WO2013098805A1 - Method and device for fast dissolution of solid protein composition - Google Patents

Method and device for fast dissolution of solid protein composition Download PDF

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Publication number
WO2013098805A1
WO2013098805A1 PCT/IL2012/000393 IL2012000393W WO2013098805A1 WO 2013098805 A1 WO2013098805 A1 WO 2013098805A1 IL 2012000393 W IL2012000393 W IL 2012000393W WO 2013098805 A1 WO2013098805 A1 WO 2013098805A1
Authority
WO
WIPO (PCT)
Prior art keywords
closed container
fibrinogen
syringe barrel
seal element
solid
Prior art date
Application number
PCT/IL2012/000393
Other languages
English (en)
French (fr)
Inventor
ILAN.Erez
Kfir Regev
Dana LEITMAN
Israel Nur
Moti Meron
John Goodman
Original Assignee
Omrix Biopharmaceuticals 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 claimed from IL217273A external-priority patent/IL217273A0/en
Priority to MX2014008033A priority Critical patent/MX351980B/es
Priority to HK15104175.2A priority patent/HK1203438B/en
Priority to CA2861722A priority patent/CA2861722C/en
Priority to BR112014016193A priority patent/BR112014016193A8/pt
Priority to EP12815839.1A priority patent/EP2797681B1/en
Priority to RU2014131276/05A priority patent/RU2605710C2/ru
Priority to AU2012360048A priority patent/AU2012360048B2/en
Priority to ES12815839.1T priority patent/ES2621363T3/es
Priority to JP2014549630A priority patent/JP6223999B2/ja
Priority to IN5901DEN2014 priority patent/IN2014DN05901A/en
Application filed by Omrix Biopharmaceuticals Ltd. filed Critical Omrix Biopharmaceuticals Ltd.
Priority to KR1020147021027A priority patent/KR102109317B1/ko
Priority to CN201280070958.7A priority patent/CN104144742B/zh
Publication of WO2013098805A1 publication Critical patent/WO2013098805A1/en
Priority to IL233361A priority patent/IL233361B/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/50—Mixing liquids with solids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/75—Fibrinogen
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle 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
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40—Static mixers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40—Static mixers
    • B01F25/45—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
    • B01F25/451—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture
    • B01F25/4512—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture with reciprocating pistons
    • 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
    • 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
    • B01F33/50112—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 of the syringe or cartridge type
    • 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
    • B01F35/71—Feed mechanisms
    • B01F35/716—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components
    • B01F35/7163—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components the containers being connected in a mouth-to-mouth, end-to-end disposition, i.e. the openings are juxtaposed before contacting the contents
    • 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
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/718—Feed mechanisms characterised by the means for feeding the components to the mixer using vacuum, under pressure in a closed receptacle or circuit system
    • 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
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly

