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: 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: A solid preparation containing tafamidis includes tafamidis, and a carrier containing one or more selected from a group consisting of magnesium aluminometasilicate, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and calcium silicate, and a method for producing the same are provided.

Abstract: The present invention provides a film coating composition for a solid preparation that is easy to take. The present invention also provides a solid preparation that is easy to take. A film coating composition according to an embodiment of the present invention contains a polyvinyl alcohol-polyethylene glycol graft copolymer and a thickening agent. The thickening agent may be composed of one or more substances that are selected from the group consisting of xanthan gum, locust bean gum, pectin, carrageenan, guar gum, gellan gum, and carboxy vinyl polymer.

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: 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: A method for producing granules containing a core particle by using a general granulation method is provided. Granules containing a core particle produced by the method are provided. In addition, a pharmaceutical composition and preparation containing the granules containing the core particle are provided. The granulation method according to an embodiment of the present invention granulates by splaying granulation liquid having a mist diameter (D50) not more than the particle size (D50) of the core particle on a mixture containing a drug substance and a core particle. The granulation liquid may be water. The particle size of the core particle (D50) may be larger than the particle size (D50) of the drug substance.

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 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 stable multilayer tablet containing telmisartan and hydrochlorothiazide, in which the decomposition of hydrochlorothiazide during storage, etc., is suppressed. A multilayer tablet comprising a first layer containing telmisartan, meglumine, and a moisture-absorbing substance and a second layer containing hydrochlorothiazide is provided. The moisture-absorbing substance may be a porous moisture-absorbing substance. The porous moisture-absorbing substance may be selected from light anhydrous silicic acid, synthetic aluminum silicate, natural aluminum silicate, calcium silicate, magnesium silicate, magnesium aluminosilicate, magnesium aluminometasilicate, hydrated silicon dioxide, and silicon dioxide.