WO2005053599A1 - 固形製剤の印刷前処理方法及び印刷前処理方法が施された固形製剤 - Google Patents
固形製剤の印刷前処理方法及び印刷前処理方法が施された固形製剤 Download PDFInfo
- Publication number
- WO2005053599A1 WO2005053599A1 PCT/JP2004/018112 JP2004018112W WO2005053599A1 WO 2005053599 A1 WO2005053599 A1 WO 2005053599A1 JP 2004018112 W JP2004018112 W JP 2004018112W WO 2005053599 A1 WO2005053599 A1 WO 2005053599A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- printing
- solid preparation
- polyethylene glycol
- treatment
- coating
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/007—Marking tablets or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B41—PRINTING; LINING MACHINES; TYPEWRITERS; STAMPS
- B41M—PRINTING, DUPLICATING, MARKING, OR COPYING PROCESSES; COLOUR PRINTING
- B41M3/00—Printing processes to produce particular kinds of printed work, e.g. patterns
-
- 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
- B41M5/0011—Pre-treatment or treatment during printing of the recording material, e.g. heating, irradiating
Definitions
- the present invention relates to a pre-printing method for a solid preparation and a solid preparation subjected to the pre-printing method.
- the present invention provides a method of treating a solid preparation, which improves the printability and abrasion resistance of the print applied to the surface of the solid preparation, and the printability or the abrasion resistance of the print obtained by the treatment are improved. It relates to a solid preparation.
- Tablets and capsules are of many types and are similar in size and color 'shape.For identification, code the company name, company badge, product name, ingredient content, etc. and label them directly on each product. Often do. Means of marking include engraving and printing. Engraving is used for uncoated uncoated tablets and some film-coated tablets, but printing is used for many film-coated tablets, dragees, and capsules.
- polishing treatment using wax for the purpose of this specification, wax in the narrow sense, that is, fatty acid ester of higher alcohol; for example, carnauba wax, beeswax, etc.
- wax for the purpose of this specification, wax in the narrow sense, that is, fatty acid ester of higher alcohol; for example, carnauba wax, beeswax, etc.
- Polishing is often performed (eg, Porter, 2 other authors, “Pan Coating of Tab lets and Granules", A ⁇ Lee Herzoleman (Herbert A. Lieberman), 1 out, “Pharmaceutical Dosage Forms” s) Tablets, Vol.
- the wax can be dissolved in an organic solvent such as Z-aceton, or suspended in a dispersing medium such as alcohol, or applied directly to the surface of the drug product as a fine powder. Solvent safety issues and accidents It is preferable to avoid large-scale equipment for the application, and when used as a suspension or powder, the coating becomes non-uniform and may cause inconvenience.
- an object of the present invention is to provide a method for polishing a solid preparation that does not use an organic solvent, which method can improve printability and print abrasion resistance of the solid preparation. It is to provide a solid preparation having improved properties and / or abrasion resistance of printing.
- the present inventors have conducted intensive studies to achieve the above object, and as a result, when the surface of the solid preparation was treated with a polyethylene glycol-containing aqueous solution and then printed, surprisingly, the surface was polished by the mouth. We have found that the printability during printing and the abrasion resistance of printing after printing are significantly improved as compared with conventional tablets. The present inventors have conducted further studies based on these findings, and have completed the present invention.
- a treatment method for improving the printability and / or abrasion resistance of a print applied to the surface of a solid preparation comprising a step of treating the surface with an aqueous solution containing polyethylene dalicol before printing.
- a method for producing a solid preparation having a surface printed thereon comprising treating the surface of the solid preparation with an aqueous solution containing polyethylene glycol and then printing the surface.
- a solid preparation, which is treated by the method according to any one of the above [1] to [5], [1 2] can be obtained by the method according to any one of the above [6] to [10].
- Solid preparation printed on the surface
- a solid preparation having a coating on the surface containing polyethylene glycol and not containing beeswax and carnauba wax, and further printed on the surface having the coating, and
- a solid preparation having a coating containing polyethylene dalicol and not containing beeswax or carnauba wax on the surface thereof, further printed on the surface of the coating,
- the present invention provides a method of treating a solid preparation to improve the abrasion resistance of the print applied to the surface of the preparation.
- "improving the abrasion resistance of the print” means that, for example, in a print abrasion test as described in detail in the Examples below, the degree of abrasion of the print applied to the solid preparation indicates that the treatment is performed. To be significantly reduced compared to Say.
- the dosage form of the solid preparation to which the treatment method of the present invention can be applied is not particular limitation, as long as it can be printed on the surface.
- the dosage form of the solid preparation to which the treatment method of the present invention can be applied for example, tablets, capsules, troches, pills, suppositories, etc.
- they are particularly preferably used in tablets and capsenole preparations.
- formulation is used to mean not only pharmaceuticals but also all compositions made in certain dosage forms, such as animal drugs, agricultural chemicals, fertilizers, and sanitary products. .
