hrcak mascot   Srce   HID

Izvorni znanstveni članak

Modeling-based Development of an Enantioselective Hydrogenation Reaction of a Sitagliptine Intermediate

I. Šoštarić ; PLIVA Croatia LTD, TAPI Croatia, TAPI R&D, API Pilot, Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
I. Nežić ; PLIVA Croatia LTD, TAPI Croatia, TAPI R&D, API Pilot, Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
F. Jović   ORCID icon orcid.org/0000-0001-7666-5680 ; PLIVA Croatia LTD, TAPI Croatia, TAPI R&D, API Pilot, Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
E. Marcelić ; PLIVA Croatia LTD, TAPI Croatia, TAPI R&D, API Pilot, Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
E. Meštrović ; PLIVA Croatia LTD, TAPI Croatia, TAPI R&D, API Pilot, Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
S. Zrnčević ; Faculty of Chemical Engineering and Technology, Department of Reaction Engineering and Catalysis, Savska cesta 16, Zagreb, Croatia

Puni tekst: engleski, pdf (2 MB) str. 1-11 preuzimanja: 608* citiraj
APA 6th Edition
Šoštarić, I., Nežić, I., Jović, F., Marcelić, E., Meštrović, E. i Zrnčević, S. (2014). Modeling-based Development of an Enantioselective Hydrogenation Reaction of a Sitagliptine Intermediate. Chemical and Biochemical Engineering Quarterly, 28 (1), 1-11. Preuzeto s https://hrcak.srce.hr/117979
MLA 8th Edition
Šoštarić, I., et al. "Modeling-based Development of an Enantioselective Hydrogenation Reaction of a Sitagliptine Intermediate." Chemical and Biochemical Engineering Quarterly, vol. 28, br. 1, 2014, str. 1-11. https://hrcak.srce.hr/117979. Citirano 17.02.2020.
Chicago 17th Edition
Šoštarić, I., I. Nežić, F. Jović, E. Marcelić, E. Meštrović i S. Zrnčević. "Modeling-based Development of an Enantioselective Hydrogenation Reaction of a Sitagliptine Intermediate." Chemical and Biochemical Engineering Quarterly 28, br. 1 (2014): 1-11. https://hrcak.srce.hr/117979
Harvard
Šoštarić, I., et al. (2014). 'Modeling-based Development of an Enantioselective Hydrogenation Reaction of a Sitagliptine Intermediate', Chemical and Biochemical Engineering Quarterly, 28(1), str. 1-11. Preuzeto s: https://hrcak.srce.hr/117979 (Datum pristupa: 17.02.2020.)
Vancouver
Šoštarić I, Nežić I, Jović F, Marcelić E, Meštrović E, Zrnčević S. Modeling-based Development of an Enantioselective Hydrogenation Reaction of a Sitagliptine Intermediate. Chemical and Biochemical Engineering Quarterly [Internet]. 2014 [pristupljeno 17.02.2020.];28(1):1-11. Dostupno na: https://hrcak.srce.hr/117979
IEEE
I. Šoštarić, I. Nežić, F. Jović, E. Marcelić, E. Meštrović i S. Zrnčević, "Modeling-based Development of an Enantioselective Hydrogenation Reaction of a Sitagliptine Intermediate", Chemical and Biochemical Engineering Quarterly, vol.28, br. 1, str. 1-11, 2014. [Online]. Dostupno na: https://hrcak.srce.hr/117979. [Citirano: 17.02.2020.]

Sažetak
This work presents a quality by design (QbD) driven approach to the plan of experiments and reaction modeling that was effective in obtaining enhanced process knowledge and defining a design space for an active pharmaceutical ingredient (API) manufacturing process. Engineering aspects of the process were explored by process modeling using computer predictive process simulators. QbD approach is presented on a case study of the process development of the sitagliptine synthesis step. The process involves an enantioselective hydrogenation step. Based on the proposed reaction mechanism and by combining the heat and mass transfer, thermodynamics, and the kinetics of the reactions, the API quality specifications (enantiomeric purity, impurity levels) are described across the modeling of process space. This process space was defined through target specifications, practical operating conditions for scale-up, and plant control capabilities. Model predictions were verified with results obtained in the laboratory, and at pilot plant scale.

Ključne riječi
Active pharmaceutical ingredient (API); Quality by Design (QbD); design space; modeling; sitaglipitine

Hrčak ID: 117979

URI
https://hrcak.srce.hr/117979

Posjeta: 819 *