Water-soluble film, water-soluble package using the water-soluble film, and method for producing, providing, and administering the same

Abstract

To provide a water-soluble film that exhibits a superior balance between solubility and strength and enables packaging of a drug, a water-soluble package obtained by packaging the drug with the water-soluble film, and a method for producing the water-soluble package.SOLUTION: A water-soluble film for packaging at least one drug, the water-soluble film having a complete dissolution time of 120 seconds or less in deionized water at 37°C and an elongation at break of 100% or more at 23°C and 50% RH.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a water-soluble film, a water-soluble packaging product using the water-soluble film, and methods for producing, providing, and using the same. [Background technology]

[0002] Conventionally, in dispensing pharmacies, medicines in the form of capsules, tablets, powders (powdered medicines), etc. are packaged in packaging paper for each patient's dose, either manually or by a packaging machine, based on prescription information issued by a medical institution. For example, Patent Document 1 describes an example of such a packaging machine, which is capable of efficiently packaging medicines for the same patient even when the prescriptions have different amounts per package.

[0003] On the other hand, elderly patients in particular frequently forget to take or accidentally ingest the individually packaged medicines as described above. For this reason, for example, Patent Document 2 proposes a "medication calendar in which storage sections containing medicines corresponding to each dose specified by date or day of the week and time period for each patient are arranged vertically and horizontally so as to correspond to a predetermined number of doses, such as 21 or 28 times in total, for a four-week period, with multiple doses such as three or four times per day" as a tool to ensure and facilitate patient medication management. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2012-086898 [Patent Document 2] Japanese Patent Publication No. 2020-110233 Summary of the Invention [Problem to be solved by the invention]

[0005] However, even if the medication is packaged in a paper packet and stored in a medication calendar, the patient must take the medication out of the packet when taking it. In this case, some elderly patients have weaker hands and find it difficult to tear the packet, or when they do tear the packet, the medication inside falls out. There was an issue of the agent spilling.

[0006] In response to these problems, the present inventors conducted extensive research and discovered that by using a water-soluble film with specific properties instead of a paper packet, patients would no longer need to remove the medication. That is, by packaging a medication in a water-soluble film with specific properties to form a water-soluble package, patients can orally ingest the entire water-soluble package without removing the medication from the water-soluble package. To obtain such a water-soluble package, the solubility of the water-soluble film is considered to be important so that the water-soluble film dissolves in the oral cavity when the entire water-soluble package is orally ingested. Furthermore, the strength of the water-soluble film is also considered to be important so that the water-soluble package can retain the medication without tearing.

[0007] Therefore, an object of the present invention is to provide a water-soluble film that has an excellent balance of solubility and strength and can be used to package a drug, a water-soluble package in which the drug is packaged with the water-soluble film, and a method for producing the water-soluble package. Another object of the present invention is to provide a method for providing the water-soluble package and a method for taking the water-soluble package. [Means for solving the problem]

[0008] As a result of extensive research, the inventors discovered that the above-mentioned problems could be solved by a water-soluble film having specific properties and a water-soluble packaging body using said water-soluble film, and after further research they were able to complete the present invention.

[0009] That is, the present invention relates to the following [1] to

[17] . [1] A water-soluble film for packaging at least one drug, which has a complete dissolution time of 120 seconds or less in deionized water at 37°C and a breaking elongation of 100% or more at 23°C-50% RH. [2] The water-soluble film according to [1], which contains polyvinyl alcohol and has a content of the polyvinyl alcohol of more than 50% by mass. [3] The water-soluble film according to [2], wherein the polyvinyl alcohol comprises at least one selected from the group consisting of unmodified polyvinyl alcohol and carboxylic acid-modified polyvinyl alcohol. [4] The water-soluble film according to [2] or [3], wherein the degree of saponification of the polyvinyl alcohol is 63 to 98 mol %. [5] A water-soluble film of any of [1] to [4] containing plant-derived ingredients. [6] The water-soluble film according to [5], wherein the plant-derived component comprises at least one selected from the group consisting of starch, cellulose-based polymers, gelatin, amylose, pullulan, casein, zein, shellac, and sandarac. [7] A water-soluble film of any of [1] to [6] containing a plasticizer. [8] The water-soluble film according to any one of [1] to [7], wherein the complete dissolution time is 1 to 30 seconds. [9] A water-soluble package in which at least one drug is packaged in any one of the water-soluble films [1] to [8].

[10] The water-soluble package of [9], wherein the drug is in the form of at least one selected from the group consisting of capsules, tablets, powders, liquids, and gels.

[11] The water-soluble packaging of [9] or

[10] , wherein prescription information for the drug is printed on the surface of the water-soluble film.