- the active ingredient contained in the solid preparation is not particularly limited.
- substances that are effective in the prevention and treatment of various diseases eg, sleep-inducing action, tranquilizer activity, antibacterial activity, antihypertensive action, antiangina activity, analgesic action, anti-inflammatory activity, tranquilizing action, diabetes treatment activity, diuresis Action, anticholinergic activity, antihyperacidic activity, antiepileptic activity, ACE inhibitory activity, — receptor antagoest or agonist activity 1 "raw, anesthetic, appetite suppressant, antiarrhythmic, antidepressant, anticoagulant Activity, anti-diarrheal action, anti-histamine activity, anti-malarial action, anti-tumor activity, immunosuppressive activity, anti-parkinsonian action, anti-psychotic action, anti-platelet activity, anti-hyperlipidemic substance etc.), Substances with cleaning action, fragrances, fertilizers, substances with deodorant action, animals and pesticides, substances with insecticidal action, substances with herbici
- the solid preparation of the present invention may contain, if necessary, an active ingredient and a carrier acceptable for its use, for example, a pharmaceutical preparation.
- Pharmaceutically acceptable carriers can be blended, if necessary, as various organic or inorganic carrier materials commonly used as pharmaceutical materials, such as excipients, lubricants, etc. , A binder, a disintegrant, a thickener, etc., are appropriately added in appropriate amounts, and if necessary, additives such as an antiseptic, an antioxidant, a coloring agent, a sweetener and the like can be used. .
- excipients include lactose, sucrose, dextrose, maltose, corn starch, flour starch, mannitol, xylitol, sorbitol, maltitol, erythritol, ratatitol, paracitrate, crystalline cellulose, light anhydrous silicic acid.
- excipients include, but are not limited to, dextrin, carboxymethyl starch, gelatin, synthetic aluminum silicate, magnesium aluminate metasilicate, magnesium oxide, calcium phosphate, calcium carbonate, calcium sulfate, and the like.
- lubricants include stearic acid, magnesium stearate, calcium stearate, talc, waxes, DL-leucine, sodium lauryl sulfate, magnesium lauryl sulfate, polyethylene glycol, and aerosil (can also be used as an antistatic agent) And the like, but are not limited thereto.
- binders examples include gelatin, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxypropylcellulose (HPC), methylcellulose (MC).
- Crystalline senorelose, polyvienolepyrrolidone (PVP) examples include, but are not limited to, polyethylene glycolonole, arabia gum, dextran, polyvinyl alcohol (PVA), starch paste, and the like.
- disintegrants include sodium carboxymethylcellulose, carboxymethyl cenoreth calcium, low-substituted hydroxypropylcellulose, cross-linked polypyrrolidone, sodium canolemellose, sodium croscanolemelose, sodium canoleboxime lenorestarch, and cations.
- disintegrants include, but are not limited to, exchange resins, partially arsenic starch, and corn starch.
- thickeners include, but are not limited to, natural gums, cellulose derivatives, acrylic acid polymers, and the like. .
- preservatives include, but are not limited to, paraoxybenzoates, chlorobutanol, benzyl alcohol, phenethyl alcohol, dehydroacetic acid, sorbic acid, and the like.
- antioxidants include, but are not limited to, sulfites, ascorbic acid and their alkali metal salts, alkaline earth metal salts, and the like.
- coloring agents include synthetic coloring agents applicable to pharmaceuticals (eg, Sunset Yellow and their aluminum lakes), yellow iron sesquioxide, iron sesquioxide, riboflavin, riboflavin organic acid esters (eg, riboflavin butyric acid) Beauty treatment ), Riboflavin phosphate or its alkali metal salts, alkaline earth metal salts, phenolphthalein, titanium oxide, and the like, but are not limited thereto.
- the light shielding agent include titanium oxide.
- sweetening agents include, but are not limited to, saccharin sodium, dipotassium glycyrrhizinate, Aspa ⁇ / retame, stevia and the like.
- the solid preparation of the present invention is obtained by formulating the above-mentioned active ingredient and a suitable carrier into a dosage form suitable for oral administration such as tablets and capsules or parenteral administration such as suppositories according to a means known per se.
- Tablets can be coated by a method known per se for the purpose of masking odors or tastes, stabilizing ingredients or maintaining drug efficacy.
- Coatings are broadly divided into sugar coatings and film coatings (including enteric coatings). Saccharose is usually used as a coating agent for sugar coating.
- gelatin, gum arabic, methylcellulose, carboxymethylcellulose, and carboxy are used to enhance the cohesion of the coating layer and increase the mechanical strength.
- It can contain sodium methylcellulose, sodium starch glycolate, crystalline cellulose, polybutylpyrrolidone, polyvinyl alcohol, sodium alginate, etc. Furthermore, excipients and talc as an anti-adhesive agent, precipitated calcium carbonate, violin, etc. However, a masking agent such as titanium oxide is used for the purpose of masking and shielding light.
