WO2014121733A1

WO2014121733A1 - Packaging device for lyophilized excipient

Info

Publication number: WO2014121733A1
Application number: PCT/CN2014/071776
Authority: WO
Inventors: 李和伟
Original assignee: Li Hewei
Priority date: 2013-02-06
Filing date: 2014-01-29
Publication date: 2014-08-14
Also published as: CN103964066B; CN103964066A

Abstract

A packaging device for a lyophilized excipient, comprising the following parts: a base plate (4), an isolation layer (3), and a sealing layer (1); the base plate has one or more base plate receptacles (43), and each base plate receptacle (43) has a receiving space with an upward opening; the isolation layer has one or more isolation layer receptacles (32) of the same shape and number as the base plate receptacles (43), and each isolation layer receptacle (32) has an isolation layer receiving space with an upward opening; the isolation layer (3) conforms to the base plate (4); the sealing layer covers the isolation layer (3) so as to seal the openings of the isolation layer receptacles (32). The device has sufficient rigidity to support and protect the lyophilized excipient (2), and has good oxygen-barrier and moisture-barrier properties as well as sealing property.

Description

Packaging device for freeze-dried forming preparation

Technical field

[1] The present invention relates to the field of packaging technology, and in particular to the field of packaging technology for freeze-dried forming preparations, the categories of which include, but are not limited to, cosmetics, foods, health foods and mouths. Background technique

[2] The freeze-dried preparation is a preparation form prepared by freeze-drying forming technology, which is formed by pouring into a molding die and freeze-drying process. Since the preparation adopts a freeze-drying process, it can protect the heat-sensitive component from being destroyed, and at the same time, the preparation itself generates a large number of micropores and pores, so that it can be rapidly disintegrated and dissolved, so that it is widely used and applied to an oral cavity collapse. Tablets, instant release tablets, chewable tablets, special cosmetics and other pharmaceuticals, food, health food and cosmetics.

[3] Due to the large number of micropores and pores in the process of freeze-dried excipients, the freeze-dried preparations have defects such as low strength, easy brittleness and high moisture absorption. Plastic packaging used in most medicines, cosmetics, and foods can protect fragile products. However, plastic packaging has poor sealing properties and affects product quality. Therefore, plastic materials have not been used as inner packaging in the freeze-dried preparation package on the market. In order to prevent the oxidative, moisture absorption and other processes of the freeze-dried preparation from damaging the stability of the functional ingredients in the preparation, most of the freeze-dried preparations on the market are packaged in a double-aluminum package. The double-aluminum package with good sealing performance can make the moisture in the freeze-dried preparation into a moisture barrier. However, due to the characteristics of the aluminum material, the double aluminum packaging generally has a low hardness and cannot be used well for the preparation in the package. Support and protection.

[4] The inventors of the present invention have conducted intensive studies and extensive practice and testing in order to solve the above problems, thereby completing the present invention while satisfying package sealing property and support protection. Two major requirements can be used to package lyophilized formulations. Summary of the invention

[5] The object of the present invention is to provide a packaging device for freeze-dried forming preparations, in particular to provide a preparation having sufficient hardness, supportable and protective lyophilized formulation, and having sufficient oxygen barrier properties and sealing Sexual packaging device.

[6] To achieve the above object, the packaging device of the present invention comprises the following components:

a chassis having one or more chassis receptacles, each of the chassis receptacles having an open chassis space;

An isolation layer having one or more spacer receptacles having a shape and number consistent with the chassis receptacle, each spacer receptacle having an open-up isolation layer receiving space, the spacer layer being conformable to the chassis;

The sealing layer can be covered on the isolation layer for sealing to encapsulate the opening of the isolation layer receptacle.

[7] The above "multiple" means 2-100, preferably 2-30, and most preferably 2-20.

[8] In certain embodiments, contained in the barrier receptacle is a lyophilized formulation.

[9] In certain embodiments, the chassis is made of a rigid plastic, polymeric resin, plastic, metal, plexiglass or glass material that acts as a support. As used herein, the expression "hard" means that the Brinell hardness (HB) is in the range of 10-100 N/mm ² .

[10] In certain embodiments, the barrier layer is an aluminum-plastic composite film or aluminum foil. In certain preferred embodiments, the barrier layer is a cold stamped solid composite sheet. The barrier layer and the sealing layer cooperate to form an airtight moisture barrier to form a sealed packaging environment.

[11] In certain embodiments, the sealing layer is an ancillary material that can be sealed from the barrier layer selected from the group consisting of aluminum foil, paper aluminum plastic, aluminum plastic composite film, or heat sealed aluminum compression sheet.

[12] In certain embodiments, each receptacle of the chassis and the barrier layer has a horizontal or spherical bottom wall, a peripheral wall extending upwardly from the edge of the bottom wall, and a top wall extending horizontally outward from a top edge of the peripheral wall The bottom wall and the peripheral wall collectively define a receiving space, and the sealing layer covers the spacer seat and the edge thereof is pressed against the top wall of the separating layer. [13] In certain embodiments, the sealing layer may leave an unsealed edge that facilitates opening, and its unsealed edge does not affect the sealing effect.

