Application of the design of experiments in optimization of drug layering of pellets with an insight into drug polymer interactions
Само за регистроване кориснике
2016
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
This study consists of two experimental designs. Within the first one, suitable technique for application of model drug onto inactive pellets was evaluated and formulation and process parameters with greatest impact to process efficency and useful yield were determined. Results of experiments showed that formulation characteristics were the ones with the greatest impact on coating efficiency and that suspension layering technique was significantly better for drug application onto inactive pellets in comparison to solution layering during which pronounced agglomeration of pellets occurred. Analysis of drug-polymer interactions by differential scanning calorimetry was performed to explain the results of experiments. The reason for agglomeration of pellets during solution layering was formation of low Tg amorphous form of model drug. The second set of experiments was performed according to central composite design experimental plan in order to optimize level of binder and concentration of... solids in the coating liquid which were found to have greatest positive impact on process efficiency and useful yield in the screening study. Statistically significant models were obtained by response surface methodology and it was possible to use them to define optimal levels of excipients in the formulation.
Извор:
International Journal of Pharmaceutics, 2016, 506, 1-2, 312-319Издавач:
- Elsevier Science BV, Amsterdam
Финансирање / пројекти:
DOI: 10.1016/j.ijpharm.2016.04.030
ISSN: 0378-5173
PubMed: 27094356
WoS: 000377031200033
Scopus: 2-s2.0-84964910529
Институција/група
PharmacyTY - JOUR AU - Kovacević, Jovana AU - Ibrić, Svetlana AU - Đuriš, Jelena AU - Kleinebudde, Peter PY - 2016 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2543 AB - This study consists of two experimental designs. Within the first one, suitable technique for application of model drug onto inactive pellets was evaluated and formulation and process parameters with greatest impact to process efficency and useful yield were determined. Results of experiments showed that formulation characteristics were the ones with the greatest impact on coating efficiency and that suspension layering technique was significantly better for drug application onto inactive pellets in comparison to solution layering during which pronounced agglomeration of pellets occurred. Analysis of drug-polymer interactions by differential scanning calorimetry was performed to explain the results of experiments. The reason for agglomeration of pellets during solution layering was formation of low Tg amorphous form of model drug. The second set of experiments was performed according to central composite design experimental plan in order to optimize level of binder and concentration of solids in the coating liquid which were found to have greatest positive impact on process efficiency and useful yield in the screening study. Statistically significant models were obtained by response surface methodology and it was possible to use them to define optimal levels of excipients in the formulation. PB - Elsevier Science BV, Amsterdam T2 - International Journal of Pharmaceutics T1 - Application of the design of experiments in optimization of drug layering of pellets with an insight into drug polymer interactions VL - 506 IS - 1-2 SP - 312 EP - 319 DO - 10.1016/j.ijpharm.2016.04.030 ER -
@article{ author = "Kovacević, Jovana and Ibrić, Svetlana and Đuriš, Jelena and Kleinebudde, Peter", year = "2016", abstract = "This study consists of two experimental designs. Within the first one, suitable technique for application of model drug onto inactive pellets was evaluated and formulation and process parameters with greatest impact to process efficency and useful yield were determined. Results of experiments showed that formulation characteristics were the ones with the greatest impact on coating efficiency and that suspension layering technique was significantly better for drug application onto inactive pellets in comparison to solution layering during which pronounced agglomeration of pellets occurred. Analysis of drug-polymer interactions by differential scanning calorimetry was performed to explain the results of experiments. The reason for agglomeration of pellets during solution layering was formation of low Tg amorphous form of model drug. The second set of experiments was performed according to central composite design experimental plan in order to optimize level of binder and concentration of solids in the coating liquid which were found to have greatest positive impact on process efficiency and useful yield in the screening study. Statistically significant models were obtained by response surface methodology and it was possible to use them to define optimal levels of excipients in the formulation.", publisher = "Elsevier Science BV, Amsterdam", journal = "International Journal of Pharmaceutics", title = "Application of the design of experiments in optimization of drug layering of pellets with an insight into drug polymer interactions", volume = "506", number = "1-2", pages = "312-319", doi = "10.1016/j.ijpharm.2016.04.030" }
Kovacević, J., Ibrić, S., Đuriš, J.,& Kleinebudde, P.. (2016). Application of the design of experiments in optimization of drug layering of pellets with an insight into drug polymer interactions. in International Journal of Pharmaceutics Elsevier Science BV, Amsterdam., 506(1-2), 312-319. https://doi.org/10.1016/j.ijpharm.2016.04.030
Kovacević J, Ibrić S, Đuriš J, Kleinebudde P. Application of the design of experiments in optimization of drug layering of pellets with an insight into drug polymer interactions. in International Journal of Pharmaceutics. 2016;506(1-2):312-319. doi:10.1016/j.ijpharm.2016.04.030 .
Kovacević, Jovana, Ibrić, Svetlana, Đuriš, Jelena, Kleinebudde, Peter, "Application of the design of experiments in optimization of drug layering of pellets with an insight into drug polymer interactions" in International Journal of Pharmaceutics, 506, no. 1-2 (2016):312-319, https://doi.org/10.1016/j.ijpharm.2016.04.030 . .