Formulation Development and In vitro Evaluation of Memantine Hydrochloride Fast Dissolving Oral Films employing different grades of Hydroxy Propyl Methyl Cellulose

Abstract

The aim of this present research work is to formulate and evaluate mouth dissoving films using Memantine hydrochloride as a model drug which is used for facilitating rapid onset of action in Alzheimer’s patients who are mentally ill. The films were designed to dissolve upon contact with a wet surface, such as tongue, within a few seconds especially for these patients who are unable to swallow. In this present research work various trials were carried out using different grades of HPMC E3, E5 and E15 by solvent casting method. The prepared films were eva1uated for morphological properties, weight variation, drug content uniformity, thickness uniformity, folding endurance, surface pH, In-vitro disintegration time,In-vitro dissolution studies and stability studies of the satisfactory formulation. Films prepared using HPMC E5 and E15 showed better morphohogical properties when compred with grade E3. Best formulations F4 and F8 prepared using HPMC E5 and E15 respectively with polymer concentration 45% showed minimum disintegration time and maximum dissolution rate. A slight increase in drug dissolution rate with F8 was observed but there is no significant difference between these two formulations was identified. These findings suggest that the fast dissolving film containing Memantine is considered to be potentially useful for the treatment of Alzheimer’s where geriatric patients feel difficulty to swallow a dosage form.