Medicinal composition
A composition and drug technology, which is applied in the direction of pharmaceutical formulation, dispersion liquid delivery, organic active ingredients, etc., can solve the problem of reducing bitterness, etc., and achieve the effect of inhibiting the decline of dissolution and excellent dissolution stability
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[0117] The hemifumarate of geritinib described in the present examples and the like used was produced by the method described in Patent Document 1 (International Publication No. 2010 / 128659) or a method based thereon.
[0118] PEARLITOL (registered trademark) 50C (manufactured by ROQUETTE) was used for mannitol described in this example, Sucralose (registered trademark) (P) (manufactured by Saneigen FFI) was used for sucralose, and aspartame Ajinomoto KK Aspartame (manufactured by Ajinomoto), HPC L (manufactured by Nippon Soda) (hereinafter sometimes referred to as HPC) is used for hydroxypropyl cellulose, and isomalt hydrate is used GalenIQ 721 (manufactured by BENEO-PALATINIT), sweet peral (registered trademark) P200 (manufactured by ROQUETTE) was used for maltitol, NEOSORB (registered trademark) XTAB 290 (manufactured by ROQUETTE) was used for sorbitol, refined white sugar (UE -E) (manufactured by Kanto Chemical Industry), Trehalose (P) (manufactured by Asahi Kasei) was use...
Embodiment 1
[0130] "Manufacture of the tablet of Example 1"
[0131] 2.21 kg of geritinib hemifumarate, 2122.0 g of mannitol, and 1680.0 g of sucralose were mixed using a fluidized bed granulator (GPCG-PRO-5, manufactured by Powrec) according to the formulation described in Table 1 3602 g (solid content: 20 weight%) of isomalt hydrate aqueous solution was sprayed and granulated as a binder liquid, and it dried and obtained the granulated product. After sieving to remove aggregates, weigh 5385.6 g from 6377.5 g of the obtained granulated product, add 288.0 g of L-HPC and 115.2 g of Mg-St, and use a mixer (Contenamikiser PM200 (60 L container), Hiroshima Metal & Machinari-manufactured) were mixed to obtain a mixture. The obtained mixture was tableted with a rotary tablet machine (HT-CVX-TYPEIII20, manufactured by Hata Tekko) to obtain plain tablets. 900.6 g of the obtained plain tablet was added to a film coating machine (HCT-30, manufactured by Floint Industrial Co., Ltd.), and film-coat...
Embodiment 2
[0132] "Manufacture of the tablet of Example 2"
[0133] According to the formula recorded in Table 1, 165.75 g of geritinib hemifumarate, 186.15 g of mannitol, and 126.0 g of sucralose were granulated with a fluidized bed granulator (GPCG-1, manufactured by Powrec) (hereinafter referred to as GPCG-1) After mixing, 475 g (solid content: 10% by weight) of an isomalt hydrate aqueous solution was sprayed and granulated as a binder liquid, and then dried to obtain a granulated product. After sieving to remove aggregates, 212.08 g was weighed from 401.9 g of the obtained granulated product, 10.84 g of L-HPC and 3.23 g of Mg-St were added, and hand-mixed with a polyethylene bag to obtain a mixed product. The obtained mixture was tableted with a rotary tablet press (EX-10, manufactured by Hata Tekko) to obtain plain tablets. 37.69 g of the obtained plain tablet was put into a film coating machine (MINI COATER / DRIER-2, manufactured by CALEVA), and film-coated with a liquid prepared b...
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