Eudragit L-100 f or enteric coating of hard gelatine capsules: Formulation and evaluation

In an attempt to combine the favourite properties of hard gelatine capsules with the protective and controlled release properties of enteric coating to get an appropriately and acceptably formulated enteric coated hard gelatine capsules with pH dependent drug release characteristic. Two hard gelatine capsule sizes were selected i.e. size #0 and size #1 in order to test the effect of capsule size on coating process. Eudragit L-100, a pH dependent solubility polymer, was tested for suitability for coating of hard gelatine capsules. A number of formulations with various Eudragit L-100 concentrations were investigated in order to select the best formula that provides the most appropriate coating properties. A formulations with 3, 5, 6.5 and 10 % (w/w) Eudragit L-100 were tested. Formula with 6.5 % (w/w) Eudragit L-100 was selected as it provides a good adhered and continuous coating film with acceptable disintegration time, dissolution test and excellent stability on storage for both capsule sizes.