JP2551881B2 - Freeze-drying container and method for producing freeze-dried drug in filled container - Google Patents

Description

Detailed Description of the Invention

[0001]

The present invention relates to a freeze-drying container and a filling container.
The present invention relates to a method for producing a freeze-dried drug in a container , and in particular, it is possible to transfer a drug equivalent to one container unit to a filling container as a lump without requiring each step of crushing and sizing after freeze-drying.
Freeze-drying container and a container using this freeze-drying container.
The present invention relates to a method for producing a freeze-dried drug in a filling container .

[0002]

2. Description of the Related Art Conventionally, a flexible filling container (packaging) made of a resin film for freeze-dried drugs such as antibiotics and protein preparations has been used.
It is usually sealed in a packaging container, but especially
Recently, in a resin film filling container, an easily peelable
It is divided into several rooms according to the rules, and each room contains antibiotics and protein preparations.
Separately enclose freeze-dried drugs such as
Break the easily peelable seal from the part to mix the two
Many medical multi-chamber containers are used (Japanese Patent Application No. 3
Over No. 61192, see Japanese Patent Application No. 3 over 86,190). However, these filling containers (packaging containers) are
Since it is made of rum and is mostly bag-shaped, it is freeze-dried in this container.
The desired drug is put in, lyophilized unsealed, and then directly
It is difficult to seal it later and
It is not suitable to freeze-dry as it is. So another
Use a freeze-drying container to lyophilize a large amount of drug in a batch, and then make it easier to fill the lumped drug.
In order to reduce the loss of chemicals due to scattering, etc.
Was sized to without after accordingly, weighed in a single container unit, it is performed to seal after filling into the filling container
It is

[0003]

However, in such a method , since many steps such as crushing, sizing, weighing, and filling are performed ,
Drugs carry the risk of or contaminated with foreign substances or bacteria or damp, extensive sterility production site in order to avoid this, it is requested to maintain the drying property, <br/> equipment to the cost, a problem that the running cost is increased
was there. In addition, after freeze-drying , a loss occurs when the drug is sized , resulting in a decrease in yield , or an error during weighing and filling.
The problem is that the accuracy of the filling amount deteriorates and tends to occur.
was there. Furthermore, there is a problem in that drug particles adhere to the mouth of the filling container during filling, resulting in poor sealing.
It was The present invention has been made in view of such circumstances, and an object of the present invention is to provide a container container in an amount equivalent to one container unit.
After freeze-drying the drug, it can be transferred as a lump to a filling container
Freeze-drying container and freeze-drying in a filled container using the freeze-drying container without the need for crushing and sizing steps
It is intended to provide a method of manufacturing a drug .

[0004]

The present invention has been made to achieve such an object, and the present invention is configured as follows. Lyophilize the drug equivalent to one container unit of A filling container,
A freeze-drying container which enables transferred to a left filling container bulk, freeze-drying container the container body and the closure Nde contains
The bottom of the container body is flat and the container
The inner side of the body has a cylindrical shape near the opening, and the inner side of the bottom has a substantially hemispherical shape.
The space between the tubular part and the tubular part is widened toward the opening side.
The inside of the container body is coated with an easy-releasing coating, and the stopper has a head part that does not fit in the mouth part of the container body and a leg part that can fit in the mouth part when capping. A protrusion is integrally formed on the outer periphery of the intermediate portion of the leg, which can be positioned in a half-stopped state by contacting the mouth of the container body.
Lyophilization container to leg Once you have like this notch the notch at least one point provided yet completely stoppered to for the solvent in the container body is sublimated or evaporated in the semi strokes plug state is closed . B In the freeze-drying container according to A above, the stopper is
A freeze-drying container having a circumferential groove on the outer circumference of the head . C Filling into the freeze-drying container according to the above A or B
A step of semi-stroke stopper was aseptically filled remains single container unit equivalent amount of the drug solution container, a step of fully stoppered at the end drying I line lyophilization after lyophilization or semi strokes plug in half strokes plug If, filling container and a step of sealing the transfer Shi filled container to fill the container remains mass removed lumps of freeze-dried drug by tilting the lyophilization vessel was unplugging under aseptic dry conditions after lyophilization completion A method for producing a freeze-dried drug. here
The "filling container" is a package for enclosing the drug after freeze-drying.
It means a container that can be worn.
The term “drug” is used when filling a lyophilized drug into a filling container.
That are removed by moisture, water, or freeze-drying
A drug containing quality that should be enclosed in one container if freeze-dried.
Will contain an amount equivalent to the unit amount of freeze-dried drug
Means a drug .

