WO2018088142A1 - Composition pour fixation de pigments, et préparation pharmaceutique solide - Google Patents

Composition pour fixation de pigments, et préparation pharmaceutique solide Download PDF

Info

Publication number
WO2018088142A1
WO2018088142A1 PCT/JP2017/037501 JP2017037501W WO2018088142A1 WO 2018088142 A1 WO2018088142 A1 WO 2018088142A1 JP 2017037501 W JP2017037501 W JP 2017037501W WO 2018088142 A1 WO2018088142 A1 WO 2018088142A1
Authority
WO
WIPO (PCT)
Prior art keywords
pigment
solid preparation
pigment fixing
water
composition
Prior art date
Application number
PCT/JP2017/037501
Other languages
English (en)
Japanese (ja)
Inventor
聡一郎 森川
Original Assignee
株式会社Ｓｃｒｅｅｎホールディングス
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社Ｓｃｒｅｅｎホールディングス filed Critical 株式会社Ｓｃｒｅｅｎホールディングス
Publication of WO2018088142A1 publication Critical patent/WO2018088142A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B41—PRINTING; LINING MACHINES; TYPEWRITERS; STAMPS
    • B41J—TYPEWRITERS; SELECTIVE PRINTING MECHANISMS, i.e. MECHANISMS PRINTING OTHERWISE THAN FROM A FORME; CORRECTION OF TYPOGRAPHICAL ERRORS
    • B41J2/00—Typewriters or selective printing mechanisms characterised by the printing or marking process for which they are designed
    • B41J2/005—Typewriters or selective printing mechanisms characterised by the printing or marking process for which they are designed characterised by bringing liquid or particles selectively into contact with a printing material
    • B41J2/01—Ink jet
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B41—PRINTING; LINING MACHINES; TYPEWRITERS; STAMPS
    • B41M—PRINTING, DUPLICATING, MARKING, OR COPYING PROCESSES; COLOUR PRINTING
    • B41M5/00—Duplicating or marking methods; Sheet materials for use therein
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D11/00—Inks
    • C09D11/54—Inks based on two liquids, one liquid being the ink, the other liquid being a reaction solution, a fixer or a treatment solution for the ink

