Mechanical properties of excipients do not affect polymer matrix formation.

摘要: Coalescence of polymer particles has been identified as a crucial step in film formation on tablets, pellets and granules. Though the significance thermal treatment matrix dosage forms is well established process coalescence forces driving it remain unexplored. The aim this study was to investigate whether stresses caused by deformation excipient during compression, provide force for formation. Polymer tablets containing Eudragit-RLPO, pH independent permeable at two levels 10 40% (w/w) were prepared direct compression. Either lactose monohydrate (brittle) or mannitol (plastic) used diluent 80 50% indomethacin, model drug present 10% (w/w). Tablets from each formulation type compression pressures either 221 MPa (above yield pressure both excipients) 74 (below excipients). compressed thermally treated 40 degrees C Tg) 70 24 h. rotating basket (100 rpm) method release studies conducted 37 900 ml phosphate buffer (0.2 M) 7.2 dissolution medium. Morphological characteristics observed scanning electron microscopy. Differences tablet structure due processing variables further evaluated disintegration tensile strength testing. Data factorial analysed analysis variance. Excipient mechanical properties determine only low level curing temperature high cured only. have different therefore behaviors, did not influence C, suggesting these are significant