EFFECT OF POLYMER AND PLASTICIZER ON THIN POLYMERIC BUCCAL FILMS OF MELOXICAM DESIGNED BY USING CENTRAL COMPOSITE ROTATABLE DESIGN.

Aim of the present work was to design fast dissolving buccal film of meloxicam using central composite rotatable design and to evaluate the effects of polymer and plasticizer on formulation and characterization of the buccal films. Meloxicam was incorporated in film as model drug, HPMC E15 was used as film forming agent and polyethylene glycol (PEG) 400 was used as plasticizer. Films were fabricated using solvent casting technique. Prepared films were subjected to study various evaluation parameters. Dissolution studies were carried out for 30 min, using phosphate buffer of pH 6.8. Drug-excipients compatibility was studied using Fourier transform infra-red spectroscopy (FTIR). X-ray diffractometry (X-RD) was used to observe the crystalline or amorphous nature of the drug. Differential scanning calorimetry was used for thermal analysis of the drug and films. Optical microscopy and scanning electron microscopy were used to study the surface morphology. Results revealed that apparently the films were of smooth surface with uniform mixing of drug and excipients. Folding fortitude was > 100 in all the formulations. Weight variations were in acceptable range. Moisture loss was directly linked with concentration of plasticizer. Although buccal films were showing rapid release of the drug but still it was noticed that increasing concentration of HPMC E15 was the cause of drug retardation as well as delay in the total dissolution time, while PEG 400 was facilitating the drug release from the formulated films. Formulation F5 released approximately 100% drug in 5 min. All formulations individually showed total dissolving time in the range of 48-120 s. There were no noticeable interactions between drug and excipients. Finally, it was concluded that meloxicam containing films can be optimized using statistical tools, and HPMC E15 in combination with PEG 400 as plasticizer can be effectively used in the films formulation.