Formulation 1 Table 3: Ingredients for formulations 1 and 2 used to test drug release kinetics. Amount (mg/tablet) Parteck® ODT excipient Paracetamol (acetaminophen) Trimyristin Silicon dioxide, highly dispersed Total Formulation 2 Parteck® ODT excipient Paracetamol (acetaminophen) Sodium stearyl fumarate Silicon dioxide, highly dispersed Total 700.0 250.0 40.0 10.0 1050.0 Amount (mg/tablet) 222.3 257.7 15.0 5.0 500 Compression force (kN) Tablet thickness (mm) Tablet weight (mg) Table 4: Physical data for paracetamol tablets based on Parteck® ODT excipient. 20 5.0 Weight variation (%RSDa Tablet strength (N) ) Hardness variation (%RSDa Disintegration (s) Friabilityb (%) a Relative standard deviation | b Friability according to the Ph.Eur./USP test method Table 4. Physical data for paracetamol tablets based on Parteck® ODT. Stability is Essential In addition to examining disintegration and dissolution properties immediately after production, the stability of ODT formulations and their performance over their shelf-life must be evaluated. As the composition of some excipient systems is not disclosed it is sometimes difficult to foresee possible instabilities in the final formulation due to the potential presence of impurities. Since excipient systems for ODT formulations are usually a combination of two or more components, their composition can be ambiguous to the formulator. Among the commonly observed impurities in solid dose excipients are peroxides. Therefore, the peroxide content in the five ODT excipient systems ) 992.8 0.49 162 15.33 44-56 0.31 Amount (%/tablet) 70.0 25.0 4.0 1.0 100 Amount (%/tablet) 44.5 51.5 3.0 1.0 100 10 4.7 498.2 0.16 172 8.66 34-54 0.25 39