ABSTRACT

This study was aimed to design a floating pulsatile device for a poorly water-soluble drug to reduce hypertension patients’ circadian symptoms. An inclusion complex of hydroxypropyl beta-cyclodextrin and nifedipine was created using the solvent evaporation method. The quick-release tablets were developed from the solid inclusion complex, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate. The tablets underwent in vitro release and in vivo pharmacodynamic studies. Floating pulsatile capsules were made with an enteric capsule body, a non-enteric cap, a delayedrelease polymer layer, two quick-release nifedipine tablets, and a polymer base layer. Delayedrelease layers were prepared with xanthan gum and K4M or E50. Formulations were evaluated for in vitro release, buoyancy and weight uniformity. The optimized floating pulsatile capsule delivered the drug immediately and 8 h later to treat early morning symptoms. This study shows that pulsatile tablets treat both hypertensive peaks, maximizing hypertension therapeutic advantages.