Performance of Nitrostat (nitroglycerin, Pfizer) tablets stored in varying packaging configurations (n = 6)
Week*† | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 4 | 8 | 12 | 24 | |||||||
Experimental storage condition | F2 | S/NS | F2 | S/NS | F2 | S/NS | F2 | S/NS | F2 | S/NS | F2 | S/NS |
Control: original borosilicate glass packaging, RT | ||||||||||||
PTFE insert, PTFE cap, RT | 64.6 | S | 69.4 | S | 84.6 | S | 86.6 | S | 87.6 | S | 52.4 | S |
Borosilicate glass insert, PTFE cap, RT | 46.9 | NS | 59.8 | S | 66.1 | S | 69.5 | S | 85.8 | S | 58.7 | S |
PTFE insert, PTFE cap, 4°C | 68.5 | S | 76.1 | S | 67.4 | S | 68.9 | S | 80.1 | S | 58.6 | S |
Borosilicate glass insert, PTFE cap, 4°C | 53.2 | S | 59.6 | S | 75.6 | S | 85.0 | S | 73.5 | S | 62.9 | S |
PTFE insert, PTFE cap, 35°C | 62.3 | S | 78.2 | S | 71.1 | S | 95.1 | S | 64.8 | S | 61.8 | S |
Borosilicate glass insert, PTFE cap, 35°C | 46.7 | NS | 71.4 | S | 64.1 | S | 82.2 | S | 58.1 | S | 26.4 | NS |
PTFE insert, PE cap, 35°C | 77.4 | S | 82.3 | S | 44.3 | NS | 46.3 | NS | 45.0 | NS | 30.2 | NS |
PTFE insert, PTFE cap, 35°C, N2 packaging | 58.8 | S | 78.7 | S | 65.1 | S | 75.7 | S | 84.2 | S | 37.1 | NS |
Borosilicate glass insert, PTFE cap, 35°C, N2 packaging | 55.0 | S | 61.2 | S | 75.8 | S | 62.0 | S | 77.1 | S | 31.1 | NS |
PTFE insert, PTFE cap, −20°C | – | – | – | – | 60.1 | S | – | – | – | – | – | – |
PTFE insert, PTFE cap, 0.3-mg, RWC | – | – | – | – | – | – | – | – | – | – | 56.0 | S |
PTFE insert, PTFE cap, 0.6-mg, RWC | – | – | – | – | – | – | – | – | – | – | 49.9 |
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.