- Film coating agents include, for example, hydroxypropylmethylcellulose, ethinoresenorelose, hydroxypropinoresenorelose, Tween 80, and titanium oxide, bengara (eg, iron sesquioxide, Dyes such as iron dioxide) are used. Further, light stability and the like can be improved by adding a masking agent and the like. These film coating formulations may further contain talc and other excipients applicable to pharmaceuticals, if necessary. As the film coating agent, a base for imparting enteric properties or controlled release may be used in addition to a substance for hiding taste, improving light stability or improving appearance.
- Droxypropylcellulose HPC
- hydroxypropylmethylcellulose HPMC
- polyvienolepyrrolidone PVP
- ethylcellulose polyvinylacetal dimethylaminoacetate
- cellulose acetate phthalate methacrylic acid copolymers
- methacrylic acid copolymers For example, methyl methallylate 'methacrylic acid copolymer (Eudragit L100 or S100, manufactured by Rohm), methacrylic acid' ethyl acrylate copolymer (Eudragit L100-55, L30D-55), methacrylic acid 'methyl acrylate' Methyl methacrylate copolymer (Eudragit F S30D, manufactured by Rohm)), hydroxypropyl methylcellulose phthalate (HP-55, HP-50, manufactured by Shin-Etsu Chemical Co., Ltd.), carboxymethylethyl cellulose (CMEC, Freund Sangyo ( Co., Ltd.), hydroxy
- hydroxypropyl methylcellulose phthalate HP-55, HP_50, manufactured by Shin-Etsu Chemical Co., Ltd.
- cellulose acetate phthalate cellulose acetate phthalate
- carboxymethyl are used as coating materials for controlling the release of the active ingredient in a pH-dependent manner.
- Ethyl cellulose (CMEC, manufactured by Freund Corporation), methyl methacrylate 'methacrylic acid copolymer (Eudragit L100 or S100, manufactured by Rohm), methacrylic acid ethyl acrylate copolymer (Eudragit L100-55, L30D-55), methacrylic acid / methyl methacrylate / methyl methacrylate copolymer (Eudragit FS30D, manufactured by Rohm), hydroxypropylcellulose acetate succinate (HPMCAS, manufactured by Shin-Etsu Chemical Co., Ltd.), polyvinylinole Acetate phthalate, shellac and the like are used.
- CMEC methyl methacrylate 'methacrylic acid copolymer
- Methacrylic acid ethyl acrylate copolymer (Eudragit L100-55, L30D-55)
- the coating agents may be used alone or in combination as needed.
- plasticizers such as polyethylene glycol, dibutyl sebacate. Getyl phthalate, triacetin, triethyl quenate, and copolyvidone, and stabilizers may be used for the coating, if necessary.
- the coating is performed by a method known per se, for example, a pan using a coating pan such as a ventilated coating apparatus (eg, Hicoater (registered trademark); Freund Corporation)
- a coating pan such as a ventilated coating apparatus (eg, Hicoater (registered trademark); Freund Corporation)
- the coating is performed by a coating method or a fluid coating method using a fluid granulation coating apparatus (eg, Flow Coater (registered trademark); Freund Corporation).
- Capsules are made by filling powders of the active ingredient, mixed powder of the active ingredient with the carrier, or fine granules or granules obtained by kneading and granulating the active ingredient into suitable capsules. can do. Fillers (especially fines or granules) may be provided with a film coating, as described above for tablets, if necessary.
- capsules examples include those obtained by mixing gelatin with a polyhydric alcohol such as glycerin or propylene glycol or a saccharide such as mannitol or sorbite as a plasticizer and appropriately molding the resulting mixture. If necessary, the capsules may further contain the same coloring agents and preservatives as described above.
- a polyhydric alcohol such as glycerin or propylene glycol or a saccharide such as mannitol or sorbite as a plasticizer
- the capsules may further contain the same coloring agents and preservatives as described above.
- the treatment may be performed after filling a filler such as an active ingredient, or after the treatment method of the present invention has been applied to an empty capsule in advance and further printed. Then, the capsule can be filled with a filler to form a final preparation.
- a filler such as an active ingredient
- the processing method of the present invention also includes not only the solid preparations described above, but also any solid composition intended to be printed on the surface, such as food (eg, sugar-coated chocolate, gum, supplements, etc.). It can also be applied to objects, especially solid compositions which require or desirably have a treatment for improving slipperiness and gloss.
- food eg, sugar-coated chocolate, gum, supplements, etc.
- solid compositions which require or desirably have a treatment for improving slipperiness and gloss.
- the treatment method of the present invention is characterized in that the surface of the solid preparation is treated with an aqueous solution containing polyethylene glycol before printing.
- “treat” means “apply”.
- the surface of the solid preparation after treatment is contacted with an aqueous solution containing polyethylene dalicol so that polyethylene glycol remains on the surface.
