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

Improved protocol and data analysis for accelerated shelf-life estimation of solid dosage forms.

Kenneth C Waterman1, Anthony J Carella, Michael J Gumkowski

  • 1Pfizer Global Research & Development, Groton, CT 06340, USA. ken.waterman@pfizer.com

Pharmaceutical Research
|March 21, 2007
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

A Novel Colon PBPK Model: Navigating the Rational Drug Design for Small-Molecule Colon-Selective Therapies.

Journal of medicinal chemistry·2025
Same author

Voices in <i>Molecular Pharmaceutics</i>: Meet Dr. Kenneth Waterman, Who Brings Drugs to Patients Faster.

Molecular pharmaceutics·2025
Same author

The activity and expression of adenylosuccinate lyase were reduced during modern human evolution, affecting brain and behavior.

Proceedings of the National Academy of Sciences of the United States of America·2025
Same author

Oxygen-Dependent Accelerated Stability Modeling of Drug Products.

Molecular pharmaceutics·2025
Same author

Deconstructing Annealing Phenomena in Modified Release Lipid Multiparticulates.

Molecular pharmaceutics·2025
Same author

Accelerated stability modeling of recrystallization from amorphous solid Dispersions: A Griseofulvin/HPMC-AS case study.

International journal of pharmaceutics·2024
Same journal

Leveraging Carnitine-functionalized Lipid Nanocarrier based Targeted Delivery of A1874 PROTAC for Glioblastoma.

Pharmaceutical research·2026
Same journal

Impact of Febrile State on Vancomycin Clearance in Pediatric Patients: Insights From Population Pharmacokinetic Modeling.

Pharmaceutical research·2026
Same journal

Sustained Intra-Articular Delivery of Triple Therapeutics Using a Phase-Transition Phospholipid-Based Gel for Effective Treatment of Gouty Arthritis.

Pharmaceutical research·2026
Same journal

Spray Dried Lysozyme Microspheres: Morphological Evolution and Enzymatic Activity Retention.

Pharmaceutical research·2026
Same journal

Colloidal Stability of Amorphous Nanoparticles in Solution: Impact of Stabilizer.

Pharmaceutical research·2026
Same journal

Impact of Mixing Approach and Bubble Formation on In Situ Forming Implant Properties.

Pharmaceutical research·2026
See all related articles

A new accelerated aging protocol for pharmaceuticals offers faster shelf-life predictions. This method uses an isoconversion paradigm and humidity-corrected Arrhenius equation for accurate drug stability assessments.

Area of Science:

  • Pharmaceutical Science
  • Chemical Engineering
  • Materials Science

Background:

  • Accurate shelf-life prediction is crucial for pharmaceutical development.
  • Current accelerated aging protocols can be time-consuming.
  • Solid-state small molecule pharmaceuticals require robust stability testing.

Purpose of the Study:

  • To propose and validate a novel accelerated aging protocol for solid-state, small molecule pharmaceuticals.
  • To enable faster and more reliable predictions of drug substance and drug product shelf-life.
  • To reduce the time and resources required for stability studies.

Main Methods:

  • Introduction of an isoconversion paradigm for solid-state pharmaceuticals.
  • Utilizing a humidity-corrected Arrhenius equation to model temperature and relative humidity effects.

Related Experiment Videos

  • Employing Monte-Carlo simulations to account for experimental imprecision and propagate variations.
  • Iterative approach: greater imprecision tolerated in early development for faster screening, with data informing later, more precise estimations.

    • Main Results:

    • Demonstrated consistency between predicted and measured shelf-life values at various temperatures and relative humidities.
    • Validation of the isoconversion paradigm and humidity-corrected Arrhenius equation for pharmaceutical stability.
    • Successful application of Monte-Carlo simulations for robust shelf-life prediction.

    Conclusions:

    • The developed accelerated aging protocol provides accurate and precise shelf-life estimations.
    • The new protocol significantly reduces the time required for stability assessments compared to current methods.
    • This approach enhances the efficiency of pharmaceutical development and quality control.