Composite film for pharmaceutical packaging

Abstract

To provide a composite film for packing medicine.SOLUTION: Provided is a composite film for packing medicine. The composite film for packing medicine includes a heat seal layer, an aluminum foil layer and an impact resistance layer. The heat seal layer contains residue induced from at least one kind of 1,4-butanediol, isophthalic acid, isopentyldiol and isopropanol, and has the melting point of 130°C to 180°C. The aluminum foil layer is installed on the heat seal layer, and the impact resistance layer is installed on the aluminum foil layer. The composite film for packing medicine is non-toxic, and has excellent impact resistance performance, and heat seal performance.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a pharmaceutical packaging material, and more particularly to a composite film for packaging pharmaceuticals. [Background technology]

[0002] Pharmaceuticals are special products used for the prevention and treatment of diseases, and are related to the health and safety of consumers. Since packaging materials come into direct contact with pharmaceuticals, if harmful substances are contained in the packaging materials, they may bleed out over time and contaminate the pharmaceuticals, affecting the safety of the pharmaceuticals. Furthermore, if the packaging materials do not have good barrier properties, the penetration of water vapor, oxygen, and light may cause chemical changes in the pharmaceuticals, shortening their shelf life. Therefore, it is necessary to pay attention to the usage performance of pharmaceutical packaging materials.

[0003] Most of the conventional pharmaceutical packaging materials are made of a composite of aluminum foil, an inner heat-sealable polyvinyl chloride (PVC) layer, and an outer plastic layer, but PVC contains toxic plasticizers, which are harmful to human health and raise safety concerns. In addition, packaging materials that use cyclic olefin copolymer (COC) or non-PVC plastics instead of PVC are commercially available, but the cost of cyclic olefin copolymer is relatively high, and non-PVC plastics are not completely non-toxic. Summary of the Invention [Problem to be solved by the invention]

[0004] The technical problem that the present invention seeks to solve is to provide a safe, non-toxic composite film for packaging medicines in response to the shortcomings of the prior art.

[0005] In order to solve the above technical problems, one of the technical means adopted by the present invention is to provide a composite film for packaging medicines. The composite film for packaging medicines includes a heat seal layer, an aluminum foil layer, and an impact resistant layer. The heat seal layer contains a residue derived from at least one of 1,4-butanediol, isophthalic acid, isopentyldiol, and isopropanol, and has a viscosity of 130° C. o C~180 o C, the aluminum foil layer is disposed on the heat seal layer, and the impact resistant layer is disposed on the aluminum foil layer.

[0006] In one embodiment of the present invention, the heat seal layer contains 1 to 50 mol % of residues derived from 1,4-butanediol, 1 to 50 mol % of residues derived from isophthalic acid, 1 to 50 mol % of residues derived from isopentyldiol, and / or 1 to 50 mol % of residues derived from isopropanol.

[0007] In one embodiment of the invention, the heat seal layer contains 10 mole % residues derived from isopentyl diol and 4 mole % residues derived from isopropanol.

[0008] In one embodiment of the present invention, the composition of the impact resistant layer includes an impact resistant polymer selected from the group consisting of polyester-based thermoplastic elastomers, nylon, polybutylene terephthalate, and polyethylene terephthalate-1,4-cyclohexanedimethanol.

[0009] In one embodiment of the present invention, the impact resistant layer is formed of a polyester composition containing the impact resistant polymer, and the content of the impact resistant polymer is 1 to 70 wt % based on 100 wt % of the polyester composition.

[0010] In one embodiment of the present invention, the polyester composition further comprises a general polyester, and the content of the general polyester is 30 to 99 wt % based on 100 wt % of the polyester composition.

[0011] In one embodiment of the present invention, the common polyester is polyethylene terephthalate (PET).

[0012] In one embodiment of the present invention, the heat seal layer has a thickness of 10 μm to 200 μm, the aluminum foil layer has a thickness of 5 μm to 20 μm, and the impact resistant layer has a thickness of 10 μm to 100 μm.

[0013] In one embodiment of the present invention, the composite film for packaging pharmaceuticals further includes a first adhesive layer and a second adhesive layer, the heat seal layer being attached to one side of the aluminum foil layer via the first adhesive layer, and the impact resistant layer being attached to another surface opposite to the one side of the aluminum foil layer via the second adhesive layer.