[12] A method for producing a water-soluble package, which comprises packaging at least one drug with any one of the water-soluble films [1] to [8].

[13] A method for producing the water-soluble packaging body of

[12] , comprising a step of printing prescription information for the drug on the surface of the water-soluble film.

[14] A method for providing a water-soluble package, comprising the steps of: packaging at least one drug in a water-soluble film according to any one of [1] to [8] to produce a water-soluble package; and providing the water-soluble package to a patient who has been prescribed the drug.

[15] A method for providing a water-soluble package according to

[14] , wherein in the process of producing the water-soluble package, at least two types of drugs are packaged together according to the dosage per dose, either manually or using a packaging machine.

[16] A method for providing a water-soluble package according to

[14] or

[15] , comprising a step of printing prescription information for the drug on the surface of the water-soluble film before or after the step of producing the water-soluble package.

[17] A method for taking a water-soluble package in which a patient who has been prescribed at least one type of drug orally takes the water-soluble package containing the drug packaged in the water-soluble film described in any one of [1] to [8]. [Effects of the Invention]

[0010] According to the present invention, there are provided a water-soluble film that has an excellent balance of solubility and strength and can be used to package a drug, a water-soluble package in which the drug is packaged in the water-soluble film, and a method for manufacturing the water-soluble package.The present invention also provides a method for providing the water-soluble package and a method for taking the drug.Because the water-soluble film of the present invention has an excellent balance of solubility and strength, the water-soluble package in which a drug is packaged in the water-soluble film can be orally taken by a patient without removing the drug from the water-soluble package, while maintaining the strength to hold the drug. DETAILED DESCRIPTION OF THE INVENTION

[0011] <Water-soluble film> [Water-soluble polymer] The components constituting the water-soluble film of the present invention are described below. The main component of the water-soluble film of the present invention is at least one selected from the group consisting of water-soluble polymers and plant-derived components, and is not particularly limited. The main component refers to a component whose content in the water-soluble film is more than 50% by mass.

[0012] In the present invention, the water-soluble polymer is not particularly limited, and is preferably at least one selected from the group consisting of polyvinylpyrrolidone, polyacrylic acid amide, polyvinyl methyl ether, polyvinyl alcohol, polyacrylic acid and its salts, and polyamino acids and its salts. That is, as long as the effects of the present invention are not impaired, one type of water-soluble polymer may be used alone, or two or more types of water-soluble polymers of different types, or the same type but different in degree of polymerization, degree of saponification, degree of modification, etc., may be used in combination.

[0013] (PVA) In the present invention, the polyvinyl alcohol (hereinafter, sometimes abbreviated as PVA) may be produced by saponifying a vinyl ester polymer obtained by polymerizing a vinyl ester monomer. Examples of the vinyl ester monomer include vinyl formate, vinyl acetate, vinyl propionate, vinyl valerate, vinyl laurate, vinyl stearate, vinyl benzoate, vinyl pivalate, and vinyl versatate, with vinyl acetate being preferred.

[0014] The vinyl ester polymer is preferably one obtained using only one or more vinyl ester monomers as the monomer, more preferably one obtained using only one vinyl ester monomer as the monomer, or may be a copolymer of one or more vinyl ester monomers with other monomers copolymerizable therewith.

[0015] Examples of other monomers copolymerizable with such vinyl ester monomers include ethylene; olefins having 3 to 30 carbon atoms such as propylene, 1-butene, and isobutene; acrylic acid or a salt thereof; acrylic acid esters such as methyl acrylate, ethyl acrylate, n-propyl acrylate, i-propyl acrylate, n-butyl acrylate, i-butyl acrylate, t-butyl acrylate, 2-ethylhexyl acrylate, dodecyl acrylate, and octadecyl acrylate; methacrylic acid or a salt thereof; methyl methacrylate, ethyl methacrylate, and methacrylic acid. methacrylic acid esters such as n-propyl methacrylate, i-propyl methacrylate, n-butyl methacrylate, i-butyl methacrylate, t-butyl methacrylate, 2-ethylhexyl methacrylate, dodecyl methacrylate, and octadecyl methacrylate; acrylamides such as acrylamide, N-methylacrylamide, N-ethylacrylamide, N,N-dimethylacrylamide, diacetone acrylamide, acrylamidopropanesulfonic acid or a salt thereof, acrylamidopropyldimethylamine or a salt thereof, and N-methylolacrylamide or a derivative thereof; methacrylamide derivatives such as methacrylamide, N-methylmethacrylamide, N-ethylmethacrylamide, methacrylamidepropanesulfonic acid or its salts, methacrylamidepropyldimethylamine or its salts, and N-methylolmethacrylamide or its derivatives; N-vinylamides such as N-vinylformamide, N-vinylacetamide, and N-vinylpyrrolidone; methyl vinyl ether, ethyl vinyl ether, n-propyl vinyl ether, i-propyl vinyl ether, n-butyl vinyl ether, and i-butyl vinyl ether vinyl ethers such as t-butyl vinyl ether, dodecyl vinyl ether, and stearyl vinyl ether; vinyl cyanides such as acrylonitrile and methacrylonitrile; vinyl halides such as vinyl chloride, vinylidene chloride, vinyl fluoride, and vinylidene fluoride; allyl compounds such as allyl acetate and allyl chloride; acrylic acid or its salts or esters; methacrylic acid or its salts or esters; maleic acid or its salts, esters, or acid anhydrides; itaconic acid or its salts, esters, or acid anhydrides; vinylsilyl compounds such as vinyltrimethoxysilane;Examples of other monomers include isopropenyl acetate. The vinyl ester polymer may have structural units derived from one or more of these other monomers.

