A Customized Screening Tool Approach for the Development of a Self-Nanoemulsifying Drug Delivery System (SNEDDS)

© 2021. The Author(s)..

The present study focused on establishing a novel, (pre-)screening approach that enables the development of promising performing self-nanoemulsifying drug delivery systems (SNEDDSs) with a limited number of experiments. The strategic approach was based on first identifying appropriate excipients (oils/lipids, surfactants, and co-solvents) providing a high saturation solubility for lipophilic model compounds with poor aqueous solubility. Excipients meeting these requirements were selected for SNEDDS development, and a special triangular mixture design was applied for determining excipient ratios for the SNEDDS formulations. Celecoxib and fenofibrate were used as model drugs. Formulations were studied applying a specific combination of in vitro characterization methods. Specifications for a promising SNEDDS formulation were self-imposed: a very small droplet size (< 50 nm), a narrow size distribution of these droplets (PDI < 0.15) and a high transmittance following SNEDDS dispersion in water (> 99% in comparison with purified water). Excipients that provided a nanoemulsion after dispersion were combined, and ratios were optimized using a customized mapping method in a triangular mixture design. The best performing formulations were finally studied for their in vitro release performance. Results of the study demonstrate the efficiency of the customized screening tool approach. Since it enables successful SNEDDS development in a short time with manageable resources, this novel screening tool approach could play an important role in future SNEDDS development. Graphical abstract.

Medienart:

E-Artikel

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

Zur Gesamtaufnahme - volume:23

Enthalten in:

AAPS PharmSciTech - 23(2021), 1 vom: 27. Dez., Seite 39

Sprache:

Englisch

Beteiligte Personen:

Schmied, Fabian-Pascal [VerfasserIn]
Bernhardt, Alexander [VerfasserIn]
Engel, Andrea [VerfasserIn]
Klein, Sandra [VerfasserIn]

Links:

Volltext

Themen:

Drug release
Dynamic light scattering
Emulsions
Journal Article
Nanoemulsion
Plant Oils
Solubility enhancement
Triangular mixture design

Anmerkungen:

Date Completed 29.12.2021

Date Revised 14.03.2022

published: Electronic

Citation Status MEDLINE

doi:

10.1208/s12249-021-02176-7

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM334977487