- the polyethylene glycol used in the present invention is not particularly limited as long as there is no restriction for other reasons (for example, when the solid preparation is a pharmaceutical preparation, a range acceptable as a pharmaceutical additive), but improves the printing durability.
- it exists as a solid at the temperature of the environment where the agent is stored (for example, 0 to 40 ° C, 10 to 30 ° C, and 15 to 25 ° C).
- the average molecular weight Is more than about 1,000, more preferably those having an average molecular weight of about 3,000 to about 9,000.
- two or more kinds of polyethylene glycols having different average molecular weights can be used in combination.
- the average molecular weight of polyethylene glycol is measured by a method similar to the method of measuring the average molecular weight of McGoal 400 in the Japanese Pharmacopoeia 14th Edition (hereinafter sometimes simply referred to as Japan Pharmacopoeia). .
- the concentration of polyethylene dalicol in the aqueous solution containing polyethylene dalicol is such that the amount of polyethylene dalicol remaining on the surface of the solid preparation after treatment is sufficient to improve the abrasion resistance of the print applied to the surface.
- the concentration is not particularly limited as long as it is such a concentration, and for example, about 1 to about 20% by weight, preferably about 5 to about 15% by weight.
- the aqueous solution containing polyethylene glycol may contain components other than polyethylene glycol within a range that does not adversely affect the performance of printing performed on the surface of the solid preparation.
- the aqueous solution containing polyethylene dalicol also functions as a film coating solution as described above, so that the solution contains a film coating agent.
- the film coating agent include those described above that are water-soluble or dispersible in an aqueous solution.
- the polyethylene glycol-containing aqueous solution may further contain, if necessary, pharmaceutical additives such as a stabilizer, a lubricant, a P-preservative, an antioxidant, a coloring agent, and a sweetener.
- pharmaceutical additives such as a stabilizer, a lubricant, a P-preservative, an antioxidant, a coloring agent, and a sweetener.
- stabilizers include tartaric acid, citric acid, succinic acid, fumaric acid, maleic acid and the like.
- lubricants include talc, titanium oxide, magnesium stearate, calcium stearate, light caffeic anhydride and the like.
- preservatives include paraoxybenzoates, chlorobutanol, benzyl Alcohol, phenethyl alcohol, dehydroacetic acid, sorbic acid and the like.
- antioxidant examples include sulfite, ascorbate and the like.
- coloring agents include water-soluble edible tar pigments (eg, edible pigments such as edible red Nos. 2 and 3, edible yellows 4 and 5, edible blues 1 and 2), and water-insoluble lake pigments (eg, , The water-soluble edible tar dye aluminum salt), natural dyes (eg, ⁇ -potassin, chlorophyll, red iron oxide) and the like.
- sweeteners include saccharin sodium, dipotassium glycyrrhizinate, aspartame, stevia and the like.
- the film coating solution may contain a plasticizer to adjust the softening temperature of the coating agent, but when the aqueous solution containing polyethylene glycol is the film coating solution, the polyethylene glycol itself is plasticized. It can function as an agent.
- the aqueous solution containing polyethylene dalicol at the concentration necessary to improve the abrasion resistance of the print applied to the solid preparation surface is sufficient to function as a plasticizer, but if necessary, another plasticizer , E.g., acetyltriptyl taenate, acetylcetyltriethyl quenate, castor oil, diacetylated monoglyceride, dibutyltin sebacate, getyl phthalonate, glycerin, mono- and diacetylated monoglycerides, propylene glycol, triacetin, triethyl citrate, etc. May be further added. ⁇
- the proportion of polyethylene glycol in the total components is about 1 to about 30% by weight, preferably about 10 to about 20% by weight. It is.
- the coating is performed by spray coating using a coating pan or a fluid coating apparatus.
- sugar-coated tablets for example, after finishing the sugar-coating process (ie, waterproof coating, underlaying, medium hanging, coloring, finishing), transfer the tablets to a cloth polished pan, While spraying, spray or pour in a predetermined amount of aqueous solution containing polyethylene glycol, or spray or pour the aqueous solution containing polyethylene dali alcohol one or several times until the coating weight reaches a predetermined value. be able to.
- finishing the sugar-coating process ie, waterproof coating, underlaying, medium hanging, coloring, finishing
- a cloth polished pan While spraying, spray or pour in a predetermined amount of aqueous solution containing polyethylene glycol, or spray or pour the aqueous solution containing polyethylene dali alcohol one or several times until the coating weight reaches a predetermined value. be able to.
- a spray gun is used to spray an aqueous solution containing polyethylene dalicol with compressed air, and the surface is dried by sending warm air.
- the method can also be carried out by spraying an aqueous solution containing polyethylene dalicol from a spray nozzle while floating and fluidizing the tablet by an air flow in a fluid coating device used for film coating, and drying the surface by the air flow. .
- the spraying of the aqueous solution containing polyethylene glycol repeats the above operation until a predetermined spraying force or a predetermined coating weight is reached.
