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CN100571802C - Drug suspension and the cartridge case with hybrid element of different densities are housed - Google Patents

Drug suspension and the cartridge case with hybrid element of different densities are housed Download PDF

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Publication number
CN100571802C
CN100571802C CNB2006800150801A CN200680015080A CN100571802C CN 100571802 C CN100571802 C CN 100571802C CN B2006800150801 A CNB2006800150801 A CN B2006800150801A CN 200680015080 A CN200680015080 A CN 200680015080A CN 100571802 C CN100571802 C CN 100571802C
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China
Prior art keywords
hybrid element
density
suspension
hybrid
cartridge case
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Expired - Fee Related
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CNB2006800150801A
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Chinese (zh)
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CN101171043A (en
Inventor
D·N·瑟伦森
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.)
Novo Nordisk AS
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Novo Nordisk AS
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Publication of CN101171043A publication Critical patent/CN101171043A/en
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Expired - Fee Related legal-status Critical Current
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/25—Mixers with loose mixing elements, e.g. loose balls in a receptacle
    • B01F33/251—Mixers with loose mixing elements, e.g. loose balls in a receptacle using balls as loose mixing element
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/30—Driving arrangements; Transmissions; Couplings; Brakes
    • B01F35/32—Driving arrangements
    • B01F35/32005—Type of drive
    • B01F35/3202—Hand driven
    • B01F35/32021—Shaking by hand a portable receptacle or stirrer for mixing
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/30—Driving arrangements; Transmissions; Couplings; Brakes
    • B01F35/32—Driving arrangements
    • B01F35/32005—Type of drive
    • B01F35/3202—Hand driven

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

本发明涉及了一种药物悬浮液的贮存和给药的装置，它包括一个容纳药物悬浮液的容器(1)，其中容器具有两个密度各不相同的混合元件(5，6)，使得第一混合元件(5)的密度明显高于基底液体的密度并且明显高于充分混合后的悬浮液密度，第二混合元件(6)的密度明显低于基底液体的密度并且明显低于充分混合后的悬浮液密度。

The invention relates to a storage and administration device for a pharmaceutical suspension comprising a container (1) containing a pharmaceutical suspension, wherein the container has two mixing elements (5, 6) of different densities such that the first The density of one mixing element (5) is significantly higher than the density of the base liquid and significantly higher than the density of the well-mixed suspension, the density of the second mixing element (6) is significantly lower than the density of the base liquid and significantly lower than the density of the well-mixed suspension density of the suspension.

