtures thereof.
  • any of the above described materials may be suitable for use as the outer layer of a capsule.
  • Further suitable materials for the outer layer of capsules herein include non-water soluble materials such as polycaprolactone and gelatinised starch based materials.
  • a suitable material for the inner layer is PVA which is possibly admixed with polyethylene oxide and optionally plasticised e.g. with glycerin.
  • the preferred material for both the inner layer and the outer layer of a capsule herein is PVA, which is available in a range of grades, types, e.g. several different grades forming a blend or one grade in isolation, solubilities and thicknesses. Additionally, such materials are commercially available e.g. in the form of ribbon-like films or can be readily manufactured e.g. by extrusion from solution. An appropriate material in the form of a film or solution can be readily selected having regard to the intended use, capsule contents and desired capsule properties.
  • Suitable first materials for the inner layer of a capsule herein include:
  • Suitable second materials for the outer layer of capsules herein include PVA film material commercially available for example from Chris Craft, 407 County Line Road, Gary, Indiana, USA; Nippon Goshei from British Traders and Shippers as above; Aichello, Japan; and Cast Film Technology Incorporated, 910 East Burnett Road, Island Lake, Illinois, USA.
  • PVA film material commercially available for example from Chris Craft, 407 County Line Road, Gary, Indiana, USA; Nippon Goshei from British Traders and Shippers as above; Aichello, Japan; and Cast Film Technology Incorporated, 910 East Burnett Road, Island Lake, Illinois, USA.
  • Suitable films are available in a range of grades (containing a single type of PVA or blends of PVA resins), thicknesses and having differing speeds of solubility.
  • An appropriate film can be readily selected having regard to the capsule type and desired capsule size.
  • PVA films of a thickness ranging between 70 microns and 120 microns are typically used.
  • Non-limiting examples of suitable films for use herein include the Monosol range available from Chris Craft (Monosol is a Trade Mark) as exemplified by Monosol M7030 and Monosol M8630 and the Hi-Rhythm range available from Nippon Goshei (Hi-Rhythm is a Trade Mark) as exemplified by cold water soluble Hi-Rhythm C200.
  • the inner layer or outer layer of the enclosing wall is chosen so as to be substantially insoluble, when for example, the delivery capsule is immersed in a solvent, particularly water, of a particular temperature or exposed to digestive juices.
  • the at least one other material of the enclosing wall is chosen having an appropriate solubility which will cause it to dissolve when the delivery capsule is exposed to the same conditions. Therefore, any particular delivery capsule will be formed from at least two such materials of differential solubility.
  • the inner layer of a first material may be less soluble than the outer layer of a second material, e.g. which may enable a capsule to be produced having an enclosing wall which dissolves at a different rate across its thickness.
  • the addition of a proportion of cold water soluble resin such as a blend of 70:30 Mowiol 28:99 and Gohsenol GL05 ((6) above) to Mowiol 28:99, will produce an inner layer which upon rupture, fragments instead of remaining substantially intact.
  • a proportion of cold water soluble resin such as a blend of 70:30 Mowiol 28:99 and Gohsenol GL05 ((6) above) to Mowiol 28:99, will produce an inner layer which upon rupture, fragments instead of remaining substantially intact.
  • the inner layer of the first material is more soluble than the outer layer of the second material.
  • the present invention facilitates the provision of capsules designed to be more stable and robust than has hitherto been possible, and which conveniently prevent premature release of the contents of the capsule upon handling, storage, manufacturing and packaging.
  • Capsules which release their contents in cold or warm water are generally more sensitive to dissolution upon handling. Hence minimal handling of these capsules before use is preferable, as incidental contact with solvent such as sweat on the hands can cause premature release of the contents.
  • Manufacture, storage, packaging and handling of soluble capsules is therefore difficult to achieve if the thickness of the capsule wall and its solubility are the only determining factors in the rate of release of the capsule contents (i.e. solubility rate).
  • a capsule which is typically water soluble and displays greater resistance to degradation of the outer layer of the enclosing wall of the capsule upon contact with solvent of an appropriate temperature e.g. upon handling or upon incidental contact with moisture, yet controllably (e.g. at a desired rate) releases its contents under appropriate conditions of temperature e.g. in cold or warm water.
  • This enables the manufacture of robust capsules (in preferred embodiments of a capsule herein), which may be readily sealed to good effect, the seal typically being constituted by the inner layers of two similar halves which have been joined together to form a complete capsule.
  • the seal generally has a thickness of about 10 microns.
  • the inner layer of a first material and/or the outer layer of a second material may be coloured with any suitable colouring agent e.g. for aesthetic or barrier purposes.
  • An inner layer and outer layer may be the same colour or different colours.
