| Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing -> Monitor Keywords |
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Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printingRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Tablets, Lozenges, Or Pills, Sustained Or Differential Release Type, Layered Unitary Dosage FormsMethod for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070116764, Method for treatment of solid pharmaceutical preparation prior to printing and solid pharmaceutical preparation subjected to treatment prior to printing. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] The present invention relates to a method for treating a solid dosage form to improve the printability and abrasion resistance of a print to be produced on a surface of the solid dosage form, and a solid dosage form having improved abrasion resistance of a print or improved printability, which is afforded by the treatment. BACKGROUND ART [0002] There are many kinds of tablets and capsules that resemble one another in the size, color tone and shape. To identify each preparation, a company name, a company mark, a product name, ingredient contents and the like are often coded and directly imprinted on the preparation. For imprinting, engraving and printing are available. While engraving is employed for plain tablets free of coating, a subset of film-coated tablets and the like, printing is employed for many film-coated tablets, sugar-coated tablets, capsules and the like. [0003] For tablets and capsules, polishing with wax (in this specification, it means "wax" in a narrow sense, namely, fatty acid ester of higher alcohol; examples: carnauba wax, bees wax and the like) is often applied for the purpose of increasing the commercial value by glossy appearance, protecting a preparation from highly humid environment, preventing staining with coloring agents, improving slip property to facilitate handling in later operations of printing, inspection, packing and the like, and the like (e.g., Porter and two others, Pan Coating of Tablets and Granules, edited by Herbert A. Lieberman and one other, Pharmaceutical Dosage Forms Tablets, vol. 3, US, Marcel Dekker Inc., 1982, p. 92). Wax can be used by dissolving in an organic solvent such as chloroform/acetone and the like, or suspending in a dispersion medium such as alcohol and the like, or directly applied to the surface of a preparation as a fine powder. However, it is desirable to avoid use of an organic solvent in view of the safety issue caused by a residual solvent, a large scale facility required to prevent accident and environmental pollution, and the like. Moreover, the use of a suspension and a powder may cause non-uniform coating, possibly leading to inconvenience. [0004] Furthermore, polishing with a wax prior to printing may cause easy scratch of prints and stain of the preparation itself as well as containers, which in turn impairs identification function and also reduces the commercial value due to the defective appearance. In addition, some kind of wax provides too much polish that can cause printing failure, and decrease the product yield (e.g., U.S. Pat. No. 4,456,629 (column 1, lines 34-39)). DISCLOSURE OF THE INVENTION [0005] It is therefore an object of the present invention to provide a method of polishing a solid dosage form without using an organic solvent, which can improve and abrasion resistance of a print and printability of the solid dosage form, and a solid dosage form improved in the abrasion resistance of a print and/or printability based on the method. [0006] The present inventors have conducted intensive studies in an attempt to solve the aforementioned problem and surprisingly found that the printability during printing and abrasion resistance of the print after printing of a solid dosage form can be remarkably improved, as compared to conventional tablets polished with a wax, by treating a surface thereof with a polyethylene glycol-containing aqueous solution prior to printing. The present inventors have conducted further studies based on these findings and completed the present invention. [0007] Accordingly, the present invention provides [0008] [1] a treatment method for improving printability and/or abrasion resistance of a print to be produced on a surface of a solid dosage form, which comprises treating said surface with a polyethylene glycol-containing aqueous solution before printing, [0009] [2] the method of the above-mentioned [1], wherein polyethylene glycol has an average molecular weight of not less than about 1,000, [0010] [3] the method of the above-mentioned [1], wherein polyethylene glycol has an average molecular weight of about 3,000 to about 9,000, [0011] [4] the method of the above-mentioned [1], wherein the amount of polyethylene glycol to be added by the treatment is about 0.01% to about 1.0% in a weight ratio to the finished preparation, [0012] [5] the method of the above-mentioned [1], wherein the solid dosage form is a film-coated tablet, [0013] [6] a method for producing a solid dosage form with a printed surface, which comprises treating the surface of the solid dosage form with a polyethylene glycol-containing aqueous solution and then printing on said surface, [0014] [7] the method of the above-mentioned [6], wherein polyethylene glycol has an average molecular weight of not less than about 1,000, [0015] [8] the method of the above-mentioned [6], wherein polyethylene glycol has an average molecular weight of about 3,000 to about 9,000, [0016] [9] the method of the above-mentioned [6], wherein the amount of polyethylene glycol to be added by the treatment is about 0.01% to about 1.0% in a weight ratio to the finished preparation, [0017] [10] the method of the above-mentioned [6], wherein the solid dosage form is a film-coated tablet, [0018] [11] a solid dosage form treated by the method of any of the above-mentioned [1] to [5], [0019] [12] a solid dosage form with a