Development and Evaluation of High Porous Mouth Dissolving Tablets Containing Lamotrigine Complexation

Lamotrigine (LMG) is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.17mg/ml at 25 0 C). Thus, in the work under taken, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:5 molar ratios). The mouth dissolving tablet of LMG was prepared by direct compression method using different concentration of subliming agent like menthol and superdisintegrant like sodium starch glycolate. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, water absorption ratio, in vitro disintegration time and in vitro dissolution studies etc. The prepared tablets were characterized by Fourier transform infra red spectroscopy, differential scanning calorimetry, powder X-ray diffraction studies, scanning electron microscopy. The disintegration time for the complexed tablets prepared by different concentration of menthol are found to be in range of 25±2.52 to 91±3.05 seconds and the formulation which are prepared by different concentration of sodium starch glycolate are found to be in range of 30±1.00 to 95±2.52 sec. All the formulation showed almost 100 percent of drug release within 40 min. Among all the formulation, F5 prepared with 40 mg menthol and F13 prepared with 35 mg sodium starch glycolate shows faster drug release, respectively 12 min and 15 min. Further formulations were subjected to stability testing for 2 months at temperature of 40±5ºC/75±5%RH. Tablets have shown no appreciable changes with respect to physical appearance, drug content, disintegration time, and dissolution profiles. INTRODUCTION Mouth-dissolving/disintegrating tablets (MDDDS) have the unique property of rapidly disintegrating and/or dissolving and releasing the drug as soon as they come in contact with saliva, thus obviating the requirement of water during administration. Therefore, these dosage forms have lured the market for a certain section of the patient population which includes dysphagic, bed ridden, psychic, and geriatric and pediatric patients. Mouth-dissolving/disintegrating tablets (MDDTs) are also called as " fast-dissolve " , " fast-melt " , " rapidly disintegrating " , " quick-melt " , " quick-dissolve " , " crunch-melt " , " bite-dispersible " , " orally disintegrating " , and orodispersible tablets. Drugs without any bitter taste, having dose lower than 20mg, Small to moderate molecular weight, good stability in water and saliva, partially non ionized at the oral cavities pH, and having ability to diffuse and partition into the epithelium of …