TY  - JOUR
AU  - Ignjatović, Jelisaveta
AU  - Šušteršič, Tijana
AU  - Bodić, Aleksandar
AU  - Cvijić, Sandra
AU  - Ðuriš, Jelena
AU  - Rossi, Alessandra
AU  - Dobričić, Vladimir
AU  - Ibrić, Svetlana
AU  - Filipović, Nenad
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3993
AB  - In vitro assessment of dry powders for inhalation (DPIs) aerodynamic performance is an inevitable test in DPI development. However, contemporary trends in drug development also implicate the use of in silico methods, e.g., computational fluid dynamics (CFD) coupled with discrete phase modeling (DPM). The aim of this study was to compare the designed CFD-DPM outcomes with the results of three in vitro methods for aerodynamic assessment of solid lipid microparticle DPIs. The model was able to simulate particle-to-wall sticking and estimate fractions of particles that stick or bounce off the inhaler’s wall; however, we observed notable differences between the in silico and in vitro results. The predicted emitted fractions (EFs) were comparable to the in vitro determined EFs, whereas the predicted fine particle fractions (FPFs) were generally lower than the corresponding in vitro values. In addition, CFD-DPM predicted higher mass median aerodynamic diameter (MMAD) in comparison to the in vitro values. The outcomes of different in vitro methods also diverged, implying that these methods are not interchangeable. Overall, our results support the utility of CFD-DPM in the DPI development, but highlight the need for additional improvements in these models to capture all the key processes influencing aerodynamic performance of specific DPIs.
PB  - MDPI
T2  - Pharmaceutics
T1  - Comparative assessment of in vitro and in silico methods for aerodynamic characterization of powders for inhalation
VL  - 13
IS  - 11
DO  - 10.3390/pharmaceutics13111831
ER  - 

@article{
author = "Ignjatović, Jelisaveta and Šušteršič, Tijana and Bodić, Aleksandar and Cvijić, Sandra and Ðuriš, Jelena and Rossi, Alessandra and Dobričić, Vladimir and Ibrić, Svetlana and Filipović, Nenad",
year = "2021",
abstract = "In vitro assessment of dry powders for inhalation (DPIs) aerodynamic performance is an inevitable test in DPI development. However, contemporary trends in drug development also implicate the use of in silico methods, e.g., computational fluid dynamics (CFD) coupled with discrete phase modeling (DPM). The aim of this study was to compare the designed CFD-DPM outcomes with the results of three in vitro methods for aerodynamic assessment of solid lipid microparticle DPIs. The model was able to simulate particle-to-wall sticking and estimate fractions of particles that stick or bounce off the inhaler’s wall; however, we observed notable differences between the in silico and in vitro results. The predicted emitted fractions (EFs) were comparable to the in vitro determined EFs, whereas the predicted fine particle fractions (FPFs) were generally lower than the corresponding in vitro values. In addition, CFD-DPM predicted higher mass median aerodynamic diameter (MMAD) in comparison to the in vitro values. The outcomes of different in vitro methods also diverged, implying that these methods are not interchangeable. Overall, our results support the utility of CFD-DPM in the DPI development, but highlight the need for additional improvements in these models to capture all the key processes influencing aerodynamic performance of specific DPIs.",
publisher = "MDPI",
journal = "Pharmaceutics",
title = "Comparative assessment of in vitro and in silico methods for aerodynamic characterization of powders for inhalation",
volume = "13",
number = "11",
doi = "10.3390/pharmaceutics13111831"
}

Ignjatović, J., Šušteršič, T., Bodić, A., Cvijić, S., Ðuriš, J., Rossi, A., Dobričić, V., Ibrić, S.,& Filipović, N.. (2021). Comparative assessment of in vitro and in silico methods for aerodynamic characterization of powders for inhalation. in Pharmaceutics
MDPI., 13(11).
https://doi.org/10.3390/pharmaceutics13111831

Ignjatović J, Šušteršič T, Bodić A, Cvijić S, Ðuriš J, Rossi A, Dobričić V, Ibrić S, Filipović N. Comparative assessment of in vitro and in silico methods for aerodynamic characterization of powders for inhalation. in Pharmaceutics. 2021;13(11).
doi:10.3390/pharmaceutics13111831 .