Definitions

  • the high fibrinogen concentration in the solution obtained by dissolving the solid fibrinogen composition in the aqueous solvent is in the range of from about 40 to about 120 mg fibrinogen/ml, such as, for example, about 40, 41, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, or 120 mg fibrinogen /ml.
  • a concentrated fibrinogen solution comprising fibrinogen at a concentration in the range of from about 63 to about 70 mg/ml is obtained. The fibrinogen is substantially completely dissolved.
  • the aqueous solvent comprises water (in some embodiments, at least 50% water by volume) and in some embodiments may optionally comprise additional ingredients such as buffering agents and/or other excipients, such as pharmaceutically acceptable excipients (including, for example, one or more selected from the group consisting of arginine hydrochloride, glycine, sodium chloride, sodium citrate, and calcium chloride).
  • the water can be, for example, BWFI (Racteriostetic Water for Injection), SWFI (Sterile Water for Injection) and the like.
  • the solution is incubated in the container (i.e. allowed to stand prior to use), for example for a time period of no longer than about 2 minutes.
  • a device suitable for dissolving a solid composition in an aqueous solvent comprising a first closed container suitable for holding a first solid composition, the first closed container including a first closed container inlet having a closed state and an open state, wherein in the closed state the first closed container inlet is sealed to the passage of fluid and in the open state the first closed container inlet provides a path for fluid communication into the first closed container.
  • the device further comprises a first movable seal element arranged within the first closed container, for sealing the first closed container and configured to maintain sealing of the first closed container while moving therein between at least a first and a second position within the first closed container, to decrease the internal volume of the first closed container.
  • the device further comprises a holding element configured to releasably hold the first movable seal element in a first position within the first closed container, and a first controller for controlling changing of the first closed container inlet between a closed state and an open state.
  • the device further comprises a second reservoir suitable for holding a second aqueous solvent and a fourth moveable seal element arranged within the second reservoir configured to maintain sealing of the second reservoir, the second reservoir comprising a second fluid outlet adapted to be in fluid communication with the second closed container inlet.
  • Figs. 8 A and B illustrate a side perspective view of the holding element of Fig. 6B located on a housing holding the solid-containing unit.
  • Fig. 14A illustrates a spacer element configured to be positioned on a piston rod according to some embodiments of the present invention.
  • FIG. 2 there is shown a cross-sectional side view of an exemplary device 30, a first syringe barrel 32 having a front end 34 having an inlet 18 and a back end 36, a first moveable seal element 22a arranged within first syringe barrel 32, a holding element 24 for releasably holding first moveable seal element 22a, and a controller 20 for changing inlet 18 from a closed state to an open state.
  • Controller 20 is indirectly or directly connected to a controller actuator 38, which when actuated causes controller 20 to change inlet 18 from a closed state to an open state.
  • First moveable seal element (Fig. 2) 22a comprises a first slideably displaceable piston having a first piston rod 40a extending out of the back end of syringe barrel 32 for operating the first piston.
  • Controller 20 is optionally located between inlet 18 and outlet 46.
  • piston rods 40 a, 40 c of solid-containing unit 52 are mechanically connected via a coupling element 56
  • piston rods 40b, 40d of solvent-containing unit 54 are mechanically connected via a coupling element 58, so that the pair of piston rods in each unit can move in unison.
  • Figure 6B illustrates an exploded view of the solid-containing unit 52 of Figure 6A, wherein piston rods 40a, 40c comprise at least one recess 70 and holding element 24 (optionally positioned directly or indirectly on the back end of solid-containing unit 52 or on housing 64) comprises at least one protrusion, such as at least one bulge 72, wherein recess 70 is configured to reversibly engage bulge 72, such that when device 50 in the initial position, bulge 72 is engaged within recess 70 and holding element 24 holds at least one moveable seal element 22a, 22c in a fixed position to maintain sub-atmospheric pressure within syringe-barrel 32a, 32b of solid-containing unit 52.
  • piston rods 40a, 40c comprise at least one recess 70
  • holding element 24 optionally positioned directly or indirectly on the back end of solid-containing unit 52 or on housing 64
  • recess 70 is configured to reversibly engage bulge 72, such that when device 50 in the initial position, bulge 72 is engaged within rece
  • controller actuator 38 is activated so that controller 20 changes inlets 18a, 18b from a closed position to an open position, such as by removal of a wider concave lower portion 84 of controller 20 from the flow path.
  • Piston rods 40b, 40d of solvent-containing unit 54 are drawn into syringe barrels 44a, 44b due to the difference in pressure between the atmospheric pressure of the surrounding environment and the sub-atmospheric pressure in headspace 16 within syringes 32a, 32b, such that solvent flows from syringe barrels 44a, 44b to syringe barrels 32a, 32b, respectively.
  • a sample of 150 ⁇ from each fibrinogen test solution was diluted 1 :400 with DDW, and OD was measured at 280-320 nm against a DDW blank. The measurement was carried out in acrylic cuvettes (Sarstedt, Germany; Cat. number 67.740) using ULTRASPEC 2100pro spectrophotometer (Amersham Pharmacia Biotech, Sweden).
  • 5 ml of stock solution was diluted with DDW to yield diluted solutions having clottable fibrinogen concentrations of 42, 32, and 21 mg/ml and final volumes of 7.5, 10 and 15 ml, respectively.
  • 5 ml of a control sample comprising fibrinogen stock solution and the final volumes of diluted solutions were each transferred into cylindrical glass cups (diameter: 30 mm height: 25 mm), designed to produce cakes able to fit within a syringe, and subjected to lyophilization according to the cycle described in the Materials and Methods section. In this experiment, the cylindrical glass cups were not capped.
  • the 50 ml syringe was connected to a first connection point of a three way stop cock (Medipharm, UK), a 5 ml syringe (TERUMO, Belgium) containing 5 ml degassed DDW (prepared as described above) was connected to the second connection point of the stop cock, and a 20 ⁇ filter (MDI, India; Cat. number SYPP0611MNXX104) was connected to the third connection point.
  • a 20 ⁇ filter MDI, India; Cat. number SYPP0611MNXX104
  • Method 2 The dissolution was carried out in a similar manner to that described above in Method 1, but with the solution comprising partially dissolved fibrinogen being transferred from one syringe to the other five times and the resulting solution was immediately filtered without any incubation period.
  • the time from the introduction of the degassed DDW until the end of the fifth transfer of the solution between the two syringes was about 30 seconds.
  • the "cakes" of the test samples were then dissolved in DDW at room temperature (22 ⁇ 2°C) to provide solutions having a fibrinogen concentration of 63 mg/ml as follows.
  • 4.4 ml degassed DDW were injected through the rubber cap into the vial containing the "cake", using a 5 ml syringe (Terumo, Belgium) connected to a 23G needle (Medi plus, China), while maintaining the pressure in the vial at the specified sub-atmospheric pressure.
  • the needle was allowed to remain within the rubber cap following the injection.
  • each obtained lyophilized "cake” was fitted into a 12 ml syringe by removing the plunger of the syringe, inserting the "cake” into the barrel of the syringe, and returning the plunger to the barrel.
  • all the obtained cakes were inserted into the same barrel.
  • the 12 ml syringe was connected to a first connection point of a three way stop cock (Medipharm, UK), a second 12 ml containing approximately 3.6 ml degassed DDW (prepared as described in the Materials and Methods section) was connected to the second connection point of the stop cock, and a vacuum pump (KNF Neuberger, Germany) was connected with a vacuum manometer (Fisher Scientific, USA) to the third connection point.
  • a vacuum pump KNF Neuberger, Germany

