FORMULATION AND EVALUATION OF ORODISPERSIBLE FILMS OF ACECLOFENAC

The present work was aimed to formulate Oro Dispersible Films (ODF) of Aceclofenac with improved solubility and patient compliance. ODFs or fast dissolving films are the new dosage formulation which are becoming most preferred drug delivery systems. ODFs have advantages over other formulations like improved solubility of poorly soluble drugs, enhanced patient compliance, instant release of drug, avoiding hepatic first pass effect, etc. Aceclofenac is one of the poorly water-soluble drug which is used as NSAID having analgesic and anti-inflammatory actions. Hence Aceclofenac was used in the present study to enhance the solubility by formulating in the form of ODF. The films were prepared by Solvent Casting method by dissolving Aceclofenac and other excipients like Hydroxy Propyl Methyl Cellulose (HPMC), β-Cyclodextrin, Propylene glycol, CrossCormellose Sodium (CCS), Sodium Saccharin. The low solubility of Aceclofenac was a greatest challenge which was overcame by incorporating β-cyclodextrin. The formulated films of Aceclofenac were evaluated in terms of Thickness, Folding endurance, Surface PH, Weight variation, Drug content, Disintrgration time, FTIR analysis, and Dissolution studies. Among all the formulations, F4 formulation was found to be optimized ODF as it has lower disintegration time and high dissolution rate due to high concentration of CCS. The other formulations showed moderate results. FTIR studies indicates that there is no interaction between drug and excipients. The addition of β-Cyclodextrin to F3 and F4 formulation showed improved solubility as compared to F1 and F2 formulations.