JP7570382B2 - Infusion set for intravenous drip infusion with an air vent-equipped infusion filter - Google Patents

Description

The present invention relates to an infusion set for intravenous drip administration that is equipped with an infusion filter with an air vent.

An infusion set has been published that connects the intravenous needle to be inserted into the patient to a lock connector, while the vial needle is inserted into the infusion solution to secure an infusion route and allow infusion (Non-Patent Document 7).

It has been reported that infusion filters consist of a hydrophilic membrane that filters the infusion and a hydrophobic membrane that removes only the air that has become mixed in with the infusion (Non-Patent Document 10). It has been reported that the main uses of infusion filters are to remove microorganisms, particles, and air that have become mixed in with the infusion (Non-Patent Document 10).

An infusion filter set with a hydrophilic membrane made of Posidyne nylon 66 has been published as an infusion filter used in actual clinical settings (Non-Patent Documents 8, 11).

It has been reported overseas that the new azole isavuconazole is effective against deep mycoses including invasive aspergillosis (IA) (Non-Patent Document 2), and preparations containing isavuconazonium sulfate are being used clinically overseas as a treatment for mycoses (Non-Patent Documents 3-5).

A freeze-dried formulation containing isavuconazonium sulfate for intravenous administration that contains 200 mg of isavuconazonium sulfate in isavuconazole equivalents is known (Non-Patent Document 4).

However, there was no known infusion filter set with an air vent for use in infusion of a drug product for intravenous administration containing 200 mg of isavuconazonium sulfate calculated as isavuconazole, in which the hydrophilic filter membrane inside the infusion filter is made of polysulfone or posidyne, and the characteristics of the filter were also unknown.

Patent No. 3787307 Republished publication WO2014/157137 Patent No. 5856718

Guidelines for diagnosis and treatment of deep mycosis (2014) Kyowa Kikaku Med. Mycol. J. (2016), Vol. 57J, J77-J88 CRESEMBA® (isavuconazonium sulfate) 186 mg capsules PATIENT EDUCATION (2020) CRESEMBA® Package Insert Revised (2019) PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCRESEMBATM, AVIR Pharma Inc. (2018) Chiba Prefecture Funabashi Municipal Medical Center Medical Safety Measures Document No. 462 Terufusion Infusion Set Package Insert Revised October 2019 (6th Edition) Manufacturer Terumo Corporation Infusion filter set package insert Revised July 2016 (4th edition (revised based on new description guidelines)) Manufacturer JMS Co., Ltd. JMS Infusion Set Package Insert Revised April 2017 (5th Edition (Revised based on new description guidelines)) Manufacturer JMS Co., Ltd. Parenteral and Enteral Nutrition Vol. 24, No. 6 2009 pp.5-8 "Infusion Filter Set" (JR-PF05, JR-PF06) Manufactured and sold by JMS Parenteral and Enteral Nutrition Vol. 29, No. 2 2014 pp.39-45

The object of the present invention is to provide an infusion filter with an air vent and excellent filtering function for use in an infusion set for intravenous drip administration containing isavuconazole or a prodrug thereof as an active ingredient, in an amount of 200 mg per dose calculated as isavuconazole.

One aspect of the present invention is an infusion set for intravenous drip administration containing isavuconazole or a prodrug thereof as an active ingredient at a dose of 200 mg in terms of isavuconazole, the infusion set comprising at least an infusion agent containing isavuconazole or a prodrug thereof, a bottle needle, a drip tube, a clamp, an infusion filter with an air vent, and an infusion tube, the infusion tube being a tube connecting the bottle needle, the drip tube, and the infusion filter with an air vent, and the material of the hydrophilic filter membrane provided in the infusion filter with an air vent is polysulfone or posidyne.

Another aspect of the present invention is an infusion filter with an air vent for use in an infusion set for intravenous drip administration containing isavuconazole or a prodrug thereof as an active ingredient in an amount of 200 mg per dose calculated as isavuconazole, the infusion filter having a hydrophilic filter membrane made of polysulfone or posidyne.

