DEVELOPMENT OF pH-INDEPENDENT ACRYLIC-WAX MATRIX TYPE SUSTAINED RELEASE DRUG DELIVERY SYSTEM OF ACEBROPHYLLINE

The aim of the present study was to improve commercial twice-a-day Acebrophylline formulation to once-a-day new formulation to improve patient compliances. The double-layered tablet was composed of the fast release layer (Acebrophylline 50 mg) and sustained release layer (Acebrophylline 150 mg). To develop the double-layered tablet, the fast release and sustained release layers were prepared using polymer, wax, excipients and malic acid. The inclusion of malic acid in sustained release layer in double-layered tablet was showed to decrease release rates in pH 1.2 equal to dissolution rate of pH 6.8. The pharmacokinetic parameters such as AUCt and Cmax of double-layered tablet having fast release and sustained release layer were tested on mini pigs. These results showed similar pharmacokinetic parameters of AUCt and Cmax between Surfolase capsule and double-layered tablet. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for double-layered tablet and Surfolase capsule were log 0.9402 ~ log 1.0245 and log 0.9983 ~ log 1.1542, respectively. This mean show that double-layered tablet using malic acid, Eudragit and carnauba wax is a promising approach for developing acebrophylline drug products.