Delayed release formulations and processes for making them

Details Delayed release formulations and processes for making them Delayed release formulations and processes for making them

A - Human Necessities

61

K

167/166, 117/45

A61K 9/14 (2006.01) A01N 25/12 (2006.01) A01N 25/34 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/26 (2006.01)

Patent

CA 1221634

ABSTRACT "DELAYED RELEASE FORMULATIONS AND PROCESSES FOR MAKING THEM" There is disclosed a granular composition having particles of average particle size as determined by sieving in the range 70 to 500 microns, the said particles comprising up to 55% of active ingredient e.g. ferrous sulphate having primary particles the maximum dimension (A) of which as determined by microscopy is less than 50 microns and a particulate water soluble extender e.g. lactose having an aver- age particle size (B) as determined by sieving in excess of 50 microns, the particles of active ingre- dient and water soluble extender being held in self- supporting spaced relationship by a water insoluble polymer film matrix e.g. of a polyacrylate polymer, providing the balance of the weight of the particle and being less than 50% by weight of the particle. The invention also extends to a blend convertible by pressure alone to a substantially continuous three-dimensional porous matrix substantially devoid of separate resin particles, of active ingredient/ water soluble extender/resin particles, e.g. as above, in which the active ingredient comprises 45 to 60%, the water soluble extender comprises 35 to 45%, and the resin comprises 5 to 15% by weight and a water insoluble extending agent or filler for the matrix resin and a water soluble or insoluble tableting aid or lubricant, the active ingredient/ water soluble extender/resin particles comprising 80 to 95%, the water insoluble extending agent or filler for the matrix resin comprising 5 to 15% and the lubricant 0.2 to 5% of the blend.

455889

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