- the method used for ordinary film coating can be used as it is.
- the same method as in the case of the film-coated tablet can be used.
- the method used for ordinary film coating can be used in the same manner.
- the present treatment is performed after filling the filler such as the active ingredient, it is preferable that the powder of the filler adhering to the capsule surface at the time of filling is removed using a conventional capsule polish machine.
- the weight of the film formed by the treatment method of the present invention is particularly important if the amount of polyethylene glycol remaining on the surface of the solid preparation after treatment is an amount sufficient to improve the abrasion resistance of the print applied to the surface.
- the weight ratio of the amount of poly (ethylene dalicol) added by the treatment to the final preparation is from about 0.01 to about 1.0%, more preferably from about 0.05 to about 0.5%. It can be appropriately selected within the range of 7%.
- the treatment method of the present invention not only improves the abrasion resistance of the printing applied to the surface of the solid preparation, but also reduces the frequency of printing defects such as print defects and printing stains during printing (that is, printing). Defect rate) can be reduced, and the overall printing performance can be improved.
- the present invention also relates to a method for producing a solid preparation having a surface printed thereon, comprising treating the surface of the solid preparation with an aqueous solution containing polyethylene glycol and then printing the surface.
- the treatment with the aqueous solution containing polyethylene glycol can be performed as described above.
- Printing can be performed by a method commonly used in the art.
- any type such as a slat type, a drum type, and a link type can be used, and it can be appropriately selected according to the production scale and the like.
- the printing method is not particularly limited, but generally, the gravure / offset printing method is often used. That is, a gravure roll engraved with an identification code or symbol by photoengraving rotates in the ink tank and adheres ink, and excess ink is removed by a blade (thin blade). The ink remaining in the engraving (recess) is transferred to a rubber offset roll, and further transferred to a solid preparation in the printing section to complete printing.
- the tablet (capsule) agent printing machine those commercially available from Markem, Heartnet, Matsuoka Machinery, Shionogi Qualicaps, etc. can be used.
- the ink used for printing is not particularly limited as long as it is harmless, but it is desirable that it be quick-drying and have good abrasion resistance after drying.
- pigments include titanium oxide, carbon black, iron oxide, and tar pigments (eg, Red No. 2, Red No. 3, Red No. 102, Red No. 104 (1), Red No. 105) (1), red No. 106, yellow No. 4, yellow No. 5, green No. 5, green No. 5, blue No. 1, blue No. 2, etc.), and shellac as a base.
- As the solvent ethanol, ⁇ -butanol, isopropanol and the like are used.
- the solid preparation printed on the surface can be obtained by performing a polishing treatment before printing using an oral solution or a powdery wax or an oral substance dissolved in an organic solvent. It has new and useful properties of significantly improved print abrasion resistance compared to conventional formulations. Therefore, the present invention also provides a method as described above.
- the solid preparation of the present invention has a coating containing polyethylene dalicol on its surface, it can be imparted with desirable properties such as excellent abrasion resistance of a print applied to the surface.
- the “coating” need not completely cover the surface of the solid dosage form, as long as the polyethylene glycol is present at least substantially in the area to be printed.
- the “coating” may be a state in which a number of fine films are adhered to the surface of the solid preparation.
- substantially uniform means uniform enough to improve the abrasion resistance of the print. Therefore, the solid preparation of the present invention is not limited to the above-mentioned method, and may be produced by any means as long as it has such a surface structure and has excellent printing abrasion resistance.
- the solid preparation of the present invention does not contain nectar ⁇ and carnauba ⁇ in the film containing polyethylene glycol.
- the solid preparation of the present invention may be administered to a subject in the same manner as a normal solid preparation.
- the present invention will be described more specifically with reference to Examples. However, these are merely examples, and do not limit the scope of the present invention in any way.
- Uncoated tablets (containing 4 mg of active substance) 130. 0
- Formulation Example 1 Formulation Example 2 Comparative Example Film-coated tablet (Reference example) 135. 0 135. 0 135. 0 Macrogol 4000 (JP) 0.1
- Carnauba wax 0.008 Sodium monooleate / levitan 0.04 n-Hexane (0.9625) Put 6,000 tablets (810 g) of the film-coated tablets obtained in the above reference example into a high coater (Freund Corporation) and pour the bread. 10 weight while rotating. /.
- Macrogol 4000 Japanese Pharmacopoeia; molecular weight 2, 600-3, 800
- Formulation Example 1 or macrogol 6000.
- Japanese Pharmacopoeia molecular weight 7, 300-9, 300
- a total of 6.063 g of Carnauba wax n-hexane solution was sprayed with a spray gun to obtain tablets of the above formulation.
- each tablet was printed by a tablet printing inspection machine (Matsuoka Machinery Co., Ltd.) according to a conventional method.