[0016] The proportion of the structural units derived from the other monomers in the vinyl ester polymer is preferably 15 mol % or less, and more preferably 5 mol % or less, based on the number of moles of all structural units constituting the vinyl ester polymer, from the viewpoints of water solubility, film strength, minimal concerns about hygiene, etc. In the present invention, minimal concerns about hygiene means that adverse effects on the human body, such as toxicity and mutagenicity, can be substantially ignored even if the polymer is ingested by the human body.

[0017] Preferred examples of other monomers copolymerizable with vinyl ester monomers include hydrophilic N-vinylamide monomers and sulfonic acid monomers that do not impair the solubility of PVA, as well as carboxylic acid monomers such as acrylic acid, its salts, or esters; methacrylic acid, its salts, or esters; maleic acid, its salts, esters, or acid anhydrides; and itaconic acid, its salts, esters, or acid anhydrides. Among these, preferred are carboxylic acid monomers, which pose little concern for human hygiene even if unreacted monomers remain in the polymer.

[0018] The water-soluble film of the present invention contains PVA, and the PVA content is preferably greater than 50% by mass. The lower limit of the PVA content is more preferably 60% by mass, even more preferably 70% by mass, and particularly preferably 80% by mass. When the PVA content is equal to or greater than the above lower limit, the water-soluble film not only has an excellent balance of solubility and strength, but also has excellent sealability (heat sealability and water sealability). The sealability of the water-soluble film allows for the sealed packaging of oxygen-sensitive drugs and liquid or fluid drugs. On the other hand, the upper limit of the PVA content is not particularly limited, but can be, for example, 96% by mass or less.

[0019] In the water-soluble film of the present invention, the PVA preferably comprises at least one selected from the group consisting of unmodified PVA and carboxylic acid-modified PVA. By limiting the type of PVA to the above types, there are fewer concerns about the hygiene of the PVA, making it suitable for use in the water-soluble film of the present invention. Note that unmodified PVA is PVA produced by saponifying polyvinyl acetate obtained by polymerizing only vinyl acetate. Furthermore, carboxylic acid-modified PVA is PVA produced by saponifying carboxylic acid-modified polyvinyl acetate obtained by polymerizing vinyl acetate and a carboxylic acid-based monomer.

[0020] In the water-soluble film of the present invention, the degree of polymerization of the PVA is not particularly limited, but from the viewpoint of the strength of the water-soluble film, the lower limit of the degree of polymerization is preferably 200 or more, more preferably 300 or more, and even more preferably 500 or more. On the other hand, from the viewpoint of the solubility and productivity of the water-soluble film, the upper limit of the degree of polymerization is preferably 8,000 or less, more preferably 5,000 or less, even more preferably 3,000 or less, and particularly preferably 2,000 or less. Here, the degree of polymerization means the average degree of polymerization measured in accordance with the description of JIS K6726-1994, and is calculated by the following formula from the intrinsic viscosity [η] (unit: deciliter / g) measured in water at 30°C after resaponifying and purifying the PVA. Degree of polymerization Po=([η]×10 4 / 8.29)(1 / 0.62)

[0021] In the water-soluble film of the present invention, the saponification degree of PVA is preferably 63 to 98 mol%. By adjusting the saponification degree within this range, the water-soluble film has an excellent balance between solubility and strength. The lower limit of the saponification degree is more preferably 70 mol% or more, and even more preferably 75 mol% or more. On the other hand, the upper limit of the saponification degree is more preferably 93 mol% or less, and even more preferably 91 mol% or less. Here, the saponification degree of PVA refers to the ratio (mol%) of the number of moles of vinyl alcohol units to the total number of moles of structural units (typically vinyl ester-based monomer units) that can be converted into vinyl alcohol units by saponification contained in the PVA and vinyl alcohol units. The saponification degree of a PVA-based polymer can be measured in accordance with the description of JIS K6726-1994.

