TY  - JOUR
AU  - Bukara, Katarina
AU  - Drvenica, Ivana
AU  - Ilić, Vesna Lj.
AU  - Stančić, Ana
AU  - Mišić, Danijela
AU  - Vasić, Borislav
AU  - Gajić, Radoš
AU  - Vučetić, Dušan
AU  - Kiekens, Filip
AU  - Bugarski, Branko
PY  - 2016
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/3318
AB  - The objective of our study was to develop controlled drug delivery system based on erythrocyte ghosts for amphiphilic compound sodium diclofenac considering the differences between erythrocytes derived from two readily available materials - porcine slaughterhouse and outdated transfusion human blood. Starting erythrocytes, empty erythrocyte ghosts and diclofenac loaded ghosts were compared in terms of the encapsulation efficiency, drug releasing profiles, size distribution, surface charge, conductivity, surface roughness and morphology. The encapsulation of sodium diclofenac was performed by an osmosis based process - gradual hemolysis. During this process sodium diclofenac exerted mild and delayed antihemolytic effect and increased potassium efflux in porcine but not in outdated human erythrocytes. FTIR spectra revealed lack of any membrane lipid disorder and chemical reaction with sodium diclofenac in encapsulated ghosts. Outdated human erythrocyte ghosts with detected nanoscale damages and reduced ability to shrink had encapsulation efficiency of only 8%. On the other hand, porcine erythrocyte ghosts had encapsulation efficiency of 37% and relatively slow drug release rate. More preserved structure and functional properties of porcine erythrocytes related to their superior encapsulation and release performances, define them as more appropriate for the usage in sodium diclofenac encapsulation process.
PB  - Elsevier Science Bv, Amsterdam
T2  - Journal of Biotechnology
T1  - Comparative studies on osmosis based encapsulation of sodium diclofenac in porcine and outdated human erythrocyte ghosts
EP  - 22
SP  - 14
VL  - 240
DO  - 10.1016/j.jbiotec.2016.10.017
ER  - 

@article{
author = "Bukara, Katarina and Drvenica, Ivana and Ilić, Vesna Lj. and Stančić, Ana and Mišić, Danijela and Vasić, Borislav and Gajić, Radoš and Vučetić, Dušan and Kiekens, Filip and Bugarski, Branko",
year = "2016",
abstract = "The objective of our study was to develop controlled drug delivery system based on erythrocyte ghosts for amphiphilic compound sodium diclofenac considering the differences between erythrocytes derived from two readily available materials - porcine slaughterhouse and outdated transfusion human blood. Starting erythrocytes, empty erythrocyte ghosts and diclofenac loaded ghosts were compared in terms of the encapsulation efficiency, drug releasing profiles, size distribution, surface charge, conductivity, surface roughness and morphology. The encapsulation of sodium diclofenac was performed by an osmosis based process - gradual hemolysis. During this process sodium diclofenac exerted mild and delayed antihemolytic effect and increased potassium efflux in porcine but not in outdated human erythrocytes. FTIR spectra revealed lack of any membrane lipid disorder and chemical reaction with sodium diclofenac in encapsulated ghosts. Outdated human erythrocyte ghosts with detected nanoscale damages and reduced ability to shrink had encapsulation efficiency of only 8%. On the other hand, porcine erythrocyte ghosts had encapsulation efficiency of 37% and relatively slow drug release rate. More preserved structure and functional properties of porcine erythrocytes related to their superior encapsulation and release performances, define them as more appropriate for the usage in sodium diclofenac encapsulation process.",
publisher = "Elsevier Science Bv, Amsterdam",
journal = "Journal of Biotechnology",
title = "Comparative studies on osmosis based encapsulation of sodium diclofenac in porcine and outdated human erythrocyte ghosts",
pages = "22-14",
volume = "240",
doi = "10.1016/j.jbiotec.2016.10.017"
}

Bukara, K., Drvenica, I., Ilić, V. Lj., Stančić, A., Mišić, D., Vasić, B., Gajić, R., Vučetić, D., Kiekens, F.,& Bugarski, B.. (2016). Comparative studies on osmosis based encapsulation of sodium diclofenac in porcine and outdated human erythrocyte ghosts. in Journal of Biotechnology
Elsevier Science Bv, Amsterdam., 240, 14-22.
https://doi.org/10.1016/j.jbiotec.2016.10.017