  • a capsule in accordance with the present invention comprises two similar halves, each half having at its periphery a circumferential flange together with a superimposed inner layer of a first material which is more soluble (typically in water) than an outer layer of a second material, the two halves being sealed together via the flanges to form a complete capsule.
  • a different formulation of material for the inner layer i.e. controlled release layer is applied to each half of the two similar halves comprising the outer layer.
  • Figure 1 is a schematic sectional view of a delivery capsule in accordance with the present invention.
  • the half shells 14 and 16 of the enclosing wall 12 each comprise an inner layer 30 of a first material and an outer layer 40 of a second material.
  • the inner layer 30 and outer layer 40 of the enclosing wall 12 together form a complete enclosure around the contents 20 of capsule 10.
  • the first and second materials have different solubility properties from one another, with one or more portions of the inner layer 30 constituting part of the outer surface of the capsule 10 at flange 18 in the inner region of the flange periphery.
  • the outer layer 40 of a second material and the inner layer 30 of a first material of the enclosing wall 12 may be chemically alike but may not be the same in terms of grade, or alternatively, the materials may be chemically different, depending on the desired properties and intended use of the capsule. However, each layer has different solubility properties from the other. This requirement may be exploited when it is desirable to formulate a capsule 10 which is generally robust, and capable of for example, being handled and stored to prevent premature release of the contents 20. A capsule demonstrating these properties can be provided when the outer layer 40 is less soluble than the inner layer 30.
  • the outer layer 40 comprises a polyvinyl alcohol material which is soluble in aqueous solution at temperatures above 30°C and the inner layer 30 comprises a polyvinyl alcohol resin which dissolves in aqueous solution at temperatures above 5°C.
  • a good quality delivery capsule containing an aqueous and oil fill was prepared as shown in Figure 1 using the method and apparatus substantially as described in WO 97/35537.
  • the delivery capsules so produced generally resisted release of their contents upon exposure to incidental moisture and sweat during handling, yet rapidly released their contents upon exposure to a volume of water having a temperature above 5°C.
  • the outer layer of the capsule was formed from two films of lOO ⁇ m warm water soluble polyvinyl alcohol, soluble in water at temperatures above 40°C.
  • a viscous solution prepared as described below:
  • the viscous solution is applied to the films in an appropriate amount to cause softening and partial dissolution of the films.
  • the solution was applied to the films forming the outer layer of a capsule at a thickness of about 35 g/m 2 .
  • the applied solution i.e. resin thus forms the inner layer of the capsule which partially dissolves in water down to a temperature of about 5°C at the inner or central region of the flange periphery typically releasing the contents of the capsule.
  • the outer layers of the film materials having superimposed thereon an inner layer were formed into opposed capsule halves containing the aqueous and oil fill.
  • the capsule halves were then brought together and sealed, the seal being created by the adhesive effect of the partially solvated inner layer applied to the outer layer.
  • the finished capsules were then cut from the films and air dried or force dried to remove any excess water, before being packaged.
  • capsules prepared as described above were placed in water at a temperature of about 20°C, the aqueous and oil fill was released from the capsules within about 60 seconds, following the ingress of water into the capsule seal formed by the inner layer at the inner or central region of the flange periphery.
  • the outer layer of the capsule remains substantially undissolved in solution.
  • Capsules are thus provided, which rapidly release their contents under desired and appropriate conditions, e.g. in cold or warm water, yet which are less susceptible to degradation through handling or exposure to incidental moisture.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une capsule constituée d'une paroi enveloppante laquelle comprend une couche intérieure préparée avec une première matière et une couche extérieure préparée avec une second matière. Les première et seconde matières présentent des propriétés de solubilité différentes. Une ou plusieurs partie(s) de la couche intérieure constitue(nt) une partie de la surface extérieure de la capsule. Selon cette invention, lorsque les capsules sont ajoutées à un solvant approprié, ce solvant entre en contact à la fois avec la couche intérieure et la couche extérieure de la paroi enveloppante de la capsule, celles-ci pouvant réagir différemment dans les mêmes conditions. Par conséquent, il est possible d'exploiter l'effet de solubilité différentielle qui existe entre la couche intérieure et la couche extérieure pour réguler, par exemple, la vitesse de libération du contenu de la capsule et/ou la température à laquelle ce contenu est libéré.
PCT/GB2001/000558 2000-02-16 2001-02-13 Capsule d'administration de substance WO2001060340A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001232068A AU2001232068A1 (en) 2000-02-16 2001-02-13 Delivery capsules