[14] In certain embodiments, to facilitate the uncovering of the sealing layer, the top wall of each of the barrier receptacles has an unsealed press-fit open edge or a pick-up on at least one side thereof, from which the edge or 抠 can be opened Uncover the seal layer from the hand.

[15] When packaged, each of the isolation layer receptacles is separately filled with a single dose of freeze-dried preparation, and the use of the freeze-dried preparation includes, but is not limited to, food, health food, cosmetics and medicine, and the user is using When the sealing layer is uncovered, the lyophilized formulation can be taken out for use.

Another object of the present invention is to provide a method of packaging a lyophilized formulation comprising the following steps:

(1) Provide a chassis and insulation layer,

The chassis has one or more chassis receptacles, each of the chassis receptacles having an open up chassis housing space.

The isolation layer has one or more isolation layer receptacles having a shape and a number consistent with the chassis receptacle, each of the isolation layer receptacles having an open upper isolation layer receiving space;

(2) placing the lyophilized formulation into the spacer receptacle or forming the freeze-dried formulation in the spacer receptacle;

(3) providing a sealing layer and covering it on the separation layer for sealing to encapsulate the opening of the spacer receptacle.

Another object of the present invention is to provide a packaged lyophilized formulation which is packaged in a packaging device as described above. DRAWINGS

[18] Figures 1-1 to 1-7 are diagrams of Embodiment 1. Figure 1-1 is a front plan view of the first embodiment; Figure 1-2 is a front elevational view of the first embodiment of the package; Figure 1-4 is a front view of the package opening mode of the first embodiment; FIG. 1-5 is a cutaway view of the embodiment 1; FIGS. 1-6 are cutaway views of the package opening mode of the embodiment 1; and FIG. 1-7 is a layered exploded view of the package of the embodiment 1. [19] Figures 2-l~2-4 are diagrams of Embodiment 2. Figure 2-1 is a view showing the form of the sealing layer of the second embodiment; Figure 2-2 is a view showing the form of the insulating layer of the second embodiment; Figure 2-3 is a view showing the form of the chassis of the second embodiment; The package layered exploded view of Example 2.

[20] Figures 3-1 to 3-2 are diagrams of Embodiment 3. Figure 3-1 is a cross-sectional view of Embodiment 3; Figure 3-2 is a layered exploded view of the package of Embodiment 3. detailed description

[21] The foregoing technical contents and features of the present invention are clearly shown in the following embodiments and detailed description.

Example 1

In this embodiment, the chassis 4 is a rigid disk body integrally made of plastic, plastic, metal, plexiglass or glass material, and has a plurality of chassis receptacles 43. Closely attached to the chassis 4 is an isolating layer 3 which is a soft or hard film made of an aluminum-plastic composite film or aluminum foil and punched out to be closely attached to the chassis receptacle 43. The layer receptacle 32, as well as the buckle 5 which is easy for the user to uncover the sealing layer. A single use amount of lyophilized formulation 2 is packaged in a barrier receptacle 32 for a single use by the user. The sealing layer 1 is an auxiliary material which can be sealed with the separator such as an aluminum foil, a paper aluminum plastic or an aluminum plastic composite film. At the time of sealing, a semi-transparent cut line 31 which is easy to open is cut out on the partition layer 3.

[23] At the time of production, the lyophilized formulation 2 is contained in the separator receptacle 32, and the sealing layer 1 is overlaid on the separator receptacle 32, and the sealing layer 1 is isolated by a press machine. The edge of the layer receptacle 32 is sealed. The chassis 4 and the spacer layer 3 are adhered and adhered in advance, or the sealing layer 3 and the spacer layer 3 are pressed and sealed, and then the spacer layer 3 and the chassis 4 are adhered and adhered. When installed, the above processes can be automated using automated machines.

[24] When using, seal layer 1 is opened from pickpocket 5, and a single dose of lyophilized formulation 2 is used after peeling off the single piece. [25] In this embodiment, the chassis 4 is a rigid disk body made of plastic having a plurality of chassis receptacles 43, a connecting edge 42 of each chassis receptacle, and a fold line 41.

[26] closely attached to the chassis 4 is a barrier layer 3, which is a soft or hard film made of an aluminum-plastic composite film or aluminum foil, and is stamped and attached to the chassis receptacle 43. The isolation layer receptacle 32. A single use amount of lyophilized formulation 2 is packaged in a barrier receptacle 32 for a single use by the user. The sealing layer 1 is a supporting material which can be sealed with the separator 3, such as an aluminum foil, a paper aluminum plastic or an aluminum-plastic composite film. At the time of sealing, a semi-transparent secant line 31 which is easily broken is cut out on the separation layer 3, and a semi-transparent secant line 11 which is easy to tear is cut out on the sealing layer 1.