Still another aspect of the present invention is a method for intravenously administering isavuconazole or a prodrug thereof to a patient, characterized by using the infusion set, a preparation for treating mycosis comprising the infusion set, and a method for filtering fine particles and/or analogues of isavuconazole or a prodrug thereof that are or may be contained in the infusion solution provided in the infusion set, using the infusion filter with air vent provided in the infusion set.

That is, the present invention relates to the following inventions, etc.

[1] An infusion set for intravenous drip administration containing isavuconazole or a prodrug thereof as an active ingredient at a dose of 200 mg calculated as isavuconazole per dose, comprising at least an infusion agent containing isavuconazole or a prodrug thereof, a bottle needle, a drip tube, a clamp, an infusion filter with an air vent, and an infusion tube, the infusion tube being a tube connecting the bottle needle, the drip tube, and the infusion filter with an air vent, and the hydrophilic filter membrane provided in the infusion filter with an air vent is a polysulfone membrane or a posidyne membrane.

[2] An infusion filter with an air vent for use in an infusion set for intravenous drip administration containing isavuconazole or a prodrug thereof as an active ingredient, in an amount equivalent to 200 mg of isavuconazole per dose, wherein the hydrophilic filter membrane of the infusion filter is a polysulfone membrane or a posidyne membrane.

[3] The infusion set for intravenous drip administration described in [1] above, in which the material of the hydrophilic filter membrane is polysulfone, and the amount of isavuconazole or its prodrug analogues that may be contained in the infusion solution can be reduced.

[4] The infusion set for intravenous administration described in [1] above, wherein the infusion solution containing isavuconazole or a prodrug thereof includes a glucose injection solution.

[5] A method for intravenously administering isavuconazole or a prodrug thereof to a patient, comprising using an infusion set for intravenous administration according to any one of [1], [3], or [4] above.

[6] A preparation for treating mycosis comprising an infusion set for intravenous administration according to any one of [1], [3], or [4] above.

The present invention provides an infusion filter with an air vent that has excellent filtering capabilities, and an infusion set for intravenous drip administration that is equipped with the same filter.

FIG. 1 shows an example of a portion of an infusion set for intravenous drip administration according to the present invention in a preliminary stage in which the infusion agent of the present invention is provided.

The present invention will be described in detail below with reference to specific embodiments. However, the present invention is not limited to the following embodiments, and can be implemented in any form without departing from the spirit of the present invention.

1. Active Ingredient In the present invention, isavuconazole means a compound represented by the following formula (I):

Isavuconazole is also called Isavuconazole or Aisavuconazole. The CAS number of isavuconazole is 241479-67-4. In the United States, preparations containing isavuconazonium sulfate, a prodrug of isavuconazole, are used clinically (Non-Patent Documents 3-5). Isavuconazonium sulfate is a compound represented by the following formula (II). Isavuconazonium sulfate can be hydrolyzed in vivo to become isavuconazole. The CAS number of isavuconazonium sulfate is 946075-13-4.

Isavuconazole or a prodrug thereof can be manufactured or prepared by a method known per se (Patent Document 1, Non-Patent Documents 3 to 5, etc.). A preferred example of a prodrug of isavuconazole is isavuconazonium sulfate.

2. Infusion filter with air vent Here, the infusion filter refers to a filter whose main purpose is to remove or reduce fine particles such as foreign matter (glass pieces, rubber pieces, fiber pieces) that have become mixed in the infusion, and microorganisms (bacteria, fungi (mold), etc.) that have become mixed in the infusion.

An infusion filter has at least a housing, a liquid inlet, a liquid outlet, and a hydrophilic filter membrane. An air vent is a component that discharges or reduces air (gaseous components) mixed in the infusion, and generally consists of a hydrophobic filter membrane and a gap on the housing for discharging air. Air that comes into contact with the hydrophobic filter membrane can be discharged to the outside through the gap.

One feature of the present invention is that the hydrophilic filter membrane in the infusion filter is a polysulfone membrane or a posidyne membrane.

Posidyne filter membranes are electrically modified nylon 6,6 filters that generally exhibit a positively charged zeta potential in solution. Posidyne is a registered trademark of Pall Corporation.

