Patent ID: 8637512
Filing Date: 2014-01-28
Classification: A61K,A61P

Abstract:
1. A sustained release formulation of lamotrigine, which has a mean serum lamotrigine concentration-time profile as shown in or substantially similar to that shown in the second graph of FIG. 8 , comprising a matrix tablet in which there are two phases in the release of lamotrigine, wherein the release rate in the first phase takes place in the oesophagus and stomach and said release is slower than the release rate in the second phase which takes place when the surrounding pH exceeds 5, wherein the sustained release formulation comprises: 1) a core comprising: 2) an outer coat covering said core comprising: in which the thickness of said outer coating is adapted such that it is substantially impermeable to the entrance of an environmental fluid, substantially impermeable to the exit of lamotrigine, dissolves when the surrounding pH exceeds 5; and includes one or more orifices extending from the outside of the coating substantially completely through said coating but not penetrating said core allowing the release of lamotrigine from the core into environmental fluid, said orifices having an area or combined area from about 10 to about 60 percent of the face area of said formulation, wherein the release of lamotrigine occurs substantially through said orifice.