DK157331B - PROCEDURE FOR PROGRESSING SOLUTION OF SOLVENTLY LYOFILIZED MEDICINAL PRODUCTS AND CONTINUING THE IMPLEMENTATION OF THE PROCEDURE. - Google Patents
PROCEDURE FOR PROGRESSING SOLUTION OF SOLVENTLY LYOFILIZED MEDICINAL PRODUCTS AND CONTINUING THE IMPLEMENTATION OF THE PROCEDURE. Download PDFInfo
- Publication number
- DK157331B DK157331B DK351481A DK351481A DK157331B DK 157331 B DK157331 B DK 157331B DK 351481 A DK351481 A DK 351481A DK 351481 A DK351481 A DK 351481A DK 157331 B DK157331 B DK 157331B
- Authority
- DK
- Denmark
- Prior art keywords
- procedure
- magnetic
- sterile
- container
- final container
- Prior art date
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Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F21/00—Dissolving
-
- 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
- B01F33/45—Magnetic mixers; Mixers with magnetically driven stirrers
- B01F33/452—Magnetic mixers; Mixers with magnetically driven stirrers using independent floating stirring elements
-
- 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
- B01F35/90—Heating or cooling systems
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- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Materials For Medical Uses (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
Description
DK 157331 BDK 157331 B
Den foreliggende opfindelse angàr en fremgangsmàde til at fremskynde oplosningen af tungt oploselige lyofiliserede læge-midler pà basis af proteiner, især human-proteiner under stérile betingelser.The present invention relates to a method of accelerating the dissolution of heavily soluble lyophilized drugs on the basis of proteins, especially human proteins under sterile conditions.
55
Ifolge DE-patentskrift 839.269 kendes et magnetisk drevet ra-reværk, ved hvilket der i en rerebeholder er anbragt et ferro-magnetisk jernlegeme, der kan sættes i rotation ved hjælp af en uden for beholderen anbragt permanent magnet. Ved hjælp af 10 et sàdan roreværk kan f.eks. oplesningen af stevformede medier i et oplosningsmiddel accelereres.According to DE-patent specification 839,269, a magnetically driven raw material is known, in which a ferro-magnetic iron body is arranged in a riser container which can be rotated by means of a permanent magnet placed outside the container. With the help of such a rudder, e.g. the solution of stiff media in a solvent is accelerated.
Forskellige proteinpræparater, der skal anvendes som lægemid-ler, lagres i slutbeholdere i fast form, fortrinsvis i lyofi-15 liseret form; fer anvendelse skal de opleses under stérile forhold, hvorunder oplesningen skal ske hurtigt, og præparatet skal skânes.Various protein preparations to be used as drugs are stored in final containers in solid form, preferably in lyophilized form; For use, they must be read under sterile conditions, under which the readings must be rapid, and the preparation scanned.
Denne procès har hidtil givet vanskeligheder, fordi der enten 20 der, hvor lægemidlet benyttes, ikke stâr en steril bank med det tiIstrækkelige udstyr til râdighed eller fordi der ved den manuelle rystning af beholderen med oplesningsmidlet dannes skum, der sætter sig dàrligt eller overhovedet ikke. Denne skumdannelse er ogsâ skadelig for proteinernes struktur; for 25 det er kendt, at der derved kan opstâ ændringer i protein- strukturen, henholdsvis en delvis nedbrydn i ng. Skumdannelsen har ogsâ den ulempe, at den oplosning, der skal indgives, kun kan doseres unojagtigt, henholdsvis kan luft i præparatet fuldstændig umuliggore injektionen. I brugsanvisningerne for 30 oplosningen anbefales dermed for det meste en forsigtig sving-ning af beholderen med oplesemediet, hvilket tager en tilsva-rende lang tid.This process has so far caused difficulties because either 20 where the drug is used does not have a sterile bank with the sufficient equipment available or because the manual shaking of the container with the solvent creates foam that settles poorly or not at all. This foaming is also detrimental to the structure of the proteins; for it is known that thereby, changes in the protein structure, or partial degradation in ng, can occur. The foaming also has the disadvantage that the solution to be administered can only be dosed inaccurately, or air in the preparation can make the injection completely impossible. Thus, in the instructions for use of the solution, a cautious oscillation of the container with the solvent is usually recommended, which takes a correspondingly long time.
Opfindelsen har til opgave at undgâ disse mangler og vanske-35 1 igheder og har til formàl at anvise en f remgangsmàde, ved hvilken det bliver muligt pâ enkel mâde hurtigt og skânende at hândtere tungt oploselige lyofiliserede lægemidler pâ basis af proteiner, hvorved oplesningen accelereres og steriliteten be-vares fra aftapningstidspunktet til anvendelsestidspunktet.The invention has the object of avoiding these deficiencies and difficulties and aims to provide a method by which it is possible in a simple way to handle rapidly and scantily soluble lyophilized drugs based on proteins, whereby the solution is accelerated and the sterility is maintained from the time of bottling to the time of use.
22
DK 157331 BDK 157331 B
Dette formâl tilgodeses ved, at den indledningsvist omtalte fremgangsmâde ifolge opfindelsen er ejendommelig ved, at der for hurtigere oplosning af lægemidlet i en siutbeholder for ifyldningsgodsets lyofi1isering under stérile betingelser ind-5 fores et magnetisk, henholdsvis et magnetiserbart legeme, og at slutbeholderen efter tilsætning af et sterilt oplosnings-middel til det lyofiliserede fyldgods pà i og for sig kendt màde anbringes i omràdet for et magnetisk drejefelt, hvorpâ det magnetiserede, henholdsvis magnetiserbare legeme sættes i 10 bevægelse.This object is met by the fact that the method of the invention according to the invention mentioned above is characterized in that a magnetic or a magnetizable body, respectively, is introduced for faster dissolution of the drug into a sieve container for lyophilization of the filling material and the final container after addition of a sterile solvent for the lyophilized filler in a manner known per se is placed in the region of a magnetic pivot field upon which the magnetized or magnetizable body is respectively moved.
Fortrinsvis benyttes der som magnetisk legeme en lille stav af ikke-rustende eller plastbetrukket ferritisk materiale.Preferably, as a magnetic body, a small rod of non-rusting or plastic-coated ferritic material is used.
15 Opfindelsen angâr ogsâ en slutbeholder til at gennemfore frem-gangsmâden ifolge krav 1 eller 2 og indeholdende et tungt oploseligt lyofi1iseret, sterilt Isgemiddel pà basis af pro-teiner, isaer human proteiner ejendommelig ved, at der i fyld-godset er indesluttet et sterilt magnetisk legeme, fortrinsvis 20 en lille stav af ikke-rustende eller plastovertrukket ferritisk materiale.The invention also relates to a final container for carrying out the method according to claim 1 or 2 and containing a heavily soluble lyophilized sterile lubricant based on proteins, in particular human proteins characterized in that a sterile magnetic material is included in the filling material. body, preferably a small rod of non-rusting or plastic-coated ferritic material.
En foretrukken udforelsesform for fremgangsmâden ifolge opfindelsen under anvendelse af en slutbeholder ifolge opfindelsen 25 forklares nærmere nedenfor under henvisning til tegningen, hvorpâ fig. 1 viser et lodret snit gennem indretningen og 30 fig. 2 viser indretningen set fra oven.A preferred embodiment of the method according to the invention using a final container according to the invention is explained in more detail below with reference to the drawing, in which fig. 1 shows a vertical section through the device and FIG. 2 shows the device from above.
I et hus 1 er der indesluttet en opvarmelig blok af ikke-magnetisk materiale, fortrinsvis aluminium, og sikret ved hjælp af en tætningsliste 1'. Blokken udviser flere optageâb-35 ninger 3, 3', 3'’... med lukkede bunde 4, 4", 4'1... Optageâb-ningerne har forskellig diameter afhængig af storrelsen af de pà taie kommende beholdere henholdsvis slutbeholdere. En eller flere optageâbninger, nemlig de med henvisningstallet 3 beteg- 3In a housing 1, a heatable block of non-magnetic material, preferably aluminum, is enclosed and secured by a sealing strip 1 '. The block exhibits multiple receptacles 3, 3 ', 3' '... with closed bottoms 4, 4 ", 4'1 ... The receptacles have different diameters depending on the size of the upcoming containers and final containers, respectively. One or more recording openings, namely those designated by reference numeral 3
DK 157331 BDK 157331 B
nede, ligger i omrâdet af et magnetisk drejefelt. I disse op-tageàbninger 3 kan der indsættes en indsatsring 5, hvis indre diameter svarer tîl den ydre diameter af en standardiseret slutbeholder. I indsatsringen 5 er siutbeholderen 6 indsat.down, lies in the area of a magnetic turning field. In these apertures 3, an insert ring 5 can be inserted, the inner diameter of which corresponds to the outer diameter of a standardized final container. In the insert ring 5, the sieve container 6 is inserted.
