USE OF A DEVICE AND A METHOD FOR PREPARING MIXTURES OF PHARMACEUTICAL SUBSTANCES
A method for the preparing mixtures of pharmaceutical or biopharmaceutical substances (11, 11″) includes arranging a preparation container (3, 3′, 3″) already made up with ingredients in a receptacle (2) of a device (1, 1′, 1″) feeding a fluid (10) from a storage container (4, 4″) into the preparation container (3, 3″) via a feed line (6), preparing the ingredients with the fluid (10, 10″) into a substance mixture (11, 11″), and removing the substance mixture (11, 11″) from the preparation container (3, 3′, 3″) into a receiving container via a discharge line (12, 12′, 12″). A device also is provided for carrying out the method.
Latest Patents:
- METHODS AND THREAPEUTIC COMBINATIONS FOR TREATING IDIOPATHIC INTRACRANIAL HYPERTENSION AND CLUSTER HEADACHES
- OXIDATION RESISTANT POLYMERS FOR USE AS ANION EXCHANGE MEMBRANES AND IONOMERS
- ANALOG PROGRAMMABLE RESISTIVE MEMORY
- Echinacea Plant Named 'BullEchipur 115'
- RESISTIVE MEMORY CELL WITH SWITCHING LAYER COMPRISING ONE OR MORE DOPANTS
This application is a continuation-in-part of PCT/EP2012/001170, which claims priority on DE 10 2011 016 767.6, filed Apr. 12, 2011, the disclosures of which are incorporated herein by reference.
BACKGROUND1. Field of the Invention
The invention relates a method that includes arranging a preparation container already made up with ingredients in a receptacle of a device, feeding a fluid from a storage container into the preparation container via a feed line, preparing the ingredients with the fluid into a substance mixture, and removing the substance mixture from the preparation container into a receiving container via a discharge line. The invention also relates to a device that includes a preparation container with ingredients that can be arranged in a receptacle, a storage container with a fluid that can be fed in a monitored manner to the preparation container via a feed line, and a receiving container that communicates with the preparation container via a discharge line.
2. Description of the Related Art
In the pharmaceutical and biopharmaceutical sector, in particular in the preclinical or clinical sector, and also in research and development, it is often necessary to prepare small volumes of buffers and media. The buffers and media are often prepared as already made up in accordance with predetermined formulations, which require careful and relatively time-consuming handling by the specialist personnel. It is particularly important in this respect to prepare substance mixtures that are made to conform to the volumes, concentrations and components or media required by the final consumer.
For example, WO 2010/125329 A1 discloses a device and a method for the portioned preparation of beverages, in particular for the preparation or brewing of coffee. This device consists of a preparation container with ingredients, that is coffee powder, that can be arranged in a receptacle of the known device, a storage container with a fluid, that is water, which is fed in a monitored manner to the preparation container via a feed line. The water that is fed to the preparation container in a heated form brews the coffee powder mixture, which is fed as a prepared substance mixture, that is as coffee, to a receiving container, that is a coffee cup, via a discharge line.
The preparation container is in this case formed as a closed capsule or cartridge, which contains the substance mixture to be prepared.
There are, however, also known devices that use a so-called pad instead of a capsule or cartridge.
The object of the invention is to provide a device and a method with which the preparation of mixtures of pharmaceutical or biopharmaceutical substances can be made possible even with prescribed small or medium volumes, concentrations and media or components that are easily and reliably made to suit the final consumer.
SUMMARY OF THE INVENTIONThis object is achieved by the use of a device for preparing mixtures of pharmaceutical or biopharmaceutical substances, comprising a preparation container with ingredients that can be arranged in a receptacle, a storage container with a fluid that can be fed in a monitored manner to the preparation container via a feed line, and a receiving container that communicates with the preparation container via a discharge line.
A storage container should also be understood as meaning a fluid preparation system and, if the fluid is water, also a water preparation system for analytically pure water, as sold for example by Sartorius AG of Göttingen under the name Arium®. Other systems that may be used here are those that produce water for injection purposes. Such systems could be designed for example in the form of multicolumn distillation or falling film evaporation.
