Table 1:

Performance of Nitrostat (nitroglycerin, Pfizer) tablets stored in varying packaging configurations (n = 6)

Week*
12481224
Experimental storage conditionF2S/NSF2S/NSF2S/NSF2S/NSF2S/NSF2S/NS
Control: original borosilicate glass packaging, RT
PTFE insert, PTFE cap, RT64.6S69.4S84.6S86.6S87.6S52.4S
Borosilicate glass insert, PTFE cap, RT46.9NS59.8S66.1S69.5S85.8S58.7S
PTFE insert, PTFE cap, 4°C68.5S76.1S67.4S68.9S80.1S58.6S
Borosilicate glass insert, PTFE cap, 4°C53.2S59.6S75.6S85.0S73.5S62.9S
PTFE insert, PTFE cap, 35°C62.3S78.2S71.1S95.1S64.8S61.8S
Borosilicate glass insert, PTFE cap, 35°C46.7NS71.4S64.1S82.2S58.1S26.4NS
PTFE insert, PE cap, 35°C77.4S82.3S44.3NS46.3NS45.0NS30.2NS
PTFE insert, PTFE cap, 35°C, N2 packaging58.8S78.7S65.1S75.7S84.2S37.1NS
Borosilicate glass insert, PTFE cap, 35°C, N2 packaging55.0S61.2S75.8S62.0S77.1S31.1NS
PTFE insert, PTFE cap, −20°C60.1S
PTFE insert, PTFE cap, 0.3-mg, RWC56.0S
PTFE insert, PTFE cap, 0.6-mg, RWC49.9
  • NS Note: N2 = nitrogen, NS = not similar, PE = polyethylene, PTFE = polytetrafluoroethylene, RT = room temperature, RWC = real-world conditions, S = similar.

  • * F2 values less than 50 indicate significant differences in the release profiles.

  • Red letters indicate results for the marketed product components and configuration of the SMHeartCard.