The polysulfone material used in polysulfone membranes is a synthetic polymer compound with a repeating structure containing sulfonyl groups, and is a hydrophobic material. In order to increase the hydrophilicity of the polysulfone material, it can be treated with a hydrophilizing agent (e.g., polyvinylpyrrolidone) to produce a hydrophilic polysulfone membrane.

The pore size of the posidyne filter membrane or polysulfone membrane is not particularly limited, but is preferably 0.2 to 1.2 μm. For the purpose of substantially completely eliminating the risk of contamination by fungi or gram-negative bacteria, the pore size is preferably 0.2 μm. Note that the size of the pore size is not a physically measured value, but is understood as a value that can be determined based on whether or not the indicator bacteria can be removed. For example, a 0.2 μm filter membrane is determined by evaluating whether it can remove the indicator bacteria Brevundimonas diminuta. Such an evaluation can be easily performed by a person skilled in the art.

In addition, it is desirable for the pozidyne filter membrane and polysulfone membrane to have as uniform a pore size as possible and to be integrated to reduce the tendency for the membrane to come off.

3. Infusion agent, bottle needle, drip tube, clamp, infusion tube Here, the infusion agent refers to an infusion agent filled in a container that contains the infusion agent to be infused, and can be, but is not limited to, an infusion agent filled in a plastic bottle, a plastic bag, or the like.

Here, a bottle needle is a connecting part between an infusion agent and an infusion tube that can be used for the purpose of passing an infusion through an infusion tube, and generally has a needle-like shape, and can pass an infusion through the infusion tube by passing the needle through a predetermined position of the infusion agent (rubber stopper, etc.). A bottle needle is sometimes called an introduction needle. The type of bottle needle is not particularly limited, and may be a side hole needle, a bud needle, a shibori needle, etc., and may be not only a metal needle but also a plastic needle. From the viewpoint of coring, it is preferable that the bottle needle is a plastic needle.

Here, the drip tube (sometimes called a drip chamber) can be understood as a reservoir for the infusion line. The main role of the drip tube is to make it easier to confirm that the infusion is flowing, to estimate the drip rate, and to remove air.

The term "clamp" as used herein generally refers to a part that is placed midway along an infusion line and is used for purposes such as adjusting the amount of fluid. Clamps are also sometimes called "clamps." There are no particular limitations on the type of clamp, and it may be a roller clamp, a V clamp, a screw clamp, etc.

Here, an infusion tube is a conduit for infusion, and refers to a soft, transparent tube made of a material such as polyvinyl chloride (PVC). There are no particular limitations on the type of infusion tube, but since polyvinyl chloride (PVC) used in infusion tubes is somewhat hardening, it is preferable to use one whose hardening property is reduced by using a plasticizer.

3. Preparation and acquisition of the infusion solution of the present invention One feature is that the dose of the active ingredient contained in the infusion set for intravenous drip administration of the present invention per administration is 200 mg in isavuconazole equivalent. When isavuconazonium sulfate is used as the active ingredient, 200 mg in isavuconazole equivalent is equivalent to 372.6 mg of isavuconazonium sulfate. It may also be described simply as equivalent to 372 mg of isavuconazonium sulfate. For example, the content of isavuconazole or a prodrug thereof contained in the infusion solution provided in the infusion set for intravenous drip administration of the present invention may be 200 mg in isavuconazole equivalent. For example, an infusion solution containing 200 mg of isavuconazonium sulfate in isavuconazole equivalent (372.6 mg as isavuconazonium sulfate) and an infusion set for intravenous drip administration provided with the infusion solution are exemplified.

When the infusion solution of the present invention is to contain 200 mg of isavuconazole or a prodrug thereof per administration, for example, a freeze-dried preparation containing 200 mg of isavuconazole or a prodrug thereof per administration may be prepared in advance, and when using the infusion set for intravenous drip administration of the present invention, the freeze-dried preparation may be dissolved in physiological saline or water for injection when needed, and the reconstituted solution may be included in a commercially available infusion solution. More specifically, for example, a freeze-dried preparation of isavuconazonium sulfate (CRESEMBA (registered trademark); Non-Patent Document 6), which is used in clinical applications overseas, may be dissolved in water for injection when needed, and the reconstituted solution may be included in a commercially available infusion solution.

