Process for making a spray-dried, directly- compressible...

A - Human Necessities – 61 – K

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A61K 31/07 (2006.01) A61K 9/16 (2006.01) A61K 31/355 (2006.01) A61K 31/59 (2006.01)

Patent

CA 1324576

ABSTRACT OF THE DISCLOSURE: A process for making a directly-compressible vitamin powder comprising: (A) combining: (1) a fat-soluble vitamin; and (2) a gelatin having a bloom number between 30 and 300; and (3) a water-soluble carbohydrate; and (4) an effective amount of water to permit spray-drying; so that a mixture is formed; (B) spray-drying the mixture in a conventional spray-dryer whereby a directly-compressible powder is formed, the relative amounts of vitamin, gelatin, and carbohydrate in the mixture being selected so that the resulting spray-dried powder comprises: (1) 20 to 60 percent by weight of the fat-soluble vitamin; and (2) 6 to 46 percent by weight of the gelatin; and (3) an effective amount of the carbohydrate to prevent extrusion. The resulting powder is useful in the manufacture of pharmaceutical tablets.

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