Ignjatović, Jelisaveta, Šušteršič, Tijana, Bodić, Aleksandar, Cvijić, Sandra, Ðuriš, Jelena, Rossi, Alessandra, Dobričić, Vladimir, Ibrić, Svetlana, Filipović, Nenad, "Comparative assessment of in vitro and in silico methods for aerodynamic characterization of powders for inhalation" in Pharmaceutics, 13, no. 11 (2021),
https://doi.org/10.3390/pharmaceutics13111831 . .

TY  - JOUR
AU  - Ignjatović, Jelisaveta
AU  - Đuriš, Jelena
AU  - Cvijić, Sandra
AU  - Dobričić, Vladimir
AU  - Montepietra, Agnese
AU  - Lombardi, Chiara
AU  - Ibrić, Svetlana
AU  - Rossi, Alessandra
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3709
AB  - The aim of this study was to optimize the parameters of the complex melt-emulsification process coupled with the spray-drying, in order to maintain the balance between solid lipid microparticles (SLMs) powders aerodynamic performance and salbutamol sulfate release rate. Quality target product profile was identified and risk management and principal component analysis were used to guide formulation development. Obtained dry powders for inhalation (DPIs) were evaluated in terms of SLMs size distribution, morphology, true density, drug content, solid state characterization studies, in vitro aerosol performance and in vitro drug release. SLMs micrographs indicated spherical, porous particles. Selected powders showed satisfactory aerosol performance with a mean mass aerodynamic diameter of around 3 μm and acceptable fine particle fraction (FPF). Addition of trehalose positively affected SLMs aerodynamic properties. The results of in vitro dissolution testing indicated that salbutamol sulfate release from the tested SLMs formulations was modified, in comparison to the raw drug release. In conclusion, SLMs in a form of DPIs were successfully developed and numerous factors that affects SLMs properties were identified in this study. Further research is required for full understanding of each factor's influence on SLMs properties and optimization of DPIs with maximized FPFs.
PB  - Elsevier B.V.
T2  - European Journal of Pharmaceutical Sciences
T1  - Development of solid lipid microparticles by melt-emulsification/spray-drying processes as carriers for pulmonary drug delivery
VL  - 156
DO  - 10.1016/j.ejps.2020.105588
ER  - 

@article{
author = "Ignjatović, Jelisaveta and Đuriš, Jelena and Cvijić, Sandra and Dobričić, Vladimir and Montepietra, Agnese and Lombardi, Chiara and Ibrić, Svetlana and Rossi, Alessandra",
year = "2021",
abstract = "The aim of this study was to optimize the parameters of the complex melt-emulsification process coupled with the spray-drying, in order to maintain the balance between solid lipid microparticles (SLMs) powders aerodynamic performance and salbutamol sulfate release rate. Quality target product profile was identified and risk management and principal component analysis were used to guide formulation development. Obtained dry powders for inhalation (DPIs) were evaluated in terms of SLMs size distribution, morphology, true density, drug content, solid state characterization studies, in vitro aerosol performance and in vitro drug release. SLMs micrographs indicated spherical, porous particles. Selected powders showed satisfactory aerosol performance with a mean mass aerodynamic diameter of around 3 μm and acceptable fine particle fraction (FPF). Addition of trehalose positively affected SLMs aerodynamic properties. The results of in vitro dissolution testing indicated that salbutamol sulfate release from the tested SLMs formulations was modified, in comparison to the raw drug release. In conclusion, SLMs in a form of DPIs were successfully developed and numerous factors that affects SLMs properties were identified in this study. Further research is required for full understanding of each factor's influence on SLMs properties and optimization of DPIs with maximized FPFs.",
publisher = "Elsevier B.V.",
journal = "European Journal of Pharmaceutical Sciences",
title = "Development of solid lipid microparticles by melt-emulsification/spray-drying processes as carriers for pulmonary drug delivery",
volume = "156",
doi = "10.1016/j.ejps.2020.105588"
}

Ignjatović, J., Đuriš, J., Cvijić, S., Dobričić, V., Montepietra, A., Lombardi, C., Ibrić, S.,& Rossi, A.. (2021). Development of solid lipid microparticles by melt-emulsification/spray-drying processes as carriers for pulmonary drug delivery. in European Journal of Pharmaceutical Sciences
Elsevier B.V.., 156.
https://doi.org/10.1016/j.ejps.2020.105588

Ignjatović J, Đuriš J, Cvijić S, Dobričić V, Montepietra A, Lombardi C, Ibrić S, Rossi A. Development of solid lipid microparticles by melt-emulsification/spray-drying processes as carriers for pulmonary drug delivery. in European Journal of Pharmaceutical Sciences. 2021;156.
doi:10.1016/j.ejps.2020.105588 .

