Abstract: Provided is an orally disintegrating tablet film-coated with a composition for film coating containing hypromellose and hydroxypropyl cellulose but not containing a plasticizer.

Abstract: A preparation containing saxagliptin having improved stability and a method for producing the same are provided. According to an embodiment of the present invention, a preparation containing saxagliptin including a plain tablet part containing one or more first additive agent selected from a group consisting of D-mannitol, lactose, anhydrous lactose, and anhydrous dibasic calcium phosphate, the plain tablet part containing less than 35% by weight of crystalline cellulose with respect to 100% by weight of the plain tablet part, and a film coating part in contact with the plain tablet part and containing saxagliptin, a salt thereof, or a hydrate thereof, and a method for producing the same are provided.

Abstract: An anhydrous dasatinib-containing preparation comprising an anhydrous dasatinib and a titanium oxide or colorant or antioxidant is provided. In one embodiment, the anhydrous dasatinib-containing preparation improves photostability upon storage. The weight ratio of the titanium oxide per the anhydrous dasatinib may be more than 0 and 2 or less, or the weight ratio of the colorant per the anhydrous dasatinib may be more than 0 and 1 or less, or the weight ratio of the antioxidant per the anhydrous dasatinib may be more than 0 and 0.5 or less.

Abstract: Provided is a novel additive for an orally disintegrating tablet which imparts a rapid disintegration property and a tablet hardness to the orally disintegrating tablet and a method for producing the same. An additive for an orally disintegrating tablet according to one embodiment of the present invention includes a D-mannitol, a low-substituted hydroxypropyl cellulose (excluding those having a mean particle size of 20 ?m or less and a substitution degree of the hydroxypropoxy groups of 11%, having a mean particle size of 45 ?m or less and a substitution degree of the hydroxypropoxy groups of 14% and having a mean particle size of 45 ?m or less and a substitution degree of the hydroxypropoxy groups of 11% together with a 90% cumulated particle size of 100 ?m or less), a crospovidone and a crystalline cellulose.

Abstract: Provided is a novel additive for an orally disintegrating tablet providing quick disintegrability and tablet hardness to the orally disintegrating tablet, and a producing method therefor. According to an embodiment of the present invention, there is provided an additive for an orally disintegrating tablet characterized by including D-mannitol, low-substituted hydroxypropyl cellulose (however, excluding the low-substituted hydroxypropyl cellulose having a mean particle size of 20 ?m or less and a substitution degree of hydroxypropoxy groups of 11%, a mean particle size of 45 ?m or less and a substitution degree of hydroxypropoxy groups of 14%, and a mean particle size of 45 ?m or less and a substitution degree of hydroxypropoxy groups of 11% and a 90% cumulated particle size of 100 ?m or less), crospovidone, and microcrystalline cellulose, wherein the low-substituted hydroxypropyl cellulose and the crospovidone are included in a ratio of 5:4.

Abstract: Provided is an orally disintegrating tablet evaluating method includes: measuring the mass of tablet; placing the tablet on a preparation placement surface of a test solution supply unit; measuring a water absorption time for a test solution to penetrate from one end of the tablet in contact with the surface to the other end of the tablet; measuring the mass of the tablet for which the time for the solution to penetrate has been measured; and calculating the water absorption rate of the tablet by the following formula (1); wherein the tablet is evaluated based on a water absorption rate of the tablet of 0.004 g/sec: water absorption rate of tablet=(mass of tablet after measurement of time for solution to penetrate?mass of tablet before measurement of time for solution to penetrate)/(time for solution to penetrate from one end to other end)??(1).

Abstract: To provide a mirabegron-containing tablet that maintains the amorphous form of mirabegron even after long-term storage. Also, to provide a mirabegron-containing pharmaceutical preparation that can maintain the purity of mirabegron while preventing the generation of related substances at the time of storage, a method for producing a mirabegron-containing pharmaceutical preparation, and a method for producing a mirabegron-containing granulated product. According to an embodiment of the present invention, there is provided a mirabegron-containing pharmaceutical preparation containing mirabegron, hypromellose, and polyvinylpyrrolidone. The mirabegron-containing pharmaceutical preparation may contain a spray-dried granulated product containing the mirabegron, the hypromellose, and the polyvinylpyrrolidone.

Abstract: A mouthfeel evaluation method for an orally disintegrating test object is provided, the method including, by a measurement apparatus, giving a predetermined distortion with a predetermine cycle as applying a predetermined pressure to the orally disintegrating test object, adding a predetermined amount of a test liquid to the test object, and measuring a loss tangent of the test object with time.

Abstract: A sustained-release preparation containing pseudoephedrine is provided comprising pseudoephedrine or a pharmaceutically acceptable salt thereof, and a hardened oil or stearic acid. The sustained-release preparation containing pseudoephedrine may contain a hardened oil or stearic acid in an amount of 100% by mass to 500% by mass with respect to the content of the pseudoephedrine or a pharmaceutically acceptable salt thereof. In addition, the sustained-release preparation containing pseudoephedrine may have a first part and a second part, the first part may contain the pseudoephedrine or a pharmaceutically acceptable salt thereof, and the first part or the second part may contain an optional active ingredient.

Abstract: Provided is an orally disintegrating tablet coated with film that allows the time elapsed before a film thereof dissolves to be shorter, has a good feel when the tablet is taken, and is capable of being easily mass-produced. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature.

