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

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2019
Authors
Vidović, Sara
Horvat, Matej
Bizjak, Alan
Planinsek, Odon
Petek, Bostjan
Burjak, Matejka
Peternel, Luka
Parojčić, Jelena
Đuriš, Jelena
Ibrić, Svetlana
Janković, Biljana
Article (Published version)
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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 fu...rther 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.

Keywords:
Multivariate data analysis / Artificial neural network / Extrusion/spheronization / Kappa-carrageenan / Pellets / Drug dissolution
Source:
International Journal of Pharmaceutics, 2019, 566, 662-673
Publisher:
  • Elsevier Science BV, Amsterdam
Projects:
  • Lek Pharmaceuticals d.d.
  • Slovenian Research Agency

DOI: 10.1016/j.ijpharm.2019.06.016

ISSN: 0378-5173

PubMed: 31181307

WoS: 000472733600060

Scopus: 2-s2.0-85067335744
[ Google Scholar ]
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/3255
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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