[0014] In one embodiment of the present invention, the first and second attaching layers are each formed of a polyolefin hot melt adhesive, and the first and second attaching layers each have a thickness of 2 μm to 5 μm. Effect of the Invention

[0015] One advantageous effect of the present invention is that the composite film for pharmaceutical packaging provided by the present invention has the technical features that "the heat seal layer is a modified polyester layer containing a residue derived from at least one of 1,4-butanediol, isophthalic acid, isopentyldiol, and isopropanol" and "the aluminum foil layer is disposed on the heat seal layer, and the impact-resistant layer is disposed on the aluminum foil layer", which ensure the quality and safety of pharmaceuticals and allow the formed pharmaceutical packaging to maintain its integrity during storage and transportation. [Brief description of the drawings]

[0016] [Figure 1] 1 is a structural schematic diagram showing a composite film for packaging medicines of the present invention. [Diagram 2]1 is a schematic diagram showing an embodiment of a composite film for packaging medicines of the present invention. FIG.

[0017] In order to better understand the features and technical contents of the present invention, reference is made to the following detailed description of the present invention and drawings, which are for reference and explanation only and do not limit the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Hereinafter, the embodiments of the "composite film for drug packaging" disclosed by the present invention will be described by way of certain specific embodiments, and those skilled in the art can understand the advantages and effects of the present invention based on the contents disclosed in this specification. The present invention can be implemented or applied by other different specific embodiments, and various modifications and changes can be made to each detail in this specification based on different perspectives and applications without departing from the concept of the present invention. In addition, as described in advance, the accompanying drawings of the present invention are simple schematic illustrations and are not drawn to actual size. The technical contents of the present invention will be described in more detail based on the following embodiments, but the disclosed contents do not limit the scope of protection of the present invention. In addition, the term "or" used in the present specification may include any one or more combinations of the relevant items listed according to the actual situation.

[0019] All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art unless otherwise defined. Terms appearing in the singular form include the plural form of this term.

[0020] All percentages referred to herein are by weight unless otherwise indicated. When a series of upper and lower ranges are given, all combinations of the ranges mentioned are intended to be included as if each combination were expressly recited.

[0021] As shown in Fig. 1, one embodiment of the present invention provides a pharmaceutical packaging composite film Z, which mainly includes a heat seal layer 1, an aluminum foil layer 2, and an impact-resistant layer 3, where the aluminum foil layer 2 is disposed on the heat seal layer 1, and the impact-resistant layer 3 is disposed on the aluminum foil layer 2. In use, the heat seal layer 1 can be melted in a thermal environment (e.g., in a pressurized thermal environment), the aluminum foil layer 2 has excellent barrier performance, thereby preventing the deterioration of the pharmaceutical due to contact with moisture, gas (oxygen) or light, and the impact-resistant layer 3 can resist external impact, thereby maintaining the integrity of the pharmaceutical packaging.

[0022] The heat seal layer 1 is a modified polyester layer, which contains residues derived from at least one of 1,4-butanediol, isophthalic acid, isopentyl diol, and isopropanol. It should be noted that 1,4-butanediol, isophthalic acid, isopentyl diol, and isopropanol can all form oligomer mixtures during the polymerization process, so that the polyester heat seal layer 1 can be 130 o C~180 o C, so that the composite film Z of the present invention can be heat-sealed in this temperature range. The thickness of the heat-seal layer 1 affects the heat-seal strength of the composite film Z, and the thicker the heat-seal layer 1, the stronger the heat-seal strength of the composite film Z. From the viewpoints of practicality and cost, the thickness of the heat-seal layer 1 can be 10 μm to 200 μm.

[0023] As shown in FIG. 2, in actual application, one or more drugs are placed between two composite films Z, the two composite films Z are stacked with the heat seal layer 1 on the inside, and then heat-pressed to melt the heat seal layer 1 with a low melting point and integrate them together, thereby completing the packaging of the drug.

[0024] In this embodiment, the heat seal layer 1 may contain 1 to 50 mol% of residues derived from 1,4-butanediol, 1 to 50 mol% of residues derived from isophthalic acid, 1 to 50 mol% of residues derived from isopentyldiol, and / or 1 to 50 mol% of residues derived from isopropanol, and preferably simultaneously contains 10 mol% of residues derived from isopentyldiol and 4 mol% of residues derived from isopropanol. The term "residue" as used herein refers to a group or unit derived from a specific compound in a product of a chemical reaction, such as a group derived from a diacid or diol component in a polyester or copolymer polyester synthesized by an esterification or polycondensation reaction.

