JP2008528396A - Medical product container and method for sealing the same - Google Patents

Abstract

A container for a medical product and a method for sealing the same, wherein the container is formed on the first side and the opposite second side, and at least one pocket formed on the first side for holding the medical product And a lid sheet having an inner surface and an outer surface, the inner surface being sealed to the first surface, wherein the base and the lid sheet are formed of metal and are sealed together by welding between the metals.
[Selection] Figure 1

Description

The present invention relates to a medical product container and a method for sealing the same. In particular, the present invention relates to a container including a base having at least one pocket and a method for sealing a lid sheet to the base.
The present application relates in particular to containers for storing moisture sensitive drugs, for example dry powder formulations for inhalation. Furthermore, the present invention is based on a consideration of the problems associated with containers used to store individual doses of medication.

It is known to create a containment chamber using injection molded plastic.
This is typically used for reservoir type devices, where the reservoir contains enough powder to be repeatedly administered and the metering device can accurately meter each dose of powder. However, the plastics typically used in injection molding have a finite moisture permeability such that if the drug is sensitive to the effects of moisture, the drug will degrade throughout storage and use.

  Alternatively, the drug can be packaged in blister packs as individual pre-metered doses. Blister packs are composed of a laminate of polymer and metal (eg, aluminum). Aluminum becomes a completely impermeable layer that completely blocks the water vapor passage. However, when an aluminum lid sheet is bonded to an aluminum laminate base, there is still a small path for water vapor transmission along the sealing polymer layer. Although this polymer layer may only be 20-100 microns thick, it is still possible to pass moisture to the extent that it affects drug properties over a long period of time.

  It is an object of the present invention to provide an improved container that reduces at least the above problems.

According to the present invention,
A base having a first surface and an opposite second surface and at least one pocket for receiving a medical product formed on the first surface; and an inner surface and an outer surface, the inner surface being sealed to the first surface A container for a medical product is provided wherein the base and the lid sheet are formed of metal and are sealed together by welding between the metals.

Moreover, according to the present invention,
A base having a first surface and an opposite second surface and at least one pocket for receiving a medical product formed on the first surface, and an inner surface and an outer surface, the inner surface being sealed to the first surface A method of sealing a medical product container, wherein the base and the lid sheet are formed of metal.
A method is provided that includes welding a base metal to a lid sheet metal.

  In this way, there is no need to provide any adhesive material or polymer layer between the lid sheet metal or the base metal. It is therefore possible to avoid any moisture permeation at the seal part.

Conventionally, in order to minimize the influence of moisture diffusion at the seal, the width of the seal portion is increased to increase the length of the diffusion path. Of course, this results in an increase in the size of the container and an increase in the size of any device used to dispense the drug from the container.
According to the present invention, the size of the container can be reduced.

The welding is preferably one of ultrasonic welding, resistance welding, laser welding and electron beam welding or other welding techniques.
It should also be noted that in the past, the lid sheet and base were joined together using heat sealing. In particular, foil laminate films were pressed together using a hot plate to melt the seal layer and bond the two films. Of course, as a result, the drug is heated, which may adversely affect the physical and chemical properties of the drug.
If at least ultrasonic welding is used, such heating does not occur.

  It is understood here that the base may have only a single pocket for a single dose container or may have a row of pockets for multiple dose containers. Will. The pocket rows can take any suitable form and the base need not necessarily be flat.

Preferably, the base includes a metal sheet having at least one indentation formed in the first surface to form the at least one pocket.
In other words, the base has the general form of a known blister pack, but no polymer is present on its first side.

The base can also be formed by pressing or cold forming.
Preferably, the base is a laminate with a polymer covering the metal sheet on the second side.
In this way, the metal sheet is provided with additional structural support and the polymer protects the metal from rupture.

Preferably, the base includes a metal substrate having at least one through hole between the first surface and the second surface, and a base sheet that seals with the second surface to form the at least one pocket. .
This is an alternative to the traditional blister pack configuration and provides a number of advantages, including pockets with steeper sides that allow more efficient packing.

Preferably, the sealing surface of the base sheet is metal and is sealed directly to the second surface by welding.
In this way, the same advantages as the lid sheet are given to the base sheet and the pockets are sealed very well.
Preferably, the lid sheet comprises a metal foil at least at the inner surface.
Of course, the metal foil may be provided with an outer coating (s) and, for example, lacquered to facilitate any necessary printing.