[0022] [Plant-derived ingredients] The water-soluble film of the present invention also preferably contains a plant-derived component. The content of the plant-derived component in the water-soluble film can be, for example, 80% by mass or more. From the viewpoint of the strength and production cost of the water-soluble film, the water-soluble film of the present invention also preferably contains a water-soluble polymer and a plant-derived component, and more preferably contains PVA and starch, which will be described later. The ratio of the content of the water-soluble polymer to the plant-derived component is preferably 50:50 to 99:1, more preferably 60:40 to 98:2, even more preferably 70:30 to 97:3, particularly preferably 80:20 to 96:4, and most preferably 85:15 to 95:5.

[0023] In the water-soluble film of the present invention, the plant-derived component is not particularly limited as long as it can be molded into a film shape. From the viewpoint of achieving an excellent balance between the solubility and strength of the water-soluble film, examples include gum arabic, starch, cellulose-based polymers, gelatin, amylose, pullulan, casein, zein, shellac, and sandarac. Among these, the plant-derived component preferably includes at least one selected from the group consisting of starch, cellulose-based polymers, gelatin, amylose, pullulan, casein, zein, shellac, and sandarac. Furthermore, the plant-derived component more preferably includes at least starch. The starch preferably includes at least one selected from the group consisting of natural starches such as corn starch, potato starch, sweet potato starch, wheat starch, rice starch, tapioca starch, and sago starch, and processed starches that have been subjected to etherification, esterification, oxidation, or the like.

[0024] [Plasticizer] The water-soluble film of the present invention preferably contains a plasticizer. By containing a plasticizer, the mechanical properties and processability of the water-soluble film can be improved. The content of the plasticizer in the water-soluble film is preferably 1 to 40 mass%, more preferably 2 to 35 mass%, even more preferably 3 to 30 mass%, and particularly preferably 3 to 26 mass%.

[0025] In the water-soluble film of the present invention, the plasticizer is not particularly limited and known plasticizers can be used. Two or more plasticizers may be combined. When the water-soluble film contains PVA, the plasticizer preferably contains at least one selected from the group consisting of ethylene glycol, glycerin, diglycerin, propylene glycol, trimethylolpropane, and sorbitol. Among these plasticizers, it is preferable to contain at least ethylene glycol or glycerin, and it is more preferable to contain at least glycerin, from the viewpoints of being less likely to bleed out onto the surface of the water-soluble film and having fewer hygiene concerns.

[0026] The water-soluble film of the present invention may contain a small amount of surfactant from the viewpoint of improving its handleability and peelability from a film-forming device when producing the water-soluble film. One surfactant may be used alone, or two or more surfactants may be used in combination. Examples of surfactants that can be used include anionic surfactants and nonionic surfactants. Examples of nonionic surfactants include lauric acid diethanolamide.

[0027] [Other ingredients] The water-soluble film of the present invention may contain other components such as moisture, antioxidants, lubricants, crosslinking agents, colorants, fillers, preservatives, and antifungal agents, as long as the components do not impair the effects of the present invention and pose little concern about hygiene. In the water-soluble film of the present invention, the total content of the water-soluble polymer and / or plant-derived component and the other components is preferably 60 to 100% by mass, more preferably 80 to 100% by mass, and even more preferably 90 to 100% by mass.

[0028] [Characteristics, etc.] The water-soluble film of the present invention must have a complete dissolution time in deionized water at 37°C (hereinafter sometimes referred to as the complete dissolution time) of 120 seconds or less. If the complete dissolution time exceeds 120 seconds, when a water-soluble package containing a drug packaged in a water-soluble film is orally taken, the water-soluble film may not dissolve sufficiently in the oral cavity, making the drug difficult to swallow. The upper limit of the complete dissolution time of the water-soluble film is preferably 90 seconds or less, more preferably 60 seconds or less, even more preferably 30 seconds or less, and particularly preferably 15 seconds or less. On the other hand, the lower limit of the complete dissolution time is preferably 1 second or more, more preferably 2 seconds or more, and even more preferably 3 seconds or more. A complete dissolution time of at least the above lower limit makes it difficult for the water-soluble film to stick to each other due to water vapor in the air during storage. In addition, it is possible to prevent the water-soluble film from tearing or sticking to the hands due to trace amounts of moisture on the skin surface, such as sweat, during handling.

