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AssigneeAllergan Pharmaceuticals International Limited
InventorsRyan Gerald LOUGHLIN, Stephen MCCULLAGH, Roger BOISSONNEAULT
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A mesalamine pharmaceutical composition with reduced delivery variability for delivery of mesalamine to the colon that includes multiple dosage elements, and each dosage element includes mesalamine and an enteric coating. The enteric coating of each different dosage element differs so the release point of the mesalamine in the GI tract is varied. In one embodiment, a first dosage element releases about 30% to about 60% by weight of the total mesalamine in the composition after 60 minutes at a pH of about 6.6 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm and a second dosage element releases about 40% to about 70% by weight of the total mesalamine after 60 minutes at a pH of about 7.2 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm.
A mesalamine pharmaceutical composition for delivery of mesalamine to the colon with reduced delivery variability, the composition comprising (i) at least one first dosage element comprising a first mesalamine dose and a first enteric coating and (ii) at least one second dosage element comprising a second mesalamine dose and a second enteric coating, wherein the first enteric coating is soluble at a pH of about 6.4 to about 6.8 in an aqueous phosphate buffer and the second enteric coating is soluble in an aqueous phosphate buffer at a pH of 0.2 to 1 units higher than the first enteric coating, wherein the solubility of the first and second enteric coating in aqueous phosphate buffer is determined after an initial exposure of the composition in 0.1 N hydrochloric acid for 2 hours at a paddle speed of 100 followed by 1 hour in a 6.0 pH phosphate buffer at a paddle speed of 100 rpm.
Dependencies are inferred from the claim text.