Design, formulation and evaluation of sustained release bilayer tablets of ciprofloxacin hydrochloride

Abstract

The present research work involve the development of a bilayer tablet of ciprofloxacin hydrochloride using a superdisintegranting agent (sodium starch glycolate) for the fast releasing layer and hydrophobic polymers like ethyl cellulose, acrycoat L100 and acrycoat S100 for the delayed releasing layer. Ciprofloxacin was used as a model drug. Tablets were prepared by wet granulation method. The prepared bilayer tablets were evaluated for angle of repose, bulk density, tapped density, Carr’s index, Hausner’s ratio at the precompression stage and thickness variation, weight variation, hardness, friability, drug content, disintegration time, in vitro drug release study at the post compression stage.. In vitro dissolution studies were carried out in a USP 24 apparatus I. In vitro dissolution kinetics followed the Higuchi model via a non-Fickian diffusion controlled release mechanism after the initial burst release. FT-IR studies revealed that there was no interaction between the drug and polymers. Statistical analysis (ANOVA) showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p < 0.05) in the amount of drug released after 12 h from optimized formulations was observed. Present research work involves the development of a bilayer tablet of ciprofloxacin hydrochloride using a superdisintegrant for the fast releasing layer and hydrophobic polymers for the delayed releasing layer. There was the initial burst effect from the formulations to provide the loading dose of the drug, followed by sustained release to provide maintenance dose of the drug.
 Keywords: Superdisintegrants, Burst release, Wet granulation, non-Fickian, Sustained release