Table 3.
Drug | Study performed | Proof of concept and study design | Results obtained compared to reference formulation | References |
---|---|---|---|---|
Aprepitant |
In vitro characterization In vitro disintegration time, wetting time and drug release |
In vivo comparative pharmacokinetic animal study | Optimized formulation containing 40–45% pullulan and 15–20% PEG 400 showed a shorter disintegration time (20 s), a greater dissolution rate (88.87%) and alike pharmacokinetic values |
Bala and Sharma, 2018 |
Two period, two sequence, cross-over | ||||
Sumatriptan succinate |
In vitro characterization In vitro disintegration time and dissolution study |
In vivo comparative pharmacokinetic studies in healthy human volunteers | Optimized formulation containing 60% PVA 20000 and 24% PEG 4400 showed a higher peak concentration (10.78 ng/mL), shorter disintegration time (0.25 h) and an increased AUC |
Tayel et al., 2016 |
Randomized, two treatment, two period, cross-over | ||||
Terbutaline sulphate |
In vitro characterization In vitro/in vivo disintegration time and dissolution study |
Bioavailability studies in healthy human volunteers | Optimized formulation containing HPMC-Na alginate-maltodextrin, PEG and water showed a quick disintegration time (25 s), a higher plasma concentration of 12.525 μg/mL and a greater AUC |
Sayed et al., 2013 |
Randomized, single dose, cross-over |
AUC: Area under the curve, HPMC: Hydroxypropyl methylcellulose, PEG: Polyethylene glycol, PVA: Polyvinyl alcohol.