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. Author manuscript; available in PMC: 2016 Sep 1.
Published in final edited form as: Pharm Res. 2015 Mar 21;32(9):2960–2972. doi: 10.1007/s11095-015-1678-2

Table2.

Stability evaluation of EFdA plus CSIC combination filmsa

Time Puncture Strength
(kg/mm)
Moisture Content
(%)
Drug Content Dissolutionb Antiviral (EC50)
(nM)

EFdA (mg/Film) CSIC (mg/Film) EFdA (%) CSIC (%)
25°C/65% R.H.
0 day 8.5 ± 1.1 6.6 ± 1.0 1.0 ± 0.02 1.1 ± 0.02 100 ± 2 100 ± 5 1.8 ± 0.2
1 M 9.9 ± 0.3 6.2 ± 0.1 1.0 ± 0.1 1.2 ± 0.1 98 ± 1 98 ± 5 1.7 ± 0.1
2 M 9.5 ± 0.8 6.8 ± 0.4 1.0 ± 0.1 1.1 ± 0.1 97 ± 3 97 ± 6 1.9 ± 0.2
3 M 8.4 ± 0.4 7.1 ± 0.2 1.0 ± 0.1 1.1 ± 0.01 100 ± 2 94 ± 5 2.0 ± 0.5
40°C/75% R.H.
0 day 8.5 ± 1.1 6.6 ± 1.0 1.0 ± 0.02 1.1 ± 0.02 100± 2 100 ± 5 1.8 ± 0.2
1 M 8.3 ± 0.1 6.4 ± 0.04 1.0 ± 0.03 1.1 ± 0.02 97 ± 0.5 102 ± 2 1.9 ± 0.3
2 M 8.6 ± 1.0 7.0 ± 0.2 1.0 ± 0.1 1.1 ± 0.06 95 ± 3 94 ± 4 2.5 ± 0.5
3 M 8.6 ± 1.0 7.3 ± 0.5 1.0± 0.04 1.1 ± 0.06 98 ± 5 95 ± 6 2.2 ± 0.6
a

: Mean ± SD of three determinations

b

: Dissolution at 60 min