[0029] The water-soluble film of the present invention must have a breaking elongation at 23°C-50% RH (hereinafter sometimes referred to as breaking elongation) of 100% or more. If the breaking elongation is less than 100%, there is a risk that the water-soluble package containing a drug packaged in a water-soluble film may break or be accidentally opened when taken by a patient. The lower limit of the breaking elongation is preferably 150% or more, more preferably 200% or more. On the other hand, the upper limit of the breaking elongation is not particularly limited, but is preferably 500% or less. When the breaking elongation is equal to or less than the above lower limit, the water-soluble package can be easily opened when intentionally opened.

[0030] The water-soluble film of the present invention preferably has a Young's modulus of 15 MPa or more and 40 MPa or less. When the Young's modulus is equal to or less than the upper limit, the strength and handleability of the water-soluble film can be improved. On the other hand, when the Young's modulus is equal to or more than the upper limit, the water-soluble film can be prevented from stretching and causing deformation of the water-soluble packaging material.

[0031] The upper limit of the thickness of the water-soluble film of the present invention is not particularly limited, but is preferably 200 μm or less, more preferably 150 μm or less, even more preferably 100 μm or less, and even more preferably 50 μm or less. When the thickness is below the above upper limit, the solubility and handleability of the water-soluble film are likely to be improved. On the other hand, the lower limit of the thickness is preferably 5 μm or more, more preferably 10 μm or more, even more preferably 15 μm or more, and particularly preferably 20 μm or more. When the thickness of the water-soluble film is above the above lower limit, the mechanical strength of the water-soluble film is likely to be maintained. The thickness of the water-soluble film can be determined by measuring the thickness at any 10 points (for example, any 10 points on a line drawn in the length direction of the water-soluble film) and averaging the measured values.

[0032] The water-soluble film of the present invention is preferably translucent or transparent from the viewpoint of visibility of the packaged drug. The water-soluble film may be colored with an edible dye to make it identifiable. Furthermore, from the viewpoint of ease of handling, the water-soluble film of the present invention is preferably capable of being incorporated into an existing packaging machine for use.

[0033] The water-soluble film of the present invention packages at least one type of drug. That is, the water-soluble film of the present invention is used as a drug packaging film that packages at least one type of drug. The water-soluble film of the present invention may package one type of drug, or may package two or more types of drugs together. Note that a water-soluble package in which at least one type of drug is packaged with the water-soluble film of the present invention is also one aspect of the present invention.

[0034] <Method of manufacturing water-soluble film> The method for producing a water-soluble film is not particularly limited, and known methods can be used. For example, a film-forming solution obtained by adding a solvent, additives, etc. to a water-soluble polymer and / or a plant-derived component to homogenize the film can be produced by any method, such as a casting film-forming method, a wet film-forming method (discharge into a poor solvent), a dry-wet film-forming method, a gel film-forming method (a method in which the film-forming solution is cooled to gel, and then the solvent is extracted and removed to obtain a water-soluble film), or a combination of these methods, or a melt-extrusion film-forming method or an inflation molding method in which the film-forming solution is obtained using an extruder or the like and extruded through a T-die or the like to form a film. Among these, the casting film-forming method and the melt-extrusion film-forming method are preferred because they can produce a homogeneous water-soluble film with good productivity.

[0035] The water-soluble film can be further subjected to heat treatment as needed. By performing heat treatment, the strength, solubility, etc. of the water-soluble film can be adjusted. The heat treatment temperature is preferably 60°C or higher and 135°C or lower.

[0036] The water-soluble film produced in this manner may be further subjected to humidity conditioning treatment, cutting of both ends (edges) of the film, etc., as necessary, and then wound into a roll on a cylindrical core or cut to an appropriate size, and then moisture-proof packaged to form the final product.

[0037] <Water-soluble packaging> A water-soluble package in which at least one drug is packaged with the water-soluble film of the present invention is also an aspect of the present invention. Because the water-soluble film of the present invention has an excellent balance of solubility and strength, the water-soluble package of the present invention can be orally taken by a patient without removing the drug from the water-soluble package.

[0038] In the water-soluble package of the present invention, the physical properties of the drug are not particularly limited, and the drug may be acidic, neutral, or alkaline. From the viewpoint of the moisture resistance of the water-soluble package, drugs with low hygroscopicity are preferred. The form of the drug is not particularly limited, but since the water-soluble film of the present invention has an excellent balance of solubility and strength, the drug is preferably in the form of at least one selected from the group consisting of capsules, tablets, powders, liquids, and gels. When the drug is in the form of a liquid or gel, it is preferable that the drug does not contain a large amount of water that can migrate into the water-soluble film, in order to prevent the water-soluble film from dissolving before the water-soluble package is taken.

