Spheroids containing 3-alkylxanthine

Details Spheroids containing 3-alkylxanthine Spheroids containing 3-alkylxanthine

A - Human Necessities

61

K

167/220

A61K 31/495 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 31/52 (2006.01) A61K 47/00 (2006.01)

Patent

CA 1296254

ABSTRACT A controlled release pharmaceutical composition comprising a plurality of film coated spheroids, the film coated spheroids comprising a 3-alkylxanthine, a non-water soluble spheronising agent and between 4% and 9% (by weight) water, wherein the in-vitro dissolution rate of the 3-alkylxanthine from the film coated spheroids, when measured by the USP Paddle Method at 100rpm in 900ml aqueous buffer (pH 6.5 at 37°C) is between 7.5% and 25.0% (by wt) release after 1 hour, between 22.5% and 45.0% (by wt) release after 2 hours, between 40.0% and 60.0% (by wt) release after 3 hours, between 50.0% and 75.0% (by wt) release after 4 hours, between 70.0% and 92.5% (by wt) release after 6 hours, and between 80.0% and 100.0% (by wt) release after 8 hours. Preferably the water content is between 4% and 8%, especially between 4% and 7% (by wt) of the film coated spheroid formulation. The preferred 3-alkylxanthine is theophylline (anhydrous or hydrate), whilst the preferred spheronising agent is microcrystalline cellulose.

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