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Disintegration of sublingual tablets: proposal for a validated test method and acceptance criterion
M Weda1, D A van Riet-Nales, P van Aalst
1National Institute for Public Health and the Environment, Centre for Quality of Chemical-Pharmaceutical Products, Postbak 40, PO Box 1, 3720 BA Bilthoven, The Netherlands. marjolein.weda@rivm.nl
Pharmeuropa Scientific Notes
|August 19, 2007
Summary
Complaints about isosorbide dinitrate sublingual tablets (product B) were investigated. In vitro disintegration testing revealed product B dissolved slower than product A, supporting in vivo effectiveness concerns.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation and Delivery
- Pharmacopeial Standards
Background:
- Market share of isosorbide dinitrate 5 mg sublingual tablets in the Netherlands is dominated by two products, A and B.
- Health care professionals reported slow/incomplete disintegration and ineffectiveness for product B.
- The European Pharmacopoeia (Ph. Eur.) lacks a disintegration time requirement for sublingual tablets.
Purpose of the Study:
- To compare the in vitro disintegration times of isosorbide dinitrate sublingual tablets A and B.
- To establish a suitable disintegration test method and acceptance criterion for sublingual tablets.
Main Methods:
- Tested products A and B using the Ph. Eur. disintegration method and three modified tests (varying medium volume and type).
- Disintegration was also assessed in Nessler tubes with varying water volumes.
- The Ph. Eur. method was applied to other sublingual tablets available in the Dutch market.
Main Results:
- Significant differences in disintegration times were observed between products A and B (p < 0.001) using the Ph. Eur. method and modified tests 1 and 2, with product B exhibiting longer times.
- The Ph. Eur. method yielded significantly lower disintegration times compared to modified tests 1 and 2 (p < 0.001) and correlated well with Nessler tube results.
- Modified test 3 (artificial saliva) did not achieve disintegration within 20 minutes.
Conclusions:
- In vivo complaints regarding product B's ineffectiveness may be linked to its slower in vitro disintegration.
- Disintegration time testing is proposed for immediate-release sublingual tablets.
- The Ph. Eur. disintegration method is suitable, with a proposed acceptance criterion of not more than 2 minutes.
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