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Health & Medical Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Mixers With Rotating Receptacles And Mixers With Vibration Mechanisms (AREA)
  • Peptides Or Proteins (AREA)
PCT/IL2012/000393 2011-12-29 2012-12-20 Method and device for fast dissolution of solid protein composition WO2013098805A1 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
CN201280070958.7A CN104144742B (zh) 2011-12-29 2012-12-20 用于固体蛋白质组合物的快速溶解的方法和装置
AU2012360048A AU2012360048B2 (en) 2011-12-29 2012-12-20 Method and device for fast dissolution of solid protein composition
CA2861722A CA2861722C (en) 2011-12-29 2012-12-20 Method and device for fast dissolution of solid protein composition
BR112014016193A BR112014016193A8 (pt) 2011-12-29 2012-12-20 método e dispositivo para dissilução rápida
EP12815839.1A EP2797681B1 (en) 2011-12-29 2012-12-20 Method and device for fast dissolution of solid protein composition
RU2014131276/05A RU2605710C2 (ru) 2011-12-29 2012-12-20 Способ и устройство для быстрого растворения твердой белковой композиции
JP2014549630A JP6223999B2 (ja) 2011-12-29 2012-12-20 固体タンパク質組成物を迅速に溶解させるための方法及び装置
MX2014008033A MX351980B (es) 2011-12-29 2012-12-20 Método y dispositivo para la disolucion rápida de composición sólida de proteinas solidas.
ES12815839.1T ES2621363T3 (es) 2011-12-29 2012-12-20 Método y dispositivo para disolución rápida de composición de proteína sólida
IN5901DEN2014 IN2014DN05901A (forum.php) 2011-12-29 2012-12-20
HK15104175.2A HK1203438B (en) 2011-12-29 2012-12-20 Method and device for fast dissolution of solid protein composition
KR1020147021027A KR102109317B1 (ko) 2011-12-29 2012-12-20 고체 단백질 조성물의 신속한 용해를 위한 방법 및 장치
IL233361A IL233361B (en) 2011-12-29 2014-06-24 Method and device for rapidly dissolving a solid proteinaceous compound