Definitions

  • the present invention relates to a pigment fixing composition and a solid preparation, and more particularly, can impart excellent scratch resistance and peeling resistance to a printed image formed on the surface of a tablet such as a pharmaceutical or food, and
  • the present invention relates to a composition for fixing a pigment and a solid preparation having good flightability from an inkjet head.
  • Ink-jet ink for printing on tablets etc. must be composed of raw materials that meet the standards stipulated in the Pharmaceutical Affairs Law.
  • ink-jet inks for example, those made of a dye ink using a water-soluble edible tar dye or the like as a color material and those made of a pigment ink using an edible iron oxide pigment or the like as a color material are manufactured and sold. ing.
  • the former dye ink has a problem in that it fades with time due to light irradiation and is inferior in light resistance as compared with the latter pigment ink. For this reason, cases of using pigment inks excellent in light resistance for printing on tablets and the like are increasing.
  • the pigment ink containing a water-insoluble edible polymer compound when dried on the end face of the inkjet head, the pigment ink may be solidified and clogged at the nozzle of the inkjet head.
  • the fixed matter of the pigment ink containing the water-insoluble edible polymer compound is very difficult to remove even with a cleaning liquid or the like.
  • the present invention has been made in view of the above problems, and its purpose is to improve the fixability of the pigment in a printed image on the surface of a solid preparation such as a pharmaceutical or food, and to coat and protect the pigment,
  • An object of the present invention is to provide a pigment fixing composition and a solid preparation capable of improving the scratch resistance and peel resistance of a printed image.
  • the inventors of the present application examined a pigment fixing composition and a solid preparation in order to solve the above problems. As a result, the inventors have found that the above problems can be solved by adopting the following configuration, and have completed the present invention.
  • the composition for fixing a pigment according to the present invention is a composition for fixing a pigment used for printing in an ink jet system on a solid preparation in order to solve the above-mentioned problem
  • the composition for fixing a pigment is the above-mentioned
  • a pigment fixing component that is permeable to a solid preparation includes at least a water-soluble and edible pigment fixing component, water, and substantially does not include a water-insoluble component. Is characterized in that an edible pigment is fixed on the surface of the solid preparation.
  • the pigment fixing composition having the above-described configuration is used for a pigment fixing process for improving the scratch resistance and peel resistance of a printed image by fixing an edible pigment on the surface of a solid preparation.
  • the pigment fixing composition having the above-described structure has a composition containing at least a pigment fixing component and water and substantially not containing a water-insoluble component.
  • the said solid formulation consists of tablets or capsules, such as a pharmaceutical and a foodstuff, and shows solubility with respect to water. Therefore, when the pigment fixing composition is brought into contact with the surface of the solid preparation, the pigment fixing composition can penetrate into the solid preparation.
  • the reason why the pigment fixing composition of the present invention can improve the fixing performance of the pigment on the surface of the solid preparation is considered to be as follows. That is, the first is to improve the mechanical strength of the surface layer portion (the portion where the pigment fixing composition has penetrated into the solid preparation) of the solid preparation by drying the pigment fixing composition that has penetrated into the solid preparation. It can be done. Thereby, even if the solid preparation receives an external force such as an impact, it is possible to suppress the pigment from being scraped off along with the surface layer portion of the solid preparation, and to reduce the transfer of the pigment to another solid preparation or the like.
  • the pigment fixing composition of the present invention can prevent the transfer of the pigment by improving the mechanical strength of the surface layer portion even for such a solid preparation.
  • the pigment fixing component contained in the pigment fixing composition functions as an adhesive that firmly fixes the pigment to the surface of the solid formulation by drying the pigment fixing composition that has penetrated the solid formulation. Is. Thereby, it can prevent that a pigment peels from the solid formulation surface.
  • the dried film functions as an overcoat layer when the pigment fixing composition is dried in a state where the pigment on the solid preparation is coated. Thereby, even if other solid preparations contact the pigment fixed on the surface of the solid preparation, the transfer of the pigment can be suppressed.
  • the composition for fixing a pigment having the above constitution can improve the mechanical strength of the surface layer portion of the solid preparation, adhere the pigment to the surface of the solid preparation, and further coat and protect the pigment as an overcoat layer. Therefore, it is possible to improve the scratch resistance and peel resistance of the printed image.
  • the pigment fixing composition having the above-described structure uses printing by an ink jet method to fix the pigment on the surface of the solid preparation, but is inherently water-soluble and substantially contains a water-insoluble component. Therefore, even if the pigment fixing composition is dried and fixed on the end face of the ink jet head or the like, it can be easily removed with an aqueous cleaning solution or the like.
  • the pigment fixing component is polyvinyl pyrrolidone having a number average molecular weight of 2,000 to 200,000, and the polyvinyl pyrrolidone is 1 to 20% by mass with respect to the total mass of the pigment fixing composition. It is preferable to be included in the range.
  • polyvinylpyrrolidone Since polyvinylpyrrolidone is soluble in water and can penetrate into a solid preparation, after the polyvinylpyrrolidone that has penetrated into the solid preparation has dried, the mechanical portion of the surface layer portion (the part into which polyvinylpyrrolidone has penetrated) of the solid preparation is dried. Strength can be improved.
  • polyvinylpyrrolidone also has an adhesive function, the pigment can be firmly fixed on the surface of the solid preparation. Furthermore, polyvinylpyrrolidone can function as an overcoat layer when a dry coating film is formed in a state where the pigment on the surface of the solid preparation is coated.
  • polyvinyl pyrrolidone having a number average molecular weight in the range of 2000 to 200,000 is used and contained in an amount of 1% by mass or more based on the total mass of the pigment fixing composition.
  • the polyvinyl pyrrolidone having a number average molecular weight in the above numerical range is contained in an amount of 20% by mass or less with respect to the total mass of the pigment fixing composition, the viscosity of the pigment fixing composition becomes too large and the viscosity is Newtonian. It is possible to prevent a great deviation from the state.
  • the pigment fixing composition is discharged by the ink jet method, it can be stably discharged from the ink jet head, and it is possible to suppress the drop of the droplet flying property of the pigment fixing composition. .