[0039] The water-soluble packaging of the present invention preferably has prescription information for the drug printed on the surface of the water-soluble film. Examples of the prescription information include the type of drug prescribed and the dosage per dose, the name of the patient prescribed the drug, and the date and time the drug is to be taken. The prescription information may be all or part of these. Printing the prescription information can prevent patients from accidentally ingesting the drug. The prescription information is preferably printed using an edible dye. Furthermore, the prescription information may be printed on the water-soluble film before packaging the drug in the water-soluble film to produce the water-soluble packaging, or may be printed on the water-soluble film after the water-soluble packaging is produced.

[0040] <Method of manufacturing water-soluble packaging body> A preferred method for producing the water-soluble package of the present invention is a method in which at least one drug is packaged in the water-soluble film of the present invention. The water-soluble package of the present invention is usually produced by packaging at least one drug in a water-soluble film manually or using a packaging machine, and then sealing the water-soluble film. When packaging at least one drug in a water-soluble film manually or using a packaging machine, it is preferable to package the drugs according to the amount to be taken per dose. In particular, when packaging at least two drugs, it is preferable to package the at least two drugs together manually or using a packaging machine according to the amount to be taken per dose, from the viewpoint of preventing patients from accidentally ingesting the drugs.

[0041] The method for sealing the water-soluble film is preferably a heat sealing method or a combination of a heat sealing method and a water sealing method. By employing these methods, uniform sealing can be achieved while suppressing a decrease in the strength of the water-soluble film. The heat sealing method is a method in which water-soluble films are heated and pressed together with a heat seal bar to seal them. The water sealing method is a method in which a small amount of water is applied to the sealed portion to dissolve part of the film and bond the films together. Furthermore, the combination of a heat sealing method and a water-soluble film is a method in which a small amount of water is incorporated into the water-soluble film during heat sealing. It is preferable that the seal strength of the sealed portion of the water-soluble film is non-peelable. Non-peelable means that the seal strength is higher than the strength of the water-soluble film, and the water-soluble film near the sealed portion will tear if an attempt is made to peel it off.

[0042] The method for producing the water-soluble packaging body of the present invention preferably includes a step of printing prescription information for the drug on the surface of the water-soluble film. The content and printing of the prescription information are the same as those described above for the prescription information in the water-soluble packaging body.

[0043] <Method of providing water-soluble packaging> The water-soluble package of the present invention is produced as described above and then provided to patients at a prescription pharmacy or the like. That is, one aspect of the present invention also includes a method for providing a water-soluble package, comprising the steps of: packaging at least one drug with the water-soluble film of the present invention to produce a water-soluble package; and providing the water-soluble package to a patient who has been prescribed the drug. In the provision method, a patient who has been prescribed at least one drug by a doctor first communicates prescription information to a pharmacist at a prescription pharmacy or the like. Based on the prescription information, the pharmacist packages at least one drug with the water-soluble film of the present invention to produce a water-soluble package, and provides the produced water-soluble package to the patient. Here, as described above, the water-soluble film of the present invention can be sealed using a heat seal method or the like, allowing pharmacists to easily produce water-soluble packages according to the type of drug. Furthermore, since the water-soluble film of the present invention is less susceptible to contamination by dust or oil and therefore poses little concern for hygiene, the water-soluble package also poses little concern for hygiene.

[0044] In the method for providing a water-soluble package of the present invention, in order to prevent patients from accidentally ingesting the drug, it is preferable that in the process of producing the water-soluble package, at least two types of drug are packaged together according to the dosage per dose, either manually or using a packaging machine.

[0045] The method for providing a water-soluble package of the present invention preferably includes a step of printing prescription information for the drug on the surface of the water-soluble film before or after the step of producing the water-soluble package. The content and printing of the prescription information are the same as those described above for the prescription information in the water-soluble package.

[0046] <How to take the water-soluble package> The water-soluble package of the present invention is provided to a patient as described above and then taken by the patient. That is, one aspect of the present invention also includes a method for taking a water-soluble package in which a patient prescribed at least one drug orally takes the water-soluble package containing the drug packaged in a water-soluble film. Because the water-soluble film of the present invention has an excellent balance of solubility and strength, the water-soluble package of the present invention can be orally taken by the patient without removing the drug from the water-soluble package. [Example]

[0047] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples. The evaluation methods used in the examples and comparative examples are shown below.

