Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
  • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes

Definitions

• the invention relates to a device for blinding the administration of non-solid pharmaceutical dosage forms in clinical trials on mammals.
• the pharmaceutical dosage form is a colorless liquid
• the pharmaceutical dosage form can be replaced, for example, by a physiological sodium chloride solution.
• an opaque application system can be used for administration. It is understood that these methods are not suitable for intrapulmonary administration.
• the double blind technique double observer technique
• the object of the present invention is to provide a device which enables the administration of non-solid pharmaceutical dosage forms to be blinded in clinical trials in a simple manner and without using the double-blind technique.
• the invention therefore relates to a device for blinding the administration of non-solid pharmaceutical dosage forms during clinical trials on mammals.
• the device is an opaque container that has at least two ports, one of which is suitable for connection to a delivery device for the pharmaceutical dosage form and the other for connection to one Application agent is suitable and the container has in its interior means for retaining the pharmaceutical dosage form (hereinafter also referred to as "non flow type" configuration).
• the invention relates to an opaque container which has at least two connections, one of which is suitable for connection to a dispensing agent for the pharmaceutical dosage form and the other is suitable for connection to an application agent, and the connections inside the Containers have a continuous connection that ensures transport of the pharmaceutical dosage form through the container (hereinafter also referred to as "flow type" configuration).
• the pharmaceutical dosage form - which is not recognizable to the person responsible for the administration - is transported through the container and administered to the patient.
• the invention relates to a container which can enable both the transport of the pharmaceutical dosage form through the container and the retention of the pharmaceutical dosage form in the same container.
• the invention therefore furthermore relates to an opaque container which has at least three connections, two of which are suitable for connection to a dispensing agent for the pharmaceutical dosage form and the third is suitable for connection to an application agent, the inside of the container being used for Retention of the pharmaceutical dosage form and one of the connections which are suitable for the connection with a delivery means inside the container has a continuous connection with the connection which is suitable for the connection with the application means and the connection ensures a transport of the pharmaceutical administration form through the container .
• the pharmaceutical dosage form is either transported through the container and administered to the patient or retained in the container.
• the container according to the invention can be rigid or flexible and can be made of all suitable solid materials.
• it is a container that was made of plastic or rubber (for example, foil pouch that is made of PVC foil).
• the means for retaining the pharmaceutical dosage form inside the container is preferably an absorbent material which can completely absorb the non-solid pharmaceutical dosage form (for example absorbent tissue).
• the inside of the container can also be completely or partially hollow. Restraint can also be ensured in this way.
• the container is preferably dimensioned such that it can completely accommodate the test substance to be administered. In a preferred embodiment of the invention, the container is dimensioned such that it can collect 300 ml of liquid.
• Preferred are containers which have an internal volume of 500 ml to 3000 ml, particularly preferably those which have an internal volume of 1000 ml to 2000 ml.
• the container should preferably have a correspondingly higher weight. This makes it difficult or impossible to compare the weight of the container before and after application of the test substance by the person entrusted with the administration of the substance. In this respect, containers with a dead weight of more than 1 kg have generally proven to be advantageous.
• the container can have weight elements on the inside in order to ensure a sufficient weight of the container.
• the weight elements can be hard rubber disks, for example.
• the connections which the container according to the invention has are preferably commercially available Luer lock connections which are suitable for connection to the dispensing or application means.
• the connections for differentiation preferably have different markings.
• the dispensing means is preferably a commercially available syringe which can be connected directly or via a hose connection to the connection provided on the container.
• the application agent is preferably an opaque application agent, for example an opaque catheter system, preferably a catheter system that is suitable for intrapulmonary application of a non-solid pharmaceutical dosage form. Such catheter systems are known to the person skilled in the art.
• the container according to the invention which causes the pharmaceutical dosage form to be retained, can furthermore be connected at the connection which is intended for connection to the delivery means by means of a hose which leads into the interior of the container and has an open end through which the pharmaceutical Dosage form is released into the interior of the container.
• the hose advantageously has a plurality of openings in the hose line. This ensures rapid delivery of the pharmaceutical dosage form into the interior of the container.
• the hose can advantageously also have a non-return valve which prevents the pharmaceutical dosage form dispensed into the interior of the container from flowing back into the hose.
• the connection provided for the connection with the application means can be provided in the interior of the container. NEN closure, so that leakage of the retained pharmaceutical dosage form in the application agent is excluded.
• this can be a closed hose leading into the interior of the container.
• the two hoses leading into the interior of the container can be connected to one another via a Y-connecting piece, the hose leading to the connection provided for the application means being tightly sealed or sealed by a pinch or weld .
• the 3rd connection of the Y-connector has an open cap, through which the supplied pharmaceutical dosage form can flow into the blister.
• the container according to the invention which causes the pharmaceutical dosage form to be transported through the container, advantageously has a continuous hose connection between the connections inside the container.
• the container can be hollow or, if desired, can also be filled with suitable materials, such as absorbent materials and weight elements.
• the container is preferably designed in accordance with the container which causes the pharmaceutical dosage form to be retained in the container.
• the container according to the invention can furthermore have a venting device (e.g. valve) in order to compensate for pressure differences which result from the retention of the pharmaceutical dosage form in the container.
• a venting device e.g. valve
• the containers according to the invention are advantageously suitable for blinding the administration of non-solid, in particular liquid administration forms by intrapulmonary application.
• Pharmaceutical dosage forms that have the properties of natural pulmonary surfactant may be mentioned as a liquid dosage form.
• the dosage forms described in W095 / 32992 may be mentioned as examples.
• the different containers are preferably designed in such a way that a differentiation by the person is not possible.
• Fig. 1 is a schematic cross-sectional view of an embodiment of an opaque container according to the invention which retains the pharmaceutical dosage form in the container.
• Fig. 2 is a schematic cross-sectional view of an embodiment of an opaque container according to the invention, which ensures the transport of the test substance through the container.
• Fig. 3 shows a container according to the invention (hereinafter also referred to as a blind bag) in a "non flow type" configuration in a partially broken perspective view.
• FIG. 4 shows a blind bag according to the invention in a "flow type" configuration in a representation according to FIG. 3.
• FIG. 1 shows the embodiment of a container 1 according to the invention, which has a connection 2 suitable for connection with a dispensing means and a connection 3 suitable for connection with an application means.
• the container 1 is filled with an absorbent material 4.
• the container 1 has at the connection 2 a hose 5 leading into the interior of the container 1, which is open at its end 5 '.
• the connection 3 also has a hose 6 leading into the interior of the container and closed at its end 6 '.
• FIG. 2 shows the embodiment of a container 1 according to the invention, which has a connection 2 suitable for connection with a dispensing means and a connection 3 suitable for connection with an application means.
• the connections 2 and 3 are connected in the interior of the container 1 with a continuous hose 5.
• the container 1 is filled with an absorbent material 4.
• a blind bag 10 according to the invention for example shown in FIG. 3, in a "non flow type" configuration has a film bag 11, formed from two film blanks 13, 14, preferably opaque, which are tightly connected to one another at the edges by means of welding, sealing or adhesive seams.
• the film bag 11 has on its opposite narrow sides 15, 16 neck-like projections 17, 18, in which on the one hand a hose 19 for introducing a medium (for example test substance) and a venting device 20 and on the other hand an outlet hose 22 are sealed.
• the venting device 20 is equipped with a conventional filter 21 for the germ-free venting of the inner region 23 of the blind bag 10.
• the inlet hose 19 has at its free outer end 24 a so-called Luerlock connection element 25 in a "femal" design, which carries a cap-like connection adapter 26.
• the end 27 of the inlet tube 19 on the inside of the bag is provided with a check valve 28 which prevents a backflow of a medium in the inlet tube 19.
• the check valve 28 is connected to a 1st connection 29 of a Y-connector 32, which is connected with its 2nd connection 30 tightly to the outlet hose 22.
• the outlet tube 22 has at its outer end 34 a so-called "male" Luer lock connection element 35 which can be connected to a tube system (not shown) which is suitably connected to, for example, a patient.
• the outlet tube 22 is sealed within the blind bag 10 or sealed by a pinch or weld 22a.
• One or more layers of an absorbent material 37 are provided in the interior 23 of the film bag 11 or blind bag 10, which is capable of absorbing and binding a defined amount of, for example, a medium.
• an open cap 36 is provided, through which the medium entered via the inlet hose 19 flows into the interior 23 of the blind bag 10 and can be absorbed by the absorbent structure 37.
• two weight elements 38 are advantageously provided in the interior of the blind bag 10, which obscure an accompanying weight gain.
• An inventive blind bag 40 according to FIG. 4 in a "flow type” configuration basically has the same elements as the "non flow type” configuration according to FIG. 3, which is also characterized by the same meaning of the reference symbols used here.
• the outlet tube 33 is designed to be open here, so that a medium can flow through the blind bag 40.
• a closed cap 41 is provided on the third connection 31 of the Y-connector 32, i.e. no medium can penetrate into the interior 23 of the blind bag.