Bukara K, Drvenica I, Ilić VL, Stančić A, Mišić D, Vasić B, Gajić R, Vučetić D, Kiekens F, Bugarski B. Comparative studies on osmosis based encapsulation of sodium diclofenac in porcine and outdated human erythrocyte ghosts. in Journal of Biotechnology. 2016;240:14-22.
doi:10.1016/j.jbiotec.2016.10.017 .

Bukara, Katarina, Drvenica, Ivana, Ilić, Vesna Lj., Stančić, Ana, Mišić, Danijela, Vasić, Borislav, Gajić, Radoš, Vučetić, Dušan, Kiekens, Filip, Bugarski, Branko, "Comparative studies on osmosis based encapsulation of sodium diclofenac in porcine and outdated human erythrocyte ghosts" in Journal of Biotechnology, 240 (2016):14-22,
https://doi.org/10.1016/j.jbiotec.2016.10.017 . .

TY  - JOUR
AU  - Bukara, Katarina
AU  - Schueller, Laurent
AU  - Rosier, Jan
AU  - Martens, Mark A.
AU  - Daems, Tinne
AU  - Verheyden, Loes
AU  - Eelen, Siemon
AU  - Van Speybroeck, Michiel
AU  - Libanati, Cristian
AU  - Martens, Johan A.
AU  - Van Den Mooter, Guy
AU  - Frerart, Francoise
AU  - Jolling, Koen
AU  - De Gieter, Marjan
AU  - Bugarski, Branko
AU  - Kiekens, Filip
PY  - 2016
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/3326
AB  - Formulating poorly water soluble drugs using ordered mesoporous silica materials is an emerging approach to tackle solubility-related bioavailability problems. The current study was conducted to assess the bioavailability-enhancing potential of ordered mesoporous silica in man. In this open-label, randomized, two-way cross-over study, 12 overnight fasted healthy volunteers received a single dose of fenofibrate formulated with ordered mesoporous silica-or a marketed product based on micronized fenofibrate. Plasma concentrations of fenofibric acid, the pharmacologically active metabolite of fenofibrate, were monitored up to 96 h post-dose. The rate (C-max/dose increased by 77%; t(max) reduced by 0.75 h) and extent of absorption (AUC(0-24h)/dose increased by 54%) of fenofibrate were significantly enhanced following administration of the ordered mesoporous silica based formulation. The results of this study serve as a proof of concept in man for this novel formulation approach.
PB  - Elsevier Science Bv, Amsterdam
T2  - European Journal of Pharmaceutics and Biopharmaceutics
T1  - Ordered mesoporous silica to enhance the bioavailability of poorly water-soluble drugs: Proof of concept in man
EP  - 225
SP  - 220
VL  - 108
DO  - 10.1016/j.ejpb.2016.08.020
ER  - 

@article{
author = "Bukara, Katarina and Schueller, Laurent and Rosier, Jan and Martens, Mark A. and Daems, Tinne and Verheyden, Loes and Eelen, Siemon and Van Speybroeck, Michiel and Libanati, Cristian and Martens, Johan A. and Van Den Mooter, Guy and Frerart, Francoise and Jolling, Koen and De Gieter, Marjan and Bugarski, Branko and Kiekens, Filip",
year = "2016",
abstract = "Formulating poorly water soluble drugs using ordered mesoporous silica materials is an emerging approach to tackle solubility-related bioavailability problems. The current study was conducted to assess the bioavailability-enhancing potential of ordered mesoporous silica in man. In this open-label, randomized, two-way cross-over study, 12 overnight fasted healthy volunteers received a single dose of fenofibrate formulated with ordered mesoporous silica-or a marketed product based on micronized fenofibrate. Plasma concentrations of fenofibric acid, the pharmacologically active metabolite of fenofibrate, were monitored up to 96 h post-dose. The rate (C-max/dose increased by 77%; t(max) reduced by 0.75 h) and extent of absorption (AUC(0-24h)/dose increased by 54%) of fenofibrate were significantly enhanced following administration of the ordered mesoporous silica based formulation. The results of this study serve as a proof of concept in man for this novel formulation approach.",
publisher = "Elsevier Science Bv, Amsterdam",
journal = "European Journal of Pharmaceutics and Biopharmaceutics",
title = "Ordered mesoporous silica to enhance the bioavailability of poorly water-soluble drugs: Proof of concept in man",
pages = "225-220",
volume = "108",
doi = "10.1016/j.ejpb.2016.08.020"
}