  • the solid preparation according to the present invention is a solid preparation in which at least an ink layer and an overcoat layer are sequentially laminated on the surface, and the ink layer contains an edible pigment.
  • the overcoat layer is made of a dry film of a pigment fixing solution made of the pigment fixing composition, and the pigment in the ink layer is a surface layer portion of the solid preparation. It is characterized in that it is fixed on the surface of the solid preparation by the pigment fixing component in the pigment fixing composition penetrating into the solid preparation.
  • the ink layer is protected by being covered with the overcoat layer formed of the dried film of the pigment fixing solution, and thus has excellent scratch resistance and peeling resistance.
  • the pigment fixing component in the penetrated pigment fixing composition, and the pigment fixing component firmly fixes the pigment of the ink layer on the surface of the solid preparation. Therefore, for example, even if the solid preparation is a film-coated tablet, a sugar-coated tablet or the like, and the pigment is substantially difficult to penetrate inside and is difficult to fix, a solid preparation having a printed image having excellent scratch resistance and peel resistance. Can be provided. Thereby, for example, even when product information or the like is directly printed on the surface of the solid preparation, it is possible to provide a solid preparation that can further improve discrimination and further prevent dispensing mistakes and accidental ingestion.
  • the pigment fixing composition of the present invention is a composition that contains at least a pigment fixing component and water, does not substantially contain a water-insoluble component, and can penetrate into a solid preparation. Therefore, when a pigment fixing treatment is performed by printing in an ink jet system using a pigment fixing liquid composed of a pigment fixing composition for a printed image composed of a pigment ink layer, the pigment fixing component that has penetrated into the solid preparation is The mechanical strength of the penetrated portion can be improved. Thereby, it is possible to prevent the pigment from being scraped by the external force or the like along with the surface layer portion of the solid preparation. In addition, since the pigment fixing component also exhibits an adhesive function to the pigment, the pigment can be firmly fixed on the surface of the solid preparation.
  • the ink layer is also protected by functioning as an overcoat layer. This makes it possible to improve the scratch resistance and peel resistance of the printed image printed on the solid production surface. As a result, it is possible to prevent the discrimination and visibility of the printed image from being deteriorated due to the peeling of the pigment, the scratch of the ink layer, and the like, and it is possible to prevent dispensing mistakes and accidental ingestion.
  • the fixing property of pigments to solid preparations such as pharmaceuticals and foods is improved, and the ink layer is covered and protected, thereby improving the scratch resistance and peel resistance of the printed image. It is possible to provide a composition for pigment fixing solution that can be improved, a pigment fixing solution containing the composition for pigment fixing solution, and a solid preparation that has been subjected to pigment fixing treatment with the pigment fixing solution.
  • the pigment fixing composition according to this embodiment will be described below.
  • the pigment fixing composition of the present embodiment is used for pigment fixing processing of a printed image printed on the surface of a solid preparation, and printing is performed by subjecting the solid preparation on which an image has been printed to pigment fixing processing.
  • the image can be improved in scratch resistance and peel resistance.
  • “scratch resistance” means that when printing is performed on the surface of a solid preparation using a pigment ink by an inkjet method, part or all of the pigment of the pigment ink fixed on the surface of the solid preparation is other It means that it can be prevented from being peeled off or damaged by rubbing with a solid preparation.
  • “peeling resistance” means that, when printing on the surface of a solid preparation using a pigment ink by an ink jet method, part or all of the pigment of the pigment ink fixed on the surface of the solid preparation is suppressed. It means getting.
  • the pigment fixing composition of the present embodiment has a configuration that includes at least a water-soluble and edible pigment-fixing component and water, and substantially does not include a water-insoluble component.
  • the composition for fixing a pigment according to the present embodiment is edible because it is composed of a material that complies with the standards of pharmaceutical additives, Japanese Pharmacopoeia or the Food Additives Standard specified by the Pharmaceutical Affairs Law. It is suitable for use in solid preparations composed of tablets or capsules for pharmaceuticals and foods.
  • the pigment fixing component contributes to fixing of the pigment in the printed image printed on the surface of the solid preparation, and has water solubility and edible properties.
  • water-soluble refers to a case where 1 g or more dissolves in 100 g of water at room temperature and normal pressure.
  • the “water-soluble component” means a component having such water solubility.
  • “edible” means a substance that is approved for oral administration as a pharmaceutical or a pharmaceutical additive and / or a food or a food additive.
  • the “normal temperature” means that the temperature is in the range of 5 ° C. to 35 ° C.
  • the “normal pressure” means a pressure (standard atmospheric pressure) in the vicinity of the atmospheric standard state, and the atmospheric standard state means an atmospheric pressure in the vicinity of about 25 ° C. and an absolute pressure of about 101 kPa. Means a condition. Further, the “normal pressure” may include a slightly positive pressure or a negative pressure with respect to the standard atmospheric pressure.
  • the pigment fixing component is not particularly limited as long as it has water solubility and edible properties.
  • polyvinyl pyrrolidone etc. are mentioned, for example.
  • Polyvinylpyrrolidone is a water-soluble polymer and corresponds to a pharmaceutical additive defined by the Pharmaceutical Affairs Law.
  • Polyvinylpyrrolidone has adhesion (wetability) and film-forming properties to pigments and the like.
  • the number average molecular weight of polyvinylpyrrolidone is preferably in the range of 2,000 to 200,000, more preferably 10,000 to 160000, and still more preferably 20,000 to 50,000.
  • the number average molecular weight of polyvinyl pyrrolidone is preferably in the range of 2,000 to 200,000, more preferably 10,000 to 160000, and still more preferably 20,000 to 50,000.
  • the viscosity of the pigment fixing composition increases excessively, and the viscosity greatly deviates from the Newtonian state. It is possible to prevent the flight performance from being lowered.
  • a number average molecular weight can be calculated
  • GPC gel permeation chromatography
  • the separation column Polymer-Laboratories PL gel 5 ⁇ m MIXED-C: solvent, dimethylformamide (0.01 mol LiBr added): column flow rate 1.0 ml / min: column temperature 50 ° C. : It can be measured using a RI detector under the condition of a sample concentration of 0.2% (W / V).
  • the content of the pigment fixing component can be appropriately set according to the type of the pigment fixing component.
