CA1182444A - Method of accelerating the dissolution of a hard- soluble lyophilized medicament using a magnetic stirrer - Google Patents
Method of accelerating the dissolution of a hard- soluble lyophilized medicament using a magnetic stirrerInfo
- Publication number
- CA1182444A CA1182444A CA000383132A CA383132A CA1182444A CA 1182444 A CA1182444 A CA 1182444A CA 000383132 A CA000383132 A CA 000383132A CA 383132 A CA383132 A CA 383132A CA 1182444 A CA1182444 A CA 1182444A
- Authority
- CA
- Canada
- Prior art keywords
- container
- lyophilized
- magnetic body
- magnetic
- dissolution
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
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
Landscapes
- 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)
Abstract
ABSTRACT OF THE DISCLOSURE:
In a method of accelerating the dissolution of hard-soluble lyophilized medicaments based on proteins, a magnetic body is introduced into an end container under sterile conditions prior to the lyophilization of the batch. The end container is brought into the region of a magnetic rotary field after addition of a solvent to the lyophilized batch, whereupon the magnetic body is set in motion. An arrangement for carrying out the method includes a heatable block of anti-magnetic material with one or more accommodation openings for the end containers. A rotating magnetic stirrer is installed below the accommodation openings.
In a method of accelerating the dissolution of hard-soluble lyophilized medicaments based on proteins, a magnetic body is introduced into an end container under sterile conditions prior to the lyophilization of the batch. The end container is brought into the region of a magnetic rotary field after addition of a solvent to the lyophilized batch, whereupon the magnetic body is set in motion. An arrangement for carrying out the method includes a heatable block of anti-magnetic material with one or more accommodation openings for the end containers. A rotating magnetic stirrer is installed below the accommodation openings.
Description
The invention relates to a method of accelerating the dissolution of hard-soluble lyophilized medicaments based on proteins, in particular human proteins.
Various protein preparations to be used as medicaments are stored in solid Eorm, preferably in lyophilized form, in end containers; they have to be dissolved under sterile con-ditions prior to their applieation, the dissolution having to take place rapidly and the preparation having to be protected.
So far, this proeedure has involved difficulties, since with the frequently applied manual shaking of the con-tainer with the dissolution medium foam forms, which does hardly, or not at all, subside. This foam formation is also detrimental to the structure of the proteins; for, it is known that thereby changes in the protein structure or a partial decomposition may occur. The foam formation also has the dis-advantage that the solution to be applied can be dosed only inaccurately, and air in the preparation can render the injec-tion completely impossible. In the directions for the dissolu-tion a cautious pivoting of the con-tainer with the dissolution medium is therefore mostly recommended, which is accordingly time-consuming.
The invention aims at a~oiding these disadvantages and difficulties and has as its object to provide a method by which a gentle and quick dissolution of hard-soluble solid pro-tein preparations under sterile conditions is facilitated whilst avoiding foam formation involving the disadvantageous conse-~uences describecl.
The invention provides a method of handling and accelerating the dissolution of hard to dissolve lyophilized medicament comprising human proteins, comprising the steps of, -introduciny a sterile medicament in liquid form into a container containing a magnetic body under sterile conditions;
4~
-lyophilizing the liquid in the container so as to obtain a solid lyophilized medicament;
-storing the sterile container containing the lyophilized medicament and magnetic body;
-adding a sterile solvent to said container;
-subjecting the container to a rotating magnetic field to set the magnetic body in motion; and -maintaining the magnetic body in motion by means of said magnetic field until the lyophilized medicament is dissolved.
The invention thus also covers an end container fox the hard-soluble lyophilized medicament, wherein a sterile magnetic body, advantageously a little rod of stainless or plastic-covered ferritic material, is enclosed in the batch.
The invention furthermore relates to an arrangement for carrying out the method of the invention, which arrangement comprises a heatable block of antimagnetic material having one or more accommodation openings for accommodating end containers containing a lyophilized batch and is characterized in that below the accommodation openings a rotating magnetic stirrer is installed.
A prefe~red embodiment consists in that insert rings of antimagnetic material are insertable into the ac~ommodation openings of the block, whose inner diameters are adapted to the dimensions of standardized end containers, wherein fixing means for the containers, preferably spring-loaded catches, are pro-vided in the inner walls of the insert rings.
The invention will now be explained in more detail by way of one embodiment with reference to the accompanying draw-ings, wherein:
Figure 1 is a vertical section of the arrangement according to the invention, and , i ~L829~
Fig. 2 is a top view of the arrangement of the inven-tion.
