TABLE II

Selected Samples for Further Study Based on Range of Glide Force and Excipients

Run No.BufferBuffer Concentration (mM)Buffer pHTonicity AgentTonicity Concentration/Ionic StrengthPS80 Concentration (%)Ave Glide Force (N) at 3 M 25 °C
54CitrateLow10Low5.5MannitolHigh5%None01.86
36HistidineLow10Mid6MannitolHigh5%None01.91
55*CitrateLow10Mid6MannitolHigh5%None02.06
43CitrateLow10Mid6NaClHigh150 mMLow0.022.26
26HistidineHigh20Mid6NaClHigh150 mMHigh0.062.28
14AcetateHigh20High5.5NaClHigh150 mMHigh0.062.33
12AcetateLow10High5.5NaClLow75 mMLow0.022.39
38CitrateLow10Low5.5MannitolHigh5%High0.062.75
53CitrateLow10VLow5MannitolHigh5%High0.062.81
33HistidineHigh20High6.5MannitolHigh5%High0.063.65
34HistidineLow10VLow5MannitolHigh5%High0.064.91
11AcetateHigh20Mid5MannitolLow2.5%Low0.025.03
5AcetateHigh20Low4.5MannitolHigh5%High0.065.37
  • * Sample used for surface tension measurements but not reflectometry or ICP.