It has not so far occurred to a person skilled in the art to consider devices and methods such as those known for the preparation of beverages, such as coffee for example, for the preparation of mixtures of pharmaceutical or biopharmaceutical substances, which must take place under high-purity, sterile conditions.
Adaptation of known devices known for the use or preparation of mixtures of pharmaceutical or biopharmaceutical substances makes it possible even under high-purity, sterile conditions to prepare mixtures of pharmaceutical or biopharmaceutical substances relatively quickly, reliably and easily from small to medium amounts or volumes, in prescribable concentrations and media or components, that are made to suit the final consumer. In principle, this device is also suitable for larger amounts or volumes.
The invention preferably involves the use of the device for the preparation of medicaments that are individual to a patient.
The device preferably has a sterile filter or a virus filter or a combination of a sterile filter and a virus filter in the feed line to the preparation container and/or in the discharge line. As a result, it is ensured that only sterile and/or virus-free fluid is fed to the preparation container and only sterile and/or virus-free prepared substance mixture is fed to the receiving container.
The preparation container may be formed as a cartridge or a capsule. A cartridge or capsule may in this case have both the feed line and the discharge line on one side. However, it is also possible to use a pad or membrane pad as the preparation container. If a membrane pad is used, the feed line and the discharge line are arranged on opposite sides of the pad.
It is also possible to feed ingredients individually to the preparation container in the device from a plurality of storage containers. In principle, it is also possible to arrange two or more preparation containers next to one another in a parallel arrangement or one behind the other in a series arrangement. The preparation containers may be connected to one another by way of hose connections, which are for example welded in a sterile manner.
The preparation container may have a mixing arrangement that facilitates the preparation process. The mixing arrangement may in this case also be formed by mixing nozzles. The preparation container or the receiving container may also be vibrated in a vibrating device for the creation of a mixing process.
The device for the preparation of mixtures of pharmaceutical or biopharmaceutical substances preferably comprises a preparation container with ingredients that can be arranged in a receptacle, a storage container with a fluid that can be fed in a monitored manner to the preparation container via a feed line, a receiving container that communicates with the preparation container via a discharge line, and a sterile or virus filter or a combination thereof that may be arranged upstream or downstream of the preparation container.
The preparation container may have the at least one sterile or virus filter or a combination thereof. This filter or combination of filters may be arranged at inlet and/or outlet opening(s), inside and/or outside the preparation container.
In this respect, the preparation container may also be formed as a pad, on or in which a sterile filter is arranged.
The preparation container and the receiving container may be connected to one another by way of a hose connection or may be connected to one another, for example by sterile welding. Thus, the preparation container could have on the output side and the receiving container (for example a bag) could have on the input side a respective welded hose, the free ends of which are welded to one another in a sterile manner in a welding unit.
A filter device may be on the receiving container there and may have a mixing nozzle that ends in the receiving container.
The receiving container with the ingredients may be connected to the filter for example by way of piercing.
The bioreactor could, for example, be connected to a controlling unit that controls a mixing operation and/or carries out pH measurements, conductivity measurements or other measurements or tests (release tests for media etc.).
The receiving container may be welded or fixedly connected directly to a sterile and/or virus filter or a combination of a sterile filter and a virus filter. The filter may be sterilized together with the receiving container. The receiving container may also be formed inter alia as a bag or bioreactor.
The receiving container may be connected releasably to a sterile and/or virus filter or a combination of a sterile filter and a virus filter.
The preparation container may be welded directly to a sterile and/or virus filter or a combination of a sterile filter and a virus filter.
The receiving container may include a mixing device of its own.
The preparation container and/or the receiving container may have at least one sensor for determining a parameter of the prepared substance mixture. In this respect, the pH value, the temperature, the conductivity or other parameters may be measured and, if appropriate, regulated by way of a controlling and monitoring unit. It is also possible to arrange a biochip, for example for determining sterility, in the preparation container and/or receiving container.