Description

Drug suspension and the cartridge case with hybrid element of different densities are housed
Technical field
The present invention relates to a kind of doser of drug suspension, particularly a kind of device, this device have the filled with medicament suspension and comprise the medicine bottle of the hybrid element of two preliminary dimensions and density, and this hybrid element is used to mix the medicine that comprises particle.
Background technology
Medicine is filled in the container usually, and this container also comprises certain gas gap on suspension.When container was stored, the particle in the drug suspension often precipitated the formation deposit.Make it even in order to rock medicine, patient is used in combination rolling container and rotation container inverted between palm.Previous process is mainly unclamped deposit from wall, and principal security then is along the suitable mixing of cartridge case length direction.Can rock suspension in addition and make it even, all these flow is owing to there is gas gap in container basically.
But, in needing the container of multiple dosing, do not have gas gap and need fill and do not have gas, but because only in this way could guarantee the repeated doses administration.Therefore, usually can not be in the time of appropriateness in this container uniform mixing because rock and can not convert bubble-free crystal suspension to required homogeneous form can accepting to rely in the time.
Known and adopted steel ball as being filled in the lubricated dispersion in the watering can and the hybrid element of coating.Yet lubricant is to be easy to dispersive material, and as molybdenum sulfide and graphite, relying on several times, jigging motion just is easy to they are converted to sprayable form.
In the medicament reservoir of multiple dosing, because unfavorable diameter and length ratio, this ratio always changes when piston or plunger propelling during use, and owing to lack gas gap, the simple hybrid element that can not look to also adopting picture to become known for watering can makes drug suspension even.
In the situation of insulin suspensions, owing to suspension is not rocked fully or precipitates once more, given crystal very little, promptly given the too insulin of low concentration.
So far adopted single mixed bead,, guaranteed the suitable suspension once more of material in the cartridge case as the glass bead of the about 2.5mm of diameter.In addition, know that many medicine crystals are also worried the change of drug particles size to the mechanical load sensitivity when therefore using hybrid element in medicament reservoir.
Adopting a patent of hybrid element is EP 235.691, and it has announced a medicament reservoir that is used for the multiple dosing of drug suspension, as the ampoule or the cartridge case of injection.Filled with medicament in the container, thus bubble do not had, and comprise the inertia hybrid element of an appropriate size at least, its density is different with the density of suspension.Hybrid element plays the effect of uniform drug suspension when rocking container.In addition, if medicament reservoir has more than one hybrid element, the material of making all hybrid elements is all identical, as mentioning in the example 2, adopts two beades to make drug suspension even.
A shortcoming of above-mentioned patent is: for the suspension that leaves standstill the long period, before reaching suitable mixing, above-mentioned action must repeat repeatedly.In addition, especially can observe for the cartridge case that is subjected to centrifugal force, hybrid element/pearl may be embedded in the deposit, and mixed process is not enough to cause once more and suspends.
Summary of the invention
The objective of the invention is to overcome above-mentioned shortcoming, and provide several advantages for the granule resuspending of initial deposition on cartridge case sidewall or end wall.
Another object of the present invention is to guarantee that one of mixed bead will never be embedded in the deposited particles.
Another purpose of the present invention is the efficient that has improved present mixed process.
In order to achieve the above object, the invention provides a kind of container that is used for the storage and the administration of drug suspension, this container has the hybrid element that two density have nothing in common with each other, make the density of a hybrid element apparently higher than the density of base liquid and be higher than abundant mixed density of suspending liquid, the density of another hybrid element is starkly lower than the density of base liquid and is lower than abundant mixed density of suspending liquid.
Though two hybrid elements are preferred numbers, can adopt any number,, have at least the density of two hybrid elements to have nothing in common with each other as long as mentioned above.
Such as here employing, term " medicine " or " medicine " mean the flowed medicament that comprises any pastille, as liquid, solution, gel or microparticle suspending liquid, this medicament can be in a controlled manner by conveyer device hollow needle for example.Representational medicine comprises following medicine, as peptide, protein (as insulin, insulin analog and C-peptide) and hormone, biologically-derived or active medicament, hormone and based on the medicament of gene, the material of nutrition prescription and other solids (dispersive) or liquid form.
Correspondingly, term " subcutaneous " injection means any method that is transported to therapist through skin.
The 'inertia' that adopts among the application means hybrid element and does not take place chemically and interaction physically with conflicting mode with pharmaceutical preparation.Therefore, can obviously not produce chemical change or physical damnification, as absorption or wearing and tearing.
" suspension " means a kind of base liquid, and particulate matter is wherein suspending.
Term " entry needle " is defined as a puncture component in addition, is suitable for penetrating the skin of therapist, is used for carrying or getting rid of liquid.
Here all reference materials of quoting, comprise publication, patent application and patent, its full content all is attached to herein as a reference, and it is attached to such degree, promptly indicate separately and specially and be combined as reference, and set forth all sidedly as each reference material.
Here title of Cai Yonging and subhead never constitute any limitation of the invention only for convenience.
Any one or all employings of giving an example, perhaps the example languages that proposes here (for example: " as ") only is used for better the present invention being described and does not limit the scope of the invention, unless otherwise stated.Can not be essential for any non-claim item of expression to implementing the present invention with the linguistic interpretation in the description.Only for convenience quote and combine patent document here, and do not reflect effectiveness, can obtain patentability and anyways enforceable these patent documents.
Present invention includes all modifications of entries listed under existing being allowed by the law, in the claims and the content of equivalence.
Description of drawings