Bukara, K., Schueller, L., Rosier, J., Martens, M. A., Daems, T., Verheyden, L., Eelen, S., Van Speybroeck, M., Libanati, C., Martens, J. A., Van Den Mooter, G., Frerart, F., Jolling, K., De Gieter, M., Bugarski, B.,& Kiekens, F.. (2016). Ordered mesoporous silica to enhance the bioavailability of poorly water-soluble drugs: Proof of concept in man. in European Journal of Pharmaceutics and Biopharmaceutics
Elsevier Science Bv, Amsterdam., 108, 220-225.
https://doi.org/10.1016/j.ejpb.2016.08.020

Bukara K, Schueller L, Rosier J, Martens MA, Daems T, Verheyden L, Eelen S, Van Speybroeck M, Libanati C, Martens JA, Van Den Mooter G, Frerart F, Jolling K, De Gieter M, Bugarski B, Kiekens F. Ordered mesoporous silica to enhance the bioavailability of poorly water-soluble drugs: Proof of concept in man. in European Journal of Pharmaceutics and Biopharmaceutics. 2016;108:220-225.
doi:10.1016/j.ejpb.2016.08.020 .

Bukara, Katarina, Schueller, Laurent, Rosier, Jan, Martens, Mark A., Daems, Tinne, Verheyden, Loes, Eelen, Siemon, Van Speybroeck, Michiel, Libanati, Cristian, Martens, Johan A., Van Den Mooter, Guy, Frerart, Francoise, Jolling, Koen, De Gieter, Marjan, Bugarski, Branko, Kiekens, Filip, "Ordered mesoporous silica to enhance the bioavailability of poorly water-soluble drugs: Proof of concept in man" in European Journal of Pharmaceutics and Biopharmaceutics, 108 (2016):220-225,
https://doi.org/10.1016/j.ejpb.2016.08.020 . .

TY  - JOUR
AU  - Bukara, Katarina
AU  - Schueller, Laurent
AU  - Rosier, Jan
AU  - Daems, Tinne
AU  - Verheyden, Loes
AU  - Eelen, Siemon
AU  - Martens, Johan A.
AU  - Van den Mooter, Guy
AU  - Bugarski, Branko
AU  - Kiekens, Filip
PY  - 2016
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/3240
AB  - The present study aims to evaluate the in vitro and in vivo performance of ordered mesoporous silica (OMS) as a carrier for the poorly water-soluble compound fenofibrate. Fenofibrate was loaded into OMS via incipient wetness impregnation to obtain a 29% drug load and formulated into capsules. Two capsule dosage forms (containing 33.5 and 16.75 mg fenofibrate, respectively) were compared with the commercially available forms-Lipanthyl (R) (fenofibrate microcrystals) and Tricor (R) (fenofibrate nanocrystals). In vitro dissolution tests showed that the amount of fenofibrate released from Lipanthyl (R) and Tricor (R) was approximately 30%, whereas approximately 66% and 60% of the drug was released from OMS capsules containing 33.5 and 16.75 mg of fenofibrate, respectively. Storage of OMS capsules loaded with 33.5 mg of fenofibrate at 25 degrees C/60% relative humidity (RH) or 40 degrees C/75% RH did not alter the release kinetics, nor the physical state of the compound, pointing the stability of the present formulation. The in vivo study in dogs confirmed satisfying level of safety and tolerability of fenofibrate-OMS formulation (eq. 33.5 mg) with the potential to improve the absorption of fenofibrate. Though some variability in the data, this formulation is promising to be further investigated in a clinical trial setting.
PB  - Wiley-Blackwell, Hoboken
T2  - Journal of Pharmaceutical Sciences
T1  - In Vivo Performance of Fenofibrate Formulated With Ordered Mesoporous Silica Versus 2-Marketed Formulations: A Comparative Bioavailability Study in Beagle Dogs
EP  - 2385
IS  - 8
SP  - 2381
VL  - 105
DO  - 10.1016/j.xphs.2016.05.019
ER  - 

