IMPLEMENTING CENTRAL COMPOSITE DESIGN FOR THE DEVELOPMENT OF TACROLIMUS FILM FOR SUBLINGUAL ADMINISTRATION

Objective: The study aimed to develop fast-dissolving films (FDFs) of the immunosuppressant drug tacrolimus monohydrate for sublingual administration, employing central composite design (CCD), improve its bioavailability. Methods: Tacrolimus: β-cyclodextrin inclusion complexes prepared earlier were formulated into FDFs. CCD was used developing optimal film formulation with desired characteristics. solvent casting method preparation films. For optimization, independent variables selected concentration hydroxy propyl methyl cellulose E5 (HPMC E5) (X1) and croscarmellose sodium (CCS) (X2) responses disintegration time (Y1) percentage release at 5 min (Y2). suggested subjected further characterization. Results: All formulations showed good mechanical properties. composition optimized FDF constituted 3.016% w/v HPMC 11.731%w/w CCS average 27.28s 83.13% mean min. Differential Scanning calorimetry (DSC) analysis complete dispersion partial conversion amorphous form drug, which also confirmed by X-ray diffraction (XRD) studies. Electron Microscopy (SEM) revealed smooth porous nature film. Conclusion: developed may be sublingually delivering efficiently, avoiding oral bioavailability problems.