Itraconazole Nanosuspensions via Dual Centrifugation Media Milling: Impact of Formulation and Process Parameters on Particle Size and Solid-State Conversion as Well as Storage Stability.

agglomeration amorphization dual centrifugation itraconazole media milling nanocrystals nanosuspension

Journal

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

Informations de publication

Date de publication:
22 Jul 2022
Historique:
received: 10 06 2022
revised: 19 07 2022
accepted: 20 07 2022
entrez: 27 7 2022
pubmed: 28 7 2022
medline: 28 7 2022
Statut: epublish

Résumé

Nanocrystal suspensions proved to be a potent enabling principle for biopharmaceutics classification system class II drugs with dissolution limited bioavailability. In the example of itraconazole (ITZ) as a model drug combined with electrosteric stabilization using hydroxypropyl cellulose (HPC-SL), sodium dodecyl sulfate (SDS) and polysorbate 80 (PS80), the impacts of formulation and process parameters of a dual centrifugal mill on material attributes such as particle size, zeta potential, particle morphology, storage stability and especially solid-state characteristics were evaluated. A minimal concentration of 0.9% (

Identifiants

pubmed: 35893783
pii: pharmaceutics14081528
doi: 10.3390/pharmaceutics14081528
pmc: PMC9332252
pii:
doi:

Types de publication

Journal Article

Langues

eng

Subventions

Organisme : Boehringer Ingelheim Pharma GmbH & Co. KG
ID : N/A

Références

Pharmaceutics. 2016 May 20;8(2):
pubmed: 27213434
Int J Pharm. 2016 Nov 20;513(1-2):319-331
pubmed: 27639622
Eur J Pharm Sci. 2005 Feb;24(2-3):179-86
pubmed: 15661489
J Phys Colloid Chem. 1947 May;51(3):631-6
pubmed: 20238663
Int J Pharm. 2014 May 15;466(1-2):223-32
pubmed: 24614581
Int J Pharm. 2019 Jun 30;565:187-198
pubmed: 31063837
Eur J Pharm Biopharm. 2015 May;92:171-9
pubmed: 25766272
Int J Pharm. 2017 May 30;524(1-2):178-192
pubmed: 28380391
Int J Pharm. 2003 Jan 30;251(1-2):165-74
pubmed: 12527186
Nat Rev Drug Discov. 2004 Sep;3(9):785-96
pubmed: 15340388
J Pharm Pharmacol. 2010 Nov;62(11):1569-79
pubmed: 21039542
J Pharm Sci. 2009 Nov;98(11):3961-86
pubmed: 19338060
Int J Pharm. 2009 Oct 1;380(1-2):40-8
pubmed: 19576976
Pharmacol Rev. 2013 Jan;65(1):315-499
pubmed: 23383426
Pharm Res. 2016 Oct;33(10):2373-87
pubmed: 27299311
Int J Pharm. 2013 Feb 25;443(1-2):209-20
pubmed: 23291552
Int J Pharm. 2017 Sep 15;530(1-2):79-88
pubmed: 28733242
J Pharm Sci. 2015 Sep;104(9):3018-28
pubmed: 25195539
Int J Pharm. 2008 Mar 3;351(1-2):236-43
pubmed: 18093763
Eur J Pharm Biopharm. 2010 May;75(1):33-41
pubmed: 20102737
Adv Drug Deliv Rev. 2018 Jun;131:101-115
pubmed: 29920294
Drug Deliv. 2021 Dec;28(1):19-36
pubmed: 33336609
Drug Dev Ind Pharm. 2011 Aug;37(8):963-76
pubmed: 21323486
Int J Pharm. 2011 Mar 15;406(1-2):145-52
pubmed: 21185926

Auteurs

Ann-Cathrin Willmann (AC)

Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany.
Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.

Kai Berkenfeld (K)

Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.

Thilo Faber (T)

Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.

Herbert Wachtel (H)

Device Development, Boehringer Ingelheim GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein, Germany.

Georg Boeck (G)

Department Discovery Research, Boehringer Ingelheim RCV GmbH & Co. KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria.

Karl G Wagner (KG)

Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.

Classifications MeSH