- Example 2 For 500 tablets of each of the three types of tablets obtained in Example 2 above, the printing defects were visually inspected, and each 100 tablets were placed in a 3K glass bottle, and reciprocating car SR-IIw (Nippon Medical Chemical Co., Ltd.) The sample was shaken with an amplitude of 40 mm and a shaking speed of 250 times / minute using a, and the degree of wear of the print was observed over time. Table 1 shows the results. table 1
- Class B Defects are recognized in some of the prints but are legible, or the length is
- Class C Some of the prints are not legible, or have print stains exceeding 1 mm in length.
- Class D Those whose prints cannot be read.
- (+ +). There is a clear change in the print state, and some of the print state is not legible. (+ + +): Significant changes in the printing condition are observed, making it almost illegible.
- the printability and abrasion resistance of the printing performed on the surface of the solid preparation can be improved, so that the identification function of the solid preparation is maintained for a long time, and the appearance is also beautiful. Since there is no loss, a solid preparation with high commercial value can be provided.
- the method for treating a solid preparation of the present invention has an effect of remarkably improving the printability and abrasion resistance of the preparation by treating the surface of the solid preparation with an aqueous solution containing polyethylene glycol before printing. While certain embodiments of the invention have been described in detail, those skilled in the art will recognize that certain embodiments illustrated therein can have various modifications and alterations without departing substantially from the teachings and advantages of the invention. It is possible to do Accordingly, all such modifications and changes are intended to be included within the spirit and scope of the invention as claimed in the following claims.
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/581,071 US20070116764A1 (en) | 2003-12-01 | 2004-11-30 | Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing |
CA 2547594 CA2547594A1 (en) | 2003-12-01 | 2004-11-30 | Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing |
EP04799960A EP1700591A4 (en) | 2003-12-01 | 2004-11-30 | PROCESS FOR TREATING SOLID PHARMACEUTICAL PREPARATION PRIOR TO PRINTING AND SOLID PHARMACEUTICAL PREPARATION SUBJECT TO PROCESSING BEFORE PRINTING |
JP2005516013A JP4999329B2 (ja) | 2003-12-01 | 2004-11-30 | 固形製剤の印刷前処理方法 |
US12/659,630 US9149437B2 (en) | 2003-12-01 | 2010-03-15 | Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2003-401691 | 2003-12-01 | ||
JP2003401691 | 2003-12-01 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/581,071 A-371-Of-International US20070116764A1 (en) | 2003-12-01 | 2004-11-30 | Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing |
US12/659,630 Continuation US9149437B2 (en) | 2003-12-01 | 2010-03-15 | Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2005053599A1 true WO2005053599A1 (ja) | 2005-06-16 |
Family
ID=34649985
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2004/018112 WO2005053599A1 (ja) | 2003-12-01 | 2004-11-30 | 固形製剤の印刷前処理方法及び印刷前処理方法が施された固形製剤 |
Country Status (5)
Country | Link |
---|---|
US (2) | US20070116764A1 (ja) |
EP (1) | EP1700591A4 (ja) |
JP (1) | JP4999329B2 (ja) |
CA (1) | CA2547594A1 (ja) |
WO (1) | WO2005053599A1 (ja) |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2007022938A (ja) * | 2005-07-13 | 2007-02-01 | Shionogi & Co Ltd | 退色を抑制した製剤 |
DE102011088909A1 (de) | 2011-08-12 | 2013-02-14 | Labtec Gmbh | Verfahren zur Herstellung und Kontrolle von oralen Wirkstoff-Filmen |
JP2013155148A (ja) * | 2012-01-31 | 2013-08-15 | Ohara Yakuhin Kogyo Kk | 口腔内崩壊錠のuvレーザー印刷方法 |
WO2014203524A1 (ja) * | 2013-06-21 | 2014-12-24 | 凸版印刷株式会社 | 固形製剤被印刷物とその製造方法 |
WO2018088142A1 (ja) * | 2016-11-14 | 2018-05-17 | 株式会社Screenホールディングス | 顔料定着用組成物及び固体製剤 |
JP2018177810A (ja) * | 2018-07-13 | 2018-11-15 | 凸版印刷株式会社 | 固形製剤用インク及び固形製剤被印刷物 |
