Patent ID: 6103262
Filing Date: 2000-08-15
Classification: A61K,A61P,Y02A

Abstract:
A granular pharmaceutical composition for compression into a modified release, once daily tablet dosage form of metronidazole, the composition comprising:(a) a first portion of metronidazole which is about 59 wt % to about 79 wt % metronidazole;(b) about 1.5 wt % to about 3.0 wt % of an aqueous insoluble poly(meth)acrylic acid ester copolymer which is aqueous permeable, aqueous expandable and pH-independent;(c) about 0.1 wt % to about 2.0 wt % detackifier;(d) 0 to about 23 wt % of a first aqueous soluble pharmaceutical diluent;(e) 0 to about 23 wt % of a second aqueous soluble diluent for forming a pharmaceutical tablet, the second aqueous soluble diluent being the same as or different from the first aqueous soluble diluent;(f) 0 to about 20 wt % of a second portion of metronidazole;(g) 0 to about 0.2 wt % glidant; and(h) 0 to about 2 wt % lubricant;wherein the composition comprises metronidazole containing granules comprising (a), (b), (c) and (d), wherein the sum of the weight percentages of metronidazole provided by (a) and (f) is between about 72 wt % and about 79 wt %, and wherein the sum of the weight percentages of the aqueous soluble diluent provided by (d) and (e) is between about 16 wt % and about 23 wt %.