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Disintegration of highly soluble immediate release tablets: a surrogate for dissolution
Abhay Gupta1, Robert L Hunt, Rakhi B Shah
1Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Science, Food and Drug Administration, 10903 New Hampshire Avenue, LS Bldg 64, Silver Spring, Maryland 20993-002, USA.
AAPS Pharmscitech
|April 24, 2009
Summary
Investigating immediate-release tablet disintegration and dissolution revealed formulation components significantly impact drug release. Only one formulation met criteria for using disintegration testing instead of dissolution testing as an acceptance criterion.
Area of Science:
- Pharmaceutical Sciences
- Formulation Development
- Drug Product Quality
Background:
- The disintegration test is a critical quality attribute for immediate-release tablets.
- Regulatory guidelines (ICH Q6A) permit using disintegration as an acceptance criterion if dissolution is not critical.
- Understanding the correlation between disintegration and dissolution is essential for formulation optimization.
Purpose of the Study:
- To investigate the correlation between disintegration and dissolution for verapamil hydrochloride immediate-release tablets.
- To identify specific formulations where the disintegration test could replace the dissolution test as an acceptance criterion.
Main Methods:
- A statistical design of experiments was employed.
- The study examined the effects of filler, binder, disintegrating agent, and tablet hardness.
- Verapamil hydrochloride tablets were formulated and tested for disintegration and dissolution.
Main Results:
- All formulation variables (filler, binder, disintegrating agent) influenced both disintegration and dissolution.
- Filler and disintegrating agent showed the most significant impact on tablet properties.
- No direct correlation was found across all formulations due to component interactions; some tablets disintegrated quickly but dissolved slowly.
Conclusions:
- Slower dissolution correlated with longer disintegration times when individual excipients were constant.
- Only one formulation was identified as suitable for using the disintegration test as the sole acceptance criterion.
- Systematic studies are crucial before replacing dissolution testing with disintegration testing for drug product acceptance.
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