Abstract
Granules are preparations consisting of solid, dry aggregates of powder particles with uniform composition, similar size and sufficiently resistant to withstand handling. Granules are presented as single-dose or multidose preparations, and a semi-product in the formation of tablets as well. The aim of the study was to evaluate the two granules with different apparent volume with caffeine. The transfer of their particles with the methods indicated by Ph. Eur. 5.0 and Polish Pharmacopoeia VIII was examined. The patent apparatus for the measurement of angle of repose and the time of flow powders and granules and modified apparatus for measurement of angle of repose which enables fractionating of reposed granule were applied. Furthermore, the spectrophotometric method for determination of caffeine in granules, was tested. It allows evaluation of distribution of the active substance in particular fractions of drug form and changes of granules density on distribution of active substance in a reposed granule.
References
1. Bacher C., Olsen P. M., Bertelsen P., Sonnergaard J. M.: Compressibility and compactibility of granules produced by wet and dry granulation. Int. J. Pharm., 349, 19, 2008.
2. Czarnecki W., Szumiło M., Wąsik D.: The influence of the size and density of particles on flow properties of granules. Acta Pol. Pharm., 5, 2009 (in press).
3. The European Pharmacopoeia 5.0; Council of Europe, Strasbourg Cedex, 2004.
4. Liu L. X., Marzano I., Bentham A. C. et al.: Effect of particle properties on the flow ability of ibuprofen powders. Int. J. Pharm., 362, 109, 2008.
5. Nerlo H., Koziejowska K., Rudzki Z.: Patent Nº P 178896, UPRP, Warsaw 1978.
6. The Polish Pharmacopoeia VI; PTFarm, Warsaw 2002.
7. The Polish Pharmacopoeia VII; PTFarm, Warsaw 2006.
8. The Polish Pharmacopoeia VIII; PTFarm, Warsaw 2009.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 Unported License.
Copyright (c) 2009 Authors