On-demand manufacturing of immediate release levetiracetam tablets using pressure-assisted microsyringe printing.


Journal

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
ISSN: 1873-3441
Titre abrégé: Eur J Pharm Biopharm
Pays: Netherlands
ID NLM: 9109778

Informations de publication

Date de publication:
Jan 2019
Historique:
received: 25 07 2018
revised: 18 09 2018
accepted: 11 11 2018
pubmed: 16 11 2018
medline: 23 4 2019
entrez: 16 11 2018
Statut: ppublish

Résumé

Fast and accurate manufacturing of individually tailored solid dosage forms is one of the main challenges for personalized medicine. The use of 3D printers has recently been studied to determine their suitability for personalized drug manufacturing. In the current work, formulations free of organic solvents were developed for a pressure-assisted microsyringe printing method (PAM). The water soluble polymer polyvinyl alcohol-polyethylene glycol graft copolymer (PVA-PEG) was used as matrix, while levetiracetam (LEV) was used as model drug. Furthermore, the influence of a second polymer, polyvinylpyrrolidone-vinyl acetate copolymer (PVP-PVAc) on the properties of the printed tablets was investigated. Tablets were printed using a 3D-Bioplotter. The printed formulations were analyzed regarding mass variation, friability and thickness. Furthermore, the disintegration behavior and dissolution profile were analyzed. Investigations of the dissolution profiles of printed tablets show that an immediate release of the API could be achieved. For tablets with PVA-PEG the drug is released completely within 10 min while the additional use of PVP-PVAc leads to a slightly delay with a complete release within 20 min. The same trend is observed regarding the disintegration time of printed tablets. Tablets with PVA-PEG disintegrated within 95 ± 10 s while tablets with additional PVP-PVAc disintegrated within 130 ± 20 s. Friability of <0.5% indicate that the used PAM printing method provides tablets without loss of structural integrity during handling. Furthermore, it could be shown that the production of tablets with a good content uniformity using a 3D Bioplotter is suitable.

Identifiants

pubmed: 30439504
pii: S0939-6411(18)30904-4
doi: 10.1016/j.ejpb.2018.11.008
pii:
doi:

Substances chimiques

Excipients 0
Kollicoat IR 0
Polyvinyls 0
Tablets 0
Levetiracetam 44YRR34555

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

29-36

Informations de copyright

Copyright © 2018 Elsevier B.V. All rights reserved.

Auteurs

Ilias El Aita (I)

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf, Universitaetsstr. 1, 40225 Duesseldorf, Germany.

Jörg Breitkreutz (J)

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf, Universitaetsstr. 1, 40225 Duesseldorf, Germany.

Julian Quodbach (J)

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf, Universitaetsstr. 1, 40225 Duesseldorf, Germany. Electronic address: julian.quodbach@uni-duesseldorf.de.

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Classifications MeSH