5 I indsatsringens indre væg er der indlagt en fastholdeindret-ning 7, fortrinsvis et fjedrende snaporgan, der forhindrer siutbeholderen 6 i at dreje. Nedenfor blokken 2 er en permanent magnet 8 fastgjort pâ en aksel 9, der drives via en pâ et 10 stativ 11 fastgjort motor 10. Ved drivning af akselen opstàr det magnetiske drejefelt inden for optageâbningen og slutbe-holderen 6. I slutbeholderen befinder det lyofi1iserede pro-teinpræparat 12 sig, hvori der under beholderens fyldning og under stérile betingelser er blevet anbragt et magnetiserbart 15 legeme, især en lille stav 13 af îkke-rustende eller plasto-vertrukket ferritisk materiale. Blokken 2's opvarmning sker via en opvarmningsstav 14. En de! af de med 3', 3'* ... beteg-nede optageâbninger kan ligeledes udstyres med en rereindret-ning som beskrevet, en anden del kan anvendes til at oplese 20 mindre folsomme præparater.5 In the inner wall of the insert ring is provided a restraint device 7, preferably a resilient snap member, which prevents the sieve container 6 from turning. Below the block 2, a permanent magnet 8 is attached to a shaft 9, which is driven via a motor 10 fixed on a stand 11. When driving the shaft, the magnetic turning field arises within the receiving opening and the end container 6. The lyophilized product is located in the end container. Initial composition 12, wherein a magnetizable body, particularly a small rod 13 of non-corrosive or plastic-coated ferritic material, has been placed under the filling of the container and under sterile conditions. Block 2's heating takes place via a heating rod 14. And they! of the 3 ', 3' * ... designated apertures may also be equipped with a cleaning device as described, another portion may be used to read 20 less sensitive compositions.
Til anskueliggorelse af opfindelsen tjener folgende eksempel:The following example serves to illustrate the invention:
Der fremstilles et til lukning af sâr beregnet fibrinklæbemid-25 del pâ basis af human-proteiner med et indhold af fibrinogen og faktor XIII i flydende form, det sterilfiltreres og fyldes i en steriliseret slutbeholder, hvori der i forvejen var blevet indlagt en steriliseret lille stav af ferritisk materiale. Derpâ fryseterres det i slutbeholderen tiIstedeværende præpa-30 rat, hvorved den lille stav blev indesluttet i den faste masse. Efter lagring og fer præparatets applikation indfertes med en injektionssprejte sterilt, destilleret vand i slutbeholderen, og beholderen blev indsat i indsatsringen, sâledes som vist i fig. 1. Sâ sættes permanentmagneten 8 i bevægelse 35 ved tilkobling af motoren, hvorved der danner sig et dreje felt, der nàr ind i slutbeholderen og sætter staven 13 i rotation. Under samtidig opvarmning sker oplesningen hurtigt og uden skumdannelse. Under hele oplesningsprocessen opret-holdes stérile betingelser.A fibrin adhesive composite prepared for closure of human proteins having a fibrinogen content and factor XIII in liquid form is prepared, sterilized and filled into a sterilized final container in which a previously sterilized small rod has been inserted. of ferritic material. There, the preparation present in the final container is frozen, thereby enclosing the small rod in the solid mass. After storage and application of the preparation, sterile distilled water was injected into the final container with an injection syringe and the container was inserted into the insert ring as shown in FIG. 1. Then the permanent magnet 8 is set in motion 35 when the motor is switched on, thereby forming a rotating field which reaches into the final container and rotates the rod 13. During simultaneous heating, the readings take place quickly and without foaming. During the entire reading process, sterile conditions are maintained.