[0048] (1)Complete dissolution time The time required for complete dissolution of the films of the following Examples and Comparative Examples when immersed in deionized water at 37° C. was measured as follows. <1> The water-soluble film was placed in a thermo-hygrostat adjusted to 20°C and 65% RH for 16 hours or more to condition the humidity. <2> A rectangular sample measuring 40 mm long and 35 mm wide was cut out from the moisture-conditioned water-soluble film, and then sandwiched and fixed between two 50 mm x 50 mm plastic plates with rectangular windows (holes) measuring 35 mm long and 23 mm wide, so that the length of the sample was parallel to the length of the windows and the sample was positioned approximately in the center of the width of the windows. <3> 300 mL of deionized water was placed in a 500 mL beaker, and the water temperature was adjusted to 37°C while stirring with a magnetic stirrer equipped with a 3 cm long bar at a rotation speed of 280 rpm. <4> the above <2> The sample fixed to the plastic plate in step 1 was immersed in deionized water in a beaker, taking care not to let it come into contact with the bar of the magnetic stirrer. <5> The time from immersion in deionized water until the sample pieces dispersed in the deionized water completely disappeared was measured as the complete dissolution time (seconds).

[0049] (2) Sealing The sealing properties of the films of the following Examples and Comparative Examples were evaluated as follows. <1> The water-soluble film was placed in a thermo-hygrostat adjusted to 20°C and 65% RH for 16 hours or more to condition the humidity. <2> Two rectangular samples measuring 40 mm long and 35 mm wide were cut out from the moisture-conditioned water-soluble film. <3-1> Heat sealability: Two samples were placed on top of each other and pressed together for 5 seconds with a household iron adjusted to 180°C. If the samples were bonded together after 5 seconds, it was rated as A, and if they were not bonded, it was rated as B. <3-2> Water sealing property: Two samples were stacked on top of each other, and a cotton ball with water on it was carefully applied around the edge of the film. After drying with air, the edges were checked and if the samples were adhered to each other, it was rated as A, and if they were not, it was rated as B.

[0050] (3) Young's modulus and breaking elongation The Young's modulus and elongation at break of the films of the following Examples and Comparative Examples were measured as follows. <1> A sample measuring 1.5 cm in width and 10 cm in length was cut out from the water-soluble film. <2> The cut samples were stored in a room at 23°C and 50% RH for 16 hours or more to condition the humidity. <3> The humidity-conditioned sample was subjected to a tensile test under the following conditions using a tensile tester, and the Young's modulus (MPa) and the breaking elongation (%) when the sample broke were determined from the initial slope of the obtained chart. Equipment: Shimadzu Corporation AG-D type Chuck spacing: 100mm Chuck speed: 100mm / min Measurement atmosphere: 23°C, 50% RH

[0051] [Example 1] A film-forming solution with a volatile content of 60% by weight was prepared, consisting of 100 parts by weight of unmodified PVA (saponification degree 88 mol%, polymerization degree 1,700) obtained by saponifying polyvinyl acetate (PVA), 20 parts by weight of glycerin as a plasticizer, 0.5 parts by weight of lauric acid diethanolamide as a surfactant, and water. The resulting film-forming solution was filtered and extruded into a film form onto a first drying roll (surface temperature 80°C) through a T-die. The PVA film was then dried on the entire non-contact surface of the first drying roll by blowing hot air at 85°C at a speed of 5 m / s to obtain a PVA film. The PVA film was then peeled from the first drying roll and dried on subsequent drying rolls (surface temperature 75°C) so that one side of the PVA film alternately contacted each drying roll, and then wound up to obtain a water-soluble film (thickness 40 μm, width 1200 m). The water-soluble films thus obtained were evaluated for complete dissolution time, sealability, Young's modulus, and breaking elongation by the methods described above. The results are shown in Table 1.

[0052] [Example 2] A water-soluble film was produced and evaluated in the same manner as in Example 1, except that maleic anhydride-modified PVA (saponification degree 96 mol%, polymerization degree 1,700, modification degree 4 mol%) was used as the PVA. The results are shown in Table 1.

[0053] [Example 3] A water-soluble film was produced and evaluated in the same manner as in Example 1, except that 2-acrylamido-2-methylpropylsulfonic acid-modified PVA (saponification degree 89 mol%, polymerization degree 1,700, modification degree 2 mol%) was used as the PVA. The results are shown in Table 1.

[0054] [Example 4] A film-forming solution with a volatile content of 96% by mass was prepared by thoroughly mixing 100 parts by mass of amylose with a weight-average molecular weight (Mw) of 95 kDa as a plant-derived component, 20 parts by mass of glycerin as a plasticizer, and water at 80°C. The resulting film-forming solution was cast onto a PET film and dried under controlled humidity conditions of 20°C and 65% RH until the volatile content reached 10% by mass or less, yielding a water-soluble film (40 μm thick, 20 cm wide, 8% moisture content). The dissolution time, sealability, Young's modulus, and elongation at break of the resulting film were evaluated using the methods described above. The results are shown in Table 1.

