TY  - JOUR
AU  - Kaljević, Olivera
AU  - Đuriš, Jelena
AU  - Čalija, Bojan
AU  - Lavrić, Zoran
AU  - Kristl, Julijana
AU  - Ibrić, Svetlana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3447
AB  - Electrospinning was used to produce carvedilol-loaded Soluplus polymer nanofibers using a systematic approach. Miscibility between drug and polymer was determined through calculation of the interaction parameter, chi, and the difference between the total solubility parameters, Delta d(t). A solubility map for Soluplus was obtained by examining different solvent systems, carrying out electrospinning, and characterizing the nanofibers formed. Miscibility studies showed that carvedilol and Soluplus can form a miscible system (chi = -2.3054; Delta delta(t)  lt  7.0 MPa1/2). Based on the Soluplus solubility map, acetone: chloroform (90: 10; w/w) represents a suitable solvent system for electrospinning of carvedilol-loaded Soluplus nanofibers. Scanning electron microscopy of these nanofiber samples showed smooth surface morphology. The nanofibers had a regular cylindrical morphology. Beads appeared along the nanofibers more frequently in formulations with lower percentages of carvedilol. Differential scanning calorimetry showed no melting endothermic peak for carvedilol, which suggests its complete conversion from the crystalline to the amorphous form (at polymer: carvedilol 1: 1). The infrared spectrum of the carvedilol-loaded Soluplus nanofibers showed no characteristic carvedilol peak at 3344.5 cm(-1), which suggests interactions between carvedilol and Soluplus. Dissolution studies of these nanofibers showed improved pure carvedilol dissolution properties, with >85% of the carvedilol released in the first 15 min, versus 20% for pure carvedilol. The use of miscibility analysis and polymer solubility studies demonstrate great technological potential to tackle the challenge for inadequate dissolution of poorly water-soluble drugs.
PB  - Elsevier
T2  - International Journal of Pharmaceutics
T1  - Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers
VL  - 533
IS  - 2
SP  - 445
EP  - 454
DO  - 10.1016/j.ijpharm.2017.05.017
ER  - 

@article{
author = "Kaljević, Olivera and Đuriš, Jelena and Čalija, Bojan and Lavrić, Zoran and Kristl, Julijana and Ibrić, Svetlana",
year = "2017",
abstract = "Electrospinning was used to produce carvedilol-loaded Soluplus polymer nanofibers using a systematic approach. Miscibility between drug and polymer was determined through calculation of the interaction parameter, chi, and the difference between the total solubility parameters, Delta d(t). A solubility map for Soluplus was obtained by examining different solvent systems, carrying out electrospinning, and characterizing the nanofibers formed. Miscibility studies showed that carvedilol and Soluplus can form a miscible system (chi = -2.3054; Delta delta(t)  lt  7.0 MPa1/2). Based on the Soluplus solubility map, acetone: chloroform (90: 10; w/w) represents a suitable solvent system for electrospinning of carvedilol-loaded Soluplus nanofibers. Scanning electron microscopy of these nanofiber samples showed smooth surface morphology. The nanofibers had a regular cylindrical morphology. Beads appeared along the nanofibers more frequently in formulations with lower percentages of carvedilol. Differential scanning calorimetry showed no melting endothermic peak for carvedilol, which suggests its complete conversion from the crystalline to the amorphous form (at polymer: carvedilol 1: 1). The infrared spectrum of the carvedilol-loaded Soluplus nanofibers showed no characteristic carvedilol peak at 3344.5 cm(-1), which suggests interactions between carvedilol and Soluplus. Dissolution studies of these nanofibers showed improved pure carvedilol dissolution properties, with >85% of the carvedilol released in the first 15 min, versus 20% for pure carvedilol. The use of miscibility analysis and polymer solubility studies demonstrate great technological potential to tackle the challenge for inadequate dissolution of poorly water-soluble drugs.",
publisher = "Elsevier",
journal = "International Journal of Pharmaceutics",
title = "Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers",
volume = "533",
number = "2",
pages = "445-454",
doi = "10.1016/j.ijpharm.2017.05.017"
}

Kaljević, O., Đuriš, J., Čalija, B., Lavrić, Z., Kristl, J.,& Ibrić, S.. (2017). Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers. in International Journal of Pharmaceutics
Elsevier., 533(2), 445-454.
https://doi.org/10.1016/j.ijpharm.2017.05.017

Kaljević O, Đuriš J, Čalija B, Lavrić Z, Kristl J, Ibrić S. Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers. in International Journal of Pharmaceutics. 2017;533(2):445-454.
doi:10.1016/j.ijpharm.2017.05.017 .