Claims (3)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AT428980 | 1980-08-25 | ||
AT0428980A AT371719B (en) | 1980-08-25 | 1980-08-25 | METHOD AND DEVICE FOR ACCELERATING THE DISOLDERING OF SLAVE-LYOPHILIZED MEDICINAL PRODUCTS |
Publications (3)
Publication Number | Publication Date |
---|---|
DK351481A DK351481A (en) | 1982-02-26 |
DK157331B true DK157331B (en) | 1989-12-18 |
DK157331C DK157331C (en) | 1990-05-14 |
Family
ID=3562079
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK351481A DK157331C (en) | 1980-08-25 | 1981-08-07 | PROCEDURE FOR PROGRESSING SOLUTION OF SOLVENTLY LYOFILIZED MEDICINAL PRODUCTS AND CONTINUING THE IMPLEMENTATION OF THE PROCEDURE. |
Country Status (14)
Country | Link |
---|---|
JP (1) | JPS5789863A (en) |
AR (1) | AR224086A1 (en) |
AT (1) | AT371719B (en) |
BE (1) | BE890002A (en) |
CA (1) | CA1182444A (en) |
CH (1) | CH659394A5 (en) |
DE (1) | DE3129995C2 (en) |
DK (1) | DK157331C (en) |
ES (1) | ES504858A0 (en) |
FR (1) | FR2488802A1 (en) |
GB (1) | GB2082929B (en) |
IT (1) | IT1137641B (en) |
NL (1) | NL189799C (en) |
SE (2) | SE8104544L (en) |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3308892A1 (en) * | 1983-03-12 | 1984-09-13 | Vereinigte Aluminium-Werke AG, 1000 Berlin und 5300 Bonn | HEATABLE MAGNETIC STIRRER FOR HIGH TEMPERATURE DIGESTIONS |
DE3439654C2 (en) * | 1984-10-30 | 1987-02-26 | Brauerei Beck GmbH & Co, 2800 Bremen | Device for evenly distributing yeast particles in yeast-containing beer |
AT382783B (en) * | 1985-06-20 | 1987-04-10 | Immuno Ag | DEVICE FOR APPLICATING A TISSUE ADHESIVE |
AT397203B (en) * | 1988-05-31 | 1994-02-25 | Immuno Ag | FABRIC ADHESIVE |
DE4017868A1 (en) * | 1990-06-02 | 1990-10-31 | Siegfried Dipl Phys Stiller | Mixing chamber - for dilution and haemolysis of blood free from air bubbles |
JPH06312009A (en) * | 1993-04-28 | 1994-11-08 | Daiichi Rajio Isotope Kenkyusho:Kk | Radioactive medicine heating apparatus |
DE4406217C2 (en) * | 1994-02-25 | 1997-04-17 | Janke & Kunkel Kg | Magnetic stirrer with a housing |
US5529391A (en) * | 1994-09-22 | 1996-06-25 | Duke University | Magnetic stirring and heating/cooling apparatus |
US5549382A (en) * | 1995-04-27 | 1996-08-27 | Correia, Ii; Bernard A. | Stirrer for food preparation |
DE19617369A1 (en) * | 1996-04-30 | 1997-11-06 | Immuno Ag | Storage-stable fibrinogen preparations |
US5899567A (en) * | 1997-09-23 | 1999-05-04 | Morris, Jr.; Joseph E. | Magnetic synchronized stirring and heating test apparatus |
US6382827B1 (en) * | 2000-11-01 | 2002-05-07 | Dade Behring Inc. | Method and apparatus for mixing liquid solutions using a rotating magnet to generate a stirring vortex action |
US6467946B1 (en) * | 2001-04-24 | 2002-10-22 | Dade Microscan Inc. | Method and apparatus for mixing liquid samples in a container using rotating magnetic fields |
US20030119060A1 (en) | 2001-08-10 | 2003-06-26 | Desrosiers Peter J. | Apparatuses and methods for creating and testing pre-formulations and systems for same |
CN101678086B (en) | 2007-03-22 | 2013-07-10 | 财团法人化学及血清疗法研究所 | Solid fibrinogen preparation |