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
IL217273A IL217273A0 (en) 2011-12-29 2011-12-29 Fast dissolution of solid fibrinogen
IL217273 2011-12-29
US201261582524P 2012-01-03 2012-01-03
US61/582,524 2012-01-03
US201261677048P 2012-07-30 2012-07-30
IL22118012 2012-07-30
IL221180 2012-07-30
US61/677,048 2012-07-30

Publications (1)

Publication Number Publication Date
WO2013098805A1 true WO2013098805A1 (en) 2013-07-04

Family

ID=48696437

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2012/000393 WO2013098805A1 (en) 2011-12-29 2012-12-20 Method and device for fast dissolution of solid protein composition

Country Status (13)

Country Link
US (2) US10618950B2 (forum.php)
EP (1) EP2797681B1 (forum.php)
JP (1) JP6223999B2 (forum.php)
KR (1) KR102109317B1 (forum.php)
AU (1) AU2012360048B2 (forum.php)
BR (1) BR112014016193A8 (forum.php)
CA (2) CA3078563A1 (forum.php)
ES (1) ES2621363T3 (forum.php)
IL (1) IL233361B (forum.php)
IN (1) IN2014DN05901A (forum.php)
MX (1) MX351980B (forum.php)
RU (1) RU2605710C2 (forum.php)
WO (1) WO2013098805A1 (forum.php)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017175209A1 (en) * 2016-04-05 2017-10-12 Omrix Biopharmaceuticals Ltd. Device and process for sample preparation
WO2018150375A1 (en) * 2017-02-17 2018-08-23 Baxter International Inc. Devices and methods for forming and delivering a tissue sealant
US10376467B2 (en) 2014-01-20 2019-08-13 Ucb Biopharma Sprl Process for reconstitution of a solid form of a pharmaceutical composition
US10618950B2 (en) 2011-12-29 2020-04-14 Omrix Biopharmaceuticals Ltd. Method and device for fast dissolution of solid protein composition

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170274012A1 (en) * 2014-09-03 2017-09-28 Entegrion, Inc. Acceleration of Reconstitution of Plasma Powder by Mixing with Small Beads
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
USD877891S1 (en) 2015-12-22 2020-03-10 Guangzhou Bioseal Biotech Co., Ltd. Reconstitution and delivery device
USD877890S1 (en) 2015-12-22 2020-03-10 Guangzhou Bioseal Biotech Co., Ltd. Reconstitution device
US10918790B2 (en) * 2015-12-22 2021-02-16 Guangzhou Bioseal Biotech Co., Ltd. Dual syringe with funnel feeding kit
USD829888S1 (en) * 2015-12-22 2018-10-02 Guangzhou Bioseal Biotech Co., Ltd. Reconstitution and delivery device
US11071782B2 (en) * 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
US10150115B2 (en) * 2016-07-21 2018-12-11 Spacepharma SA System and method for rehydrating powder and delivering the rehydrated powder to a reactor
US11717797B2 (en) 2017-07-06 2023-08-08 Plas-Tech Engineering, Inc. Systems and methods related to fluid pumping
WO2023119277A1 (en) 2021-12-21 2023-06-29 Omrix Biopharmaceuticals Ltd. Highly soluble fibrinogen compositions

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3052240A (en) * 1959-01-29 1962-09-04 Silver Disposable hypodermic syringe
US3405712A (en) * 1966-02-07 1968-10-15 Richard L. Pierick Desiccative syringe
US5122117A (en) * 1990-06-05 1992-06-16 Habley Medical Technology Corp. Component mixing syringe
DE20216631U1 (de) * 2002-10-28 2004-03-11 Haindl, Hans, Dr.med. Selbstentlüftende Spritze für das Mischen von flüssigen und pulverförmigen Substanzen
DE102005017985A1 (de) * 2005-04-19 2006-10-26 Theo Arnitz Verfahren und Vorrichtungen zum Auflösen von Medikamenten für Injektionen
US20110196342A1 (en) * 2008-01-01 2011-08-11 Rudolf Matusch Disposable injector with dual-piston dual-chamber system

