| US 7,575,762 B2 | ||
| Composition comprises sustained-release fine particles and manufacturing method thereof | ||
| Tatsuki Shinoda, Shizuoka (Japan); Atsushi Maeda, Shizuoka (Japan); Naoki Itou, Shizuoka (Japan); Takao Mizumoto, Shizuoka (Japan); Shigeru Yamazaki, Shizuoka (Japan); and Yuuki Takaishi, Shizuoka (Japan) | ||
| Assigned to Astellas Pharma Inc., Tokyo (Japan) | ||
| Filed on May 02, 2007, as Appl. No. 11/743,616. | ||
| Application 11/743616 is a continuation of application No. 10/206010, filed on Jul. 25, 2002, granted, now 7,255,876. | ||
| Claims priority of provisional application 60/308303, filed on Jul. 27, 2001. | ||
| Prior Publication US 2007/0202168 A1, Aug. 30, 2007 | ||
| This patent is subject to a terminal disclaimer. | ||
| Int. Cl. A61K 9/16 (2006.01); A61K 9/22 (2006.01); A61K 9/26 (2006.01); A61K 9/46 (2006.01) | ||
| U.S. Cl. 424—490 [424/466; 424/468; 424/469; 424/470; 424/493] | 8 Claims |
| 1. A method of manufacturing a composition comprising sustained-release fine particles, said method comprising:
providing sustained-release fine particles having controlled dissolution for quick-disintegrating tablets in the buccal cavity,
wherein each particle comprises a coated drug over a core selected from the group consisting of microcrystalline cellulose,
sodium chloride and silicon dioxide, and further a coating of a polymer substance over the drug; and
granulating by intermittent spraying said sustained-release fine particles and one or two or more fillers selected from the
group consisting of sugars and sugar alcohols together with a binder for quick-disintegrating tablets in the buccal cavity,
and wherein the ratio of ungranulated sustained-release fine particles in the entire composition is 0 to 15% and the coefficient
of variation (CV %) of the amount of drug is 3.5% or less, wherein the mean particle diameter of the sustained-release fine
particles is approximately 0.1 μm to approximately 350 μm to produce said composition;
wherein the binder for quick-disintegrating tablets in the buccal cavity is one or two or more selected from the group consisting
of saccharides of high moldability, water-soluble polymer substances, and saccharides with a low melting point, and wherein
the sugar or sugar alcohol is one or two or more selected from the group consisting of saccharides with low moldability, saccharides
with a high melting point, and saccharides with a low melting point.
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