  • the lower limit of the content thereof is preferably 1% by mass or more, more preferably 2% by mass or more, based on the total mass of the pigment fixing composition. Especially preferably, it is 5 mass% or more.
  • the upper limit of the content of polyvinyl pyrrolidone is preferably 20% by mass or less, more preferably 15% by mass or less, and particularly preferably 10% by mass or less with respect to the total mass of the pigment fixing composition.
  • the water contained in the pigment fixing composition of the present embodiment is water from which ionic impurities such as ion-exchanged water, ultrafiltered water, reverse osmosis water, distilled water, or ultrapure water have been removed.
  • ionic impurities such as ion-exchanged water, ultrafiltered water, reverse osmosis water, distilled water, or ultrapure water have been removed.
  • water sterilized by ultraviolet irradiation or the like is preferable because generation of mold and bacteria can be prevented over a long period of time.
  • it does not specifically limit as content of water, It can set suitably as needed.
  • the pigment fixing composition of the present embodiment does not substantially contain a water-insoluble component and is water-soluble. Therefore, the pigment fixing composition of the present embodiment can penetrate into a solid preparation when the pigment fixing composition is in a liquid state before drying.
  • water-insoluble means substantially insoluble in water, and more specifically, means that the solubility under normal temperature and normal pressure is less than 1 g with respect to 100 g of water.
  • water-insoluble component means a component having such water-insolubility, and specifically includes a polymer emulsion and the like.
  • examples of the polymer emulsion include polymers such as methacrylic acid, methyl methacrylate, butyl methacrylate, dimethylaminomethyl methacrylate, ethyl acrylate, and trimethylammonium ethyl methacrylate, and copolymers thereof.
  • polymer emulsions include Eudragit E100 (aminoalkyl methacrylate copolymer E), Eudragit EPO (aminoalkyl methacrylate copolymer E), Eudragit L100 (methacrylic acid copolymer L), Eudragit L30D-55 (methacrylic acid copolymer LD).
  • Eudragit L100-55 dry methacrylic acid copolymer LD
  • Eudragit S100 methacrylic acid copolymer S
  • Eudragit RL100 ammonioalkyl methacrylate copolymer
  • Eudragit RLPO ammonioalkyl methacrylate copolymer
  • Eudragit RL30D ammonioalkyl methacrylate copolymer) Dispersion
  • Eudragit RS10 Ammonioalkyl methacrylate copolymer
  • Eudragit RSPO ammonioalkyl methacrylate copolymer
  • Eudragit RS30D ammonioalkyl methacrylate copolymer dispersion
  • Eudragit NE30D ethyl acrylate / methyl methacrylate copolymer dispersion
  • Eudragit FS30D (acrylic acid) Methyl, methyl methacrylate, methacrylic acid copolymer) and the like. All of these commercially
  • the pigment fixing composition is substantially free of water-insoluble components, not only when the water-insoluble components are not present at all, but also in such an amount that the content is unavoidably present as impurities. This also includes the case where
  • the pigment fixing composition of the present embodiment may contain a surface tension adjusting agent as required.
  • the surface tension modifier is not particularly limited as long as it conforms to standards such as the Pharmaceutical Affairs Law, for example, caprylic acid decaglyceryl, lauric acid hexaglycerin ester, oleic acid hexaglycerin ester, condensed linolenic acid tetraglycerin ester, Examples include fatty acid ester palm palm, decaglyceryl laurate having an HLB of 15 or less, and decaglyceryl oleate having an HLB of less than 13. You may use these individually by 1 type or in mixture of 2 or more types.
  • a commercially available product can be used as the decaglyceryl caprylate, and examples of such a commercially available product include Ryoto (registered trademark) polyglycerate CE19D (trade name, manufactured by Mitsubishi Chemical Foods Co., Ltd., HLB). Value 15), SY glister MCA750 (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 16), and the like.
  • the HLB value is a value in the range of 0 to 20. The larger the HLB value, the stronger the hydrophilicity, and the smaller the HLB value, the stronger the hydrophobicity.
  • the decaglyceryl laurate those having an HLB of 15 or less can be used.
  • the decaglyceryl laurate has an HLB of more than 15, the ejection stability is lowered, for example, the occurrence of fading due to clogging of the nozzles of the inkjet head.
  • the lower limit of HLB is preferably 10 or more from the viewpoint of solubility in an aqueous solvent.
  • a commercially available product can be used as decaglyceryl laurate having an HLB of 15 or less.
  • NIKKOL registered trademark
  • DECAGLYN 1-L trade name, Nikko Chemicals ( HLB value 14.5)
  • SY Glister ML-750 trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 14.8, and the like.
  • the decaglyceryl oleate those having an HLB of less than 13 can be used.
  • the HLB is 13 or more, the ejection stability is deteriorated, such as blurring due to clogging of the nozzles of the inkjet head.
  • the minimum of HLB is 10 or more from a viewpoint of the solubility with respect to a water solvent.
  • a commercially available product can be used as decaglyceryl oleate having an HLB of less than 13 as decaglyceryl oleate having an HLB of less than 13, a commercially available product can be used.
  • Examples of such a commercially available product include NIKKOL (registered trademark) DECAGLYN 1-OV (trade name, Nikko Chemicals ( Co., Ltd., HLB value 12), SY Glister MO-7S (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 12.9), and the like.
  • lauric acid hexaglycerin ester a commercially available product can be used, and as such a commercially available product, for example, NIKKOL (registered trademark) HEXAGLYN 1-L (trade name, manufactured by Nikko Chemicals Co., Ltd., HLB) Value 14.5), SY Glister ML-500 (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 13.5), and the like.
  • NIKKOL registered trademark
  • HEXAGLYN 1-L trade name, manufactured by Nikko Chemicals Co., Ltd., HLB Value 14.5
  • SY Glister ML-500 trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 13.5
  • oleic acid hexaglycerin ester examples include SY Glyster MO-5S (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 11. 6) and the like.
  • fatty acid ester palm palm a commercially available product can be used, and examples of such a commercially available product include Tirabazole W-01 (trade name, manufactured by Taiyo Kagaku Co., Ltd.).
  • the content of the surface tension adjusting agent is preferably in the range of 0.5% by mass to 5% by mass with respect to the total mass of the pigment fixing composition, and is in the range of 1% by mass to 3% by mass. It is more preferable.
  • the content of the surface tension adjusting agent is 0.5% by mass or more, when printing is performed by an inkjet method, ejection failure due to poor meniscus surface formation at the nozzle in the inkjet head is prevented, and It is possible to prevent clogging. As a result, the discharge stability can be improved.
  • the content of the surface tension adjusting agent is 5% by mass or less, it is possible to prevent an adverse effect on discharge due to insoluble matter or poor emulsification of the surface tension adjusting agent.
  • additives may be blended in the pigment fixing composition of the present embodiment.
  • other additives are within the range that does not impede the solution of the problems of the present invention, and are compatible with the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law. Cost.
  • examples of such other additives include surfactants, viscosity modifiers, preservatives, lubricants, foaming agents, viscosity modifiers, antifoaming agents, and the like.
