Preparation and in vitro release of meloxicam oral fast dissolving films

LIAN Wang-quan; SHEN Bao-de; SHEN Cheng-ying; LIU Xiao; LIAO Wei-bo; YUAN Hai-long

Abstract：Objective:To prepare meloxicam oral fast dissolving films (MLX-OFDF) and evaluate its in vitro release characteristics.Methods:MLX-OFDF was prepared with meglumine (MEG) as cosolvent by solvent casting method.First,the film forming material and plasticizer of MLX-OFDF were selected by single factor experiment.Then the formulation of MLX-OFDF was optimized by employing orthogonal design with the amounts of hydroxypropyl methylcellulose E30 (HPMC-E30),polyethylene glycol 400 (PEG-400) and potassium dihydrogen phosphate(KH2PO4) as investigation factors,and percent elongation,surface pH and disintegration time as evaluation indexes.Finally,the disintegration time,content uniformity and in vitro release of the optimized formulation were also evaluated.Results:MLX-OFDF prepared by the optimized formulation [1.50％ (g· mL-1) MLX,1.10％ (g· mL-1) MEG,3.00％ (g· mL-1) HPMC-E30,4.00％ (g· mL-1) PEG-400,0.15％ (g· mL-1) KH2PO4] could disintegrate within 30 s,the cumulative release in vitro at 5 min reached (95.51 ± 1.38)％,and the conformity of drug content was up to the standard (A + 2.2S ＜ 15).Conclusion:Using single factor test method and orthogonal design to prepare MLX-OFDF is effective and feasible.The optimized MLX-OFDF which has a good appearance and rapid disintegration and release is a new preparation for MLX with profound application prospect.