Lamotrigine extended release tablet based on a controlled-porosity osmotic pump system

Osmotic pump delivery systems have made significant advances inthe 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 productioncost 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 drilltechnology in reference, Lamictal XR®. The tablet core was coated by a polymerblend of Acryl-EZE® and HPMC E5. Lactose and HPMC were added in the CPOPcore 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. Comparisonsof 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 inlarger 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 methodfor Lamictal XR®, which could circumvent the laser drill technology and promotethe osmotic pump generalization.

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