The invention also relates to a method for preparing mixtures of pharmaceutical or biopharmaceutical substances comprising the steps:
a) arranging a preparation container already made up with ingredients in a receptacle of a device,
b) feeding a fluid from a storage container into the preparation container via a feed line,
c) preparing the ingredients with the fluid into a substance mixture, and
d) removing the substance mixture from the preparation container into a receiving container via a discharge line.
The method step c) may be performed in a bag or bioreactor.
Adaptation of known methods for preparing mixtures of pharmaceutical or biopharmaceutical substances makes it possible, even under high-purity and/or sterile conditions, to prepare mixtures of pharmaceutical or biopharmaceutical substances relatively quickly, reliably and easily in small to medium amounts or volumes, in prescribable concentrations and media or components, that are made to suit the final consumer.
The feed line may also comprise a filter, for example a sterile filter. Similarly, the removal of the substance mixture may take place via such a filter. The filter may also be attached here directly to the receiving container (for example also be welded to it). Furthermore, the filter may include a mixing nozzle on the output side.
The already made up preparation container is closed off from its surroundings and is only connected to the feed line and the discharge line when it is received by the device, for example by piercing with a piercing spike.
Use of the already made up preparation container ensures the correct dosage of the ingredients.
The invention also relates to a method comprising the following steps:
a) arranging a preparation container in a receptacle of a device,
b) feeding ingredients from a plurality of storage containers into the preparation container,
c) feeding a fluid from a storage container into the preparation container via a feed line,
d) preparing the ingredients with the fluid into a substance mixture, and
e) removing the substance mixture from the preparation container into a receiving container via a discharge line for the preparation of mixtures of pharmaceutical or biopharmaceutical substances.
Feeding ingredients from a plurality of storage containers into the receiving container means that individual preparation with different components is possible or a variable composition of the substance mixture is possible while using the same preparation container.
The methods may be used for the preparation of medicaments that are individual to a patient, such as infusions or cytostatics or parenterals for example. Similarly, preparation of artificial blood, synthetic blood or blood substitute, such as hemoglobin-based blood substitutes or perfluorocarbons, for example, is possible.
The method may further include using a reading unit for reading out a coding of the preparation container after arranging the preparation container in the receptacle of a device and then calling up from a memory parameters that are necessary for carrying out the method and making the coding and those parameters available to a monitoring and controlling unit. Thus automated preparation of the substance mixture is easy and reliable and at the same time makes an individual composition possible. Similarly, an identification can be implemented with the aid of electromagnetic waves (RFID) or other identification mechanisms.
Further details of the invention emerge from the following detailed description and the accompanying drawings, in which preferred embodiments of the invention are illustrated by way of example.
A device 1 substantially consists of a receptacle 2 for a preparation container 3, a storage container 4 and a controlling and monitoring unit 5.
In the exemplary embodiment of
The exemplary embodiment of
Consequently, a method can be carried out for example with the following steps:
a) arranging the preparation container 3′ in the receptacle of the device 1′,
b) monitored automatic feeding of ingredients and a fluid (for example water) 10 from corresponding storage containers into the preparation container 3′,
c) preparing the ingredients with the fluid into a substance mixture, the substance mixture being thoroughly mixed by the mixing arrangement 18 or the agitator 19 thereof,
d) measuring prescribed parameters (for example conductivity, pH value and temperature) and approval
e) removing the substance mixture from the preparation container 3′ via the sterile filter 22 (for example by breaking through a barrier) and via the discharge line 12′ into the receiving container 13′,
f) printing out a label and adhesive attachment to the preparation container, and
g) closing the preparation container 3′ or the disposable bag 21 (for example by welding and detachment of the discharge line hose 12′).
In the exemplary embodiment of
Of course, the embodiments discussed in the specific description and shown in the figures only represent illustrative exemplary embodiments of the present invention. In the light of the disclosure here, a person skilled in the art is offered a wide spectrum of possibilities for variation.