JP2020132600A (ja) * | 2019-02-25 | 2020-08-31 | 沢井製薬株式会社 | フィルムコーティング錠剤、およびその製造方法 |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9101160B2 (en) | 2005-11-23 | 2015-08-11 | The Coca-Cola Company | Condiments with high-potency sweetener |
US8017168B2 (en) | 2006-11-02 | 2011-09-13 | The Coca-Cola Company | High-potency sweetener composition with rubisco protein, rubiscolin, rubiscolin derivatives, ace inhibitory peptides, and combinations thereof, and compositions sweetened therewith |
US20200297734A1 (en) | 2015-06-19 | 2020-09-24 | Melt Pharmaceuticals, Inc. | Pharmaceutical compositions and methods for anesthesiological applications |
US10555952B2 (en) | 2015-06-19 | 2020-02-11 | Melt Pharmaceuticals, Inc. | Pharmaceutical compositions and methods for anesthesiological applications |
US10391102B2 (en) | 2015-06-19 | 2019-08-27 | Melt Pharmaceuticals, Inc. | Pharmaceutical compositions and methods for anesthesiological applications |
US10166240B2 (en) | 2015-06-19 | 2019-01-01 | Imprimis Pharmaceuticals, Inc. | Pharmaceutical compositions and methods for anesthesiological applications |
EP3310439B1 (en) * | 2015-06-19 | 2024-05-29 | Melt Pharmaceuticals, Inc. | Pharmaceutical compositions for anesthesiological applications comprising benzodiazepine and ketamine |
US10179136B2 (en) | 2015-06-19 | 2019-01-15 | Imprimis Pharmaceuticals, Inc. | Pharmaceutical compositions and methods for anesthesiological applications |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5352618A (en) | 1976-10-25 | 1978-05-13 | Sumitomo Chem Co Ltd | Preparation of printed sugar-coated tablet |
JPS54138118A (en) | 1978-04-19 | 1979-10-26 | Sumitomo Chem Co Ltd | Manufacturing of glossy, printed sugar-coated tablet |
US4456629A (en) | 1982-07-12 | 1984-06-26 | E. R. Squibb & Sons, Inc. | Powdered wax, tablet coated therewith and method |
US5314697A (en) | 1992-10-23 | 1994-05-24 | Schering Corporation | Stable extended release oral dosage composition comprising loratadine and pseudoephedrine |
JP2002293734A (ja) * | 2000-04-26 | 2002-10-09 | Shin Etsu Chem Co Ltd | フィルムコーティング層で被覆された固形製剤及びフィルムコーティング剤 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3751277A (en) * | 1971-03-24 | 1973-08-07 | Dow Chemical Co | Tablet coating process and composition |
JPS58152813A (ja) | 1982-03-08 | 1983-09-10 | Sumitomo Chem Co Ltd | 鮮明な刻印を有する錠剤およびその製法 |
US4482387A (en) * | 1982-07-12 | 1984-11-13 | E. R. Squibb & Sons, Inc. | Powdered wax, tablet coated therewith and method |
GB2257363B (en) | 1991-01-30 | 1994-09-28 | Wellcome Found | Water dispersible tablets containing acyclovir |
GB9215908D0 (en) | 1992-07-27 | 1992-09-09 | Wellcome Found | Water dispersible tablets |
ATE293440T1 (de) * | 1995-05-09 | 2005-05-15 | Phoqus Pharmaceuticals Ltd | Pulverbeschichtungszusammensetzung für elektrostatische beschichtung von pharmazeutischen substraten |
AU4040800A (en) | 1999-03-29 | 2000-10-16 | American Home Products Corporation | Coating system |
AU2277101A (en) * | 1999-12-20 | 2001-07-03 | Schering Corporation | Stable extended release oral dosage composition |
US6254888B1 (en) * | 2000-01-28 | 2001-07-03 | Boehringer Ingelheim Pharmaceuticals, Inc. | Method for coating pharmaceutical dosage forms |
KR100721088B1 (ko) * | 2000-04-26 | 2007-05-23 | 신에쓰 가가꾸 고교 가부시끼가이샤 | 필름 코팅층으로 피복된 고형제제 및 필름 코팅제 |
-
2004
- 2004-11-30 CA CA 2547594 patent/CA2547594A1/en not_active Abandoned
- 2004-11-30 JP JP2005516013A patent/JP4999329B2/ja active Active
- 2004-11-30 WO PCT/JP2004/018112 patent/WO2005053599A1/ja not_active Application Discontinuation
- 2004-11-30 EP EP04799960A patent/EP1700591A4/en not_active Withdrawn
- 2004-11-30 US US10/581,071 patent/US20070116764A1/en not_active Abandoned
-
2010
- 2010-03-15 US US12/659,630 patent/US9149437B2/en active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5352618A (en) | 1976-10-25 | 1978-05-13 | Sumitomo Chem Co Ltd | Preparation of printed sugar-coated tablet |
JPS54138118A (en) | 1978-04-19 | 1979-10-26 | Sumitomo Chem Co Ltd | Manufacturing of glossy, printed sugar-coated tablet |
US4456629A (en) | 1982-07-12 | 1984-06-26 | E. R. Squibb & Sons, Inc. | Powdered wax, tablet coated therewith and method |
