Formulation and pharmaceutical evaluation of ferric-maltol floating table

Abstract

ABSTRACT The new drug delivery systems have been developed, which can remain in the stomach for prolonged period of time. The effervescent floating tablet is one of these systems. Iron deficiency anaemia is a common disease in the world. Ferrous sulphate is the most common ferrous preparation used to treat and prevent iron deficiency, but it has little bioavailability and several complications. Ferric-maltol complex (FMC) is a ferric compound which doesn’t have ferrous complications. In this study FMC was used for preparing effervescent floating tablets that are designed to prolong the gastric residence time of drug, increase drug bioavailability and treat iron deficiency. At first the active ingredient (FMC) was synthesized from maltol and ferric chloride, the formation of complex was confirmed. Eleven tablet formulations were designed using different amounts of gel-forming agents (HPMC K4M, Carbopol 934 P), and effervescent agents (sodium bicarbonate and citric acid ). Pre-compression parameters of powder blend (bulk density, tapped density, angel repose, Carr’s index, hausner’s ratio) were measured; t he tablets from each formulation were prepared by direct compression method. Buoyancy study of tablets was investigated. The F3-F11 tablets were selected for further post compression evaluations (thickness, hardness, friability, weight variation, drug content , in vitro dissolution study, swelling ability, drug release mechanism determination). F9, F10, F11 were the most appropriate formulations. They were very similar in consideration of swelling property, total floating time and drug release kinetic & mechanism. Among these three formulations, F11 was selected as the best formulation with more suitable buoyancy behavior. The F11 tablets were able to float immediately and remained buoyant for more than 18 hours. The drug release pattern followed zero order kinetic with non-fickian diffusion. 98.54% of FMC released from F11 floating tablets after 12 hours. Physical stability of F11 tablets was evaluated according to ICH guidelines. This formulation showed no-significant change in physical properties after storage at 40 o C and 75% RH for 3months.