[0025] Furthermore, the heat seal layer 1 may be formed of a first polyester composition, which mainly includes a general polyester and a modifier. For example, the first polyester composition may be melt-extruded to form a molten layer, and the molten layer may be cooled and shaped to form the heat seal layer 1. In the first polyester composition, the general polyester is polyethylene terephthalate (PET), and the modifier is selected from at least one of 1,4-butanediol, isophthalic acid, isopentyl diol, and isopropanol. Based on 100% by weight of the first polyester composition, the content of the general polyester may be 30 to 99% by weight, and the content of the modifier may be 1 to 50% by weight. However, the above content is merely a possible embodiment and is not intended to limit the present invention. In some embodiments, the general polyester may be polypropylene terephthalate (PPT), polybutylene terephthalate (PBT), polyethylene naphthalate (PEN), or polybutylene naphthalate (PBN).

[0026] The aluminum foil layer 2 can be made of high-purity aluminum foil (containing 99% or more aluminum) or modified aluminum doped with metal and nonmetal elements, and the thickness of the aluminum foil layer 2 can be 5 μm to 20 μm, preferably 10 μm. If the aluminum foil layer 2 is too thick (i.e., the thickness of the aluminum foil layer is 20 μm or more), the production cost increases, and if the aluminum foil layer 2 is too thin (i.e., the thickness of the aluminum foil layer is 5 μm or less), the essential barrier effect cannot be achieved. It should be noted that in the presence of the aluminum foil layer 2, moisture, oxygen, light, etc. cannot directly contact the drug and cause adverse effects, so that the quality and safety of the drug can be ensured and the shelf life of the drug can be extended. In some embodiments, in order to increase the pinhole resistance and extensibility of the aluminum foil layer 2, the aluminum foil layer 2 is doped with iron and silicon. In particular, the iron content can be 0.1 to 5 wt %, and preferably 0.3 to 1 wt %, and the silicon content can be 0.1 to 5 wt %, and preferably 0.3 to 1 wt %.

[0027] The impact-resistant layer 3 is a polyester layer, the composition of which includes an impact-resistant polymer. It should be noted that in the presence of the impact-resistant layer 3, the impact strength of the composite film Z of the present invention is increased by nearly 1-fold, so that the formed pharmaceutical packaging can maintain its integrity during storage and transportation. To achieve the required impact resistance effect, the thickness of the impact-resistant layer 3 can be 50 μm to 100 μm. In some embodiments, the thickness of the impact-resistant layer 3 is 55 μm, 60 μm, 65 μm, 70 μm, 75 μm, 80 μm, 85 μm, 90 μm, or 95 μm.

[0028] Furthermore, the impact-resistant layer 3 may be formed of a second polyester composition, which mainly includes a general polyester and an impact-resistant polymer. For example, the second polyester composition may be melt-extruded to form a molten layer, and the molten layer may be cooled and shaped to form the impact-resistant layer 3. In the second polyester composition, the general polyester is PET, PPT, PBT, PEN, or PBN, preferably PET, and the impact-resistant polymer is selected from the group consisting of polyester-based thermoplastic elastomer (TPEE), nylon (e.g., nylon 6, nylon 11, nylon 66, or nylon 12), polybutylene terephthalate, and polyethylene terephthalate-1,4-cyclohexanedimethanol (Polyethylene Terephthalate-Glycol, PETG), and based on 100% by weight of the second polyester composition, the content of the general polyester may be 30 to 99% by weight, and the amount of the impact-resistant polymer may be 1 to 70% by weight. However, the above content is merely a possible embodiment and is not intended to limit the present invention.

[0029] According to practical application, the second polyester composition may contain at least one functional additive, such as colorants, inorganic polyester modifiers, flow processing aids, crystal nucleating agents, and / or antioxidants. Furthermore, the appearance color of the composite film Z can be changed by adding colorants, such as carbon black, titanium dioxide, barium sulfate, and calcium carbonate.

[0030] The inorganic polyester modifier can increase the heat resistance of the impact-resistant layer 3, and in the presence of the inorganic polyester modifier, the impact-resistant layer 3 can have a predetermined surface roughness and haze. Specific examples of the inorganic polyester modifier include silicon dioxide (SiO2), titanium dioxide (TiO2), aluminum hydroxide (Al(OH)3), aluminum oxide (Al2O3), magnesium hydroxide (Mg(OH)2), magnesium oxide (MgO), calcium carbonate (CaCO3), boron oxide (B2O3), calcium oxide (CaO), strontium titanate (SrTiO3), barium titanate (BaTiO3), calcium titanate (CaTiO3), magnesium titanate (2MgO·TiO2), cerium dioxide (CeO2), fumed silica (fumed Examples of inorganic polyester modifiers include silica, talc, barium carbonate, calcium sulfate, barium sulfate, lithium phosphate, calcium phosphate, magnesium phosphate, boron nitride (BN), aluminum nitride (AlN), carbon black, and kaolin. The inorganic polyester modifier may be present as particles, and the content of the inorganic polyester modifier may be 0.01 to 2 wt % based on 100 wt % of the second polyester composition.