  • the content of these other additives is not particularly limited, and can be appropriately set as necessary.
  • the viscosity of the pigment fixing composition is preferably 2 mPa ⁇ s to 7 mPa ⁇ s, more preferably 3 mPa ⁇ s to 5 mPa ⁇ s when discharging the ink jet nozzle in consideration of ejection stability from the ink jet nozzle.
  • the viscosity of the pigment fixing composition can be obtained, for example, by measuring using a viscometer (trade name: VISCOMATE MODEL VM-10A, manufactured by Seconic Co., Ltd.) at a measurement temperature of 25 ° C.
  • the pigment fixing composition of the present embodiment can be produced by mixing the above-described components by an appropriate method.
  • the mixing method and addition order of each component are not particularly limited. After mixing, the mixture is sufficiently stirred, and if necessary, filtration is performed to remove coarse particles and foreign matters that cause clogging. Thereby, the pigment fixing composition according to the present embodiment can be obtained.
  • the pigment fixing composition of the present embodiment uses an edible pigment fixing component that complies with the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law, etc. Therefore, it can be directly applied on a printed image of a solid agent composed of tablets or capsules such as pharmaceuticals or supplements.
  • the pigment fixing composition of the present embodiment is used for fixing a pigment in a printed image printed on the surface of a solid preparation.
  • the fixing process is performed by applying a pigment fixing solution made of a pigment fixing composition to the printed image.
  • the application is performed by an inkjet method, and more specifically, the pigment fixing liquid is ejected as droplets onto a solid preparation on which an image is printed from a fine nozzle, and the droplets are adhered onto the printed image.
  • the discharge method is not particularly limited, and for example, a known method such as a continuous injection type (charge control type, spray type, etc.), an on-demand type (piezo type, thermal type, electrostatic suction type, etc.) can be employed. .
  • the discharge amount of the droplets from which the pigment fixing droplets are discharged from the nozzle may be appropriately set in consideration of the degree of penetration of the pigment fixing solution into the solid preparation, the thickness of the overcoat layer, the printing speed, the drying time, etc. it can. Usually, it is in the range of 1 pl to 30 pl, preferably 2 pl to 20 pl, more preferably 3 pl to 10 pl.
  • the pigment fixing solution penetrating the surface layer portion of the solid preparation can be dried, and the pigment fixing component contained in the pigment fixing solution removes the pigment fixed to the surface of the solid preparation.
  • Firmly fix on the preparation surface Moreover, the coating film layer formed on the ink layer becomes a dry film by drying and functions as an overcoat layer.
  • the drying time and the drying temperature are not particularly limited, and can be appropriately set according to the printing speed, the type of solid preparation, and the like.
  • the method for heating and drying is not particularly limited as long as it promotes evaporation of the solvent (water) in the pigment fixing solution.
  • a hot air treatment such as radiant heating, conduction heating, and high-frequency drying
  • a method of heating with a heater since the pigment fixing composition of the present embodiment does not substantially contain a water-insoluble component, it is assumed that the pigment fixing liquid composed of the pigment fixing composition is dried and fixed on the end face of the inkjet head or the like. Can be easily removed with an aqueous cleaning solution or the like.
  • Solid preparation means food preparations and pharmaceutical preparations, and examples of the form of the solid preparation include tablets or capsules such as OD tablets, plain tablets, FC tablets, dragees and the like.
  • At least an ink layer and an overcoat layer are sequentially laminated on the surface.
  • the ink layer is made of a dry film of an ink-jet aqueous ink containing an edible pigment, and forms a printed image.
  • edible pigments include carbon black, yellow iron oxide, yellow iron sesquioxide, iron sesquioxide, bengara or black that comply with the standards of pharmaceutical additives stipulated by the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia or the Food Additives Official Regulations.
  • iron oxides such as iron oxide, edible red No. 2, edible red No. 3, edible red No. 40, edible yellow No. 4, edible yellow No. 5, edible blue No. 1 or edible blue No. 2, etc. .
  • the ink layer can be formed by printing with an ink jet method under arbitrary conditions.
  • the thickness of the ink layer is not particularly limited, and can be appropriately set as necessary.
  • the overcoat layer is made of a dried film of a pigment fixing solution made of a pigment fixing composition, and is provided in a state of covering the ink layer.
  • the overcoat layer can physically protect the ink layer, and more specifically allows protection of the ink layer from scratching, abrasion, blocking and ferrotyping.
  • the overcoat layer preferably has light transparency from the viewpoint of ensuring good visibility of the printed image (that is, the ink layer).
  • the overcoat layer has an arbitrary color for color correction and other purposes within a range that does not adversely affect the visibility when the printed image is viewed through the overcoat layer. Also good.
  • the pigment fixing solution for forming the overcoat layer may contain a water-soluble dye or the like that meets the standards defined by the Pharmaceutical Affairs Law.
  • the “light transparency” means that the printed image formed by the ink layer can be visually recognized through the overcoat layer.
  • a pigment fixing component is present in the surface layer portion of the solid preparation (the portion into which the pigment fixing liquid made of the pigment fixing composition has permeated).
  • This pigment fixing component is derived from the pigment fixing composition, and is a residual component after drying of the pigment fixing solution that has penetrated into the surface layer portion of the solid preparation.
  • the mechanical strength of the said surface layer part can be improved.
  • the pigment fixing component present in the surface layer portion exhibits adhesiveness to the pigment of the ink layer, so that the pigment is firmly fixed (fixed) on the surface of the solid preparation. This further improves the scratch resistance and peel resistance of the ink layer.
  • the pigment of the ink layer formed on the solid preparation is firmly fixed by the pigment fixing component present on the surface layer portion of the solid preparation, Since the coating layer covers and protects the ink layer, it has a printed image having excellent scratch resistance and peeling resistance. As a result, even when product information related to solid preparations is displayed as a printed image, it is possible to suppress a decrease in the identification and visibility of the printed image due to peeling of the pigment or scratching of the ink layer, etc. Occurrence can be further prevented.
  • the pigment dispersion solution, the surface tension agent, the wetting agent and the ion exchange water are mixed, and the pigment concentration is 3% by mass, the surface tension adjusting agent concentration is 2% by mass, and the wetting agent concentration is 40% by mass.
  • a water-based ink composition for inkjet was prepared so as to be%.
