A FORMULA OPTIMIZATION OF NIFEDIPINE TABLET COMBINATION WITH FLOATING MUCOADHESIEVE SYSTEM IN A SIMPLEX LATTICE DESIGN

Nifedipine has poor dissolution characteristics due to its poor wetability and dispersibility in body fluits,  floating mucoadhesieve system in a Simplex Lattice Design were combined in an attempt to prolong its gastric residence time. This research was aimed to find an optimum formula, through finding effects of adding polymers (Carbopol 934P, gelatin) concentration and optimum gas generating, to be combined with its Nifedipine spray-dry release with PVP K-30. Nifedifine was produced by a spray-dried method with the 30% drugloads using PVP K-30. All performed dispersions were characterized by using Scanning Electron Microscopy (SEM), X-ray Powder Difractometry (XRPD), Differential Scanning Calorimetry (DSC) and in-vitro drug release. The 5% and 15% concentration of Carbopol 934P, gelatin, and (citric acid:Na₂CO₃) were used. Based on the Design Expert Optimation program, the optimum formula of Nifedipine tablets was obtained that it consisted of 12.02% Carbopol 934P, 5% gelatin, and 7.98% gas generating which resulting the physical characteristics of 3.00% moisture content, 10.51 g/sec  flow-rate, 4.51 kg/cm² hardness, 0.48% fragility, 58.10% DE, 100.20 sec Floating Lag Time (FLT), and 0.1011 N mucoadhesieve power.