Osmotic pump delivery systems have made significant advances in
the past decades for controlled drug release over a long period of time. Usually, osmotic pump products require sophisticated and expensive laser drill technology resulting in increase in production
cost and decrease in production efficiency. In this study, a lamotrigine extended release tablet based on a controlled-porosity osmotic pump (CPOP) system was developed to circumvent laser drill
technology in reference, Lamictal XR®. The tablet core was coated by a polymer
blend of Acryl-EZE® and HPMC E5. Lactose and HPMC were added in the CPOP
core to adjust the release profile. An orthogonal design was employed to optimize the formulation from factors, i.e., core composition, coating materials ratio and coating levels. Comparisons
of in vitro drug release profiles were also conducted. The optimized formulation showed a satisfactory zero-order release profile (R2 = 0.9912). Similarity factor, f 2 of 77 was obtained in
larger scale. The lamotrigine extended release tablets based on the CPOP system showed ideal reproducibility and stability. The developed system has the ability to be an alternative production method
for Lamictal XR®, which could circumvent the laser drill technology and promote
the osmotic pump generalization.