Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Drug-excipient compatibility testing using a high-throughput approach and statistical design.

Nicole Wyttenbach1, Christian Birringer, Jochem Alsenz

  • 1F. Hoffmann-La Roche Ltd., Pharmaceutical and Analytical R & D, Basel, Switzerland. nicole.wyttenbach@roche.com

Pharmaceutical Development and Technology
|December 24, 2005
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Formulation of amorphous solid dispersion of clofazimine, an extremely water-insoluble basic drug, via hot-melt extrusion by applying acid-base supersolubilization principle.

International journal of pharmaceutics·2026
Same author

Establishing experimental parameters for biphasic transfer in vitro lipolysis model.

International journal of pharmaceutics·2026
Same author

Deep eutectic systems as enabling pharmaceutical formulations: mechanisms and applications.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences·2026
Same author

High-throughput screening of amorphous solid dispersions: a systematic approach to enhance bioaccessibility of a poorly soluble drug.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences·2025
Same author

Exploring co-milling of poorly water-soluble drugs with swellable polymers to enhance the dissolution rate.

AAPS PharmSciTech·2025
Same author

High-throughput analysis of aqueous drug solubility, supersaturation, and aggregation behaviour using second harmonic light scattering.

International journal of pharmaceutics·2025

This study developed a miniaturized, high-throughput drug-excipient compatibility test. The method quickly identifies interactions, enabling early selection of pharmaceutical additives for solid dosage forms.

Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Analytical Chemistry

Background:

  • Drug-excipient compatibility is crucial for solid dosage form stability.
  • Traditional compatibility testing can be time-consuming and require large sample amounts.
  • Developing rapid, miniaturized screening methods is essential for efficient drug development.

Purpose of the Study:

  • To develop and validate a miniaturized, high-throughput drug-excipient compatibility testing method.
  • To identify specific drug-excipient interactions affecting the stability of acetylsalicylic acid and fluoxetine hydrochloride.
  • To determine the influence of temperature, humidity, and time on drug degradation in binary mixtures.

Main Methods:

  • Utilized a 96-well microtiter plate format for miniaturized sample preparation.

Related Experiment Videos

  • Employed statistical experimental design to plan and evaluate compatibility tests.
  • Analyzed chemical drug degradation using fast gradient high-performance liquid chromatography (HPLC).

    • Main Results:

    • Acetylsalicylic acid showed instability with magnesium stearate, dibasic calcium phosphate, and sodium starch glycolate.
    • Fluoxetine hydrochloride degraded significantly only in the presence of lactose.
    • Relative humidity was identified as the most influential factor affecting drug-excipient blend stability.

    Conclusions:

    • The developed technique provides a fast and efficient method for drug-excipient compatibility testing.
    • The assay requires minimal drug quantities (0.1 mg per data point), facilitating early-stage rational selection of pharmaceutical additives.
    • This method supports streamlined solid dosage form development by predicting potential incompatibilities early on.