Development of immediate-release formulation with reliable absorption of rivaroxaban in various meal regimes

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F24%3A10482404" target="_blank" >RIV/00064165:_____/24:10482404 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/24:10482404 RIV/00216208:11310/24:10482404

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=hidd3J08gw" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=hidd3J08gw</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/cts.13820" target="_blank" >10.1111/cts.13820</a>

Result language

angličtina

Original language name

Development of immediate-release formulation with reliable absorption of rivaroxaban in various meal regimes

Original language description

The bioavailability of rivaroxaban at the higher doses (15 and 20 mg) is considerably reduced when the drug is administered on an empty stomach. This can lead to inadequate anticoagulant effect, and therefore, it is recommended to use the higher doses at fed state. However, proper posology may represent a barrier for some patients. Therefore, the aim of this study was to evaluate innovative rivaroxaban-containing formulations designed to eliminate the food effect to ensure reliable absorption and thus to improve patient adherence with the treatment. Three prototypes (Cocrystal, HPMCP and Kollidon) with rivaroxaban were developed and their bioavailability and food effect in comparison to the reference product was tested in open label, randomized, single oral dose, crossover studies, where test products were administered under fasting and fed conditions and the reference product was administered under fed conditions. Comparable bioavailability for all tested prototypes both under fed and fasting conditions was demonstrated as the 90% confidence intervals of the geometric mean ratios for area under the concentration-time curve remained within the standard acceptance range of 80.00%-125.00%. An innovative immediate release form of rivaroxaban with no food effect on drug bioavailability has been developed, which may represent an important step toward increasing adherence, improving treatment outcome and reducing health care costs.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30104 - Pharmacology and pharmacy

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Clinical and Translational Science

ISSN

1752-8054

e-ISSN

1752-8062

Volume of the periodical

17

Issue of the periodical within the volume

5

Country of publishing house

GB - UNITED KINGDOM

Number of pages

12

Pages from-to

e13820

UT code for WoS article

001219211600001

EID of the result in the Scopus database

2-s2.0-85192900468