  Indeed, it is also possible to apply a thin lacquer coating on one or both of the first and inner surfaces. The welding process involves welding through a lacquer, but metal-to-metal contact is still possible. Therefore, at least one of the first surface of the base and the inner surface of the lid sheet can have a thin lacquer (after the welding process) in a region other than where the metal is welded.

At least one of the lid sheet and the base may include a metal portion that surrounds the pocket and is welded to the other metal of the lid sheet and the base.
For example, a thin bead of metal or third foil can be sandwiched between the base and the lid sheet to effectively mold a portion of the base or lid sheet. In fact, all that is required is to seal the lid sheet to the base with metal-to-metal contact. If this is done, any form of insert can be used.
Preferably the metal is aluminum.

Preferably, the medical product is a dry powder for inhalation.
The present invention is particularly important for dry powder containers. This is because such products are particularly susceptible to moisture.

The base may be welded to the lid sheet along a thin line around the periphery of the at least one pocket.
Alternatively, the base may be welded to the lid sheet around the entire first surface around at least one pocket.
The particular seal location and area may be selected according to the particular design of the container.

The invention will be more clearly understood from the following description, given by way of example only, with reference to the accompanying drawings, in which:
In the accompanying drawings,
FIG. 1 shows a cross section through a pocket according to the invention.
FIG. 2 shows a cross section through another pocket according to the invention.
FIG. 3 shows a modification of FIG.
FIG. 4 shows a modification of FIG.
FIG. 5 schematically shows a device for sealing a pocket according to the invention.

  The present invention relates to an improved method for joining a metal lid sheet to a base component of a storage system for pharmaceutical products and the resulting improved container. The present invention is particularly important for inhalation products in the form of dry powder and relates to the use of welding, in particular ultrasonic welding, to join an aluminum lid foil to an aluminum base component.

  Ultrasonic welding works by applying high frequency mechanical energy to generate vibration and friction at the point of connection. To join aluminum, the two components are given high pressure and mechanical vibrational energy. This causes the two components to flow on a microscopic scale and fuse together.

FIG. 1 shows a cross section through a pocket of a container according to the invention. It will now be understood that the container may include one or more pockets as shown.
The container includes a base component 10 formed from an aluminum laminate 10a and a polymer 10b.

  The base component 10 has a first surface 12 and a second surface 14. Base component 10 is formed by pressing or cold forming to provide indentation 16 in the first surface, thereby creating pocket 18.

  As will become apparent later, the polymer layer 10b is on the outer surface or second surface of the base, while the inner surface or first surface is untreated aluminum 10a or lacquered aluminum, in the latter case the lacquered layer is Thin enough to allow welding through.

The lid sheet 20 formed from a thin aluminum layer has an inner surface 22 and an outer surface 24. As illustrated, the inner surface 22 of the lid sheet 20 is sealed with the first surface 12 of the base 10. The sealing operation is performed using welding such as ultrasonic welding, resistance welding, laser welding, or electron beam welding so that the aluminum 10a is directly coupled to the aluminum of the lid sheet 20. In this way, the pocket is completely surrounded by metal.
It should be noted here that the outer surface 24 of the lid sheet can be coated, for example with lacquer, to facilitate printing.

FIG. 2 shows another embodiment.
As in FIG. 1, only one pocket is shown. However, the container may include a plurality of such pockets.
The base 30 has a first surface 32 and a second surface 34. The base is formed as a substrate from a relatively thick metal plate. A through hole 36 is formed in the plate, and the through hole 36 extends from the first surface 32 to the second surface 34 and serves as a pocket 38 for storing a medicine.

  Similar to the embodiment of FIG. 1, the lid sheet 40 is provided as having an inner surface 42 and an outer surface 44. The inner surface 42 of the lid sheet 40 is sealed to the first surface 32 of the base 30 by welding. The lid is preferably a thin aluminum layer and optionally the outer surface 44 is coated with lacquer to facilitate printing.

As can be seen in FIG. 2, the base 30 also includes a base sheet 46 having a sealing surface 48 that faces the second surface 34. The sealing surface 48 of the base sheet 46 seals together with the second surface 34 to form the pocket 38 at the through hole 46. The base sheet is also preferably formed from metal, such as aluminum, and sealed in the same manner as the lid sheet 40 by welding. In this way, the pocket is completely surrounded by metal.
Of course, the outer surface of the base sheet 46 may be coated with lacquer or the like.

  It is also possible here to coat the sealing surface with a thin lacquer before the welding process. The metal is then welded through the lacquer. FIG. 3 shows a pocket similar to the pocket of FIG. 1 with the coatings 17, 21 and the weld 11. FIG. 4 shows a pocket similar to the pocket of FIG. 2 with a coating 49 and a weld 47.