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB0003424A GB0003424D0 (en) 2000-02-16 2000-02-16 A controlled release capsule
GB0003424.9 2000-02-16
GB0102204.5 2001-01-29
GB0102204A GB2361643B (en) 2000-02-16 2001-01-29 Delivery capsules

Publications (1)

Publication Number Publication Date
WO2001060340A1 true WO2001060340A1 (fr) 2001-08-23

Family

ID=26243649

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2001/000558 WO2001060340A1 (fr) 2000-02-16 2001-02-13 Capsule d'administration de substance

Country Status (3)

Country Link
AU (1) AU2001232068A1 (fr)
GB (1) GB2398499B (fr)
WO (1) WO2001060340A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1421010B2 (fr) † 2001-08-16 2012-01-18 Warner-Lambert Company LLC Enveloppe soluble dans l'eau
CN116919915A (zh) * 2023-07-25 2023-10-24 维卓(嘉兴)营养品有限公司 一种双层软胶囊、制备方法和应用

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2290965A (en) * 1994-07-11 1996-01-17 Therapicon Srl Multiple layer capsules for drugs
WO1996040083A2 (fr) * 1995-06-07 1996-12-19 R.P. Scherer Corporation Procedes et compositions pour preparer des gelules molles de gelatine presentant des enveloppes resistant a l'infiltration par des substances de remplissage
WO1997035537A1 (fr) * 1996-03-26 1997-10-02 Bioprogress Technology Limited Ameliorations en matiere d'encapsulation
NL1009107C2 (nl) * 1997-11-12 1999-06-15 Banner Pharmacaps Inc Gelatine-uitspreidende doos met meervoudige, aanpasbare poortklep en meerlagig zacht gel.
WO2000027367A1 (fr) * 1998-11-11 2000-05-18 Bioprogress Technology International Incorporated Systeme d'administration de medicaments a base de gelules
WO2001003676A1 (fr) * 1999-07-09 2001-01-18 Bioprogress Technology International, Inc. Perfectionnements apportes aux capsules a liberation
EP1103254A1 (fr) * 1999-11-19 2001-05-30 Greither, Peter Procédé de préparation de corps moulés,masse à base d'amidon homogénéisé et dispositif pour préparer des capsules molles

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1455884A (en) * 1973-02-14 1976-11-17 Lilly Industries Ltd Production of capsules
US4692336A (en) * 1984-03-19 1987-09-08 Alza Corporation Self controlled release device for administering beneficial agent to recipient
US5324280A (en) * 1990-04-02 1994-06-28 Alza Corporation Osmotic dosage system for delivering a formulation comprising liquid carrier and drug
US5443459A (en) * 1991-01-30 1995-08-22 Alza Corporation Osmotic device for delayed delivery of agent

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2290965A (en) * 1994-07-11 1996-01-17 Therapicon Srl Multiple layer capsules for drugs
WO1996040083A2 (fr) * 1995-06-07 1996-12-19 R.P. Scherer Corporation Procedes et compositions pour preparer des gelules molles de gelatine presentant des enveloppes resistant a l'infiltration par des substances de remplissage
WO1997035537A1 (fr) * 1996-03-26 1997-10-02 Bioprogress Technology Limited Ameliorations en matiere d'encapsulation
NL1009107C2 (nl) * 1997-11-12 1999-06-15 Banner Pharmacaps Inc Gelatine-uitspreidende doos met meervoudige, aanpasbare poortklep en meerlagig zacht gel.
US6183845B1 (en) * 1997-11-12 2001-02-06 Banner Pharmacaps, Inc. Multiple layer softgel
WO2000027367A1 (fr) * 1998-11-11 2000-05-18 Bioprogress Technology International Incorporated Systeme d'administration de medicaments a base de gelules
WO2001003676A1 (fr) * 1999-07-09 2001-01-18 Bioprogress Technology International, Inc. Perfectionnements apportes aux capsules a liberation
EP1103254A1 (fr) * 1999-11-19 2001-05-30 Greither, Peter Procédé de préparation de corps moulés,masse à base d'amidon homogénéisé et dispositif pour préparer des capsules molles

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Derwent World Patents Index; Class A16, AN 1970-06531R, XP002172505 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1421010B2 (fr) † 2001-08-16 2012-01-18 Warner-Lambert Company LLC Enveloppe soluble dans l'eau
CN116919915A (zh) * 2023-07-25 2023-10-24 维卓(嘉兴)营养品有限公司 一种双层软胶囊、制备方法和应用
CN116919915B (zh) * 2023-07-25 2023-12-22 维卓(嘉兴)营养品有限公司 一种双层软胶囊、制备方法和应用

Also Published As

Publication number Publication date
GB2398499A (en) 2004-08-25
AU2001232068A1 (en) 2001-08-27
GB0411917D0 (en) 2004-06-30
GB2398499B (en) 2004-11-24

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