Dissolution of lithium carbonate from three types extended-release capsules in paddle, basket and flow-through apparatus

Authors

  • Malgorzata Sznitowska Department of Pharmaceutical Technology, Medical University of Gdansk, Poland Author
  • Pawel Pietkiewicz Department of Pharmaceutical Technology, Medical University of Gdansk, Poland Author
  • Agnieszka Dorosz Department of Physical Chemistry with Laboratory of Instrumental Analysis, Medical University of Gdansk, Poland Author
  • Jerzy Lukasiak Department of Physical Chemistry with Laboratory of Instrumental Analysis, Medical University of Gdansk, Poland Author
  • An Vermeire Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences Ghent University, Belgium Author
  • Jean Paul Remon Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences Ghent University, Belgium Author

DOI:

https://doi.org/10.12923/j.2084-980X/25.2/a.11

Keywords:

dissolution test, pellets, minitablets, lithium carbonate, extended-release capsules

Abstract

Three types of 24-h extended-release multiparticulate capsules containing a dose of 480-504 mg lithium carbonate in a form of either pellets or 2 mm minitablets or 6 mm tablets were prepared. Dissolutions tests were performed using three different pharmacopoeial apparatus: basket, paddle and flow-through apparatus. Only capsules filled with pellets showed the same dissolution profiles, irrespective of the apparatus used in the study. In the case of two other formulations, the slowest dissolution occurred in the flow-through apparatus. The largest difference between release profiles from different apparatus was observed for the capsule filled with 6 mm tablets. The observations may indicate that probability of good reproducibility of dissolution profiles obtained in different test conditions, including change of apparatus, is related to either size or a number of the units in a capsule.

References

1. Crison JR: Developing dissolution tests for modified release dosage forms: General considerations. Dissol. Technol., 6/2, 5, 1999.

2. EMEA Note for Guidance on Quality of Modified Release Products (2000). Committee for Proprietary Medicinal Products. London: EMEA.

3. FDA Guidance for Industry. Extended release oral dosage forms: Development, evaluation and application of in vitro / in vivo correlations (1997). Food and Drug Administration Center for Drug Evaluation and Research (CDER).

4. Fotaki N: Flow-through cell apparatus (USP apparatus 4): operation and features. Dissol. Technol., 46, Nov 2011.

5. Jantratid E et al.: Application of biorelevant dissolution tests to the prediction of in vivo performance of diclofenac sodium from an oral modified-release pellet dosage form. Eur. J. Pharm. Sci., 37, 434, 2009.

6. Jones BE (2004). Capsule standards. In: Pharmaceutical Capsules. Podcheck F, Jones BE (editors). London: Pharmaceutical Press; p. 239.

7. Kortejarvi H et al.: Development of level A, B and C in vitro-in vivo correlations for modified-release levosimendan capsules. Int. J. Pharm., 241, 87, 2002.

8. Meyer MC et al.: The effect of gelatin cross-linking on the bioequivalence of hard and soft gelatin capsules. Pharm. Res., 17, 962, 2000.

9. Pietkiewicz P et al.: Lithium carbonate 24-h extended-release capsule filled with 6 mm tablets. Boll. Chim. Farm., 142, 69, 2003.

10. Vervaet C, Baert L, Remon JP: Extrusion-spheronization. A literature review. Int. J. Pharm., 116, 131, 1995.

11. Webb AL, Solomon DA, Ryan CE: Lithium levels and toxicity among hospitalized patients. Psychiatr. Serv., 52, 229, 2001.

12. Zahirul M, Khan I: Dissolution testing for sustained or controlled release oral dosage forms and correlation with in vivo data: challenges and opportunities. Int. J. Pharm., 140, 131, 1996.

Downloads

Published

2012-04-01

How to Cite

Sznitowska , M., Pietkiewicz , P., Dorosz, A., Lukasiak, J., Vermeire, A. ., & Remon, J. P. (2012). Dissolution of lithium carbonate from three types extended-release capsules in paddle, basket and flow-through apparatus. Current Issues in Pharmacy and Medical Sciences, 25(2), 164-167. https://doi.org/10.12923/j.2084-980X/25.2/a.11