  • Polyglycerin fatty acid ester (trade name: SY Glister, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) was used as the surface tension adjusting agent, and propylene glycol was used as the wetting agent.
  • Table 1 The numerical values in Table 1 are mass% values with respect to the total mass of the pigment dispersion solution, and the numerical values in Table 2 are mass% values with respect to the total mass of the aqueous ink composition unless otherwise specified. .
  • Each material complies with the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law.
  • Printing was performed only on one side of each of the sugar-coated tablets and the film-coated tablets (both having a diameter of about 7 mm) by the inkjet recording method using the above-described aqueous ink composition.
  • Printing was performed by a single pass (one pass) method using an inkjet printer (a printing jig with a KC 600 dpi head).
  • the printing conditions were a mass per droplet of 5 ng and an appropriate amount of liquid of 5 pl. Further, after printing, the printed image surface was dried by natural drying for 24 hours.
  • Example 1 A pigment fixing composition according to this example was prepared with the composition shown in Table 3 below. That is, 20.0% by mass of polyvinylpyrrolidone K12 (manufactured by BASF Japan Ltd.) having a number average molecular weight of about 4000 as a pigment fixing component, and decaglyceryl caprylate (manufactured by Sakamoto Pharmaceutical Co., Ltd.) as a surface tension adjuster.
  • a pigment fixing composition according to this example was prepared by putting 0% by mass and 78.0% by mass of ion-exchanged water into a container and mixing with stirring.
  • Example 2 polyvinyl pyrrolidone K17 (manufactured by BASF Japan Ltd.) having a number average molecular weight of about 10,000 was used as a pigment fixing component. Other than that was carried out similarly to Example 1, and produced the pigment fixing composition which concerns on a present Example.
  • Example 3 polyvinylpyrrolidone K30 (BASF Japan Co., Ltd.) having a number average molecular weight of about 40,000 was used as the pigment fixing component, and the content of polyvinylpyrrolidone K30 was 5 with respect to the total mass of the pigment fixing composition. 0.0% by mass, and the content of ion-exchanged water was changed to 93.0% by mass.
  • a pigment fixing composition according to this example was prepared in the same manner as Example 1 except for the above.
  • Example 4 In this example, polyvinyl pyrrolidone K60 (manufactured by Tokyo Chemical Industry Co., Ltd.) having a number average molecular weight of about 160,000 was used as the pigment fixing component, and the content of polyvinyl pyrrolidone K60 relative to the total mass of the pigment fixing composition. 1.0 mass% and content of ion-exchange water were changed to 97.0 mass%.
  • a pigment fixing composition according to this example was prepared in the same manner as Example 1 except for the above.
  • Comparative Example 1 Comparative Example 1
  • polyvinylpyrrolidone K90 manufactured by BASF Japan Ltd.
  • a pigment fixing composition according to this comparative example was produced in the same manner as in Example 4 except for the above.
  • the number average molecular weight of polyvinylpyrrolidone is a value determined by gel permeation chromatography under the following conditions using polystyrene as a standard product.
  • Measuring device LC-6A (manufactured by Shimadzu Corporation) Separation column: PL gel 5 ⁇ m MIXED-C (manufactured by Polymer Laboratories) Eluent: Dimethylformamide (0.01 mol LiBr added)
  • Molecular weight standard Standard polystyrene
  • Matt paper (trade name: Superfine paper, manufactured by Epson Corporation) was prepared as a recording medium, and printing was performed by an inkjet method using the pigment fixing compositions of Examples 1 to 4 and Comparative Example 1, respectively. . Printing was performed by a single pass (one pass) method using an inkjet printer (printing jig with KC 600 dpi head).
  • the evaluation of the flying property of the pigment fixing composition was carried out by discharging the pigment fixing composition from the head, then stopping the ink jet printer, and then increasing how much nozzle missing in the printed image when reprinted. This was done depending on whether sleep was observed.
  • nozzle chipping means that droplets made of the pigment fixing composition are not ejected from a nozzle where clogging has occurred. Sleeping means that in the initial stage of printing, non-ejection of the droplets of the pigment fixing composition occurs, and the printed portion of the printed image is blurred and unclear.
  • the amount of blurring is less than 1 cm and the number of increase in nozzle clogging is 0.
  • the amount of blurring is 2 cm or more, or the number of increase in nozzle clogging is 10 or more.
  • the evaluation of flying property does not correspond to any of the above ⁇ and ⁇ .
  • the evaluation of flying property was performed for printing after an open time of 15 minutes (the time interval from when the pigment fixing composition was first ejected from the head to when it stopped and then to printing again).
  • the amount of blurring means the length (cm) until the wrinkle of writing due to the fact that the pigment fixing composition is not ejected in a single-pass printed image.
  • the increased number of nozzle clogging means the number of nozzles that are unable to discharge the pigment fixing composition due to, for example, dry fixation of the pigment fixing composition on the head end face while the inkjet printer is stopped. .
  • Example 3 (Abrasion resistance / peeling resistance) Using the pigment fixing composition of Example 3, 20 tablets each of the sugar-coated tablets and film-coated tablets on which images were printed were subjected to pigment fixing treatment.
  • the pigment fixing treatment was performed by a single pass (one pass) method using an ink jet printer (a printing jig equipped with a KC 600 dpi head).
  • the discharge conditions of the pigment fixing composition were such that the mass per droplet was 7 ng, and the appropriate amount was 7 pl. Furthermore, after discharging the pigment fixing composition, it was naturally dried at room temperature (25 ° C.) for 24 hours.
  • a bottle shaking test was performed to confirm the scratch resistance and peel resistance of the pigment. Specifically, 20 sugar-coated tablets after pigment fixing treatment were put into a 50 cc glass bottle, and the bottle was manually shaken for 1 minute. As a result, a collision load was applied to the printed surface to evaluate scratch resistance and peel resistance. Moreover, the same bottle shaking test was done also about the film coat tablet. After the bottle shaking test, the presence or absence of the transfer of the pigment on the surface opposite to the printing surface of each sugar-coated tablet or film-coated tablet was observed using an electronic loupe. In addition, a bottle shaking test was also conducted on sugar-coated tablets and film-coated tablets on which image printing had not been performed. The results are shown in Table 4 below. Table 4 lists the pigments with the greatest degree of transfer.
  • each of the pigment fixing compositions of Examples 1 to 4 containing polyvinyl pyrrolidone having a number average molecular weight in the range of 2000 to 200,000 as a pigment fixing component has good flight properties and discharge properties. It was confirmed that the performance was excellent.
  • the polyvinyl pyrrolidone content is 1.0% by mass with respect to the total mass. Was also confirmed to be inferior in flight.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inks, Pencil-Leads, Or Crayons (AREA)
  • Ink Jet Recording Methods And Recording Media Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Ink Jet (AREA)