Kaljević, Olivera, Đuriš, Jelena, Čalija, Bojan, Lavrić, Zoran, Kristl, Julijana, Ibrić, Svetlana, "Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers" in International Journal of Pharmaceutics, 533, no. 2 (2017):445-454,
https://doi.org/10.1016/j.ijpharm.2017.05.017 . .

TY  - JOUR
AU  - Kaljević, Olivera
AU  - Đuriš, Jelena
AU  - Čalija, Bojan
AU  - Lavrić, Zoran
AU  - Kristl, Julijana
AU  - Ibrić, Svetlana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2882
AB  - Electrospinning was used to produce carvedilol-loaded Soluplus polymer nanofibers using a systematic approach. Miscibility between drug and polymer was determined through calculation of the interaction parameter, chi, and the difference between the total solubility parameters, Delta d(t). A solubility map for Soluplus was obtained by examining different solvent systems, carrying out electrospinning, and characterizing the nanofibers formed. Miscibility studies showed that carvedilol and Soluplus can form a miscible system (chi = -2.3054; Delta delta(t)  lt  7.0 MPa1/2). Based on the Soluplus solubility map, acetone: chloroform (90: 10; w/w) represents a suitable solvent system for electrospinning of carvedilol-loaded Soluplus nanofibers. Scanning electron microscopy of these nanofiber samples showed smooth surface morphology. The nanofibers had a regular cylindrical morphology. Beads appeared along the nanofibers more frequently in formulations with lower percentages of carvedilol. Differential scanning calorimetry showed no melting endothermic peak for carvedilol, which suggests its complete conversion from the crystalline to the amorphous form (at polymer: carvedilol 1: 1). The infrared spectrum of the carvedilol-loaded Soluplus nanofibers showed no characteristic carvedilol peak at 3344.5 cm(-1), which suggests interactions between carvedilol and Soluplus. Dissolution studies of these nanofibers showed improved pure carvedilol dissolution properties, with >85% of the carvedilol released in the first 15 min, versus 20% for pure carvedilol. The use of miscibility analysis and polymer solubility studies demonstrate great technological potential to tackle the challenge for inadequate dissolution of poorly water-soluble drugs.
PB  - Elsevier Science BV, Amsterdam
T2  - International Journal of Pharmaceutics
T1  - Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers
VL  - 533
IS  - 2
SP  - 445
EP  - 454
DO  - 10.1016/j.ijpharm.2017.05.017
ER  - 

@article{
author = "Kaljević, Olivera and Đuriš, Jelena and Čalija, Bojan and Lavrić, Zoran and Kristl, Julijana and Ibrić, Svetlana",
year = "2017",
abstract = "Electrospinning was used to produce carvedilol-loaded Soluplus polymer nanofibers using a systematic approach. Miscibility between drug and polymer was determined through calculation of the interaction parameter, chi, and the difference between the total solubility parameters, Delta d(t). A solubility map for Soluplus was obtained by examining different solvent systems, carrying out electrospinning, and characterizing the nanofibers formed. Miscibility studies showed that carvedilol and Soluplus can form a miscible system (chi = -2.3054; Delta delta(t)  lt  7.0 MPa1/2). Based on the Soluplus solubility map, acetone: chloroform (90: 10; w/w) represents a suitable solvent system for electrospinning of carvedilol-loaded Soluplus nanofibers. Scanning electron microscopy of these nanofiber samples showed smooth surface morphology. The nanofibers had a regular cylindrical morphology. Beads appeared along the nanofibers more frequently in formulations with lower percentages of carvedilol. Differential scanning calorimetry showed no melting endothermic peak for carvedilol, which suggests its complete conversion from the crystalline to the amorphous form (at polymer: carvedilol 1: 1). The infrared spectrum of the carvedilol-loaded Soluplus nanofibers showed no characteristic carvedilol peak at 3344.5 cm(-1), which suggests interactions between carvedilol and Soluplus. Dissolution studies of these nanofibers showed improved pure carvedilol dissolution properties, with >85% of the carvedilol released in the first 15 min, versus 20% for pure carvedilol. The use of miscibility analysis and polymer solubility studies demonstrate great technological potential to tackle the challenge for inadequate dissolution of poorly water-soluble drugs.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "International Journal of Pharmaceutics",
title = "Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers",
volume = "533",
number = "2",
pages = "445-454",
doi = "10.1016/j.ijpharm.2017.05.017"
}

Kaljević, O., Đuriš, J., Čalija, B., Lavrić, Z., Kristl, J.,& Ibrić, S.. (2017). Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers. in International Journal of Pharmaceutics
Elsevier Science BV, Amsterdam., 533(2), 445-454.
https://doi.org/10.1016/j.ijpharm.2017.05.017

Kaljević O, Đuriš J, Čalija B, Lavrić Z, Kristl J, Ibrić S. Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers. in International Journal of Pharmaceutics. 2017;533(2):445-454.
doi:10.1016/j.ijpharm.2017.05.017 .