JP6223999B2 (en) | 2011-12-29 | 2017-11-01 | オムリックス・バイオファーマシューティカルズ・リミテッドOmrix Biopharmaceuticals Ltd. | Method and apparatus for rapidly dissolving solid protein compositions |
TWI590817B (en) * | 2015-10-14 | 2017-07-11 | 鈺邦科技股份有限公司 | Impregnation apparatus and impregnation method |
CN113576756A (en) * | 2021-07-15 | 2021-11-02 | 伊索曼(中山)医疗器械有限公司 | Method for improving structural uniformity of freeze-dried dressing |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE498056A (en) * | 1949-03-25 | |||
FR1200467A (en) * | 1958-06-25 | 1959-12-22 | Rech S Et De Controle Du Caout | Stirring and thermal regulation device, particularly applicable in laboratories |
GB921719A (en) * | 1960-05-06 | 1963-03-20 | Nat Res Dev | Improvement in magnetic stirrers |
US3356346A (en) * | 1966-01-03 | 1967-12-05 | Landsberger Kurt | Test tube stirring support |
CA1072538A (en) * | 1975-07-03 | 1980-02-26 | Leonard E. Brown | Bottom supported magnetic stirring element |
US3997272A (en) * | 1975-12-15 | 1976-12-14 | Varian Associates | Magnetic stirrer improvement |
SE397637B (en) * | 1976-03-09 | 1977-11-14 | Wik G | MAGNETOMRORARE |
-
1980
- 1980-08-25 AT AT0428980A patent/AT371719B/en not_active IP Right Cessation
-
1981
- 1981-07-24 SE SE8104544A patent/SE8104544L/en unknown
- 1981-07-29 DE DE3129995A patent/DE3129995C2/en not_active Expired
- 1981-08-04 CA CA000383132A patent/CA1182444A/en not_active Expired
- 1981-08-05 NL NLAANVRAGE8103695,A patent/NL189799C/en not_active IP Right Cessation
- 1981-08-07 DK DK351481A patent/DK157331C/en not_active IP Right Cessation
- 1981-08-12 GB GB8124601A patent/GB2082929B/en not_active Expired
- 1981-08-18 BE BE0/205701A patent/BE890002A/en not_active IP Right Cessation
- 1981-08-20 ES ES504858A patent/ES504858A0/en active Granted
- 1981-08-20 FR FR8116002A patent/FR2488802A1/en active Granted
- 1981-08-24 CH CH5442/81A patent/CH659394A5/en not_active IP Right Cessation
- 1981-08-24 AR AR286518A patent/AR224086A1/en active
- 1981-08-24 IT IT23609/81A patent/IT1137641B/en active
- 1981-08-24 JP JP56133224A patent/JPS5789863A/en active Granted
-
1991
- 1991-11-14 SE SE9103372A patent/SE510742C2/en not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
SE8104544L (en) | 1982-02-26 |
JPS5789863A (en) | 1982-06-04 |
NL8103695A (en) | 1982-03-16 |
IT1137641B (en) | 1986-09-10 |
SE510742C2 (en) | 1999-06-21 |
DE3129995A1 (en) | 1982-05-27 |
DK157331C (en) | 1990-05-14 |
CH659394A5 (en) | 1987-01-30 |
GB2082929B (en) | 1985-02-27 |
ES8303111A1 (en) | 1983-02-01 |
IT8123609A0 (en) | 1981-08-24 |
SE9103372D0 (en) | 1991-11-14 |
AT371719B (en) | 1983-07-25 |
FR2488802A1 (en) | 1982-02-26 |
BE890002A (en) | 1981-12-16 |
CA1182444A (en) | 1985-02-12 |
GB2082929A (en) | 1982-03-17 |
NL189799B (en) | 1993-03-01 |
JPS6353823B2 (en) | 1988-10-25 |
ATA428980A (en) | 1982-12-15 |
SE9103372L (en) | 1991-11-14 |
FR2488802B1 (en) | 1985-01-04 |
DK351481A (en) | 1982-02-26 |
AR224086A1 (en) | 1981-10-15 |
ES504858A0 (en) | 1983-02-01 |
DE3129995C2 (en) | 1987-01-15 |
NL189799C (en) | 1993-08-02 |
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AHB | Application shelved due to non-payment | ||
PUP | Patent expired |