Abstract

L'invention fournit une composition pour fixation de pigments qui tout en améliorant les propriétés de fixation de pigments sur une image imprimée à la surface d'une préparation pharmaceutique solide telle qu'un médicament, un aliment, ou similaire, permet d'améliorer la résistance à l'abrasion ainsi que la résistance au pelage de l'image imprimée en revêtant et protégeant des pigments. L'invention fournit également une préparation pharmaceutique solide. La composition pour fixation de pigments de l'invention est mise en œuvre dans une impression de type à jet d'encre sur la préparation pharmaceutique solide. Ladite composition pour fixation de pigments est caractéristique en ce qu'elle permet une perméation vis-à-vis de ladite préparation pharmaceutique solide, elle contient au moins un composant de fixation de pigments hydrosoluble et comestible, et une eau, et ne contient de manière pratique aucun composant non hydrosoluble. En outre, ledit composant de fixation de pigments fixe des pigments comestibles à la surface de ladite préparation pharmaceutique solide.
PCT/JP2017/037501 2016-11-14 2017-10-17 Composition pour fixation de pigments, et préparation pharmaceutique solide WO2018088142A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016221381A JP6755165B2 (ja) 2016-11-14 2016-11-14 顔料定着用組成物及び固体製剤
JP2016-221381 2016-11-14

Publications (1)

Publication Number Publication Date
WO2018088142A1 true WO2018088142A1 (fr) 2018-05-17

Family

ID=62109802

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2017/037501 WO2018088142A1 (fr) 2016-11-14 2017-10-17 Composition pour fixation de pigments, et préparation pharmaceutique solide

Country Status (2)

Country Link
JP (1) JP6755165B2 (fr)
WO (1) WO2018088142A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210187460A1 (en) * 2019-12-19 2021-06-24 Advansix Resins & Chemicals Llc Surfactants for inks, paints, and adhesives
US12049589B2 (en) 2019-12-31 2024-07-30 Advansix Resins & Chemicals Llc Surfactants for oil and gas production