Family Cites Families (41)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT366916B (de) * 1980-04-02 1982-05-25 Immuno Ag Vorrichtung zur applikation eines gewebeklebstoffes auf basis von menschlichen oder tierischenproteinen
AT371719B (de) 1980-08-25 1983-07-25 Immuno Ag Verfahren und vorrichtung zur beschleunigung des aufloesens von schwerloeslichen lyophilisierten arzneimitteln
DE3203775A1 (de) 1982-02-04 1983-08-11 Behringwerke Ag, 3550 Marburg Fibrinogenzubereitung, verfahen zu ihrer herstellungund ihre verwendung
US4610666A (en) * 1985-06-24 1986-09-09 Pizzino Joanne L Dual syringe
US4742128A (en) * 1985-10-15 1988-05-03 Stamicarbon B.V. Process for preparing a polymer alloy, molded product, and reaction injection molded products
US4978336A (en) * 1987-09-29 1990-12-18 Hemaedics, Inc. Biological syringe system
AT397203B (de) 1988-05-31 1994-02-25 Immuno Ag Gewebeklebstoff
AT392972B (de) 1988-08-16 1991-07-25 Chemiefaser Lenzing Ag Verfahren zur herstellung von loesungen von cellulose sowie einrichtung zur durchfuehrung des verfahrens
SU1697836A1 (ru) 1989-01-24 1991-12-15 Московский научно-исследовательский онкологический институт им.П.А.Герцена Устройство дл смешивани и введени жидких быстроструктурирующихс компонентов
US5181909A (en) * 1991-05-15 1993-01-26 Mcfarlane Richard H Ampule-container medical syringe and methods
US5792835A (en) * 1991-09-05 1998-08-11 Baxter International Inc. Method of preparing a topical fibrinogen complex
EP0534178B1 (en) 1991-09-27 2001-04-18 Omrix Biopharmaceuticals S.A. Improved tissue glue prepared by using cryoprecipitate
JP3063935B2 (ja) 1992-05-12 2000-07-12 宇部興産株式会社 接着性、耐熱性および耐カ−ル性を兼ね備えたポリイミドシロキサン組成物
US5599790A (en) * 1992-06-11 1997-02-04 The Scripps Research Institute Fibrinogen γ chain polypeptide and compositions thereof
US5330974A (en) * 1993-03-01 1994-07-19 Fibratek, Inc. Therapeutic fibrinogen compositions
AT400675B (de) * 1993-10-18 1996-02-26 Immuno Ag Spritzengarnitur zur aufbewahrung und applikation eines mehrkomponentenmaterials, spritzenvorrichtung und betätigungseinrichtung hiefür sowie verfahren zum herstellen einer befüllten, sterilen spritzenvorrichtung
US6599515B1 (en) * 1995-01-16 2003-07-29 Baxter International Inc. Fibrin porous structure
US6965014B1 (en) * 1996-01-16 2005-11-15 Baxter International Inc. Fibrin material and method for producing and using the same
WO1997033633A1 (fr) 1996-03-15 1997-09-18 Juridical Foundation The Chemo-Sero-Therapeutic Research Institute Adhesif pour tissus, applique par pulverisation
DE19617369A1 (de) 1996-04-30 1997-11-06 Immuno Ag Lagerstabile Fibrinogen-Präparate
FR2749169B1 (fr) 1996-06-04 1998-08-21 Delab Procede pour constituer une preparation injectable et dispositif pour la mise en oeuvre de ce procede
JP3063935U (ja) * 1999-05-17 1999-12-10 川澄化学工業株式会社 二液同時混合注出器及びプランジャ結合部材
WO2002018546A2 (en) * 2000-09-01 2002-03-07 Virginia Commonwealth University Intellectual Property Foundation Plasma-derived-fibrin-based matrices and tissue
SK288005B6 (sk) 2001-05-21 2012-10-02 Omrix Biopharmaceuticals S. A. In vitro method for specifically removing or isolating plasminogen or plasmin and support used in this method
DE10211227A1 (de) 2002-03-13 2003-10-02 Aventis Behring Gmbh Verfahren zur Rekonstitution von Iyophilisierten Proteinen
AU2003265511A1 (en) * 2002-08-21 2004-03-11 Pharmacia Corporation Injectable pharmaceutical suspension in a two-chamber vial
EP1592373B1 (en) * 2003-01-30 2013-04-24 ProChon Biotech Ltd. Freeze-dried fibrin matrices and methods for preparation thereof
US6669667B1 (en) * 2003-04-11 2003-12-30 Jih-Hsiung Yang Safety syringe
HRP20140442T1 (hr) * 2003-06-23 2014-07-04 Kiacta Sàrl Metoda za pripremu spoja 1,3-propan disulfonske kiseline
WO2006124634A1 (en) * 2005-05-16 2006-11-23 Mallinckrodt Inc. Multi-barrel syringe having integral manifold
CA2632608C (en) 2006-01-17 2013-08-06 Baxter International Inc. Device, system and method for mixing
DE102006009611A1 (de) 2006-03-02 2007-09-06 Bernd Hansen System zum Zubereiten und Bereitstellen eines durch Vermischen einer Trockensubstanz mit einem Fluid gebildeten fließfähigen Mediums
US8322637B2 (en) * 2006-11-02 2012-12-04 Omrix Biopharmaceuticals Ltd. Method of micronization
US20080221584A1 (en) * 2007-03-06 2008-09-11 Downer David A Lens Delivery System
JP5393447B2 (ja) 2007-03-22 2014-01-22 一般財団法人化学及血清療法研究所 固体状フィブリノゲン製剤
US20090198211A1 (en) * 2008-02-06 2009-08-06 Intravena, Llc Convenience IV kits and methods of use
US8512740B2 (en) * 2008-03-26 2013-08-20 Baxter International Inc. Fibrin foam and process for making
JP5264545B2 (ja) * 2008-06-16 2013-08-14 テルモ株式会社 液体混合方法
JP5318684B2 (ja) * 2009-07-14 2013-10-16 テルモ株式会社 シリンジおよびシリンジ連結体
EP2475308A1 (en) * 2009-09-08 2012-07-18 Baxter International Inc Reconstitution and applicator system for wound sealant product
WO2013098805A1 (en) 2011-12-29 2013-07-04 Omrix Biopharmaceuticals Ltd. Method and device for fast dissolution of solid protein composition