In order to be easier to understand the present invention, the existing embodiment that describes it with reference to the accompanying drawings with way of example.Accompanying drawing has constituted the part of explanation, and the detailed description of preferred embodiment that below provides is used to illustrate its principle.
Fig. 1 has illustrated a kind of state, and wherein cartridge/container has left standstill the long period, and the granule that density is higher than base liquid has been deposited near the far-end that exports.
Fig. 2 has illustrated a kind of state, and wherein cartridge/container has left standstill the long period, and the granule that density is lower than base liquid has been deposited in the near-end near plunger.
Fig. 3 shows the rolling movement of cartridge case in suspension process once more.
Fig. 4 shows the upside down turn motion of cartridge case in suspension process once more.
Fig. 5 has illustrated that cartridge case has been sidelong and has stored some times that deposition materials has the density bigger than liquid.
Fig. 6 has illustrated the upside down turn process that has the cartridge case of two mixed bead according to the present invention.
Fig. 7 has illustrated suitable mixed bead size, this mixed bead be used for being implemented in cartridge case suitable pass through the position.
The specific embodiment
Below adopted term " on " with D score, " right side " and " left side ", " level " and " vertical ", " clockwise " and " counterclockwise " and similar relevant expression way, these are only applicable to accompanying drawing rather than actual user mode.Shown in accompanying drawing for the signal representation, for this reason the configuration of different structure with and relative size as illustrative purposes only.
Can stipulate easily in context: term in the accompanying drawing " near-end " is meant the cartridge case end of filling with plunger, and term " far-end " is meant the other end of the cartridge case of filling, and this end has the outlet that is connected with entry needle in use.
Describe a preferred embodiment of the present invention referring now to accompanying drawing, wherein identical Reference numeral is represented identical or intimate element.Although specific configuration and setting have been discussed, should be understood that the purpose of doing so only is to illustrate for example.Persons skilled in the art will be appreciated that, can adopt other configurations and setting and without departing from the spirit and scope of the present invention.
In addition, in the drawings, hybrid element is preferably sphere, but persons skilled in the art are appreciated that the shape of hybrid element is not limited to sphere.As shown in Figure 1, container 1 has movable plunger 2 at near-end, and filled with medicament suspension and do not have bubble, and comprises one or more spherical hybrid element 5,6.At relative far-end, container 1 is provided with an outlet 4 that covers with rubber membrane usually, and this rubber membrane can be penetrated by entry needle.
Fig. 1 shows a kind of state, and wherein cartridge case 1 has left standstill the long period, and granule 3 has precipitated, and its density is greater than the density of base liquid, and first hybrid element 5 is embedded in the granule 3.Second hybrid element 6 is outside the zone of granule 3.The reason of second hybrid element 6 outside the zone of granule 3 be because the density of second hybrid element 6 less than the density of base liquid.Therefore buoyancy has guaranteed that the second lighter hybrid element 6 can be used for mixed process.
Similarly as shown in Figure 2, buoyancy has guaranteed the first heavier hybrid element 5 outside the suspension zone, and can be used for mixed process.
Therefore Fig. 1 and 2 has illustrated that one of two hybrid elements are embedded within the deposited particles never, always can be used for mixing.
Fig. 3 to 7 has shown that the efficient of mixed process is improved owing to there are two hybrid elements with different densities.
Fig. 3 shows the rolling movement of cartridge case in suspension process once more.Though 5,6 pairs of the hybrid elements process role that suspends once more is little when rolling, and compares with the situation with an element, exists two elements that the efficient of element is approximately doubled.
Under cartridge case upside down turn status of processes as shown in Figure 4, light hybrid element 6 will cartridge case towards above a side, and reblending element 5 will towards below a side, therefore the mode with dual function realizes mixing.
This is possible, because two hybrid elements have different density, respectively above and below base liquid, so they will be in cartridge case on the different positions forever.
Another kind of state may occur after cartridge case has kept flat some times, the result is the downside that the deposition materials 7 bigger than fluid density will be deposited on cartridge case, as shown in Figure 5.
In cartridge case upside down turn process as shown in Figure 6, deposition materials 7 may be bonded on the surface, if cartridge case rotates into the upside that makes deposition materials 7 be positioned at cartridge case by chance, then in suspension process once more heavy hybrid element 5 in fact outside deposition materials 7.Therefore, increase by second hybrid element 6 and increased the probability of described element by deposition materials.
Another kind of state as shown in Figure 7 because the interaction between the hybrid element, it has improved mixed process.In Fig. 7, cartridge case is shown as and is in reversed position, and heavy hybrid element 5 will move down along the downside of wall, and low-density hybrid element 6 will move up along the upside of wall.Adopt the pearl of appropriate size and density, can adjust the speed of two pearls 5,6 on demand.For example, if gently hybrid element is with half operation of reblending element 5 speed, then during the complete upside down turn of cartridge case as shown in the figure, two elements will meet at 1/3 and 2/3 place of cartridge case length respectively.
Lighter hybrid element 6 can adopt hollow glass ball.Or, can adopt low density material as plastics.Above-mentioned material should be an inertia with respect to drug suspension.The size of above-mentioned light element 6 is determined according to the performance of existing high density components 5, is made that the speed of light hybrid element 6 is the sub-fraction of high density components 5 speed.This speed is the function of element and fluid density, liquid viscosity and component size.The density of suspension can not alter a great deal, and therefore the scope of required low density elements/beads depends primarily on the scope of viscosity.Can estimate suitable component size and density according to better simply calculating.
Below shown some preferred embodiments, but should emphasize, the present invention is not limited to these embodiment, and may be embodied in other ways in the entry contents of stipulating in the following claim.The present invention has been described clearly with reference to subcutaneous injection.But it will be fully understood that the present invention also is applicable to other situations.