[0031] The flow processing aid can reduce the mechanical torque during melt extrusion of polyester raw materials and reduce the molecular chain scission of polymers. The flow processing aid can be pentaerythritol tetrastearate (PETS) or its analogs, which has good thermal stability and low volatility at high temperatures, as well as higher flowability and mold release properties, and has good nucleation effect on some crystalline polyesters. Based on 100% by weight of the second polyester composition, the content of the flow processing aid can be 0.01-2% by weight.

[0032] The nucleating agent can improve the heat resistance of the impact-resistant layer 3 by increasing the crystallinity, and can also refine the crystal size, reduce the generation of coarse spherulites, and prevent the film surface from becoming brittle by promoting the growth of crystals. The nucleating agent can be a mineral material, a metal oxide, a silicon compound, a metal salt of an organic acid or an inorganic acid, a phosphate metal salt, a polyol derivative, a sulfimide compound, a glass powder, a metal powder, or any combination thereof, and the content of the nucleating agent can be 0.0003-2 wt% based on 100 wt% of the second polyester composition.

[0033] Examples of the mineral materials include graphite, talc, and kaolin as nucleating agents; examples of the metal oxides include zinc oxide, aluminum oxide, and magnesium oxide as nucleating agents; examples of the silicon compounds include silicon oxide, calcium silicate, and magnesium silicate as nucleating agents; examples of the metal salts of organic or inorganic acids include metal carbonates such as magnesium carbonate, calcium carbonate, sodium carbonate, and potassium carbonate, barium sulfate, calcium sulfate, sodium benzoate, and aluminum pt-butylbenzoate as nucleating agents; examples of the metal salts of phosphates include metal salts of aromatic phosphates; and examples of the polyol derivatives include dibenzylidene sorbitol as nucleating agents.

[0034] As the antioxidant of the second polyester composition forming the impact-resistant layer 3, a primary antioxidant and a secondary antioxidant can be used alone or simultaneously. The primary antioxidant can terminate the radical chain by reacting quickly with peroxy radical (ROO·), and the secondary antioxidant can react with hydroperoxide (ROOH) to convert it into a non-radical inactive product. It should be noted that the primary antioxidant and the secondary antioxidant can exert a good synergistic effect to provide a better antioxidant effect.

[0035] The primary antioxidant may be selected from phenolic compounds or amine compounds, specific examples of which include commercial products with the trade names Irganox 1010, Irganox 1425, Irganox 245, Anox 1315, Anox PP18, Anox 20, Lowinox 1790, Lowinox TBM-68, and Naugard 445, and the content of the primary antioxidant may be 0.01 to 1% by weight based on 100% by weight of the second polyester composition. The secondary antioxidant may be selected from phosphorous compounds or thioester compounds, specific examples of which include commercial products with the trade names Sandostab P-EPQ, Irgafos 168, and Naugard 412S, and the content of the secondary antioxidant may be 0.01 to 1% by weight based on 100% by weight of the second polyester composition.

[0036] Also, the unstretched impact-resistant layer 3 can be stretched to provide better mechanical properties. In some embodiments, the stretching process can be sequential biaxial stretching, i.e., the unstretched impact-resistant layer 3 is stretched in the machine direction (or "longitudinal direction", MD) at a predetermined temperature and stretch ratio, and then stretched in the perpendicular direction (or "transverse direction", TD) at a predetermined temperature and stretch ratio, and the order of stretching in the machine direction and the perpendicular direction can be reversed according to actual needs. In some embodiments, the stretching process can be simultaneous biaxial stretching, i.e., the unstretched impact-resistant layer 3 can be stretched in the machine direction and the perpendicular direction at a predetermined temperature and stretch ratio simultaneously.