Ignjatović, Jelisaveta, Đuriš, Jelena, Cvijić, Sandra, Dobričić, Vladimir, Montepietra, Agnese, Lombardi, Chiara, Ibrić, Svetlana, Rossi, Alessandra, "Development of solid lipid microparticles by melt-emulsification/spray-drying processes as carriers for pulmonary drug delivery" in European Journal of Pharmaceutical Sciences, 156 (2021),
https://doi.org/10.1016/j.ejps.2020.105588 . .

TY  - JOUR
AU  - Velaga, Sitaram P.
AU  - Đuriš, Jelena
AU  - Cvijić, Sandra
AU  - Rozou, Stavroula
AU  - Russo, Paola
AU  - Colombo, Gaia
AU  - Rossi, Alessandra
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3187
AB  - In vitro dissolution testing is routinely used in the development of pharmaceutical products. Whilst the dissolution testing methods are well established and standardized for oral dosage forms, i.e. tablets and capsules, there are no pharmacopoeia methods or regulatory requirements for testing the dissolution of orally inhaled powders. Despite this, a wide variety of dissolution testing methods for orally inhaled powders has been developed and their bio-relevance has been evaluated. This review provides an overview of the in vitro dissolution methodologies for dry inhalation products, with particular emphasis on dry powder inhalers, where the dissolution behavior of the respirable particles can have a role on duration and absorption of the drug. Dissolution mechanisms of respirable particles as well as kinetic models have been presented. A more recent biorelevant dissolution set-ups and media for studying inhalation biopharmaceutics were also reviewed. In addition, factors affecting interplay between dissolution and absorption of deposited particles in the context of biopharmaceutical considerations of inhalation products were examined.
PB  - Elsevier Science BV, Amsterdam
T2  - European Journal of Pharmaceutical Sciences
T1  - Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products
VL  - 113
SP  - 18
EP  - 28
DO  - 10.1016/j.ejps.2017.09.002
ER  - 

@article{
author = "Velaga, Sitaram P. and Đuriš, Jelena and Cvijić, Sandra and Rozou, Stavroula and Russo, Paola and Colombo, Gaia and Rossi, Alessandra",
year = "2018",
abstract = "In vitro dissolution testing is routinely used in the development of pharmaceutical products. Whilst the dissolution testing methods are well established and standardized for oral dosage forms, i.e. tablets and capsules, there are no pharmacopoeia methods or regulatory requirements for testing the dissolution of orally inhaled powders. Despite this, a wide variety of dissolution testing methods for orally inhaled powders has been developed and their bio-relevance has been evaluated. This review provides an overview of the in vitro dissolution methodologies for dry inhalation products, with particular emphasis on dry powder inhalers, where the dissolution behavior of the respirable particles can have a role on duration and absorption of the drug. Dissolution mechanisms of respirable particles as well as kinetic models have been presented. A more recent biorelevant dissolution set-ups and media for studying inhalation biopharmaceutics were also reviewed. In addition, factors affecting interplay between dissolution and absorption of deposited particles in the context of biopharmaceutical considerations of inhalation products were examined.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "European Journal of Pharmaceutical Sciences",
title = "Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products",
volume = "113",
pages = "18-28",
doi = "10.1016/j.ejps.2017.09.002"
}

Velaga, S. P., Đuriš, J., Cvijić, S., Rozou, S., Russo, P., Colombo, G.,& Rossi, A.. (2018). Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products. in European Journal of Pharmaceutical Sciences
Elsevier Science BV, Amsterdam., 113, 18-28.
https://doi.org/10.1016/j.ejps.2017.09.002

Velaga SP, Đuriš J, Cvijić S, Rozou S, Russo P, Colombo G, Rossi A. Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products. in European Journal of Pharmaceutical Sciences. 2018;113:18-28.
doi:10.1016/j.ejps.2017.09.002 .

Velaga, Sitaram P., Đuriš, Jelena, Cvijić, Sandra, Rozou, Stavroula, Russo, Paola, Colombo, Gaia, Rossi, Alessandra, "Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products" in European Journal of Pharmaceutical Sciences, 113 (2018):18-28,
https://doi.org/10.1016/j.ejps.2017.09.002 . .