Kaljević, Olivera, Đuriš, Jelena, Čalija, Bojan, Lavrić, Zoran, Kristl, Julijana, Ibrić, Svetlana, "Application of miscibility analysis and determination of Soluplus solubility map for development of carvedilol-loaded nanofibers" in International Journal of Pharmaceutics, 533, no. 2 (2017):445-454,
https://doi.org/10.1016/j.ijpharm.2017.05.017 . .

TY  - JOUR
AU  - Kaljević, Olivera
AU  - Đuriš, Jelena
AU  - Đurić, Zorica
AU  - Ibrić, Svetlana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2595
AB  - Compression coating technique has been used in formulation of chronotherapeutic drug delivery systems with pulsatile carvedilol release with polyethylene oxide as controlling release agent. FMEA, risk analysis tool, was applied within Quality by Design approach with aim to detect process and formulation parameters affecting the carvedilol release profile from compression coated tablets. It gives Risk Priority Numbers (RPNs) for each failure mode. Also, using experimental designs, statistical significance of the formulation parameters influence was estimated. High RPNs in case of the lag time as critical quality attribute (CQA) was obtained for polymer molecular weight, compression of coat and low concentration of sodium chloride. For percent of released carvedilol from coated tablets (Q), second CQA, RPNs were high for low concentration of sodium chloride, sodium starch glycolate and crospovidone, polymer molecular weight and also for compression of the tablet coat. Experiments performed according to experimental plans, showed statistically significant influence of Polyox (R) WSR N60K arid sodium chloride concentration on lag time, and concentration of polymer, sodium chloride, mannitol and type of superdisintegrant on Q. These studies demonstrate that FMEA may be a useful tool for Formulation by Design of compression coated tablets.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Drug Delivery Science and Technology
T1  - Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets
VL  - 32
SP  - 56
EP  - 63
DO  - 10.1016/j.jddst.2016.02.004
ER  - 

@article{
author = "Kaljević, Olivera and Đuriš, Jelena and Đurić, Zorica and Ibrić, Svetlana",
year = "2016",
abstract = "Compression coating technique has been used in formulation of chronotherapeutic drug delivery systems with pulsatile carvedilol release with polyethylene oxide as controlling release agent. FMEA, risk analysis tool, was applied within Quality by Design approach with aim to detect process and formulation parameters affecting the carvedilol release profile from compression coated tablets. It gives Risk Priority Numbers (RPNs) for each failure mode. Also, using experimental designs, statistical significance of the formulation parameters influence was estimated. High RPNs in case of the lag time as critical quality attribute (CQA) was obtained for polymer molecular weight, compression of coat and low concentration of sodium chloride. For percent of released carvedilol from coated tablets (Q), second CQA, RPNs were high for low concentration of sodium chloride, sodium starch glycolate and crospovidone, polymer molecular weight and also for compression of the tablet coat. Experiments performed according to experimental plans, showed statistically significant influence of Polyox (R) WSR N60K arid sodium chloride concentration on lag time, and concentration of polymer, sodium chloride, mannitol and type of superdisintegrant on Q. These studies demonstrate that FMEA may be a useful tool for Formulation by Design of compression coated tablets.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Drug Delivery Science and Technology",
title = "Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets",
volume = "32",
pages = "56-63",
doi = "10.1016/j.jddst.2016.02.004"
}

Kaljević, O., Đuriš, J., Đurić, Z.,& Ibrić, S.. (2016). Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets. in Journal of Drug Delivery Science and Technology
Elsevier Science BV, Amsterdam., 32, 56-63.
https://doi.org/10.1016/j.jddst.2016.02.004

Kaljević O, Đuriš J, Đurić Z, Ibrić S. Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets. in Journal of Drug Delivery Science and Technology. 2016;32:56-63.
doi:10.1016/j.jddst.2016.02.004 .

Kaljević, Olivera, Đuriš, Jelena, Đurić, Zorica, Ibrić, Svetlana, "Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets" in Journal of Drug Delivery Science and Technology, 32 (2016):56-63,
https://doi.org/10.1016/j.jddst.2016.02.004 . .