Table 2.
Products | Oral products |
Vaginal products |
||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
I |
II |
III |
IV |
V |
VI |
VII |
VIII |
IX |
||||||||||
Dosage form* | Sachet 1† | Sachet 2† | Capsule 1† | Capsule 2† | Drops | Sachet | Sachet 1† | Sachet 1† | Capsule | Tablet | Tablet | Drops | Tablet | Drops | Vaginal capsule | Vaginal capsule | Vaginal capsule | Vaginal capsule |
T1 CFU/dose | 2.7×109a | 6.2×109 | 2.9×109 | 6.4×109 | 5.2×109 | 5.2×109a | 7.8×109 | 22.1×109a | 22.3×109 | 23.5×109 | 3.0×108c | 2.7×108c | 3.1×108c | 3.5×108c | 7.5×108c | 6.8×108c | 1.5×107 | 4.6×107 |
T2 CFU/dose | 2.5×109a | 5.7×109 | 2.8×109 | 5.9×109 | 4.8×109 | 4.5×109b | 7.7×109 | 20.0×109b | 20.3×109b | 21.0×109a | 2.5×108c | 2.3×10c | 2.8×108c | 3.0×108c | 6.5×108c | 6.0×108c | 1.0×107 | 4.0×107 |
Product label CFU/dose | 3.0×109 | 6.0×109 | 3.0×109 | 6.0×109 | 5.0×109 | 6.0×109 | ⩾8.0×109 | ⩾24.0×109 | ⩾24.0×109 | ⩾24.0×109 | 1.0×108 | 1.0×108 | 1.0×108 | 1.0×108 | 1.0×108 | 1.0×108 | N/A | N/A |
N/A, not applicable; T1, half shelf life; T2, 3 months to deadline.
Dosage of different formulations= one sachet (powder), one capsule, one tablet, one vaginal capsule, five drops.
Same formulation with different CFU/dose.
Statistically significant difference between T1 and label and between T2 and label: aP ⩽0.05; bP ⩽0.001; cP ⩽0.0001.
Not statistically significant values are not indicated. For the products VIII and IX ANOVA test cannot be applied.