Landscapes

• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Health & Medical Sciences (AREA)
• Public Health (AREA)
• Wood Science & Technology (AREA)
• Zoology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Bag Frames (AREA)
• Packages (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)
• Investigating Or Analysing Biological Materials (AREA)
• Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Priority Applications (6)

Applications Claiming Priority (2)

Publications (1)

Family

ID=7886853

Family Applications (1)

Country Status (9)

Families Citing this family (5)

Citations (5)

Family Cites Families (8)

• 1998
  • 1998-11-06 DE DE19851119A patent/DE19851119C2/de not_active Expired - Fee Related
• 1999
  • 1999-11-05 EP EP99971721A patent/EP1126888B1/de not_active Expired - Lifetime
  • 1999-11-05 ES ES99971721T patent/ES2258350T3/es not_active Expired - Lifetime
  • 1999-11-05 JP JP2000580675A patent/JP2002529151A/ja active Pending
  • 1999-11-05 DE DE59913117T patent/DE59913117D1/de not_active Expired - Lifetime
  • 1999-11-05 CA CA002350644A patent/CA2350644C/en not_active Expired - Fee Related
  • 1999-11-05 AU AU13801/00A patent/AU1380100A/en not_active Abandoned
  • 1999-11-05 WO PCT/EP1999/008476 patent/WO2000027448A1/de not_active Ceased
  • 1999-11-05 AT AT99971721T patent/ATE317275T1/de active
  • 1999-11-05 US US09/830,427 patent/US6544250B1/en not_active Expired - Fee Related

Patent Citations (5)

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