[0037] Please refer to Figure 1 again. As shown in Figure 1, in this embodiment, the heat seal layer 1 can be bonded to one side (e.g., inner side) of the aluminum foil layer 2 through the first bonding layer 4, and the impact-resistant layer 3 can be bonded to the surface (e.g., outer side) opposite to the one side of the aluminum foil layer 2 through the second bonding layer 5. The first bonding layer 4 and the second bonding layer 5 can each be a polyolefin adhesive layer, the composition of which includes polyolefin (PO) and hot melt adhesive, and the thickness of the first bonding layer 4 and the second bonding layer 5 can be 2 μm to 5 μm. EXAMPLES

[0038] Table 1 shows some representative examples of the composite film Z for packaging medicines of the present invention, but the present invention is not limited to these examples. [Table 1] ◎: Very good ○: Good △: Poor ×: Very poor [Advantageous Effects of the Embodiments]

[0039] One advantageous effect of the present invention is that the composite film for pharmaceutical packaging provided by the present invention has the technical features that "the heat seal layer contains a residue derived from at least one of 1,4-butanediol, isophthalic acid, isopentyldiol, and isopropanol" and "the aluminum foil layer is disposed on the heat seal layer, and the impact-resistant layer is disposed on the aluminum foil layer", which ensure the quality and safety of pharmaceuticals and allow the formed pharmaceutical packaging to maintain its integrity during storage and transportation.

[0040] Moreover, the heat seal layer is a modified polyester layer, which is safe, non-toxic and does not cause environmental pollution, and is used instead of the polyvinyl chloride (PVC) heat seal layer commonly used in the industry. In addition, 1,4-butanediol, isophthalic acid, isopentyl diol and isopropanol can all form oligomer mixtures during the polymerization process, so that the polyester heat seal layer 1 can be 130 o C~180 o C, so that the composite film of the present invention can be heat-sealed in a lower temperature range, thus reducing the cost, and the heat-seal strength can be controlled by adjusting the thickness of the heat-seal layer in practical application.

[0041] Furthermore, the composition of the impact-resistant layer includes an impact-resistant polymer selected from the group consisting of polyester thermoplastic elastomer (TPEE), nylon (e.g., nylon 6, nylon 11, nylon 66, or nylon 12), polybutylene terephthalate, and polyethylene terephthalate-1,4-cyclohexanedimethanol (Polyethylene Terephthalate-Glycol, PETG), and therefore the impact strength of the composite film Z of the present invention can be increased by nearly 1-fold.

[0042] The above disclosure is merely a preferred embodiment of the present invention, and the scope of the claims of the present invention is not limited thereto. Therefore, all equivalent technical modifications made by utilizing the contents of the specification and drawings of the present invention are included in the scope of the claims of the present invention. [Explanation of symbols]

[0043] Z: Composite film 1…Heat seal layer 2...Aluminum foil layer 3...Impact-resistant layer 4...First lamination layer 5…Second lamination layer D: Drugs

Claims

1. 130 ｏ C to 180 ｏ A heat seal layer having a melting point of C, an aluminum foil layer disposed on the heat seal layer, and an impact resistant layer disposed on the aluminum foil layer, 1. A composite film for packaging medicines, wherein the heat seal layer is a modified polyester layer containing only a modified polyester containing 10 mol % of a residue derived from isopentyldiol and 4 mol % of a residue derived from isopropanol.

2. 2. The composite film for packaging medicines according to claim 1, wherein the composition of the impact-resistant layer comprises an impact-resistant polymer selected from the group consisting of polyester-based thermoplastic elastomers, nylon, polybutylene terephthalate, and polyethylene terephthalate-1,4-cyclohexanedimethanol.

3. 3. The composite film for packaging pharmaceuticals according to claim 2, wherein the impact-resistant layer is formed of a polyester composition containing the impact-resistant polymer, and a content of the impact-resistant polymer is 1 to 70 wt % based on 100 wt % of the polyester composition.

4. 4. The composite film for packaging medicines according to claim 3, wherein the polyester composition further comprises a general polyester, and the content of the general polyester is 30 to 99 wt% based on 100 wt% of the polyester composition.

5. The composite film for packaging medicines according to claim 4, wherein the common polyester is polyethylene terephthalate.

6. 2. The composite film for packaging medicines according to claim 1, wherein the heat seal layer has a thickness of 10 μm to 200 μm, the aluminum foil layer has a thickness of 5 μm to 20 μm, and the impact resistant layer has a thickness of 10 μm to 100 μm.

7. 2. The composite film for packaging pharmaceuticals according to claim 1, further comprising a first attachment layer and a second attachment layer, wherein the heat seal layer is attached to one surface of the aluminum foil layer via the first attachment layer, and the impact resistant layer is attached to another surface opposite to the one surface of the aluminum foil layer via the second attachment layer.

8. The first and second adhesive layers are each formed of a polyolefin hot melt adhesive, and the thickness of the first and second adhesive layers is 2 μm to 5 μm.

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