| abstract |
The disclosure relates to a pharmaceutical composition suitable for preventing or reducing niacin-induced flushing, wherein the pharmaceutical composition comprises: niacin microparticles having a pH-dependent release profile, and aspirin microparticles having a pH-independent release profile, wherein the niacin microparticles have a reduced capacity to provoke a cutaneous flushing reaction in a subject; wherein the aspirin microparticles are present in an amount effective to reduce the cutaneous flushing caused by the niacin; wherein there is a lag time between release of aspirin and release of niacin following administration of the composition; and wherein the amount of aspirin in the composition is between 80 mg and 500 mg that is released based on an aspirin release profile, wherein about 70% to 90% of aspirin AUC is released over a period of time of 2 to 16 hours following administration of the composition, or wherein the aspirin concentration in plasma is greater than 5% of Cmax over a period of time of 2 to 16 hours following administration of the composition. These pharmaceutical compositions are suitable for preventing or reducing niacin-induced flushing. |