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 polymorphism and dosage form design: a practical perspective.

Dharmendra Singhal1, William Curatolo

  • 1Pharmaceutical Research and Development Department, Groton Laboratories, Pfizer Global Research and Development, Groton, CT 06340, USA. singhald@groton.pfizer.com

Advanced Drug Delivery Reviews
|February 14, 2004
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

The impact of hot melt extrusion and spray drying on mechanical properties and tableting indices of materials used in pharmaceutical development.

Journal of pharmaceutical sciences·2013
Same author

The impact of roller compaction and tablet compression on physicomechanical properties of pharmaceutical excipients.

Pharmaceutical development and technology·2013
Same author

A novel approach to determine solid fraction using a laser-based direct volume measurement device.

Pharmaceutical development and technology·2013
Same author

Supersolubilization and amorphization of a model basic drug, haloperidol, by interaction with weak acids.

Pharmaceutical research·2013
Same author

Improved human bioavailability of vemurafenib, a practically insoluble drug, using an amorphous polymer-stabilized solid dispersion prepared by a solvent-controlled coprecipitation process.

Journal of pharmaceutical sciences·2013
Same author

Understanding and optimizing the dual excipient functionality of sodium lauryl sulfate in tablet formulation of poorly water soluble drug: wetting and lubrication.

Pharmaceutical development and technology·2012

Developing metastable drug forms requires careful risk assessment. Ensuring product stability and bioavailability is crucial, especially when no significant medical benefit is evident.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Physical Chemistry

Background:

  • Drug formulation requires physical and chemical stability, manufacturability, and bioavailability.
  • Polymorphism is common in drugs; the most stable form ensures reproducible bioavailability.
  • Metastable or amorphous forms may be developed for medical benefits like faster absorption or higher drug concentration.

Purpose of the Study:

  • To evaluate the justification and risks of developing metastable drug forms.
  • To outline mitigation strategies for the risks associated with metastable drug development.
  • To emphasize the importance of ensuring product quality and bioavailability regardless of the chosen drug form.

Main Methods:

  • Review of principles governing drug polymorphism and stability.

Related Experiment Videos

  • Analysis of scenarios justifying the use of metastable drug forms.
  • Discussion of risk mitigation strategies including laboratory testing and analytical controls.

    • Main Results:

    • Developing the most thermodynamically stable polymorph is generally preferred for consistent bioavailability.
    • Metastable forms may be justified by significant medical benefits, such as improved drug absorption or efficacy.
    • If no medical benefit exists, the risks of using metastable forms are harder to justify.

    Conclusions:

    • The development of metastable crystalline or amorphous drug forms necessitates rigorous risk assessment and mitigation.
    • Ensuring product quality and bioavailability under real-world conditions is paramount.
    • Robust analytical methods and sampling procedures are essential to detect potential issues before products reach patients.