Claims (9)

1. device that is used for the storage and the administration of drug suspension, it comprises a container (1) that contains drug suspension, this suspension comprises base liquid and particle (3), it is characterized in that, container (1) comprises that two is the hybrid element (5 that inertia and density have nothing in common with each other with respect to drug suspension, 6), the density that makes the hybrid element of winning (5) is apparently higher than the density of base liquid and apparently higher than abundant mixed density of suspending liquid, and the density of second hybrid element (6) is starkly lower than the density of base liquid and is starkly lower than abundant mixed density of suspending liquid.
2. according to the described device of claim 1, it is characterized in that the container (1) that holds drug suspension is cylindrical cartridge case (1), it seals with an outlet (4) with a movable plunger (2) sealing and in the bottom at the top.
3. according to claim 1 or 2 described devices, it is characterized in that first hybrid element (5) and second hybrid element (6) have identical shaped.
4. according to claim 1 or 2 described devices, it is characterized in that first hybrid element (5) and second hybrid element (6) have difformity.
5. according to the described device of claim 3, it is characterized in that first hybrid element (5) and second hybrid element (6) are hollow
6. according to the described device of claim 3, it is characterized in that first hybrid element (5) and second hybrid element (6) are glass or plastics
Figure C2006800150800002C2
7. according to the described device of claim 6, it is characterized in that first and second hybrid elements have same diameter.
8. according to the described device of claim 6, it is characterized in that first and second hybrid elements (5,6) have different-diameter.
9. according to the described device of claim 1, it is characterized in that the density of first hybrid element (5) and second hybrid element (6) depends on the viscosity of suspension.
CNB2006800150801A 2005-05-03 2006-04-28 Drug suspension and the cartridge case with hybrid element of different densities are housed Expired - Fee Related CN100571802C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP05388039 2005-05-03
EP05388039.9 2005-05-03

Publications (2)

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CN100571802C true CN100571802C (en) 2009-12-23

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US (1) US20080161756A1 (en)
EP (1) EP1890747A1 (en)
JP (1) JP2008539838A (en)
CN (1) CN100571802C (en)
WO (1) WO2006117340A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009097791A1 (en) * 2008-02-01 2009-08-13 Shaolei Guan Cartridge of pen-type insulin injector
EP2394920A1 (en) 2010-06-14 2011-12-14 Nestec S.A. Dispensing container for probiotics
EP3632399B1 (en) * 2011-10-20 2023-11-29 Becton, Dickinson and Company Mixing element for container assemblies
CN112791255A (en) * 2021-03-08 2021-05-14 华中科技大学同济医学院附属协和医院 A new type of retention enema

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EP0745369A2 (en) * 1995-06-02 1996-12-04 Eli Lilly And Company Containers for liquid medicaments
US6379032B1 (en) * 2000-02-18 2002-04-30 Steve Sorensen Flow-through agitator

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US4928857A (en) * 1987-05-15 1990-05-29 Ecker Frederick K Hand operated soap dispenser
EP0745369A2 (en) * 1995-06-02 1996-12-04 Eli Lilly And Company Containers for liquid medicaments
US6379032B1 (en) * 2000-02-18 2002-04-30 Steve Sorensen Flow-through agitator

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CN101171043A (en) 2008-04-30
US20080161756A1 (en) 2008-07-03
JP2008539838A (en) 2008-11-20
EP1890747A1 (en) 2008-02-27
WO2006117340A1 (en) 2006-11-09

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