Relative bioavailability of diclofenac potassium from softgel capsule versus powder for oral solution and immediate-release tablet formulation

2015 ◽  
Vol 5 (1) ◽  
pp. 76-82 ◽  
Author(s):  
Girish Bende ◽  
Shibadas Biswal ◽  
Prafulla Bhad ◽  
Yuming Chen ◽  
Atish Salunke ◽  
...  
Keyword(s):  
Immediate Release ◽  
Relative Bioavailability ◽  
Oral Solution ◽  
Tablet Formulation ◽  
Release Tablet

scholarly journals Influence of immediate release tablet formulation on dissolution profile of paracetamol

2018 ◽  
Vol 5 (3) ◽  
pp. 705-714
Author(s):  
Nemanja Todorović ◽  
Svetlana Goločorbin-Kon ◽  
Kristina Kermeci ◽  
Jelena Jovičić-Bata ◽  
Nebojša Pavlović ◽  
...  
Keyword(s):  
Immediate Release ◽  
Tablet Formulation ◽  
Dissolution Profile ◽  
Release Tablet

scholarly journals On Absorption Modeling and Food Effect Prediction of Rivaroxaban, a BCS II Drug Orally Administered as an Immediate-Release Tablet

Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 283
Author(s):  
Varun Kushwah ◽  
Sumit Arora ◽  
Miklós Tamás Katona ◽  
Dattatray Modhave ◽  
Eleonore Fröhlich ◽  
...  
Keyword(s):  
Pbpk Model ◽  
Food Effect ◽  
Solid Dispersions ◽  
Immediate Release ◽  
Oral Solution ◽  
In Vitro Dissolution ◽  
Fed State ◽  
Release Tablet

The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro–in vivo correlation (IVIVC) models. The bioavailability of Riva upon oral administration of Xarelto IR tablet is reported to exhibit a positive food effect. The PBPK model for Riva was developed and verified using the previously reported in vivo data for oral solution (5 and 10 mg) and Xarelto IR tablet (5 and 10 mg dose strength). Once the PBPK model was established, the in vivo performance of the tablet formulation with the higher dose strength (Xarelto IR tablet 20 mg in fasted and fed state) was predicted using the experimentally obtained data of in vitro permeability, biorelevant solubility and in vitro dynamic dissolution data using United States Pharmacopeia (USP) IV flow-through cell apparatus. In addition, the mathematical IVIVC model was developed using the in vitro dissolution and in vivo profile of 20 mg strength Xarelto IR tablet in fasted condition. Using the developed IVIVC model, the pharmacokinetic (PK) profile of the Xarelto IR tablet in fed condition was predicted and compared with the PK parameters obtained via the PBPK model. A virtual in vivo PK study was designed using a single-dose, 3-treatment cross-over trial in 50 subjects to predict the PK profile of the Xarelto® IR tablet in the fed state. Overall, the results obtained from the IVIVC model were found to be comparable with those from the PBPK model. The outcome from both models pointed to the positive food effect on the in vivo profile of the Riva. The developed models thus can be effectively extended to establish bioequivalence for the marketed and novel complex formulations of Riva such as amorphous solid dispersions.

scholarly journals Immediate release tablet formulation of varenicline salicylate and comparative pharmacokinetic study in human volunteers

2018 ◽  
Vol Volume 12 ◽  
pp. 3377-3392
Author(s):  
Seong Shin Kwak ◽  
Eun Seok Lee ◽  
Ho Yub Yoon ◽  
Chang Hyun Kim ◽  
Yoon Tae Goo ◽  
...  
Keyword(s):  
Pharmacokinetic Study ◽  
Immediate Release ◽  
Tablet Formulation ◽  
Comparative Pharmacokinetic ◽  
Human Volunteers ◽  
Release Tablet
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