Claims
1. A method preparing mixtures of pharmaceutical or biopharmaceutical substances (11, 11″) comprising the steps:
- a) arranging a preparation container (3, 3′, 3″) already made up with ingredients in a receptacle (2) of a device (1, 1′, 1″);
- b) feeding a fluid (10) from a storage container (4, 4″) into the preparation container (3, 3″) via a feed line (6);
- c) preparing the ingredients with the fluid (10, 10″) into a substance mixture (11, 11″); and
- d) removing the substance mixture (11, 11″) from the preparation container (3, 3′, 3″) into a receiving container (13, 13′, 13″) via a discharge line (12, 12′, 12″).
2. The method of claim 1, wherein the pharmaceutical or biopharmaceutical substances are medicaments that are individual to a patient.
3. The method of claim 1, wherein after arranging the preparation container (3, 3′, 3″) in the receptacle (2) of the device (1, 1′, 1″), the method further comprises using a reading unit (17) for reading out a coding (16) of the preparation container (3), calling up from a memory parameters necessary for carrying out the method and making the coding (16) and the parameters available to a monitoring and controlling unit (5).
4. A method for preparing mixtures of pharmaceutical or biopharmaceutical substances (11′) comprising the steps:
- a) arranging a preparation container (3″) in a receptacle of a device (1″),
- b) feeding ingredients from a plurality of ingredient storage containers (23, 24, 25, 26) into the preparation container (3″),
- c) feeding a fluid (10″) from a fluid storage container (4″) into the preparation container (3″) via a feed line (6″),
- d) preparing the ingredients with the fluid (10″) into a substance mixture (11″), and
- e) removing the substance mixture (11″) from the preparation container (3″) into a receiving container (3″) via a discharge line (12″).
5. The method of claim 4 wherein the pharmaceutical or biopharmaceutical substances are medicaments that are individual to a patient.
6. The method of claim 4, wherein after arranging the preparation container (3, 3′, 3″) in the receptacle (2) of the device (1, 1′, 1″), the method further comprises using a reading unit (17) for reading out a coding (16) of the preparation container (3), calling up from a memory parameters necessary for carrying out the method and making the coding (16) and the parameters available to a monitoring and controlling unit (5).
7. A device (1, 1′, 1″) for the preparation of mixtures of pharmaceutical or biopharmaceutical substances (11, 11″), comprising:
- a preparation container (3, 3′, 3″) with ingredients;
- a receptacle (2) configured to receive the preparation container (3, 3′, 3″), a storage container (4, 4″) with a fluid (10, 10″) that can be fed in a monitored manner to the preparation container (3, 3′, 3″) via a feed line (6);
- a receiving container that communicates with the preparation container (3, 3′, 3″) via a discharge line (12, 12′, 12″); and
- at least one sterile filter (22), or at least one virus filter or at least one combination of a sterile filter and a virus filter arranged upstream or downstream of the preparation container (3, 3′, 3″).
8. The device of claim 7, wherein the preparation container (3, 3′, 3″) has the at least one sterile filter (22) or the at least one virus filter or the at least one combination of a sterile filter and a virus filter.
9. The device of claim 7, the preparation container (3, 3′, 3″) a pad, on or in which the sterile filter or the virus filter or the combination of the sterile filter and the virus filter is arranged.
10. The device of claim 7, wherein the preparation container (3, 3′, 3″) and the receiving container (13, 13′, 13″) are welded to one another by way of a hose connection.
11. The device of claim 7, wherein at least one of the preparation container (3, 3′, 3″) and the receiving container (13, 13′, 13″) has at least one sensor for determining a parameter of the prepared substance mixture.
12. The device of claim 7, the at least one sterile filter (22), the at least one virus filter or the at least one combination of a sterile filter and a virus filter is connected fixedly to the receiving container (13, 13′, 13″).
13. The device of claim 12, further comprising a mixing nozzle connected to the receiving container or to the at least one sterile filter (22), the at least one virus filter or the at least one combination of a sterile filter.
Type: Application
Filed: Oct 2, 2013
Publication Date: Feb 13, 2014
Applicant: (Goettingen)
Inventors: Maik Jornitz (Manorville, NY), Stefan Schlack (Goettingen)
Application Number: 14/044,435
International Classification: B65B 3/00 (20060101);