Abstract: In masking particles comprising a drug-containing particle containing a drug of a salt with an acid and containing a carbonate, the drug-containing particle being coated with a coating layer containing a water-insoluble polymer, drug release in the oral cavity and pharynx is sufficiently suppressed, the drug is rapidly released after swallowing, and the release suppression time of the drug is easily controlled. The drug-containing particle may comprise a core particle and an interlayer on the core particle, and the core particle may contain the drug of a salt with an acid, and the interlayer contains the carbonate, or the core particle may contain the carbonate, and the interlayer may contain the drug of a salt with an acid.

Abstract: The present invention chiefly aims to provide a new API particle in which a metal or the like is coated on the API itself of a pharmaceutical solid dosage form. The present invention includes, for example, a coated API particle, wherein the surface of an API particle is coated with a metal or a metal oxide (e.g., iron oxide) by sputter deposition, and a process for manufacturing a pharmaceutical solid dosage form (e.g., tablet) using the coated API particles. According to the present invention, for example, it is possible to improve the photostability of an API itself or of pharmaceutical solid dosage forms produced with the API.

Abstract: A spherical core containing an esomeprazole compound as an active ingredient and having a median particle diameter (d50) of 50 ?m or more is coated with a coat containing a controlled release layer to prepare a controlled release granule containing a controlled release granule with a median particle diameter (d50) of 350 ?m or less. The spherical core may contain the esomeprazole compound at a proportion of 50% by mass or more relative to the spherical core. The spherical core may be a spherical particle containing the esomeprazole compound as a drug. The spherical core has a median particle diameter (d50) of 50 ?m or more. The spherical core may have a sphericity of 0.6 or more. The coat may be in a multilayer free from an esomeprazole compound as an active ingredient. The controlled release layer may be an enteric coating layer. The proportion of the coat may be 80% by mass or more relative to the whole amount of the preparation.

Abstract: Masking particles which comprise a drug-containing particle containing a drug, an acid, and a carbonate, the drug-containing particle being coated with a coating layer containing a water-insoluble polymer sufficiently suppress drug release in the oral cavity and pharynx, rapidly release a drug after swallowing, and easily control the release suppression time of a drug. The acid may be at least one organic acid. The carbonate may be at least one water-soluble carbonate. Oral pharmaceutical compositions include tablets, granules, fine granules, powders.

Abstract: Super continuum light having a continuous spectrum over at least 1100 to 1300 nm is emitted from a pulsed light source, is pulse-stretched by a stretching element such that a relationship between a wavelength and an elapsed time in one pulse is one to one, and is radiated to a product. The light transmitted through the product is received by a light receiver, and output data is input to the determination unit. A quality determination program of the determination unit calculates an absorption spectrum from the output data, quantifies the absorption spectrum by chemometrics, and compares the absorption spectrum with a reference value to determine quality. The product determined to be a defective product is excluded by an exclusion mechanism.

Abstract: The present invention provides a method for obtaining a specifically-shaped crystal (specifically, spherocrystal) of a compound with good reproducibility. This method for producing a specifically-shaped crystal (specifically spherocrystal) of a compound comprises: (1) a step for preparing a supersaturated solution of a compound having a degree of supersaturation equal to or higher than a critical degree of supersaturation; and (2) a step for precipitating a specifically-shaped crystal (specifically spherocrystal) of a compound from the supersaturated solution.

Abstract: The main object is to provide a novel pharmaceutical solid preparation containing a pharmaceutically active ingredient, wherein the solid preparation is coated with a light shielding agent in a nano-order thickness. The present invention can include a pharmaceutical solid preparation containing at least one pharmaceutically active ingredient, wherein the surface of the solid preparation is coated with a light shielding agent or a metal oxide to a thickness in a range of 1 nm to 500 nm to form a coating layer, or is coated with a light shielding agent or a metal oxide which is present in a range of 5×10?6 mg/mm2 to 3×10?3 mg/mm2 to form a coating layer, and a process for producing a solid preparation containing at least one pharmaceutically active ingredient, comprising a step of coating a light shielding agent or a metal oxide by sputtering on the surface of the solid preparation to a thickness in a range of 1 nm to 500 nm.

