DEVELOPMENT AND EVALUATION OF ORODISPERSIBLE FILMS OF LAMOTRIGINE: HYDROXYPROPYL Β CYCLODEXTRIN INCLUSION COMPLEX.

Orodispersible film is the type of drug delivery systems which when placed in the oral cavity disintegrates or dissolves within few seconds without water intake. This type of technology offer a convenient alternative way of dosing medication, not to special population groups, but also to the general population. The present investigation highlights on the formulation and evaluation of orodispersible films of poorly soluble antiepileptic drug lamotrigine. Dissolution characteristics of the drug was improved by forming inclusion complexes with hydroxypropyl β‐cyclodextrin (HPβCD) employing co-evaporation technique and the complexes were  characterized by differential scanning calorimetry (DSC) and fourier transformation infrared spectroscopy (FTIR). Orodispersible films of LMN-HPβCD (1:1) were prepared by the solvent-casting method; using water soluble film forming polymers such as hydroxyl propyl methyl cellulose (HPMC15), polyvinyl alcohol (PVA) and Sodium carboxy methyl cellulose (SCMC).Propylene glycol and glycerin were used as plasticizers. The prepared films were evaluated for their physicochemical characteristics such as appearance, thickness, folding endurance, drug content uniformity, surface pH, disintegration time and mechanical properties, in vitro drug release and stability studies were performed for the optimized formula according to the ICH guideline under 40°C/75% RH for three months. Amongst all formulations F2 films prepared with1% w/v PVA plasticized with 3% glycerin was considered as the optimized formulation, it has the highest drug release, satisfactory in vitro disintegration time, tensile strength, % elongation, folding endurance and stable formula. Overall results suggest that PVA is an excellent film former for antiepileptic drug lamotrigine. Therefore, orodispersible films is considered to be potentially suitable for the immediate release whenever required of lamotrigine to improve patient compliance.