In a casing 1 a heatable block 2 of antimagnetic ma-terial, preferably aluminium, is enclosed and secured by a seal ledge 1'. The block has several accommodation openings 3, 3', 3", ~... with closed bottoms 4, 4', 4", ....
The accommodation openings have different diameters acco~na to the sizes of the containers or end containers in question.
One or more accommodation openings, in the Example that de-noted by 3, lie in the region of a magnetic rotary field.Into this accommodation opening 3 an insert ring 5 is inser-table, whose inner diameter corresponds to the outer diameter o~ a standardized end container. An end container 6 is in-serted into the insert ring 5.
According to an advantageous embodiment a fixing means 7, preferably a spring-loaded catch, is incorporated in the inner wall of the insert ring, preventing a rotation of the end container 6. ~elow the block 2 a permanent magnet 8 is fastened on a shaft 9, which is driven by a motor 10 fastened on rods 11. By driving the shaft the magnetic ro-tary field is formed within the accommodation opening 3 and the end container 6. In the end container there is the lyophilized pro-tein preparation 12, into which a magnetiz-able body, in particular a little rod 13 of stainless or plastic-covered ferritic material, was introduced during ~illing of the container under sterile conditions. The heating of the block 2 ~s effected by a heating rod 14. Part of the accommodation openings designed by 3', 3", ... may also be equipped with stirring means as described, another part may be used for dissolving less sensible preparations.
The following Example serves for illustrating the invention:
A fibrin adhesive destined for the sealing of wounds, based on human proteins and having a con-tent oE fibrinogen and factor XIII is prepared in liquid form, sterile filtered and filled into a sterilized end container into which a sterilized rod of ferritic material had previously been in-serted. Then the preparation present in the end con-tainer is freeze-dried with the rod being enclosed in the solid mass. After storage and prior to the application of the preparation, sterile distilled water is introduced into the end container with an injection syringe and the container is inserted into the insert ring, as described in Fig. 1.
Then the permanent magnet 8 is set in motion by starting the motor, with a rotary field forming which reaches into the end container and sets the steel rod 13 in motion. By simul-taneous heating, the dissolution takes place rapidly and without foam formation. During the whole dissolution pro-cess sterile conditions are maintained.
Various protein preparations to be used as medicaments are stored in solid Eorm, preferably in lyophilized form, in end containers; they have to be dissolved under sterile con-ditions prior to their applieation, the dissolution having to take place rapidly and the preparation having to be protected.
So far, this proeedure has involved difficulties, since with the frequently applied manual shaking of the con-tainer with the dissolution medium foam forms, which does hardly, or not at all, subside. This foam formation is also detrimental to the structure of the proteins; for, it is known that thereby changes in the protein structure or a partial decomposition may occur. The foam formation also has the dis-advantage that the solution to be applied can be dosed only inaccurately, and air in the preparation can render the injec-tion completely impossible. In the directions for the dissolu-tion a cautious pivoting of the con-tainer with the dissolution medium is therefore mostly recommended, which is accordingly time-consuming.
The invention aims at a~oiding these disadvantages and difficulties and has as its object to provide a method by which a gentle and quick dissolution of hard-soluble solid pro-tein preparations under sterile conditions is facilitated whilst avoiding foam formation involving the disadvantageous conse-~uences describecl.
The invention provides a method of handling and accelerating the dissolution of hard to dissolve lyophilized medicament comprising human proteins, comprising the steps of, -introduciny a sterile medicament in liquid form into a container containing a magnetic body under sterile conditions;
4~
-lyophilizing the liquid in the container so as to obtain a solid lyophilized medicament;
-storing the sterile container containing the lyophilized medicament and magnetic body;
-adding a sterile solvent to said container;
-subjecting the container to a rotating magnetic field to set the magnetic body in motion; and -maintaining the magnetic body in motion by means of said magnetic field until the lyophilized medicament is dissolved.
The invention thus also covers an end container fox the hard-soluble lyophilized medicament, wherein a sterile magnetic body, advantageously a little rod of stainless or plastic-covered ferritic material, is enclosed in the batch.
The invention furthermore relates to an arrangement for carrying out the method of the invention, which arrangement comprises a heatable block of antimagnetic material having one or more accommodation openings for accommodating end containers containing a lyophilized batch and is characterized in that below the accommodation openings a rotating magnetic stirrer is installed.
A prefe~red embodiment consists in that insert rings of antimagnetic material are insertable into the ac~ommodation openings of the block, whose inner diameters are adapted to the dimensions of standardized end containers, wherein fixing means for the containers, preferably spring-loaded catches, are pro-vided in the inner walls of the insert rings.
