Pharmaceutical Compositions for Minocycline

摘要

The present application relates to a method of orally administering once daily tablet of minocycline to a subject in need thereof, wherein said tablet is substantially free of lactose. The present application also relates to processes for preparing said once daily tablet of minocycline that provides reduced stock keeping units with improved inventory by supplying multiple doses of minocycline in single tablet.

主权项

1. A pharmaceutical composition comprising minocycline and one or more pharmaceutically acceptable excipient(s), wherein said composition comprises (i) about 20 to about 40 percent of minocycline in an immediate release (IR) portion and (ii) about 80 to about 60 percent of minocycline in an extended release (ER) portion; and exhibits at least one of the following dissolution profiles when measured in USP type I apparatus at 100 rpm in 900 ml of simulated gastric fluid with a pH of 2.1 and at 37° C.: (a) about 15% to about 25% of minocycline in 15 minutes, (b) about 35% to about 50% of minocycline in 30 minutes, (c) about 50% to about 65% of minocycline in 60 minutes and (d) about 70% to about 90% of minocycline in 120 minutes.