Abstract: The present invention provides a method for obtaining a specifically-shaped crystal (specifically, spherocrystal) of a compound with good reproducibility. This method for producing a specifically-shaped crystal (specifically spherocrystal) of a compound comprises: (1) a step for preparing a supersaturated solution of a compound having a degree of supersaturation equal to or higher than a critical degree of supersaturation; and (2) a step for precipitating a specifically-shaped crystal (specifically spherocrystal) of a compound from the supersaturated solution.

Abstract: An orally disintegrating tablet combinable with a variety of drugs and exhibits excellent disintegrating properties in an oral cavity but having strength and the like allowing ability to form a tablet. The annular orally disintegrating tablet containing a drug and a disintegrating agent; and having a hole in a central portion making it annular. The content of the disintegrating agent relative to total weight is 2% to 50% by weight. It exhibits excellent disintegrating properties, i.e., when a gradient of disintegrating time (seconds) of the tablet with respect to tableting pressure (kN) upon compression-forming is defined as “a” and a gradient of disintegrating time (seconds) of a disk-shaped orally disintegrating tablet with respect to tableting pressure (kN) upon compression-forming is defined as “b”, the disk-shaped orally disintegrating tablet having the same weight and external diameter as the annular orally disintegrating tablet the ratio (a/b) is 0.90 or less.

Abstract: An orally disintegrating tablet is disclosed possessing both advantageous hardness and disintegrability. The orally disintegrating tablet is (a) a compression molding product of a mixture comprising: a pharmaceutically active ingredient-containing composition selected from a group consisting of a pharmaceutically active ingredient-containing powder and pharmaceutically active ingredient-containing granules; rapidly disintegrating granules; and a lubricant, (b) wherein the rapidly disintegrating granules comprise a sugar and/or a sugar alcohol, and one or more organic and/or inorganic, hydrophilic and water-insoluble additives.

Abstract: A highly pure optically active proton pump inhibitor compound can be produced safely and inexpensively in a high yield and enantioselectivity by a method of producing an optically active sulfoxide of Formula 2 or a salt thereof, comprising oxidizing a sulfide of Formula 1 or a salt thereof with hydrogen peroxide using an iron salt in the presence of a chiral ligand of Formula 3; wherein A is CH or N; R1 is hydrogen atom, an alkyl optionally substituted by halogen(s), or an alkoxy optionally substituted by halogen(s); one to three R2 may exist, and each of R2 is independently an alkyl, a dialkylamino, or an alkoxy optionally substituted by halogen(s) or alkoxy(s); each of R3 is independently hydrogen atom, a halogen, cyano or the like; R4 is a tertiary alkyl; and * and ** represent respectively R configuration or S configuration.

Abstract: The present invention pertains to spherical water-dispersible amorphous particles having a particle diameter of 10-990 nm and a PDI of 0.01-0.5, wherein the amorphous particles contain an organic compound having a molecular weight of 50-1500, and a method for preparing the same.

Abstract: A fat emulsion comprises a prostaglandin as an active ingredient, the fat emulsion comprising a phospholipid that comprises phosphatidylcholine (PC) and phosphatidylglycerol (PG) and has a ratio of PC to PG (PC:PG) of 85:15 to 99.7:0.3.

Abstract: A sodium bicarbonate dialysate comprising an electrolyte granule A composed mainly of sodium chloride and containing no sodium bicarbonate and an electrolyte granule B containing sodium bicarbonate, wherein the granule B is granules of sodium bicarbonate primary particles having a particle size of at most 250 .mu.m, and the particle size of the secondary particles after granulation is from 0.1 to 10 mm.