Effect of Particle Size,Content in Lubricant,Mixing Time and Storage Relative Humidity on Drug Release from Hard Gelatin Ampicillin Capsules

Abstract

The influence of several variables on the release of ampicillin from hard gelatin capsules is studied. 18 lots of ampicillin capsules were prepared, with the following affecting variables: a) time of mixing the materials before filling the capsules, b) ampicillin particle size, c) Content in lubricant (magnesium stearate), d) Storage under several humidity conditions. It was found that dissolution rate is significantly affected by the size of ampicillin particles. Similar effects by variation of the other parameters are observed.