[27] At the time of production, in the same manner as in Example 1, the lyophilized formulation 2 was housed in the separator receptacle 32 and the sealing layer 1 was sealed with the edge of the separator receptacle 32. When installed, the above processes can be automated using automated machines.

[28] In use, along the crease 41, the connecting edge 42, the semi-transparent line 11 of the sealing layer 1 and the semi-transparent line 31 of the isolating layer 3 are simultaneously broken, and the receptacle is used separately, and is never sealed. The sealing layer 1 is uncovered and the lyophilized formulation 2 is taken out for use. Example 3:

[29] In this embodiment, the chassis 4 is a circular, square or irregular shaped bottle made of plastic, plexiglass or glass, having a single chassis receptacle 43, a spacer receptacle 32 and a chassis receptacle The 43 is closely attached, and the insulation layer 3 is stamped from a soft or hard aluminum-plastic composite film, aluminum foil material or plastic.

[30] In production, the sealing layer 1 is a heat-sealed aluminum pressing piece, embedded in the screw top cover 7, and after the lyophilized forming preparation 2 is accommodated in the separating layer receptacle 32, the top cover 7 is tightened. , Seal with a bottle sealer. When installed, the above processes can be automated and automated using automated machinery.

[31] When in use, the top cover 7 is unscrewed, the sealing layer 1 is uncovered, and the freeze-dried preparation 2 is taken out and used. [32] As can be seen from the above description, the packaging device of the present invention can be designed to dispense a single amount of lyophilized formulation into the spacer receptacle 32, and the sealing layer 1 is used to enhance the sealing property and cooperate with the chassis 4 to enhance product support. The single-use lyophilized preparation can be hygienically, safely and effectively protected. The sealing layer 1 can be used and the method can be used. Therefore, the invention has the advantages of safety and convenience.

The packaging device of the present invention is not limited to the embodiments shown in the embodiments, and the above embodiments are merely preferred embodiments of the present invention, and the scope of protection is not limited thereto. Variations and modifications of the cartridges made within the scope of the claims of the invention are within the scope of the invention.

Claims

Rights request

1. A packaging device for freeze-dried excipient preparations, which includes the following components:

The chassis has one or more chassis receptacles, and each of the chassis receptacles has a chassis receptacle space with an opening facing upward;

The isolation layer has one or more isolation layer receptacles with the same shape and number as the chassis receptacles. Each of the isolation layer receptacles has an isolation layer accommodating space with an opening upward. The isolation layer can be connected to the isolation layer receptacle. Chassis fit; and

The sealing layer can cover the isolation layer for sealing, so as to seal the opening of the isolation layer receptacle.

2. The packaging device according to claim 1, wherein what is contained in the isolation layer container is a freeze-dried excipient preparation.

3. The packaging device according to claim 1 or 2, wherein the material of the chassis is hard plastic, polymer resin, plastic, metal, organic glass or glass material.

4. The packaging device according to any one of claims 1 to 3, wherein the isolation layer is an aluminum-plastic composite film or aluminum foil, and the aluminum-plastic composite film can be a cold-stamped solid composite hard sheet.

5. The packaging device according to any one of claims 1 to 4, wherein the sealing layer is selected from the group consisting of aluminum foil, paper-aluminum plastic, aluminum-plastic composite film or heat-sealed aluminum sheeting, which can be combined with the isolation layer. Sealed supporting materials.

6. The packaging device according to any one of claims 1 to 5, wherein each receptacle of the chassis and the isolation layer has a horizontal or spherical bottom wall and a peripheral wall extending upward from the edge of the bottom wall, And a top wall extending horizontally outward from the top edge of the peripheral wall, the bottom wall and the peripheral wall jointly define a containing space, the sealing layer covers the isolation layer container and its edge is in contact with the The top wall of the isolation layer is pressed.

7. The packaging device according to any one of claims 1 to 6, wherein the sealing layer leaves an unsealed edge for easy opening, and the unsealed edge does not affect the sealing effect.

8. The packaging device according to any one of claims 1 to 7, wherein at least one side of the top wall of each isolation layer container has an unsealed opening edge or a handle, which can be accessed from The opening edge or the handle lifts upward to uncover the sealing layer.

9. A method of packaging freeze-dried excipient preparations, which includes the following steps:

(1) Provide chassis and isolation layer,

The chassis has one or more chassis receptacles, each of the chassis receptacles having an opening The upward chassis storage space,

The isolation layer has one or more isolation layer receptacles with the same shape and number as the chassis receptacles, and each of the isolation layer receptacles has an isolation layer accommodation space with an upward opening;

(2) Place the freeze-dried excipient preparation into the isolation layer holder, or form the freeze-dry excipient preparation in the isolation layer holder;

(3) Provide a sealing layer and cover it on the isolation layer for sealing, so as to seal the opening of the isolation layer receptacle.

10. A packaged freeze-dried excipient preparation, which is packaged in the packaging device described in any one of claims 1-8.