The invention will now be explained in more detail by way of one embodiment with reference to the accompanying draw-ings, wherein:
Figure 1 is a vertical section of the arrangement according to the invention, and , i ~L829~
Fig. 2 is a top view of the arrangement of the inven-tion.
In a casing 1 a heatable block 2 of antimagnetic ma-terial, preferably aluminium, is enclosed and secured by a seal ledge 1'. The block has several accommodation openings 3, 3', 3", ~... with closed bottoms 4, 4', 4", ....
The accommodation openings have different diameters acco~na to the sizes of the containers or end containers in question.
One or more accommodation openings, in the Example that de-noted by 3, lie in the region of a magnetic rotary field.Into this accommodation opening 3 an insert ring 5 is inser-table, whose inner diameter corresponds to the outer diameter o~ a standardized end container. An end container 6 is in-serted into the insert ring 5.
According to an advantageous embodiment a fixing means 7, preferably a spring-loaded catch, is incorporated in the inner wall of the insert ring, preventing a rotation of the end container 6. ~elow the block 2 a permanent magnet 8 is fastened on a shaft 9, which is driven by a motor 10 fastened on rods 11. By driving the shaft the magnetic ro-tary field is formed within the accommodation opening 3 and the end container 6. In the end container there is the lyophilized pro-tein preparation 12, into which a magnetiz-able body, in particular a little rod 13 of stainless or plastic-covered ferritic material, was introduced during ~illing of the container under sterile conditions. The heating of the block 2 ~s effected by a heating rod 14. Part of the accommodation openings designed by 3', 3", ... may also be equipped with stirring means as described, another part may be used for dissolving less sensible preparations.
The following Example serves for illustrating the invention:
A fibrin adhesive destined for the sealing of wounds, based on human proteins and having a con-tent oE fibrinogen and factor XIII is prepared in liquid form, sterile filtered and filled into a sterilized end container into which a sterilized rod of ferritic material had previously been in-serted. Then the preparation present in the end con-tainer is freeze-dried with the rod being enclosed in the solid mass. After storage and prior to the application of the preparation, sterile distilled water is introduced into the end container with an injection syringe and the container is inserted into the insert ring, as described in Fig. 1.
Then the permanent magnet 8 is set in motion by starting the motor, with a rotary field forming which reaches into the end container and sets the steel rod 13 in motion. By simul-taneous heating, the dissolution takes place rapidly and without foam formation. During the whole dissolution pro-cess sterile conditions are maintained.
Claims (5)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A method of handling and accelerating the dissolution of hard to dissolve lyophilized medicament comprising human proteins, comprising the steps of, - introducing a sterile medicament in liquid form into a container containing a magnetic body under sterile conditions;
- lyophilizing the liquid in the container so as to obtain a solid lyophilized madicament;
- storing the sterile container containing the lyophilized medicament and magnetic body;
- adding a sterile solvent to said container;
- subjecting the container to a rotating magnetic field to set the magnetic body in motion; and - maintaining the magnetic body in motion by means of said magnetic field until the lyophilized medicament is dissolved.
- lyophilizing the liquid in the container so as to obtain a solid lyophilized madicament;
- storing the sterile container containing the lyophilized medicament and magnetic body;
- adding a sterile solvent to said container;
- subjecting the container to a rotating magnetic field to set the magnetic body in motion; and - maintaining the magnetic body in motion by means of said magnetic field until the lyophilized medicament is dissolved.