Abstract: A candesartan cilexetil-containing preparation contains candesartan cilexetil and lauromacrogol. The lauromacrogol may be contained at a ratio of 2.4 parts by weight or less with respect to 100 parts by weight of the candesartan cilexetil-containing preparation. The candesartan cilexetil-containing preparation may further contain at least one kind of pharmacologically acceptable additives among a diluent, a disintegrant and a binder.

Abstract: The present invention provides: a pitavastatin-containing preparation containing pitavastatin or a pharmacologically acceptable salt thereof and at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds, and an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation having a pH of more than 8 and 10 or less; and a method for producing a pitavastatin-containing preparation, including blending at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds with pitavastatin or a pharmacologically acceptable salt thereof, to make an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation have a pH of more than 8 and 10 or less.

Abstract: The invention provides an orally disintegrating tablet containing (a) one or more saccharides or sugar alcohols selected from the group consisting of mannitol, lactose, xylitol, sucrose, erythritol and glucose and (b) low substituted hydroxypropylcellulose and substantially free of a starch disintegrant, which tablet is produced by steps of granulating a composition containing the above-mentioned components (a) and (b) by an agitation granulation method, and compression-molding the obtained granulation product. The invention also provides a method of producing an orally disintegrating tablet substantially free of a starch disintegrant, including steps of granulating a composition containing the above-mentioned components by an agitation granulation method, and compression-molding the obtained granulation product.

Abstract: The present invention provides a pitavastatin-containing preparation containing pitavastatin or a pharmacologically acceptable salt thereof and at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds, and an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation having a pH of more than 8 and 10 or less; and a method for producing a pitavastatin-containing preparation, including blending at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds with pitavastatin or a pharmacologically acceptable salt thereof, to make an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation have a pH of more than 8 and 10 or less.

Abstract: The present invention provides a method for producing spherical fine particles containing tamsulosin hydrochloride, the method includes the steps of: (1) mixing and stirring tamsulosin hydrochloride (a), microcrystalline cellulose (b), and water until a mixture of the component (a) and the component (b) is uniformly impregnated with the water; (2) granulating the mixture obtained in step (1) using an stirring granulator whose peripheral speed is set to be 5.5 to 9.0 m/s; and (3) drying the granules obtained in step (2). The present invention also provides spherical fine particles obtained according to the method, coated fine particles obtained by applying a coating to the spherical fine particles, and an orally disintegrating tablet containing the coated fine particles.

Abstract: The present invention provides an atorvastatin-containing coated preparation comprising a solid formulation containing atorvastatin, a pharmacologically acceptable atorvastatin salt, or a solvate thereof coated with a coating agent comprising a polyvinyl alcohol copolymer, a method for inhibiting generation of related substances of atorvastatin, a pharmacologically acceptable atorvastatin salt, or a solvate thereof, comprising coating the solid formulation with a coating agent comprising a polyvinyl alcohol copolymer, and a method for stabilizing atorvastatin, a pharmacologically acceptable atorvastatin salt, or a solvate thereof.

Abstract: The present invention provides a method for producing spherical fine particles containing tamsulosin hydrochloride, the method includes the steps of: (1) mixing and stirring tamsulosin hydrochloride (a), microcrystalline cellulose (b), and water until a mixture of the component (a) and the component (b) is uniformly impregnated with the water; (2) granulating the mixture obtained in step (1) using an stirring granulator whose peripheral speed is set to be 5.5 to 9.0 m/s; and (3) drying the granules obtained in step (2). The present invention also provides spherical fine particles obtained according to the method, coated fine particles obtained by applying a coating to the spherical fine particles, and an orally disintegrating tablet containing the coated fine particles.

Abstract: The invention provides an orally disintegrating tablet containing (a) one or more saccharides or sugar alcohols selected from the group consisting of mannitol, lactose, xylitol, sucrose, erythritol and glucose and (b) low substituted hydroxypropylcellulose and substantially free of a starch disintegrant, which tablet is produced by steps of granulating a composition containing the above-mentioned components (a) and (b) by an agitation granulation method, and compression-molding the obtained granulation product. The invention also provides a method of producing an orally disintegrating tablet substantially free of a starch disintegrant, including steps of granulating a composition containing the above-mentioned components by an agitation granulation method, and compression-molding the obtained granulation product.

Abstract: A process capable of conveniently preparing voglibose at a low cost in a safe process, and an intermediate which can be suitably used in the process and a process for preparing the intermediate are provided. An inositol derivative represented by the formula (VI): wherein Prt is a protecting group of hydroxyl group; a process for preparing the inositol derivative, wherein a cyclohexanone compound represented by the formula (IV): wherein Prt is as defined above, is dihydroxyaminated using a dihydroxyaminating agent and a reducing agent; and a process for preparing voglibose represented by the formula (VIII): wherein the inositol derivative is oxidized to give an inositol compound, and the protecting group, Prt of the inositol compound is deprotected.

Abstract: A reagent for the detection of an antibody against an acid-fast bacterial antigen comprising at least one compound selected from the group comprising mycolic acids, mycolic acid salts, mycolic acid esters and esters of fatty acids having a carbon number of 14 or more other than mycolic acid with a mono- or disaccharide, a method of detecting an antibody against an acid-fast bacterial antigen using said reagent and a method of diagnosis of acid-fast bacterial infections by said detection method are simpler in procedures and offer much higher specificity in comparison with conventional reagents and methods, enabling identification of acid-fast bacterial genera (including the genera Mycobacterium, Nocardia and Rhodococcus) and acid-fast bacterial species, and thus it is possible to make diagnoses to identify the infecting acid-fast bacterium, which leads to the quick choice of therapeutic drug for the disease.