[0055] [Example 5] A film-forming solution with a volatile content of 60% by mass was prepared using 90 parts by mass of unmodified PVA (saponification degree 88 mol%, polymerization degree 1,700) obtained by saponifying polyvinyl acetate as the PVA, 10 parts by mass of starch (corn starch) as a plant-derived component, 20 parts by mass of glycerin as a plasticizer, 0.5 parts by mass of lauric acid diethanolamide as a surfactant, and water. A water-soluble film was produced and evaluated in the same manner as in Example 1, except that this film-forming solution was used. The results are shown in Table 1.

[0056] [Comparative Example 1] Using commercially available starch medicinal wafers (thickness 40 μm), the complete dissolution time, sealing property, Young's modulus, and breaking elongation were evaluated. The results are shown in Table 1.

[0057] [Reference example 1] A water-soluble film was produced and evaluated in the same manner as in Example 1, except that unmodified PVA (saponification degree 99 mol% or more, polymerization degree 1,700) obtained by saponifying polyvinyl acetate was used as the PVA. The results are shown in Table 1.

[0058] [Table 1]

[0059] As shown in Table 1, the water-soluble films of Examples 1 to 5 had complete dissolution times of 120 seconds or less and breaking elongations of 100% or more, and were excellent in the balance of solubility and strength compared to the conventional packaging paper of Comparative Example 1. Because the water-soluble films of the present invention have an excellent balance of solubility and strength, the water-soluble package in which a drug is packaged in the water-soluble film maintains the strength to hold the drug, and the patient can orally take the drug together with the water-soluble package without removing it from the water-soluble package.

[0060] Furthermore, as shown in Table 1, the water-soluble films of Examples 1 to 3 and 5, which had a PVA content of more than 50% by mass, were evaluated as "A" in both heat sealability and water sealability, and were therefore excellent in sealability.

Claims

1. A water-soluble film for packaging at least one drug, which has a complete dissolution time in deionized water at 37°C of 120 seconds or less and a breaking elongation of 100% or more at 23°C-50% RH.

2. 2. The water-soluble film according to claim 1, which contains polyvinyl alcohol, and the content of said polyvinyl alcohol is more than 50% by mass.

3. The water-soluble film according to claim 2, wherein the polyvinyl alcohol comprises at least one selected from the group consisting of unmodified polyvinyl alcohol and carboxylic acid-modified polyvinyl alcohol.

4. 4. The water-soluble film according to claim 2, wherein the degree of saponification of the polyvinyl alcohol is 63 to 98 mol %.

5. The water-soluble film according to any one of claims 1 to 3, which contains a plant-derived component.

6. 6. The water-soluble film according to claim 5, wherein the plant-derived component comprises at least one selected from the group consisting of starch, cellulose-based polymers, gelatin, amylose, pullulan, casein, zein, shellac, and sandarac.

7. The water-soluble film according to any one of claims 1 to 3, which contains a plasticizer.

8. 4. The water-soluble film according to claim 1, wherein the complete dissolution time is 1 to 30 seconds.

9. A water-soluble package comprising at least one drug packaged in the water-soluble film according to any one of claims 1 to 3.

10. The water-soluble package according to claim 9, wherein the drug is in the form of at least one selected from the group consisting of capsules, tablets, powders, liquids, and gels.

11. The water-soluble package according to claim 9 or 10, wherein prescription information for the drug is printed on the surface of the water-soluble film.

12. A method for producing a water-soluble package, comprising packaging at least one drug with the water-soluble film according to any one of claims 1 to 3 to produce the water-soluble package.

13. The method for producing a water-soluble package according to claim 12, further comprising the step of printing prescription information for the drug on the surface of the water-soluble film.

14. A method for providing a water-soluble package, comprising the steps of: packaging at least one drug with the water-soluble film according to any one of claims 1 to 3 to produce a water-soluble package; and providing the water-soluble package to a patient who has been prescribed the drug.

15. The method for providing a water-soluble package according to claim 14, wherein in the step of producing the water-soluble package, at least two types of drugs are packaged together according to the dosage per dose, either manually or using a packaging machine.

16. The method for providing a water-soluble package according to claim 14 or 15, further comprising the step of printing prescription information for the drug on the surface of the water-soluble film before or after the step of producing the water-soluble package.

17. A method for taking a water-soluble package, in which a patient who has been prescribed at least one type of drug orally takes the water-soluble package containing the drug packaged in the water-soluble film according to any one of claims 1 to 3.

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