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Dissolution testing of soft shell capsules-acetaminophen and nifedipine
C B Bottom1, M Clark, J T Carstensen
1Banner Pharmacaps, Inc., High Point, NC 27261, USA.
Journal of Pharmaceutical Sciences
|September 19, 1997
Summary
Pelliculation in soft gelatin capsules is a common issue. The United States Pharmacopeia (USP) apparatus III dissolution method effectively distinguished between acceptable and substandard acetaminophen capsules, unlike the USP apparatus II method.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Pelliculation, or hardening, of soft gelatin capsules upon aging is a significant challenge in pharmaceutical formulation.
- This phenomenon differs from hard shell capsules due to the larger gelatin mass in softgel dosage forms.
- Previous studies indicated that the United States Pharmacopeia (USP) apparatus II dissolution method failed to differentiate between acceptable and failing nifedipine soft shell capsules.
Purpose of the Study:
- To evaluate the suitability of the USP apparatus III dissolution testing method for assessing pelliculation in soft gelatin capsules.
- To determine the optimal dissolution medium for distinguishing between acceptable and substandard soft gelatin capsules exhibiting pelliculation.
- To investigate the impact of formaldehyde concentration on controlled pelliculation in acetaminophen soft gelatin capsules.
Main Methods:
- Acetaminophen soft gelatin capsules were prepared with varying formaldehyde concentrations (0, 20, 80 ppm) to induce controlled pelliculation.
- Capsules were subjected to both ambient and accelerated storage conditions.
- Dissolution testing was performed using both the USP apparatus II and USP apparatus III methods.
Main Results:
- The USP apparatus III method demonstrated superior ability to differentiate between acceptable and substandard capsules compared to the USP apparatus II method.
- Formaldehyde concentration directly influenced the degree of pelliculation observed in the soft gelatin capsules.
- Dissolution profiles obtained from USP apparatus III testing correlated well with the physical changes indicative of pelliculation.
Conclusions:
- The USP apparatus III dissolution method is a more suitable tool for assessing the quality of soft gelatin capsules prone to pelliculation.
- The findings provide a basis for developing more robust dissolution testing protocols to ensure the stability and efficacy of soft gelatin drug products.
- Further research into dissolution media optimization could enhance the predictive power of this method for capsule aging studies.