Preferable examples of such commercially available infusion solutions include "Japanese Pharmacopoeia Physiological Saline (Terumo Corporation)" (Non-Patent Document 13, Terumo TP-A03NS) or "Japanese Pharmacopoeia Glucose Injection (5 w/v%) (Terumo Corporation)" (Non-Patent Document 14, Terumo TP-A03G05V).

When preparing a formulation (e.g., lyophilized formulation, prefilled syringe solution) containing 200 mg of isavuconazole or a prodrug thereof per administration, it can be prepared by adding excipients, stabilizers, pH regulators, preservatives, solubility enhancers, antioxidants, buffers, preservatives, antifreeze agents, etc. as appropriate. For example, a lyophilized formulation containing 200 mg of isavuconazole or a prodrug thereof per administration can be produced by preparing a solution containing isavuconazonium sulfate (372.6 mg), a sugar alcohol such as mannitol (10 to 200 mg), and a pH regulator (sulfuric acid, etc.), filling the solution into a vial, and lyophilizing it by a conventional method.

The infusion solution of the present invention may contain sodium chloride and glucose as appropriate. The osmotic pressure of the infusion solution of the present invention is not particularly limited, but the ratio to the osmotic pressure of blood or physiological saline (osmotic pressure ratio) is preferably about 1 to 3. The pH of the infusion solution of the present invention is also not particularly limited, but taking into consideration irritation to blood vessels and blood cells, it is preferably about 6 to 8.

4. Production and Acquisition of the Air Vent-Equipped Infusion Filter of the Present Invention The air vent-equipped infusion filter of the present invention can be easily produced or obtained by a method known per se (Patent Document 3, Non-Patent Documents 7 to 11). As an air vent-equipped infusion filter having a hydrophilic filter membrane in which the hydrophilic filter membrane is a posidyne membrane, a preferred example is the "infusion filter (ELD)" provided in the product "JMS infusion set (JMS JR-PF06)" (Non-Patent Document 8) manufactured and sold by JMS Co., Ltd. As an air vent-equipped infusion filter having a hydrophilic filter membrane in which the hydrophilic filter membrane is a polysulfone membrane, a preferred example is the "air vent-equipped filter" provided in the product "Terufusion infusion set" (Non-Patent Document 7, "TI-J352P") manufactured and sold by Terumo Corporation.

5. Production, Procurement, Use, etc. of the Infusion Set for Intravenous Drip Infusion of the Present Invention The infusion set for intravenous drip infusion of the present invention can be easily produced or obtained by a method known per se (Patent Document 3, Non-Patent Documents 7 to 11). The infusion set for intravenous drip infusion of the present invention comprises at least an infusion agent containing isavuconazole or a prodrug thereof, a bottle needle, a drip cylinder, a clamp, an infusion filter with an air vent, and an infusion tube, but as described above, the infusion agent and the infusion filter can be easily produced or obtained by a person skilled in the art, and the other parts can be purchased and used from a commercially available infusion set comprising at least a bottle needle, a drip cylinder, a clamp, and an infusion tube.

Examples of such commercially available infusion sets include the "Terufusion Infusion Set" (Non-Patent Document 7, "TI-J352P") manufactured and sold by Terumo Corporation and the "JMS Infusion Set" (Non-Patent Document 9, "JMS JY-PB343L") manufactured and sold by JMS Co., Ltd. When using the "JMS Infusion Set" (Non-Patent Document 9, "JMS JY-PB343L"), it is necessary to replace the infusion filter with the infusion filter of the present invention, and a preferred example of a replacement filter is the "infusion filter (ELD)" provided in the "JMS Infusion Set (Non-Patent Document 8, "JMS JR-PF06")."

As described above, an embodiment of the infusion set for intravenous drip administration of the present invention can be manufactured by obtaining or producing the infusion agent of the present invention, and then inserting the needle of the "Terfusion infusion set" into the infusion agent.

As described above, an embodiment of the infusion set for intravenous drip administration of the present invention can be manufactured by obtaining or producing the infusion agent of the present invention and then inserting the needle of the "JMS infusion set" into the infusion agent.

A preferred embodiment of the infusion set for intravenous drip administration of the present invention is an infusion set obtained by inserting 1) or 2) into the infusion agent of the present invention and connecting it thereto.
1) "Terufusion Infusion Set" (Non-Patent Document 7, "TI-J352P")
2) "JMS infusion set (Non-patent document 9, "JMS JY-PB343L")
(However, the infusion filter provided in the infusion set will be replaced with the "JMS infusion set (Non-Patent Document 8, "JMS JR-PF06")" etc.)

By obtaining or manufacturing the venous needle described below and fitting the venous needle into the connecting connector at the opposite end of the infusion set for intravenous drip administration of the present invention, priming and intravenous drip administration can be performed using the infusion set for intravenous drip administration of the present invention. There are two main types of infusion supply for intravenous drip administration: one is infusion supply by gravity (natural fall), and the other is infusion supply using an infusion pump or device. Those skilled in the art can easily select the infusion supply method.

A venous needle is a needle that is inserted into a vein in the arm, etc., and can be, but is not limited to, an infusion needle, a butterfly needle, or a peripheral venous indwelling needle. In general, an infusion needle or butterfly needle is used as a venous needle for intravenous infusion for a few hours, and a peripheral venous indwelling needle is preferably used for a longer period. A peripheral venous indwelling needle is a plastic catheter that is inserted into a vein in the arm, etc., and generally, after the peripheral venous indwelling needle is inserted into the patient, the metal needle contained within the peripheral venous indwelling needle is removed and the catheter is left in place.

6. Performance Evaluation of the Infusion Set for Intravenous Drip Administration of the Present Invention As described above, an infusion filter refers to a filter whose main purpose is to remove or reduce fine particles contained in the infusion, such as foreign matter, or microorganisms contained in the infusion. Those skilled in the art can easily evaluate the performance of these infusion filters.

The infusion set for intravenous drip administration of the present invention can be evaluated by comparing 1) the analytical results of the infusion solution of the present invention with 2) the analytical results of the infusion solution of the present invention that has been filtered through the infusion set for intravenous drip administration of the present invention.

Preferred evaluation items include visual observation, removal or reduction of fine particles, and removal or reduction of isavuconazole or its prodrug analogues. Examples of evaluation items include clarity and coloration. Evaluation items for fine particle removal or reduction include the removal rate of fine particles with a particle size of 10 μm or more, and the removal rate of fine particles with a particle size of 25 μm or more. An example of the removal or reduction of isavuconazole or its prodrug analogues, etc., isavuconazole. Those skilled in the art can easily perform these evaluations using methods known per se.

When evaluating, the lyophilized preparation containing isavuconazole or a prodrug thereof of the present invention (e.g., CRESEMBA (registered trademark); Non-Patent Document 6) is dissolved in saline or water for injection at the time of use, and the reconstituted solution is mixed with a commercially available infusion to produce the infusion of the present invention. The commercially available infusion is preferably saline or glucose injection.

7. Method of administration, therapeutic drug, intravenous drip infusion method An embodiment of the present invention is a method of intravenously administering isavuconazole or a prodrug thereof to a patient, characterized by using an infusion set for intravenous drip infusion of the present invention. The route of administration, site of administration, frequency of administration, etc. can be appropriately determined by medical professionals. The dose per administration is 200 mg in terms of isavuconazole (equivalent to 372.6 mg of isavuconazonium sulfate when isavuconazonium sulfate is used).

An embodiment of the present invention is a preparation for treating mycoses comprising the infusion set for intravenous drip administration of the present invention. Preferred examples of mycoses include deep mycoses such as invasive aspergillosis (IA).

An embodiment of the present invention is a method for treating mycosis, characterized by using an infusion set for intravenous drip administration of the present invention. The route of administration, site of administration, frequency of administration, etc. can be appropriately determined by medical professionals. The dosage per administration is 200 mg in isavuconazole equivalent.

The present invention will be described in more detail below with reference to examples. However, the present invention is not limited to the following examples, and can be implemented in any form without departing from the spirit of the present invention.

Example 1: Production of an infusion set for intravenous drip administration (1) Production of the infusion agent of the present invention Four types of infusion agents were produced.

(A) An infusion set for intravenous drip administration, comprising an infusion filter with an air vent, the hydrophilic filter membrane of which is a polysulfone membrane, and to which an infusion agent of the present invention, which is made by adding a reconstituted solution of a freeze-dried formulation of isavuconazonium sulfate to physiological saline, is connected by puncture (hereinafter, also referred to as a physiological saline-polysulfone type infusion set)

(B) An infusion set for intravenous drip administration, comprising an infusion filter with an air vent, the hydrophilic filter membrane of which is a Posidyne membrane, and to which the infusion agent of the present invention, which is made by adding a reconstituted solution of a freeze-dried formulation of isavuconazonium sulfate to physiological saline, is connected by puncture (hereinafter, also referred to as a physiological saline-Posidyne type infusion set)

(C) An infusion set for intravenous drip administration, comprising an infusion filter with air vents, the hydrophilic filter membrane of which is a polysulfone membrane, and to which the infusion agent of the present invention, which is made by adding a reconstituted solution of a freeze-dried formulation of isavuconazonium sulfate to a glucose injection solution, is connected by puncture (hereinafter also referred to as a glucose injection-polysulfone type infusion set).

(D) An infusion set for intravenous drip administration, comprising an infusion filter with air vents, the hydrophilic filter membrane of which is a Posidyne membrane, and to which the infusion agent of the present invention, which is made by adding a reconstituted solution of a freeze-dried formulation of isavuconazonium sulfate to a glucose injection solution, is connected by puncture (hereinafter, also referred to as a glucose injection solution-Posidyne type infusion set)

As the physiological saline solution, "Japanese Pharmacopoeia Physiological Saline Solution (Terumo Corporation)" (Non-Patent Document 13, Terumo TP-A03NS) was used. The volume of the physiological saline solution was 250 mL, and its salt concentration was 0.9%. The physiological saline solution was for intravenous injection or drip infusion.

As the glucose injection, "Japanese Pharmacopoeia Glucose Injection (5 w/v%) (Terumo Corporation)" (Non-Patent Document 14, Terumo TP-A03G05V) was used. The volume of the glucose injection was 250 mL, and the glucose concentration was 5%. The glucose injection was for intravenous injection or intravenous drip infusion.

The isavuconazonium sulfate lyophilized preparation used in the reconstitution solution of the isavuconazonium sulfate lyophilized preparation added to physiological saline or glucose injection was "CRESEMBA (registered trademark)" (Non-Patent Document 6), which is used clinically overseas. The reconstitution solution was prepared by adding 5.0 mL of water for injection to the lyophilized preparation "CRESEMBA (registered trademark)" (Non-Patent Document 6) and shaking the vial, which is the container for the lyophilized preparation.

5 mL was removed from the saline or glucose injection to obtain 245 mL of saline or glucose injection, to which 5 mL of the reconstituted solution of the isavuconazonium sulfate lyophilized preparation was added, and the mixture was shaken 20 times within a period of 40 seconds to produce two types of infusions of the present invention (hereinafter sometimes referred to as saline-based infusions and glucose injection-based infusions).

By connecting the infusion agent of the present invention to a "Terfusion infusion set" (Non-Patent Document 7, "TI-J352P") by puncture, (A) a saline-polysulfone type infusion set and (C) a glucose injection-polysulfone type infusion set were produced.

(B) Saline-Posidyne type infusion set and (D) Glucose injection-Posidyne type infusion set were manufactured by connecting the infusion agent of the present invention to a "JMS infusion set (Non-Patent Document 9, "JMS JY-PB343L") by puncture. However, the infusion filter provided in the infusion set was replaced with a "JMS infusion filter set (Non-Patent Document 8, "JMS JR-PF06")."