printed surface, which can be obtained by any of the above-mentioned [6] to [10], [0020] [13] a solid dosage form which has a coating film comprising polyethylene glycol but free of bees wax and carnauba wax on its surface, and is printed on the surface of the coating film, and [0021] [14] a solid dosage form which has a coating comprising polyethylene glycol but free of bees wax and carnauba wax on its surface, and is printed on the surface of the coating. DETAILED DESCRIPTION OF THE INVENTION [0022] The present invention provides a method for treating a solid dosage form to improve the abrasion resistance of a print to be produced on a surface of the solid dosage form. As used herein, by "to improve the abrasion resistance of a print" is meant, for example, significantly reducing the degree of abrasion of the print produced on the solid dosage form as compared to a case free of such treatment, in the print abrasion test to be described in detail in the Examples to be mentioned below. [0023] The solid dosage form applicable to the treatment method of the present invention is not particularly limited in the dosage form as long as its surface can be printed on and, for example, tablet, capsule, troche, pill, suppository and the like can be mentioned. In view of the necessity of imprinting by printing, the method is particularly preferably applied to tablets and capsules. [0024] In this specification, the "solid dosage form" means not only pharmaceutical products but also any composition processed to have a certain dosage form of animal drug, agricultural chemical, fertilizer, sanitary products and the like. [0025] The active ingredient to be contained in the solid dosage form is not particularly limited. For example, substances effective for the prophylaxis or treatment of various diseases, which are exemplified by, but not limited to, substances having sleep-inducing action, tranquilizer activity, antibiotic activity, hypotensive action, antianginal activity, analgesic activity, anti-inflammatory activity, mental stabilizing action, diabetes treatment activity, diuretic action, anticholine activity, antihyperacidic action, antiepileptic action, ACE inhibitory activity, .beta.-receptor antagonistic or agonistic activity, anesthetic action, anorexigenic action, antiarrhythmic action, antidepressive action, anticoagulant activity, anti diarrheal action, antihistaminic activity, antimalarial action, antitumor activity, immunosuppressive activity, anti-Parkinson's syndrome action, antipsychotic action, antiplatelet activity, antihyperlipidemic action and the like, and the like, substance having detergent action, substances having flavoring, fertilizer, and deodorizing actions, animal/pest exterminating substances, substances having insecticidal action, substances having herbicidal action, plant growth regulators and the like. [0026] Where necessary, the solid dosage form of the present invention can contain a carrier acceptable for the use of the solid dosage form, together with the active ingredient. In the case of a pharmaceutical preparation, for example, it can contain a pharmaceutically acceptable carrier. As the pharmaceutically acceptable carrier, various organic or inorganic carriers conventionally used as preparation materials are used and, for example, excipient, lubricant, binder, disintegrant, thickener and the like are appropriately added in suitable amounts. Where necessary, additives such as preservative, antioxidant, coloring agent, sweetening agent and the like can also be used. [0027] Examples of the excipient include, but are not limited to, lactose, sucrose, glucose, maltose, corn starch, flour starch, mannitol, xylitol, sorbitol, maltitol, erythritol, lactitol, palatinit, crystalline cellulose, light anhydrous silicic acid, dextrin, carboxymethylstarch, gelatin, synthesis aluminum silicate, magnesium alumino metesilicate, magnesium oxide, calcium phosphate, calcium carbonate, calcium sulfate and the like. [0028] Examples of the lubricant include, but are not limited to, stearic acid, magnesium stearate, calcium stearate, talc, waxes, DL-leucine, sodium lauryl sulfate, magnesium lauryl sulfate, polyethylene glycol, aerosil (usable as antistatic agent) and the like. [0029] Examples of the binder include, but are not limited to, gelatin, pullulan, hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), methylcellulose (MC), crystalline cellulose, polyvinylpyrrolidone (PVP), polyethylene glycol, gum arabic, dextran, polyvinyl alcohol (PVA), starch paste and the like. [0030] Examples of the disintegrant include, but are not limited to, carboxymethylcellulose, calcium carboxymethylcellulose, low-substituted hydroxypropylcellulose, crosslinking polyvinylpyrrolidone, carmellose sodium, croscarmellose sodium, sodium carboxymethyl starch, cation exchange resin, partially pregelatinized starch, corn starch and the like. [0031] Examples of the thickener include, but are not limited to, natural rubbers, cellulose derivative, acrylic acid polymer and the like. [0032] Examples of the preservative include, but are not limited to, p-hydroxybenzoic acid esters, chlorobutanol, benzyl alcohol, phenethyl alcohol, dehydroacetic acid, sorbic acid and the like. [0033] Examples of the antioxidant include, but are not limited to, sulfite, ascorbic acid and their alkali metal salts, alkaline earth metal salts and the like. [0034] Examples of the coloring agent include, but are not limited to, synthetic coloring agents applicable to pharmaceutical products (e.g., sunset yellow etc. and aluminum lake thereof and the like), yellow ferric oxide, red ferric oxide, riboflavin, riboflavin organic acid esters (e.g., riboflavin butyric acid ester), phosphoric acid riboflavin or alkali metal salt thereof, alkaline earth metal salt, phenol phthalein, titanium oxide and the like. As the light shielding agent, titanium oxide and the like can be mentioned. 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