@article{
author = "Bukara, Katarina and Schueller, Laurent and Rosier, Jan and Daems, Tinne and Verheyden, Loes and Eelen, Siemon and Martens, Johan A. and Van den Mooter, Guy and Bugarski, Branko and Kiekens, Filip",
year = "2016",
abstract = "The present study aims to evaluate the in vitro and in vivo performance of ordered mesoporous silica (OMS) as a carrier for the poorly water-soluble compound fenofibrate. Fenofibrate was loaded into OMS via incipient wetness impregnation to obtain a 29% drug load and formulated into capsules. Two capsule dosage forms (containing 33.5 and 16.75 mg fenofibrate, respectively) were compared with the commercially available forms-Lipanthyl (R) (fenofibrate microcrystals) and Tricor (R) (fenofibrate nanocrystals). In vitro dissolution tests showed that the amount of fenofibrate released from Lipanthyl (R) and Tricor (R) was approximately 30%, whereas approximately 66% and 60% of the drug was released from OMS capsules containing 33.5 and 16.75 mg of fenofibrate, respectively. Storage of OMS capsules loaded with 33.5 mg of fenofibrate at 25 degrees C/60% relative humidity (RH) or 40 degrees C/75% RH did not alter the release kinetics, nor the physical state of the compound, pointing the stability of the present formulation. The in vivo study in dogs confirmed satisfying level of safety and tolerability of fenofibrate-OMS formulation (eq. 33.5 mg) with the potential to improve the absorption of fenofibrate. Though some variability in the data, this formulation is promising to be further investigated in a clinical trial setting.",
publisher = "Wiley-Blackwell, Hoboken",
journal = "Journal of Pharmaceutical Sciences",
title = "In Vivo Performance of Fenofibrate Formulated With Ordered Mesoporous Silica Versus 2-Marketed Formulations: A Comparative Bioavailability Study in Beagle Dogs",
pages = "2385-2381",
number = "8",
volume = "105",
doi = "10.1016/j.xphs.2016.05.019"
}

Bukara, K., Schueller, L., Rosier, J., Daems, T., Verheyden, L., Eelen, S., Martens, J. A., Van den Mooter, G., Bugarski, B.,& Kiekens, F.. (2016). In Vivo Performance of Fenofibrate Formulated With Ordered Mesoporous Silica Versus 2-Marketed Formulations: A Comparative Bioavailability Study in Beagle Dogs. in Journal of Pharmaceutical Sciences
Wiley-Blackwell, Hoboken., 105(8), 2381-2385.
https://doi.org/10.1016/j.xphs.2016.05.019

Bukara K, Schueller L, Rosier J, Daems T, Verheyden L, Eelen S, Martens JA, Van den Mooter G, Bugarski B, Kiekens F. In Vivo Performance of Fenofibrate Formulated With Ordered Mesoporous Silica Versus 2-Marketed Formulations: A Comparative Bioavailability Study in Beagle Dogs. in Journal of Pharmaceutical Sciences. 2016;105(8):2381-2385.
doi:10.1016/j.xphs.2016.05.019 .

Bukara, Katarina, Schueller, Laurent, Rosier, Jan, Daems, Tinne, Verheyden, Loes, Eelen, Siemon, Martens, Johan A., Van den Mooter, Guy, Bugarski, Branko, Kiekens, Filip, "In Vivo Performance of Fenofibrate Formulated With Ordered Mesoporous Silica Versus 2-Marketed Formulations: A Comparative Bioavailability Study in Beagle Dogs" in Journal of Pharmaceutical Sciences, 105, no. 8 (2016):2381-2385,
https://doi.org/10.1016/j.xphs.2016.05.019 . .