| abstract |
A pyridoxal-5′-phosphate pharmaceutical formulation suitable for oral administration is provided comprising a dissolution profile, when measured in a standard dissolution apparatus, according to the United States Pharmacopoeia dissolution test, at 37° C. in a 0.05M phosphate buffered solution having a pH of 6.8 at 75 rpm, as follows: (a) greater than about 30% at 15 minutes, (b) greater than about 85% at 30 minutes, (c), greater than about 90% at 45 minutes, or (d) greater than about 95% at 60 minutes. Additionally, in vivo oral intake of between 15 and 60 mg/kg of a pyridoxal-5′-phosphate pharmaceutical formulation can produce a maximum plasma level (C max ) of between about 1 mg/L and 8 mg/L. A pharmaceutical formulation provided comprises (a) a core, wherein said core comprises pyridoxal-5′-phosphate or a pharmaceutically acceptable salt thereof; (b) a sub-coat surrounding the core; and (c) an enteric coat surrounding the sub-coat. |