2. A method as set forth in claim 1, wherein said magnetic body is a little rod of stainless ferritic material.
3. A method as set forth in claim 1, wherein said magnetic body is a little rod of plastic-covered ferritic material.
4. A method as set forth in claim 1, 2 or 3 wherein said magnetic body and said container are sterilized separately.
5. A method of accelerating the dissolution of a human fibrin adhesive in an end container, which method comprises the steps or introducing a magnetic rod and the fibrin adhesive containing fibrinogen and Factor XIII in liquid form into said end container under sterile conditions, subsequently lyophilizing the fibrin adhesive in liquid form in said end container so as to obtain a lyophilized fibrin adhesive, storing said lyophilized fibrin adhesive, adding sterile distilled water to said end container with an injection syringe, bringing said end container into the region of a magnetic rotary field and heat, and thereby, setting said magnetic rod in motion and simultaneously heating said end container until said lyophilized fibrin adhesive has been dissolved.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AT0428980A AT371719B (en) | 1980-08-25 | 1980-08-25 | METHOD AND DEVICE FOR ACCELERATING THE DISOLDERING OF SLAVE-LYOPHILIZED MEDICINAL PRODUCTS |
ATA4289/80 | 1980-08-25 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA1182444A true CA1182444A (en) | 1985-02-12 |
Family
ID=3562079
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA000383132A Expired CA1182444A (en) | 1980-08-25 | 1981-08-04 | Method of accelerating the dissolution of a hard- soluble lyophilized medicament using a magnetic stirrer |
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) | DE3129995A1 (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) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4735616A (en) * | 1985-06-20 | 1988-04-05 | Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte | Arrangement for applying a tissue adhesive |
US4909251A (en) * | 1988-05-31 | 1990-03-20 | Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte | Tissue adhesive |
WO2008117746A1 (en) | 2007-03-22 | 2008-10-02 | Juridical Foundation The Chemo-Sero-Therapeutic Research Institute | Solid fibrinogen preparation |
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 (14)
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 |
DE3439654A1 (en) * | 1984-10-30 | 1986-04-30 | Beck & Co, 2800 Bremen | Process and apparatus for uniform distribution of yeast particles in yeast-containing beer |
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 |
EP1425577A4 (en) | 2001-08-10 | 2004-12-29 | Symyx Technologies Inc | Apparatuses and methods for creating and testing pre-formulations and systems for same |
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 DE19813129995 patent/DE3129995A1/en active Granted
- 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 FR FR8116002A patent/FR2488802A1/en active Granted
- 1981-08-20 ES ES504858A patent/ES504858A0/en active Granted
- 1981-08-24 JP JP56133224A patent/JPS5789863A/en active Granted
- 1981-08-24 AR AR286518A patent/AR224086A1/en active
- 1981-08-24 IT IT23609/81A patent/IT1137641B/en active
- 1981-08-24 CH CH5442/81A patent/CH659394A5/en not_active IP Right Cessation
-
1991
- 1991-11-14 SE SE9103372A patent/SE510742C2/en not_active IP Right Cessation
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4735616A (en) * | 1985-06-20 | 1988-04-05 | Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte | Arrangement for applying a tissue adhesive |
US4909251A (en) * | 1988-05-31 | 1990-03-20 | Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte | Tissue adhesive |
WO2008117746A1 (en) | 2007-03-22 | 2008-10-02 | Juridical Foundation The Chemo-Sero-Therapeutic Research Institute | Solid fibrinogen preparation |
US9775884B2 (en) | 2007-03-22 | 2017-10-03 | The Chemo-Sero-Therapeutic Research Institute | Solid fibrinogen preparation |
US10618950B2 (en) | 2011-12-29 | 2020-04-14 | Omrix Biopharmaceuticals Ltd. | Method and device for fast dissolution of solid protein composition |
US11634473B2 (en) | 2011-12-29 | 2023-04-25 | Omrix Biopharmaceuticals Ltd. | Method and device for fast dissolution of solid protein composition |
Also Published As
Publication number | Publication date |
---|---|
FR2488802A1 (en) | 1982-02-26 |
CH659394A5 (en) | 1987-01-30 |
SE9103372L (en) | 1991-11-14 |
ATA428980A (en) | 1982-12-15 |
GB2082929A (en) | 1982-03-17 |
SE8104544L (en) | 1982-02-26 |
AT371719B (en) | 1983-07-25 |
SE510742C2 (en) | 1999-06-21 |
AR224086A1 (en) | 1981-10-15 |
ES8303111A1 (en) | 1983-02-01 |
DK157331C (en) | 1990-05-14 |
BE890002A (en) | 1981-12-16 |
DK157331B (en) | 1989-12-18 |
DK351481A (en) | 1982-02-26 |
SE9103372D0 (en) | 1991-11-14 |
NL8103695A (en) | 1982-03-16 |
JPS5789863A (en) | 1982-06-04 |
DE3129995C2 (en) | 1987-01-15 |
FR2488802B1 (en) | 1985-01-04 |
GB2082929B (en) | 1985-02-27 |
IT1137641B (en) | 1986-09-10 |
NL189799C (en) | 1993-08-02 |
DE3129995A1 (en) | 1982-05-27 |
JPS6353823B2 (en) | 1988-10-25 |
ES504858A0 (en) | 1983-02-01 |
NL189799B (en) | 1993-03-01 |
IT8123609A0 (en) | 1981-08-24 |
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Legal Events
Date | Code | Title | Description |
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MKEX | Expiry |