  FIG. 4 also shows another modification. A thin metal or foil bead 28 can be provided between the lid sheet and the base. This can be considered part of the lid sheet or base and can be welded to the lid sheet and base to form the desired metal-to-metal contact.

FIG. 5 schematically shows an apparatus for sealing a lid sheet of a container as shown in FIG. This apparatus uses the preferred ultrasonic welding technique.
A support 50 is provided for the base. After placing the lid sheet in a predetermined position, a force is applied on the lid sheet with a press 60 to push the lid sheet against the base.
Next, the ultrasonic generator 70 applies ultrasonic waves to the press 60 to form an ultrasonic weld between the lid sheet and the base.

As shown, the press 60 contacts the lid sheet only at a thin line around the periphery of the pocket to form a corresponding seal. However, it should be understood that other presses that form other seals may be used here. For example, it is possible to press and seal the lid sheet at all portions that come into contact with the base.
It should also be understood that a press suitable for sealing a plurality of pockets at a time can be performed.

  As described above, the apparatus of FIG. 3 is very schematic and can always be arranged for containers of any desired shape or size, and also for containers having the configuration of FIG.

  In accordance with the present invention, the container can be hermetically sealed because the bond is metal-to-metal and there is no thin layer of polymer or other permeable material that is permeable to water. Since the seal is very effective, the sealing performance does not depend greatly on its width. Thus, the width of the seal can be significantly reduced, thus reducing the overall product dimensions without compromising the integrity of the seal.

  Finally, since the welding process generates little heat, there is no risk of heat damage to the drug, eg inhalable powder.

2 shows a cross section through a pocket according to the invention. Figure 3 shows a cross section through another pocket according to the invention. The modification of FIG. 1 is shown. The modification of FIG. 2 is shown. 1 schematically shows a device for sealing a pocket according to the invention.

Claims (19)

  A base having a first surface and an opposing second surface and at least one pocket formed on the first surface for receiving a medical product; and an inner surface and an outer surface, the inner surface being sealed to the first surface A container for a medical product, wherein the base and the lid sheet are formed of metal and are sealed to each other by welding between the metals.   The container of claim 1, wherein the base includes a metal sheet having at least one indentation formed in the first surface to form at least one pocket.   The container according to claim 2, wherein the base is a laminate having a polymer covering the metal sheet on the second surface.   2. The base of claim 1, wherein the base includes a metal substrate having at least one through hole between the first surface and the second surface and a base sheet that seals on the second surface to form at least one pocket. Container as described.   5. A container according to claim 4, wherein the sealing surface of the base sheet is metal and is sealed directly to the second surface by welding.   6. A container according to any one of the preceding claims, wherein the lid sheet comprises a metal foil at least at the inner surface.   The container according to any one of claims 1 to 6, wherein at least one of the first surface of the base and the inner surface of the lid sheet includes a thin lacquer in a region other than where the metal is welded.   The container according to any one of claims 1 to 7, wherein at least one of the lid sheet and the base includes a metal part surrounding the pocket and welded to the other metal of the lid sheet and the base.   The container according to any one of claims 1 to 8, wherein the metal is aluminum.   The container according to any one of claims 1 to 9, wherein the medical product is a dry powder for inhalation.   11. A container according to any one of the preceding claims, wherein the base is welded to the lid sheet along a thin line around the periphery of at least one pocket.   11. A container according to any one of the preceding claims, wherein the base is welded to the lid sheet over substantially the entire first surface around at least one pocket.   A method for sealing a container according to any one of the preceding claims, comprising welding the base to a lid sheet.   A first surface and an opposite second surface; and a base formed on the first surface and having at least one pocket for receiving a medical product; and an inner surface and an outer surface, the inner surface being sealed to the first surface A method of sealing a medical product container comprising a lid sheet, wherein the base and the lid sheet are formed of metal, comprising welding the base metal to the metal of the lid sheet.   15. The method according to claim 13 or 14, further comprising welding the base to the lid sheet along a thin line around the periphery of the at least one pocket.   13. The method of claim 11 or 12, further comprising welding the base to the lid sheet about the entire first surface about at least one pocket.   The method according to any one of claims 13 to 16, wherein the welding step comprises one of ultrasonic welding, resistance welding, laser welding and electron beam welding.   A medical product container constructed and arranged substantially as described above with reference to the accompanying drawings and substantially as illustrated by the accompanying drawings.   A method of sealing a container for a medical product substantially as described above with reference to the accompanying drawings and substantially as illustrated by the accompanying drawings.

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