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According to the values of the correlation coefficients and the criterion for model selection (MSC), the data fit better to the biexponential equation (Table 4) for both formulations, showing a burst release at an early stage followed by a sustained phase.
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The in vitro release behaviour of both formulations showed a classic biphasic sustained release of protein over 5 weeks which was influenced by pH of the release medium.
Two weeks after the second injection, the groups immunized with lower concentrations of rPA (5 µg/ml and 25 µg/ml) in both formulations showed a robust response to rPA with each group only having one non-responder (Figure 7).
As shown in Figure 4 c,d), both the formulations showed a typical time- and concentration dependent cytotoxicity in cancer cells.
The in vitro drug release profile of both nanoparticle formulations showed a biphasic release pattern.
However, compared to the rutin ethanolic solution [k = (35.0 ± 3.7) 10−3 min−1], both nanostructured formulations showed a significant lower rutin degradation rate (ANOVA, p ≤ 0.05).
Although the cornea is a major barrier, both formulations showed similar concentrations in all tissues at the present study.
The release pattern in both formulations showed burst release.
Both formulations showed longer duration of action than the ∼8 h considered typical of human regular insulin at a lower dosage.
Both formulations show average diameter less than 50 nm, polydispersity index (PDI) below 0.25, and negative zeta potential, regardless of the duration of storage.
Both formulations showed almost parallel dissolution profiles, but with higher dissolved amount in case of batch80, which qualitatively corresponded with the in vivo results.
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