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7154956B2 (ja) * 2018-11-02 2022-10-18 株式会社Ｓｃｒｅｅｎホールディングス インクジェット用オーバーコート組成物及び印刷物
JP7315383B2 (ja) * 2019-06-27 2023-07-26 株式会社Ｓｃｒｅｅｎホールディングス インクジェット用水性組成物及び固体製剤
JP7361530B2 (ja) * 2019-08-09 2023-10-16 株式会社Ｓｃｒｅｅｎホールディングス 固体製剤及び固体製剤への印刷方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005053599A1 (fr) * 2003-12-01 2005-06-16 Takeda Pharmaceutical Company Limited Procede de traitement d'une preparation pharmaceutique solide anterieurement a l'impression et preparation pharmaceutique solide soumise au traitement avant impression
WO2009051794A1 (fr) * 2007-10-17 2009-04-23 Stefan Klocke Pilule pharmaceutique moirée
JP2015120678A (ja) * 2013-12-24 2015-07-02 キョーリンリメディオ株式会社 Ｕｖレーザ印刷用２層被覆錠剤とその製造方法
WO2016063891A1 (fr) * 2014-10-21 2016-04-28 株式会社Ｓｃｒｅｅｎホールディングス Composition de pigment, et composition d'encre aqueuse pour impression à jet d'encre
JP2016176005A (ja) * 2015-03-20 2016-10-06 紀州技研工業株式会社 インクジェットインク及びその印字方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6345504B2 (ja) * 2014-06-26 2018-06-20 日新化成株式会社 インクジェットインク組成物

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005053599A1 (fr) * 2003-12-01 2005-06-16 Takeda Pharmaceutical Company Limited Procede de traitement d'une preparation pharmaceutique solide anterieurement a l'impression et preparation pharmaceutique solide soumise au traitement avant impression
WO2009051794A1 (fr) * 2007-10-17 2009-04-23 Stefan Klocke Pilule pharmaceutique moirée
JP2015120678A (ja) * 2013-12-24 2015-07-02 キョーリンリメディオ株式会社 Ｕｖレーザ印刷用２層被覆錠剤とその製造方法
WO2016063891A1 (fr) * 2014-10-21 2016-04-28 株式会社Ｓｃｒｅｅｎホールディングス Composition de pigment, et composition d'encre aqueuse pour impression à jet d'encre
JP2016176005A (ja) * 2015-03-20 2016-10-06 紀州技研工業株式会社 インクジェットインク及びその印字方法

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210187460A1 (en) * 2019-12-19 2021-06-24 Advansix Resins & Chemicals Llc Surfactants for inks, paints, and adhesives
US12054663B2 (en) * 2019-12-19 2024-08-06 Advansix Resins & Chemicals Llc Surfactants for inks, paints, and adhesives
US12049589B2 (en) 2019-12-31 2024-07-30 Advansix Resins & Chemicals Llc Surfactants for oil and gas production

Also Published As

Publication number Publication date
JP2018080117A (ja) 2018-05-24
JP6755165B2 (ja) 2020-09-16

Similar Documents

Publication Publication Date Title
WO2018088142A1 (fr) Composition pour fixation de pigments, et préparation pharmaceutique solide
CN110088212B (zh) 喷墨用水性油墨组合物、固体制剂的印刷图像褪色抑制方法和固体制剂
US9789720B2 (en) Image forming method, image forming apparatus, and recorded matter
JP6348279B2 (ja) インクジェット記録方法
EP0606490A1 (fr) Procede d'impression par jet d'encre du type a transfert intermediaire
EP0586101A1 (fr) Composition d'encre pour enregistrement à jet d'encre
JP5692490B2 (ja) 水性インク組成物、およびインクジェット記録方法ならびに記録物
US10759206B2 (en) Recording method and recording apparatus
JP2011152747A (ja) 水性インク組成物、およびインクジェット記録方法ならびに記録物
US10202563B2 (en) Cleaning fluid and cleaning method
JP6446953B2 (ja) 反応液及び記録方法
JP2011201230A (ja) インクジェット記録方法
JP2012251049A (ja) インク組成物及びインクジェット記録方法
JP5741839B2 (ja) インク組成物及びインクジェット記録方法
CN111094475B (zh) 喷墨用水性油墨组合物、固体制剂的印刷图像的褪色抑制方法和固体制剂
JP7154956B2 (ja) インクジェット用オーバーコート組成物及び印刷物
JP7315383B2 (ja) インクジェット用水性組成物及び固体製剤
JP2020152783A (ja) インク
JP7361530B2 (ja) 固体製剤及び固体製剤への印刷方法
JP6574065B2 (ja) インクジェット用水性インク組成物及び固体製剤
JP2015091658A (ja) インクジェット記録方法
JP7171296B2 (ja) インクセット、印刷方法及び印刷物
JP2020196779A (ja) インクジェット記録用水性インク
KR102290817B1 (ko) 잉크젯용 수성 잉크 조성물, 고체 제제의 인쇄 화상의 퇴색 억제 방법 및 고체 제제
JP2015083630A (ja) 捺染用インクジェットインク組成物

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17870350

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 17870350

Country of ref document: EP

Kind code of ref document: A1