Hot-Melt Extrusion of the Thermo-Sensitive Peptidomimetic Drug Enalapril Maleate.

HPLC method development analytics of extrudates content uniformity hot-melt extrusion peptidomimetic drug personalized medicine thermal degradation treatment of hypertension and heart failure

Journal

Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003

Informations de publication

Date de publication:
30 Sep 2022
Historique:
received: 08 09 2022
revised: 26 09 2022
accepted: 27 09 2022
entrez: 27 10 2022
pubmed: 28 10 2022
medline: 28 10 2022
Statut: epublish

Résumé

The aim of this research was the production of extrudates for the treatment of hypertension and heart failure and the investigation of the degradation of the peptidomimetic drug enalapril maleate (EM) during hot-melt extrusion (HME). A fast HPLC method was developed to quantify enalapril maleate and possible degradation products. Screening experiments revealed that the diketopiperazine derivative (Impurity D) was the main degradation product. Hot-melt extrusion of enalapril maleate with the polymer Soluplus

Identifiants

pubmed: 36297525
pii: pharmaceutics14102091
doi: 10.3390/pharmaceutics14102091
pmc: PMC9608079
pii:
doi:

Types de publication

Journal Article

Langues

eng

Subventions

Organisme : German Federal Ministry of Education and Research
ID : 13XP5064B

Déclaration de conflit d'intérêts

The authors 1,3 declare that they have no conflicts of interest. Jörg Breitkreutz is a minority shareholder of Ethicare GmbH, a small company developing a pediatric drug with enalapril.

Références

Eur J Pharm Biopharm. 2002 Sep;54(2):249-54
pubmed: 12191699
AAPS PharmSciTech. 2021 Jun 17;22(5):184
pubmed: 34142250
Colloids Surf B Biointerfaces. 2011 Sep 1;86(2):275-84
pubmed: 21592751
Eur J Pharm Biopharm. 2010 Feb;74(2):340-51
pubmed: 19818402
Drug Dev Ind Pharm. 2007 Sep;33(9):909-26
pubmed: 17891577
J Pharm Biomed Anal. 2008 Aug 5;47(4-5):934-7
pubmed: 18472382
Adv Pharm Bull. 2018 Aug;8(3):495-505
pubmed: 30276147
Eur J Pharm Biopharm. 2017 Oct;119:56-67
pubmed: 28583588
Drug Dev Ind Pharm. 2013 Jul;39(7):1070-83
pubmed: 22803806
Eur J Pharm Sci. 2019 Mar 1;129:110-123
pubmed: 30610954
AAPS PharmSciTech. 2016 Feb;17(1):148-57
pubmed: 26511936
Molecules. 2015 Jun 19;20(6):11345-56
pubmed: 26102068
Eur J Pharm Biopharm. 2011 Feb;77(2):297-305
pubmed: 21168487
Pharm Dev Technol. 2012 Jul-Aug;17(4):502-10
pubmed: 21284576
Int J Pharm. 2011 Oct 31;419(1-2):12-9
pubmed: 21782911
Drug Dev Ind Pharm. 2015 Jun;41(6):959-68
pubmed: 24842545
J Chromatogr Sci. 2017 Nov 1;55(10):979-988
pubmed: 28985272
Eur J Pharm Biopharm. 2002 Sep;54(2):107-17
pubmed: 12191680
Int J Pharm. 2018 Jul 10;545(1-2):144-152
pubmed: 29705104
AAPS PharmSciTech. 2016 Feb;17(1):106-19
pubmed: 26335416
Adv Drug Deliv Rev. 2012 Apr;64(5):461-78
pubmed: 22300653
Pharmaceutics. 2019 Apr 22;11(4):
pubmed: 31013578
Int J Pharm. 2019 Jun 30;565:316-324
pubmed: 31022504
J Pharm Biomed Anal. 2008 Jan 7;46(1):113-20
pubmed: 17964751
Eur J Pharm Sci. 2018 Oct 15;123:484-494
pubmed: 30041029
Pharm Res. 2019 Jun 27;36(9):128
pubmed: 31250313
Pharm Res. 2018 Apr 20;35(6):124
pubmed: 29679157
Eur J Pharm Sci. 2007 Dec;32(4-5):349-56
pubmed: 17949952
Eur J Pharm Sci. 2014 May 13;55:1-11
pubmed: 24456933
J Pharm Pharmacol. 2014 Feb;66(2):148-66
pubmed: 24325738
Eur J Pharm Biopharm. 2011 Jan;77(1):170-7
pubmed: 20940049
Drug Dev Ind Pharm. 2018 Feb;44(2):206-214
pubmed: 29145748
Eur J Pharm Biopharm. 2009 Jun;72(2):463-70
pubmed: 19462482
J Pharm Sci. 2017 Aug;106(8):1933-1943
pubmed: 28435140
Pharm Res. 2004 Nov;21(11):2127-32
pubmed: 15587937

Auteurs

Lena Hoffmann (L)

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstraße 1, 40225 Düsseldorf, Germany.

Jörg Breitkreutz (J)

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstraße 1, 40225 Düsseldorf, Germany.

Julian Quodbach (J)

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstraße 1, 40225 Düsseldorf, Germany.
Department of Pharmaceutics, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands.

Classifications MeSH