Formulation And Evaluation Of Chlorothalidone Loaded Mouth Dissolving Film-A Bioavailability Enhancement Approach Using Multilevel Categoric Design

Objective: The intension of the present study includes fabrication and optimization of mouth dissolving film loaded with Chlorothalidone by solvent evaporation techniques using two components and their three levels as multilevel Categoric design. Methods: Major problem associated with the development of film loaded with BCS class II drug is to increase its solubility. Here the Chlorothalidone solubility achieved by co-solvents, such as methanol. After dissolving the drug in co-solvent, this drug solution is poured into an aqueous dispersion of Hydroxypropyl Methylcellulose E5 (HPMC E5) and Polyethylene glycol 400 (PEG 400). The two independent variables selected are factor A (concentration of HPMC E5) and factor B (concentration of PEG 400) was selected on the basis of preliminary trials. The percentage drug release (R1), Disintegration time in sec (R2) and folding endurance (R3) were selected as dependent variables. Here HPMC E5 used as a film former, PEG 400 as plasticizer, mannitol as bulking agent, Sodium starch glycolate as a disintegrating agent, tween 80 as the surfactant, tartaric acid as saliva stimulating agent, sodium saccharin as a sweetener and orange flavour etc. These fabricated films were evaluated for physicochemical properties, disintegration time and In vitro drug release study. Results: The formulation F6 has more favorable responses as per multilevel categoric design is % drug release about 98.95 %, average disintegration time about 24.33 second and folding endurance is 117. Thus formulation F6 was preferred as an optimized formulation. Conclusion: The present formulation delivers medicament accurately with good therapeutic efficiency by oral administration, this mouth dissolving films having a rapid onset of action than conventional tablet formulations.

Enhancement of dissolution rate of rapidly dissolving oral film of meclizine hydrochloride by complexation of Meclizine hydrochloride with ß-cyclodextrine.

Motion sickness is a very common disturbance of the inner ear that is caused by repeated motion such as from the swell of the sea, the movement of a car, the motion of a plane in turbulent air, etc. Most medications for motion sickness need to be taken at least 30 minutes prior exposure to the activity that can cause the problem. This project is based on the hypothesis that Mouth Dissolving Films (MDF) are rapidly dissolving dosage forms which when placed in the mouth release the drug immediately. These dosage forms would be preferred by pediatric and geriatric patients since these are not associated with fear of choking. The fast dissolving films prepared by solvent casting method with suitable appearance, mechanical strength, peelability and disintegration time were obtained using Methocel E-5 as a primary film former. Meclizine HCl, a poorly water soluble and bitter drug could be successfully incorporated in the fast dissolving films with the help of solubilizers such as β-Cyclodextrine and PEG-400.