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Published on: August 9, 2022
Physical aging in pharmaceutical polymers and the effect on solid oral dosage form stability
Shawn A Kucera1, Linda A Felton, James W McGinity
1Merck KGaA, Frankfurter Strasse 250, Darmstadt 64293, Germany.
International Journal of Pharmaceutics
|February 23, 2013
Summary
Physical aging of amorphous polymeric films used in drug delivery alters mechanical and release properties. Strategies to prevent this aging phenomenon are crucial for consistent drug product performance.
Area of Science:
- Materials Science
- Pharmaceutical Science
- Polymer Chemistry
Background:
- Polymeric films are used to control drug release from oral dosage forms.
- Amorphous polymers in these films undergo physical aging, affecting film properties.
- Physical aging involves polymer relaxation, densification, and reduced free volume.
Purpose of the Study:
- To review the process of physical aging in polymeric films for drug delivery.
- To discuss analytical techniques for investigating polymer aging.
- To highlight strategies for preventing physical aging in pharmaceutical coatings.
Main Methods:
- Literature review of physical aging in amorphous polymeric films.
- Discussion of analytical methods to study polymer aging (e.g., DSC, TGA, mechanical testing).
- Analysis of factors influencing aging (temperature, humidity, excipients).
Main Results:
- Physical aging leads to changes in mechanical properties and drug release profiles.
- Polymer densification and decreased free volume are key aspects of aging.
- Environmental factors and formulation excipients significantly impact the aging rate.
Conclusions:
- Understanding and mitigating physical aging is essential for stable drug delivery systems.
- Various analytical techniques can characterize the aging process.
- Preventive strategies are key to ensuring long-term performance of polymeric drug coatings.
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