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Elucidating molecular properties of kappa-carrageenan as critical material attributes contributing to drug dissolution from pellets with a multivariate approach

Vidović, Sara; Horvat, Matej; Bizjak, Alan; Planinsek, Odon; Petek, Bostjan; Burjak, Matejka; Peternel, Luka; Parojčić, Jelena; Đuriš, Jelena; Ibrić, Svetlana; Janković, Biljana

(Elsevier Science BV, Amsterdam, 2019)

TY  - JOUR
AU  - Vidović, Sara
AU  - Horvat, Matej
AU  - Bizjak, Alan
AU  - Planinsek, Odon
AU  - Petek, Bostjan
AU  - Burjak, Matejka
AU  - Peternel, Luka
AU  - Parojčić, Jelena
AU  - Đuriš, Jelena
AU  - Ibrić, Svetlana
AU  - Janković, Biljana
PY  - 2019
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3255
AB  - Multivariate data analysis (MVDA) and artificial neural networks (ANN) are supporting statistical methodologies required for successful development and manufacturing of drug products. To address this purpose, a complex dataset from 49 industrially produced capsules filled with pellets was first analyzed through the development of a multiple linear regression model focused on determining raw material attributes or process parameters with a significant impact on drug dissolution. Based on the model, the following molecular and micrometrics properties of K-carrageenan have been identified as critical material attributes with the highest contribution to drug dissolution: molecular weight and polydispersity index, viscosity, content of potassium ions, wettability, particle size, and density. The process parameters identified to control the drug dissolution behavior of pellets were amount of granulation liquid, torque of dry blend, spheronization parameters, and yields after screening. To further scrutinize the dataset, an ANN model was subsequently built, incorporating 29 batches addressing drug particle size and process parameters such as torque during granulation and spheronization time as critical factors. Finally, this study demonstrates the ability of MVDA and ANN to allow prediction of the key performance drivers influencing the drug dissolution of industrially developed capsules filled with pellets and it highlights their complementary relationship.
PB  - Elsevier Science BV, Amsterdam
T2  - International Journal of Pharmaceutics
T1  - Elucidating molecular properties of kappa-carrageenan as critical material attributes contributing to drug dissolution from pellets with a multivariate approach
VL  - 566
SP  - 662
EP  - 673
DO  - 10.1016/j.ijpharm.2019.06.016
ER  - 
@article{
author = "Vidović, Sara and Horvat, Matej and Bizjak, Alan and Planinsek, Odon and Petek, Bostjan and Burjak, Matejka and Peternel, Luka and Parojčić, Jelena and Đuriš, Jelena and Ibrić, Svetlana and Janković, Biljana",
year = "2019",
abstract = "Multivariate data analysis (MVDA) and artificial neural networks (ANN) are supporting statistical methodologies required for successful development and manufacturing of drug products. To address this purpose, a complex dataset from 49 industrially produced capsules filled with pellets was first analyzed through the development of a multiple linear regression model focused on determining raw material attributes or process parameters with a significant impact on drug dissolution. Based on the model, the following molecular and micrometrics properties of K-carrageenan have been identified as critical material attributes with the highest contribution to drug dissolution: molecular weight and polydispersity index, viscosity, content of potassium ions, wettability, particle size, and density. The process parameters identified to control the drug dissolution behavior of pellets were amount of granulation liquid, torque of dry blend, spheronization parameters, and yields after screening. To further scrutinize the dataset, an ANN model was subsequently built, incorporating 29 batches addressing drug particle size and process parameters such as torque during granulation and spheronization time as critical factors. Finally, this study demonstrates the ability of MVDA and ANN to allow prediction of the key performance drivers influencing the drug dissolution of industrially developed capsules filled with pellets and it highlights their complementary relationship.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "International Journal of Pharmaceutics",
title = "Elucidating molecular properties of kappa-carrageenan as critical material attributes contributing to drug dissolution from pellets with a multivariate approach",
volume = "566",
pages = "662-673",
doi = "10.1016/j.ijpharm.2019.06.016"
}
Vidović, S., Horvat, M., Bizjak, A., Planinsek, O., Petek, B., Burjak, M., Peternel, L., Parojčić, J., Đuriš, J., Ibrić, S.,& Janković, B.. (2019). Elucidating molecular properties of kappa-carrageenan as critical material attributes contributing to drug dissolution from pellets with a multivariate approach. in International Journal of Pharmaceutics
Elsevier Science BV, Amsterdam., 566, 662-673.
https://doi.org/10.1016/j.ijpharm.2019.06.016
Vidović S, Horvat M, Bizjak A, Planinsek O, Petek B, Burjak M, Peternel L, Parojčić J, Đuriš J, Ibrić S, Janković B. Elucidating molecular properties of kappa-carrageenan as critical material attributes contributing to drug dissolution from pellets with a multivariate approach. in International Journal of Pharmaceutics. 2019;566:662-673.
doi:10.1016/j.ijpharm.2019.06.016 .
Vidović, Sara, Horvat, Matej, Bizjak, Alan, Planinsek, Odon, Petek, Bostjan, Burjak, Matejka, Peternel, Luka, Parojčić, Jelena, Đuriš, Jelena, Ibrić, Svetlana, Janković, Biljana, "Elucidating molecular properties of kappa-carrageenan as critical material attributes contributing to drug dissolution from pellets with a multivariate approach" in International Journal of Pharmaceutics, 566 (2019):662-673,
https://doi.org/10.1016/j.ijpharm.2019.06.016 . .
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Ultra-thin-layer chromatography mass spectrometry and thin-layer chromatography mass spectrometry of single peptides of angiotensin-converting enzyme inhibitors