US5314697A (en) | 1992-10-23 | 1994-05-24 | Schering Corporation | Stable extended release oral dosage composition comprising loratadine and pseudoephedrine |
JP2002293734A (ja) * | 2000-04-26 | 2002-10-09 | Shin Etsu Chem Co Ltd | フィルムコーティング層で被覆された固形製剤及びフィルムコーティング剤 |
Non-Patent Citations (1)
Title |
---|
See also references of EP1700591A4 * |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2007022938A (ja) * | 2005-07-13 | 2007-02-01 | Shionogi & Co Ltd | 退色を抑制した製剤 |
DE102011088909A1 (de) | 2011-08-12 | 2013-02-14 | Labtec Gmbh | Verfahren zur Herstellung und Kontrolle von oralen Wirkstoff-Filmen |
WO2013023841A1 (de) | 2011-08-12 | 2013-02-21 | Tesa Se | Verfahren zur herstellung und kontrolle von oralen wirkstoff-filmen |
JP2013155148A (ja) * | 2012-01-31 | 2013-08-15 | Ohara Yakuhin Kogyo Kk | 口腔内崩壊錠のuvレーザー印刷方法 |
WO2014203524A1 (ja) * | 2013-06-21 | 2014-12-24 | 凸版印刷株式会社 | 固形製剤被印刷物とその製造方法 |
JP2015003883A (ja) * | 2013-06-21 | 2015-01-08 | 凸版印刷株式会社 | 固形製剤被印刷物とその製造方法 |
WO2018088142A1 (ja) * | 2016-11-14 | 2018-05-17 | 株式会社Screenホールディングス | 顔料定着用組成物及び固体製剤 |
JP2018177810A (ja) * | 2018-07-13 | 2018-11-15 | 凸版印刷株式会社 | 固形製剤用インク及び固形製剤被印刷物 |
JP2020132600A (ja) * | 2019-02-25 | 2020-08-31 | 沢井製薬株式会社 | フィルムコーティング錠剤、およびその製造方法 |
JP7263047B2 (ja) | 2019-02-25 | 2023-04-24 | 沢井製薬株式会社 | フィルムコーティング錠剤 |
JP7519496B2 (ja) | 2019-02-25 | 2024-07-19 | 沢井製薬株式会社 | フィルムコーティング錠剤 |
Also Published As
Publication number | Publication date |
---|---|
JPWO2005053599A1 (ja) | 2007-06-28 |
US9149437B2 (en) | 2015-10-06 |
CA2547594A1 (en) | 2005-06-16 |
EP1700591A1 (en) | 2006-09-13 |
US20070116764A1 (en) | 2007-05-24 |
EP1700591A4 (en) | 2011-08-03 |
JP4999329B2 (ja) | 2012-08-15 |
US20110014130A1 (en) | 2011-01-20 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US9149437B2 (en) | Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing | |
US5006362A (en) | Branding pharmaceutical dosage forms, food and confectionery products with aqueous ingestible inks | |
US9988542B2 (en) | Tablet having dry-ink film on surface thereof, and ink for inkjet printer | |
US5405642A (en) | Method of highlighting intagliations in tablets | |
AU696601B2 (en) | Oral 2-methyl-thieno-benzodiazepine formulation | |
KR20010074914A (ko) | 오메프라졸 제형 | |
JPWO2006126561A1 (ja) | 経口投与用組成物のマーキング方法 | |
US20080254112A1 (en) | Pharmaceutical Active-Ingredient-Containing Formulation with Coating | |
US20100266687A1 (en) | Improved tablet coating | |
KR20050086767A (ko) | 수성 쉘락 피막제, 그 제조 방법, 상기 피막제를 사용한코팅된 식품, 그 제조 방법, 코팅된 의약품, 그 제조 방법,유성 과자의 광택성 부여용 조성물, 광택성 부여 방법, 및광택성 부여된 유성 과자 | |
JP2004250336A (ja) | コーティング錠及び糖衣錠の製造法 | |
CN101815765B (zh) | 包含聚葡萄糖的涂覆组合物,其制备方法以及用于涂覆可摄取固体剂型的用途 | |
JP2007517038A (ja) | 薬学的組成物 | |
JPH092976A (ja) | 被覆組成物 | |
JP7165626B2 (ja) | インクジェット印刷を行う錠剤向けのコーティング用組成物、これを用いた水性インクによる印字を有する錠剤及びその製造方法 | |
JP2004155656A (ja) | 糖衣錠 | |
WO2001056550A1 (en) | Gellan gum dipped products | |
Hemchand et al. | Recent advances in different aspects of tablet coating | |
TWI317290B (ja) | ||
US20110117142A1 (en) | Method for coating tablets | |
RU2609198C1 (ru) | Твердая лекарственная форма имипрамина немедленного высвобождения и способ ее получения |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AK | Designated states |
Kind code of ref document: A1 Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW |
|
AL | Designated countries for regional patents |
Kind code of ref document: A1 Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2005516013 Country of ref document: JP |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2004799960 Country of ref document: EP Ref document number: 2547594 Country of ref document: CA |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2007116764 Country of ref document: US Ref document number: 10581071 Country of ref document: US |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
WWW | Wipo information: withdrawn in national office |
Ref document number: DE |
|
WWP | Wipo information: published in national office |
Ref document number: 2004799960 Country of ref document: EP |
|
WWP | Wipo information: published in national office |
Ref document number: 10581071 Country of ref document: US |