Enhanced Solubility and Dissolution Rate of Lamotrigine Hcl by Inclusion Complexation, Solid Dispersion Technique and Optimization of Formulation Parameters Using Factorial Design and Desirability Function

The solid state properties and dissolution behavior of lamotrigine in its inclusion complex with βCyclodextrin were investigated.Preformulation study of lamotrigine was carried out. Dialysis study of lamotrigine with β-Cyclodextrin in pretreated dialysis bags showed that lamotrigine binds with βCyclodextrin in the ratio of 1:2. Solid dispersions were prepared by kneading and spray dried method. And were evaluated for % drug content and saturation solubility. Trial batch LCD 04 was found to have a saturation solubility of 0.0947 mg/ml and drug content of 3.674 (108.05%). Spray dried solid dispersions LSCD 02 and LSCD 03 were found to have a drug content of 3.43 (100%) and 3.44 (100%) respectively. LSCD 01 had a drug content of 3.30(97%).LSCD 01 had a saturation solubility of 8.13 μg/ml. LSCD 02 and LSCD 03 were found to have a saturation solubility of 110.03 μg/ml and 131.3 μg/ml respectively. Micromeretic properties of lamotrigine and solid dispersions were also investigated. A 3 2 factorial design was applied which comprises of total nine formulations and the desirability function was designed to study the effects of amounts of β-Cyclodextrin