Controlled release formulation

The controlled release monolithic tablet formulation comprising 100-1300 mg of drug and 0.1% to 4.5% w/w of one or more than one rate controlling cellulosic ether polymer wherein the total tablet weight is not more than 1500 mg and the one or more than one rate controlling polymers have a viscosity of about 4,000 cps or more.

An extended release formulation comprising 1000 mg of clarithromycin and pharmaceutically acceptable excipients, and from about 0.1%, to about 4.5% w/w of one or more rate controlling high viscosity cellulosic ether polymers, wherein the total weight of the dosage unit is not more than 1500 mg wherein the rate controlling polymer has a viscosity of about 4,000 cps or more.

An extended release pharmaceutical unit dose composition of 1000 mg of clarithromycin comprising from about 0.1% to about 4.5% weight of a high viscosity hydroxypropyl methylcellulose polymer the rate controlling polymer having a viscosity of about 4,000 cps or more, wherein when ingested orally, the composition provides area under the concentration-time curve and the maximum plasma concentration substantially equivalent to the commercially available daily dose of two 500 mg strength clarithromycin tablets administered together.

A unit dose extended release tablet composition comprising 1000 mg of clarithromycin and from about 0.1% to about 4.5% by weight of high viscosity hydroxypropyl methylcellulose polymer the rate controlling polymer having a viscosity of about 4,000 cps or more, wherein the 90% confidence interval of clarithromycin area under the concentration-time curve and maximum plasma concentration is within the interval 0.80-1.25 when compared with commercially available daily dose of two 500 mg strength clarithromycin tablets administered together.