[0005]

Embodiments of the present invention will now be described in detail with reference to the drawings. In FIGS. 1 and 2, 10 is a container body and 12 is a stopper, which constitutes a freeze-drying container. As shown in FIGS. 3 and 4, the container body 10 is a bottomed member having an opening as shown in FIGS. 3 and 4, and the bottom outer side 14 has a planar shape, the bottom inner side 16 has a substantially hemispherical shape, and the inner middle portion. The upper portion has a cylindrical shape, and a tapered surface portion 18 is formed between the cylindrical portion and the substantially hemispherical portion as shown in FIG. A Teflon coating layer 20 is provided as a functional coating treatment.

As shown in FIGS. 6 to 8, the stopper 12 is a head 2
8 and a leg portion 30, and the leg portion 30 is the container body 1 when capping.
The head portion 28 is a portion that does not fit in the mouth portion although it can fit in the mouth portion or opening portion of 0. A projection 32 is integrally formed on the outer periphery of the middle portion of the leg portion 30 in the circumferential direction, and the projection 32 comes into contact with the mouth portion of the container main body 10 at the time of stoppering, so that it can be easily positioned in a half stoppered state. Has been Further, the leg portion 30 is provided with a cutout portion 34 so that the inside of the container body 10 can communicate with the outside air through the cutout portion 34 in the half-stopped state. The notch 34 is preferably wide enough not to interfere with the stopper in order to facilitate sublimation of the solvent contained in the container body 10. Further, the length of the leg portion 30 and the position of the protrusion 32 are such that the tip of the leg portion 30 does not reach the liquid surface of the drug solution contained in the container body 10 at the time of half stoppering, and the leg portion 30 at the time of complete stoppering. Is determined to be slightly above the top surface of the lyophilized drug. The stopper 12 is made of butyl rubber, and has the same coating treatment as that of the container body 10. A groove portion 36 is formed on the outer periphery of the head portion 30 to facilitate the opening operation.

The freeze-drying container of the above embodiment is used, for example, as shown in FIG. That is, (a) drug solution 3
8 is aseptically filled into the container body 10 in an amount containing the drug in a container unit. (B) Next, freeze-drying is performed in the freeze-dryer while the stopper 12 is half-inserted into the mouth of the container body 10 to prevent foreign matter from entering. (C) After the freeze-drying is completed, cap the tube completely, seal it, and remove it from the freeze-dryer. 40
Is a lyophilized mass of drug. (D) After that, move to the filling step, perform air cleaning, ultraviolet sterilization, etc. on the outside of the container, and open in the aseptic drying area. (E) After opening, tilt the container body 10 on the filling port 44 of the filling container 42,
The lump 40 of the drug is rolled into the filling container 42. (F) The filling port 44 of the filling container 42 is sealed. this
Thereby, a freeze-dried drug in a filled container is obtained. In addition,
The freeze-drying container can be used repeatedly.

In the embodiment constructed as described above, the container body 10 is frozen because the portion connected to the substantially hemispherical portion of the inner bottom portion 16 forms the tapered surface portion 18 that widens toward the mouth portion. It has the advantage that it is easy to remove the dried drug mass. Note that the tapered surface portion can be expanded to the opening end. Further, since the container body 10 is made of aluminum and has good thermal conductivity, there is an advantage that efficiency during heating and cooling is good. Further, since the stopper 12 is also coated with Teflon, it is possible to prevent the drug from adhering. Furthermore, the tip of the leg part is slightly above the top surface of the freeze-dried drug when the stopper is completely plugged, so the drug does not move violently in the container during transportation and the lump is prevented from collapsing. There is also an advantage that you can. In the filling method described above, the drug is filled as it is as a lump, but this does not cause difficulty in dissolution, and the drug can be easily dissolved almost in the same manner as in the case of powder.

In the above embodiment, the container body 10 can be made of various materials in place of aluminum, but is preferably made of a metal having good thermal conductivity such as aluminum or copper. . Further, the outer surface of the container body 10 is a cylindrical surface, but instead of this, the shape may be such that the cross section becomes larger toward the upper end.
Instead of the Teflon coating on the container body 10 and the stopper 12, silicon coating or the like may be used. Further, the plug 12 may be made of elastic material such as silicone rubber instead of butyl rubber. It is also possible to form a protrusion by forming a groove in the leg portion 30 instead of the protrusion 32 as the half-plug stopper positioning means and fitting an O-ring member therein. Although the embodiments of the present invention have been described above, the present invention is not limited to such embodiments, and it goes without saying that the present invention can be implemented in various modes without departing from the scope of the present invention.