[Example 2] Evaluation test of the infusion set for intravenous drip administration (1) Test method As described above, the infusion set for intravenous drip administration of the present invention was evaluated by comparing the analytical results of the infusion agent of the present invention (hereinafter, also referred to as the pre-filtered infusion agent) with the analytical results of the infusion agent of the present invention (hereinafter, also referred to as the filtered infusion agent) which was filtered by passing the infusion agent of the present invention through the infusion set for intravenous drip administration.

The first 20 mL of filtrate obtained by passing a saline-based infusion or a glucose injection-based infusion through the infusion set for intravenous drip administration of the present invention and filtering it was discarded, and a post-filtration infusion sample was taken from the subsequent filtrate. The pre-filtration infusion was again shaken 20 times for 40 seconds, and a pre-filtration infusion sample was taken from the pre-filtration infusion.

The main test evaluation items were visual observation, particle removal rate, and removal rate of isavuconazole or its prodrug analogues. Visual observation was performed in three items: clarity, coloration, and visible particle. Particle removal rate was performed in two items: removal rate (%) of particles with a particle diameter of 10 μm or more, and removal rate (%) of particles with a particle diameter of 25 μm or more. The removal rate of isavuconazole or its prodrug analogues was taken as the isavuconazole removal rate (%). The analogue removal evaluation was performed by repeating three times and using the arithmetic average (n=3).

(2) Test Results The evaluation results of the saline-polysulfone type infusion set are shown in Table 1.

The physiological saline-polysulfone type infusion set was found to be an infusion set that could not only significantly reduce particulates but also isavuconazole.

The evaluation results of the physiological saline-Posidyne type infusion set are shown in Table 2.

Saline - It was found that the Posidyne type infusion set can significantly reduce fine particles with a diameter of 10 μm or more.

The evaluation results of the glucose injection - polysulfone type infusion set are shown in Table 3.

The glucose injection-polysulfone type infusion set was found to be an infusion set that not only significantly reduced particulates but also, unexpectedly, the analogue isavuconazole. As saline-polysulfone type infusion sets also have similar excellent properties, it was inferred that infusion sets equipped with air vent infusion filters in which the hydrophilic filter membrane is a polysulfone membrane can achieve a significant isavuconazole reduction effect, regardless of the type of infusion.

The evaluation results of glucose injection - Posidyne type infusion set are shown in Table 4.

Glucose injection - Posidyne type infusion set was found to have a significant removal rate of particles with a diameter of 10 μm or more.

[Comparative Example]
The results of a test similar to that in Example 1 was carried out using a polyethersulfone membrane (PES), and are shown in the following table, where the numbers indicate isavuconazole (%).

INDUSTRIAL APPLICABILITY The present invention provides an infusion filter with an air vent having excellent filtering function, and an infusion set for intravenous drip administration equipped with the filter. The present invention is extremely useful in the pharmaceutical industry.

Claims (4)

An infusion set for intravenous drip administration containing isavuconazonium sulfate as an active ingredient at a dose of 200 mg in terms of isavuconazole,
The infusion device includes at least an infusion agent containing isavuconazonium sulfate , a bottle needle, a drip tube, a clamp, an infusion filter with an air vent, and an infusion tube;
the infusion tube is a tube connecting the bottle needle, the drip tube, and the infusion filter with an air vent;
An infusion set for intravenous drip administration, wherein the hydrophilic filter membrane provided in the infusion filter with air vent is a polysulfone membrane . An infusion filter with an air vent for use in an infusion set for intravenous drip administration, containing isavuconazonium sulfate as an active ingredient, in terms of isavuconazole, at a dose of 200 mg,
An infusion filter with an air vent, wherein the hydrophilic filter membrane of the infusion filter is a polysulfone membrane . 2. The infusion set for intravenous drip administration according to claim 1, which can reduce the amount of isavuconazole that may be contained in the infusion solution. 2. The infusion set for intravenous drip administration according to claim 1, wherein the infusion solution containing isavuconazonium sulfate comprises a glucose injection solution.