Vovk, Irena; Popović, Gordana; Simonovska, Breda; Albreht, Alen; Agbaba, Danica

(Elsevier Science BV, Amsterdam, 2011)

TY  - JOUR
AU  - Vovk, Irena
AU  - Popović, Gordana
AU  - Simonovska, Breda
AU  - Albreht, Alen
AU  - Agbaba, Danica
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1570
AB  - The separation of structurally related angiotensin-converting enzyme (ACE) inhibitors lisinopril, cilazapril, ramipril and quinapril and their corresponding active diacid forms (prilates) by conventional TLC silica gel 60 plates was contrasted with that afforded by monolithic ultra-thin-layer chromatographic (UTLC) plates. For the use of UTLC plates technical modifications of the commercially available equipments for the sample application, development and detection were made. Plates were developed in modified horizontal developing chamber using ethyl acetate-acetone-acetic acid-water (4:1:0.25:0.5, v/v). Detection of the separated compounds was performed densitometrically in absorption/reflectance mode at 220 nm and after exposure to iodine also by image analysis. The obtained results showed that monolithic layer is more efficient for the separation of structurally similar polar compounds, such as prilates than conventional silica layers. Identification of the compounds was confirmed by ESI-MS after their on-line extraction from the UTLC and TLC plates by means of Camag TLC-MS interface.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Chromatography A
T1  - Ultra-thin-layer chromatography mass spectrometry and thin-layer chromatography mass spectrometry of single peptides of angiotensin-converting enzyme inhibitors
VL  - 1218
IS  - 20
SP  - 3089
EP  - 3094
DO  - 10.1016/j.chroma.2011.03.039
ER  - 
@article{
author = "Vovk, Irena and Popović, Gordana and Simonovska, Breda and Albreht, Alen and Agbaba, Danica",
year = "2011",
abstract = "The separation of structurally related angiotensin-converting enzyme (ACE) inhibitors lisinopril, cilazapril, ramipril and quinapril and their corresponding active diacid forms (prilates) by conventional TLC silica gel 60 plates was contrasted with that afforded by monolithic ultra-thin-layer chromatographic (UTLC) plates. For the use of UTLC plates technical modifications of the commercially available equipments for the sample application, development and detection were made. Plates were developed in modified horizontal developing chamber using ethyl acetate-acetone-acetic acid-water (4:1:0.25:0.5, v/v). Detection of the separated compounds was performed densitometrically in absorption/reflectance mode at 220 nm and after exposure to iodine also by image analysis. The obtained results showed that monolithic layer is more efficient for the separation of structurally similar polar compounds, such as prilates than conventional silica layers. Identification of the compounds was confirmed by ESI-MS after their on-line extraction from the UTLC and TLC plates by means of Camag TLC-MS interface.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Chromatography A",
title = "Ultra-thin-layer chromatography mass spectrometry and thin-layer chromatography mass spectrometry of single peptides of angiotensin-converting enzyme inhibitors",
volume = "1218",
number = "20",
pages = "3089-3094",
doi = "10.1016/j.chroma.2011.03.039"
}
Vovk, I., Popović, G., Simonovska, B., Albreht, A.,& Agbaba, D.. (2011). Ultra-thin-layer chromatography mass spectrometry and thin-layer chromatography mass spectrometry of single peptides of angiotensin-converting enzyme inhibitors. in Journal of Chromatography A
Elsevier Science BV, Amsterdam., 1218(20), 3089-3094.
https://doi.org/10.1016/j.chroma.2011.03.039
Vovk I, Popović G, Simonovska B, Albreht A, Agbaba D. Ultra-thin-layer chromatography mass spectrometry and thin-layer chromatography mass spectrometry of single peptides of angiotensin-converting enzyme inhibitors. in Journal of Chromatography A. 2011;1218(20):3089-3094.
doi:10.1016/j.chroma.2011.03.039 .
Vovk, Irena, Popović, Gordana, Simonovska, Breda, Albreht, Alen, Agbaba, Danica, "Ultra-thin-layer chromatography mass spectrometry and thin-layer chromatography mass spectrometry of single peptides of angiotensin-converting enzyme inhibitors" in Journal of Chromatography A, 1218, no. 20 (2011):3089-3094,
https://doi.org/10.1016/j.chroma.2011.03.039 . .
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