Vapor Phase Transfers Including Sublimation

Pharmaceuticals containing components that sublime easily may undergo changes in drug content owing to the sublimation of the drug substances or excipients. In the case of nitroglycerin, which is a liquid with a significant vapor pressure, sublingual tablets exhibited significant variations in drug content during storage owing to intertablet migration through the vapor phase, as shown in Fig. 140.595596 This transfer was inhibited by adding water-soluble, nonvolatile fixing agents such as polyethylene glycol.597

assay as a percent of label claim

Figure 140. Change in nitroglycerin content uniformity in sublingual tablet due to vapor-phase transfer, before (a) and after storage at 25°C for 5 months (b). (Reproduced from Ref. 596 with permission.)

assay as a percent of label claim

Figure 140. Change in nitroglycerin content uniformity in sublingual tablet due to vapor-phase transfer, before (a) and after storage at 25°C for 5 months (b). (Reproduced from Ref. 596 with permission.)

64 68 72 76 60 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144

64 68 72 76 60 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144

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