THe Incorporation and in Vitro Release Profiles of Liquid, Deliquescent or Unstable Drugs with Fusible Excipients in Hard Gelatin Capsules

The in vitro release profiles of four liquid or deliquescent model drugs incorporated in various GelucireR excipients were examined. In every case, it was possible to obtain release of the active substance as rapidly as with the equivalent commercial soft gelatine capsules tested. GelucireR grades with high HLB values (despite having high melting points) were found to be the most favorable. Release patterns could be related to the behaviour of the GelucireR bases in the gastric fluidDrug-excipient ratio played a prominent role, which differed when hydrophilic or hydrophobic GelucireR types were used. Storage of the capsule formulations for more than two years did not usually change the drug release profiles significantly, but chloral hydrate capsules could not be stocked for more than a few months