[0010]

The present invention is constructed as described above.
In an effect to be next described. Freeze-drying according to claim 1.
According to the container for drying,
Transfer the drug to the filling container by tilting the freeze-drying container and sealing.
If you do so, you can fill the filling container, like the conventional example
The process of crushing, sizing, and weighing after freeze-drying is unnecessary,
The work efficiency of filling the filling container is improved, and since the outer bottom part of the container body is flat, it is in good contact with the mounting part and heat transfer is good, so the efficiency during freeze-drying Gayo rather, further, since the EkiHanare type of coating treatment to the inside of the container body, freeze mass of the dry drug without sticking or adhering to the container body, the bottom inside of the container body thereon substantially hemispherical the portion opening subsequent container body inside with to a planar
Because headed are directions in the name of the tapered surface shape that extends transferred conversion to easily fill container retrieving away lumps of freeze-dried drug
There is an advantage that it is easy to read . Freezing according to claim 2
According to the drying container, there is a groove on the outer circumference of the head of the stopper.
Has the advantage that it is easy to open the freeze-drying container.
There is . According to the method for producing a freeze-dried drug in a filled container according to claim 3 , since the freeze-dried drug is filled into the filling container as a lump, the crushing, sizing, and sizing after freeze-drying as in the conventional example are performed.
Eliminates the need for weighing steps, resulting in filling work
Efficiency Ri is extremely small risk of drug or contaminated with foreign substances or bacteria or moist with improved sterility of the manufacturing site, it requires less range to maintain drying, equipment costs, running costs Can be reduced ,
Were, after freeze-drying, is not performed sizing agents, drug loss almost rather name further freeze dried to fill the filling container
The amount of dry drug is injected into the freeze-drying container during freeze-drying.
Since determined by the amount of liquid medicine one container unit equivalent amount, it can moderate more first container unit equivalent amount <br/> volume and concentration of the chemical solution, followed
Then, as in the conventional example, it is freeze-dried and then powdered before filling.
It is easy to moderate as compared to the case to be filled in, and the accuracy is rather high, furthermore, the filling container from the lyophilizer container
Since the time of filling is was transferred remain mass lyophilized drug, without grain conventional drug like adheres to the mouth portion of the container, the risk of seal failure or the like occurs is rather name also
Frozen drying vessel lyophilized Drugs remain solution
And, since it is Re be filled remains filled container mass, conventional example
As compared to filling in a granular or powder form after freeze-drying ,
The advantage of being much easier to fill aseptically
There is.

[Brief description of drawings]

FIG. 1 is a cross-sectional view showing one usage mode of a freeze-drying container.

FIG. 2 is a cross-sectional view showing another usage mode of the freeze-drying container.

FIG. 3 is a cross-sectional view of a container body.

FIG. 4 is a plan view of a container body.

FIG. 5 is an enlarged cross-sectional view of a container body.

FIG. 6 is a front view of the stopper.

FIG. 7 is a side view of the stopper.

FIG. 8 is a bottom view of the stopper.

FIG. 9 is an explanatory diagram showing a method of using the freeze-drying container.

[Explanation of symbols]

 10 Container Main Body 12 Plug 14 Bottom Outside 16 Bottom Inside 28 Head 30 Leg 32 Protrusion 34 Notch

Claims (3)

(57) [Claims] 1. Freezing a drug equivalent to one container unit of a filling container
Freeze that can be transferred to a filling container as it is dried and solidified.
A binding container for drying, freeze-drying container the container body and the closure becomes Nde including container body bottom outer container body inside with forming a planar openings near portion a cylindrical shape, or
The inside of the bottom part has a substantially hemispherical shape , and the substantially hemispherical shape
Between the minute part and the cylindrical part widens toward the opening side.
Direction is tapered, and the inside of the container body is coated with an easy-releasing coating, and the stopper does not fit inside the mouth of the container body at the time of tapping and the leg that can fit inside the mouth. with the door, and integrally projecting portion that can be positioned in a semi-stroke stopper state by the intermediate portion outer periphery of the leg abutting the mouth of the container body
In addition, at least one notch is provided on the leg for sublimating or evaporating the solvent in the container body in the state of half stoppering, and the notch is closed when completely stoppering. Drying container. 2. The freeze-drying container according to claim 1, wherein the stopper is provided with a circumferential groove on the outer circumference of the head . 3. A step of aseptically filling a lyophilization container according to claim 1 or 2 with a drug equivalent to one container unit of a filling container as a solution and half-capping, and after half-capping. a step of fully stoppered when freeze-drying or freeze-drying the dried finished I line after a half stroke stopper, a mass of lyophilized drugs by tilting the lyophilization vessel was unplugging under aseptic dry conditions after lyophilization completion filling container Shi moved to leave the filling container of the extraction mass
A method for producing a freeze-dried drug in a filled container, the method comprising: