A.R. Shabaraya

Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. Fast dissolving film is a dosage form which when placed in the oral cavity, quickly gets hydrated, sticks onto the site of application and then disintegrates to release the drug. Fast dissolving oral films of isosorbide mononitrate were prepared by solvent casting method. Optimization was carried out to study the effect of independent variables (different polymer and plasticizer concentration) such as HPMC E5 and HPMC E50 as polymer and PEG 400 as a plasticizer on the dependent variables like T90% (sec), in-vitro disintegration time (sec) & % moisture absorption (%). Design expert software (version 8.0.1.6) was used to optimize the formulation. Prepared films were subjected to different evaluation parameters such as surface pH, weight uniformity, thickness of strip, % moisture absorption, % moisture loss, swelling index, drug content, in-vitro disintegration time, in-vitro drug release, stability studies and mechanical properties like folding endurance, tensile strength.

  Aceclofenac is a non-steroidal anti-inflammatory, analgesic and antipyretic drug used in the treatment of rheumatic arthritis, post-traumatic pain, masculo-skeletal and joint disorder. Problem with this drug is poor solubility in water hence poor bioavailability after oral administration. The objective of the research work was to develop and evaluate mouth dissolving tablets of Aceclofenac by using sublimation technique. The sublimation technique is used to increase the porosity of the tablets in which camphor was used as subliming agents which in turn forms the porous structure on the surface of tablets after sublimation. Aspartame was used as sweetening agent. The formulated tablets were evaluated for different parameters like weight variation, hardness, friability, drug content, disintegration time, wetting time, water absorption ratio, and In-vitro dissolution studies. Based on the results, formulation F-3 & F-6 containing Crosprovidon and Kyron T-314 10% concentration as superdisintegrants showed the least wetting time of about 17 & 13 sec, disintegration time of 25 & 18 sec and drug release of about 89.13 & 99.14% within 180 sec respectively and was found to be promising and selected as the optimized formulations. From the results, it was concluded that mouth dissolving tablets with improved Aceclofenac dissolution could be prepared by sublimation of tablets containing suitable subliming agent. Key words: Aceclofenac, mouth dissolving tablets, in-vitro, sublimation technique.