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3052240A (en) * 1959-01-29 1962-09-04 Silver Disposable hypodermic syringe
US3405712A (en) * 1966-02-07 1968-10-15 Richard L. Pierick Desiccative syringe
US5122117A (en) * 1990-06-05 1992-06-16 Habley Medical Technology Corp. Component mixing syringe
DE20216631U1 (de) * 2002-10-28 2004-03-11 Haindl, Hans, Dr.med. Selbstentlüftende Spritze für das Mischen von flüssigen und pulverförmigen Substanzen
DE102005017985A1 (de) * 2005-04-19 2006-10-26 Theo Arnitz Verfahren und Vorrichtungen zum Auflösen von Medikamenten für Injektionen
US20110196342A1 (en) * 2008-01-01 2011-08-11 Rudolf Matusch Disposable injector with dual-piston dual-chamber system

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10618950B2 (en) 2011-12-29 2020-04-14 Omrix Biopharmaceuticals Ltd. Method and device for fast dissolution of solid protein composition
US10376467B2 (en) 2014-01-20 2019-08-13 Ucb Biopharma Sprl Process for reconstitution of a solid form of a pharmaceutical composition
WO2017175209A1 (en) * 2016-04-05 2017-10-12 Omrix Biopharmaceuticals Ltd. Device and process for sample preparation
US10466258B2 (en) 2016-04-05 2019-11-05 Omrix Biopharmaceuticals Ltd. Device and process for sample preparation
US11009513B2 (en) 2016-04-05 2021-05-18 Omrix Biopharmaceuticals Ltd. Device and process for sample preparation
US20210263053A1 (en) * 2016-04-05 2021-08-26 Omrix Biopharmaceuticals Ltd. Device and process for sample preparation
US12203947B2 (en) * 2016-04-05 2025-01-21 Omrix Biopharmaceuticals Ltd. Device and process for sample preparation
WO2018150375A1 (en) * 2017-02-17 2018-08-23 Baxter International Inc. Devices and methods for forming and delivering a tissue sealant

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US11634473B2 (en) 2023-04-25
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