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(searched for: Formulation-and-Evaluation-of-Dexlansoprazole-Delayed-Release-Capsules)
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Sciprofile linkMichael Kukulka, Sai Nudurupati, Maria Claudia Perez
Therapeutic Advances in Gastroenterology, Volume 9, pp 759-769; doi:10.1177/1756283X16670073

Abstract: The pharmacokinetics
and
pharmacodynamics
of
a novel orally disintegrating tablet (ODT)
formulation
of
delayed-release
dexlansoprazole
30 mg was
evaluated
versus the
dexlansoprazole
30 mg
capsule
in this phase I, open-label, multiple-dose, randomized, two-period crossover study. Healthy adults received daily doses
of
30 mg
dexlansoprazole
ODT or 30 mg
dexlansoprazole
delayed-release
capsule
for 5 days during two treatment periods, separated by a 7-day washout interval. Blood samples for
dexlansoprazole
plasma concentrations
and
intragastric pH measurements were collected through 24 hours postdose on days 1
and
5
of
each period. Bioequivalence between the 30 mg ODT
and
30 mg
capsule
dosage forms was demonstrated by the primary endpoints
of
dexlansoprazole
peak concentration (Cmax)
and
systemic exposure (AUC) values contained within the prespecified 90% confidence interval (CI) range
of
0.80–1.25. Additional primary endpoints
of
intragastric mean pH values
and
percentage
of
time with pH > 4 over the 24-hour postdose interval were equivalent for
dexlansoprazole
ODT
and
dexlansoprazole
capsule
. Treatment-emergent adverse events were reported in 23%
and
28%
of
participants receiving the ODT
and
capsule
formulations
, respectively. Headache was the most common adverse event in both treatment regimens (5.8% with ODT
and
6.0% with
capsule
). Administration
of
dexlansoprazole
30 mg ODT or 30 mg
capsule
provided equivalent plasma exposure when either was administered as a single dose or as once daily doses for 5 days. Pharmacodynamic equivalence between the two
formulations
was demonstrated by similar intragastric pH parameters on both day 1
and
day 5. No effect
of
day on
dexlansoprazole
pharmacokinetics was observed.
Dexlansoprazole
ODT
and
dexlansoprazole
capsule
were both well tolerated.
Veera Venkata Satyanarayana Reddy Karri
Journal of Pharmacy and Pharmaceutics, Volume 3, pp 1-9; doi:10.15436/2377-1313.16.016

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