dr. Konrád Sántha1, Dr. Nikolett Kállai-Szabó1, Dr. István Antal1
1 Department of Pharmaceutics, Semmelweis University, Budapest
Introduction: Multiple-unit pellet systems (MUPSs) provide a valuable tool in today’s pharmaceutic therapy; not only do they reduce the risk of side-effects, but allow the formulation of a combination of therapies in one product (such as starting and sustaining doses), even in the case of some of the drugs’ incompatibility. To characterise the pellets used in these dosage forms, there are multiple methods, of which microscopic image analysis is the most widespread. However, when confronted with the task of assessing the morphology of said pellets after compression into tablets, one has to search for other, non-destructive methods, such as microfocus X-ray (MFX).
Aims: The tabletability of coated pellets using several different excipient-combinations was studied. Data from the usual spectrum of tablet characterisation measurements (hardness, friability, mass uniformity, dissolution, etc.) were to be cross-referenced with those gained from image analysis of pictures from various sources.
Methods: Analysis of images produced by MFX of pellets compressed into tablets was carried out to determine the integrity of the pellets’ coating. To verify these results, tablets were disintegrated and further image analysis was performed on the pellets remaining. After this, in vitro tablet dissolution test was carried out to confirm the similarity of the dissolution profiles before and after compression.
Results: The conclusions drawn from the model-independent evaluation of tablet dissolution profiles were supported by the data gained from image analysis, both in the case of images taken of compressed tablets by MFX, and of pellets after tablet disintegration, by a microscope.
Conclusion: The results of this study show that the MFX technique is a good alternative to the already used microscopic image analysis methods regarding the characterisation of particulates, compressed into other forms (e.g. tablets). While some minor drawbacks exist, the method is also easy-to-use, fast and non-destructive.
Doctoral School: Pharmaceutical Sciences
Program: Modern Trends in Pharmaceutical Scientific Research
Supervisor: István Antal
E-mail address: firstname.lastname@example.org
Poster is preferred