The use of ultrasound in the crystallization process of an active pharmaceutical ingredient

Majal Belca, Lucija (avtor), Ručigaj, Aleš (avtor), Teslič, Dušan (avtor), Krajnc, Matjaž (avtor)

In this research, ultrasound was used in the crystallization process as an alternative to conventional spontaneous crystallization and seeding crystallization. The study was implemented on an active pharmaceutical ingredient ticagrelor, where the influence of ultrasound on its physical properties was evaluated. Process parameters of spontaneous crystallization, seeding crystallization and ultrasound-assisted crystallization were extensively studied while the pros and cons of each were adequately exposed. Compared to spontaneous crystallization and seeding crystallization ultrasound-assisted crystallization has significantly improved fundamental crystallization parameters: nucleation, the growth of crystals and filtration time. At the same time, the tendency of particles to agglomerate was reduced, which lead to the avoidance of energy and time-consuming process of final product deagglomeration, often problematic in conventional crystallization. In addition, different physical properties of ticagrelor were reached and evaluated, for instance, morphology, particle size distribution and different polymorphic forms. Polymorphic forms I, II and III were efficiently produced in a repeatable, robust and optimal way. Ultrasound-assisted crystallization was proved to have a beneficial effect on the crystallization process of API, even on the industrial scale, and can successfully replace spontaneous crystallization and seeding crystallization.

• Jezik: Angleški jezik
• Ključne besede: crystallization, ultrasound, active pharmaceutical ingredient, ticagrelor, physical properties
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: FKKT - Fakulteta za kemijo in kemijsko tehnologijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2019
• Št. strani: Str. 1-10
• Številčenje: Vol. 58, art. 104642
• PID: 20.500.12556/RUL-108115
• UDK: 66.09
• ISSN pri članku: 1350-4177
• DOI: 10.1016/j.ultsonch.2019.104642
• COBISS.SI-ID: 1538246083

Avtorske pravice

V članku navedeno: "© 2019 Elsevier B.V. All rights reserved." Na pristajalni strani članka navedeno: "Under a Creative Commons license"; s povezavo https://creativecommons.org/licenses/by-nc-nd/4.0/. (18. 3. 2021) Na pristajalni strani članka tudi povezava "Get rights and content", kjer navedeno tudi: "This article is available under the Creative Commons CC-BY-NC-ND license and permits non-commercial use of the work as published, without adaptation or alteration provided the work is fully attributed." (https://s100.copyright.com/AppDispatchServlet?publisherName=ELS&contentID=S1350417719306820&orderBeanReset=true, 16. 3. 2021)

• Datum objave v RUL: 18.06.2019

Gradivo je del revije

• Naslov: Ultrasonics Sonochemistry
• Skrajšan naslov: Ultrason. sonochem.
• Založnik: Butterworth-Heinemann, Elsevier Science
• ISSN: 1350-4177
• COBISS.SI-ID: 707668

Licence

• Licenca: CC BY-NC-ND 4.0, Creative Commons Priznanje avtorstva-Nekomercialno-Brez predelav 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by-nc-nd/4.0/deed.sl
• Opis: Najbolj omejujoča licenca Creative Commons. Uporabniki lahko prenesejo in delijo delo v nekomercialne namene in ga ne smejo uporabiti za nobene druge namene.
• Začetek licenciranja: 18.06.2019

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: kristalizacija, ultrazvok, aktivna farmacevtska sestavina, inhibitor ticagrelor, fizikalne lastnosti

Projekti

• Financer: Drugi - Drug financer ali več financerjev
• Program financ.: Lek Pharmaceuticals d.d.