Posts

UV Imaging of MUPS Tablets Stability, Functionality, and Outcomes

Introduction to UV Imaging of MUPS Tablets

UV imaging of MUPS tablets (multiple unit pellet system) is a growing field in pharmaceutical research. These tablets combine many coated pellets into one compressed unit. After ingestion, the tablet breaks apart and releases the active pharmaceutical ingredient (API). Researchers explored whether multispectral UV imaging could track the degradation of acetylsalicylic acid (ASA) into salicylic acid (SA). The goal was to confirm that this non-destructive method could monitor stability inside these complex formulations.

Scientific Approach to UV Imaging of MUPS Tablets

The study used CELLETS® 700 as neutral microcrystalline cellulose cores. Scientists layered ASA on these cores and coated them with Eudragit RL PO. They then compressed the pellets into MUPS tablets. The tablets were stored at different temperatures and humidity levels for several months.

At each time point, the tablets were examined with multispectral UV reflectance imaging. This technology captured detailed spectral fingerprints across the surface. To interpret the data, the team applied partial least squares regression (PLS). They predicted the concentration of SA as the main degradation product. High-performance liquid chromatography (HPLC) provided reference values for comparison, ensuring accuracy.

Results of UV Imaging of MUPS Tablets

The outcomes showed that UV imaging worked well for tracking degradation inside the tablets. The predictions matched closely with HPLC results, proving the method’s reliability. Moreover, the technique detected even small amounts of salicylic acid despite the tablet’s protective coating.

Importantly, UV imaging did more than quantify. It created spatial maps that revealed where degradation occurred on the tablet surface. These maps gave new insights into stability that destructive tests could not provide. As a result, the method proved fast, precise, and suitable for quality control and stability studies.

Role of CELLETS® 700 in the Research

CELLETS® 700 played a key role in the experiment. These spherical microcrystalline cellulose pellets range from 700 to 1,000 µm. Their smooth, uniform surface made it easy to apply ASA and coatings evenly. In addition, their chemical stability ensured that imaging signals came only from the coating and degradation layers.

Because CELLETS® 700 are robust, they maintained their structure during compression. This consistency improved the reliability of UV imaging results. Thus, the choice of these pellet cores supported both the technical and analytical goals of the study.

Conclusion

UV imaging of MUPS tablets offers a powerful tool for monitoring stability and degradation. By combining multispectral imaging with statistical modeling, researchers gained accurate and non-destructive insights into tablet quality. CELLETS® 700 provided the structural foundation that made the method effective. Consequently, this approach holds promise as a process-analytical technology for pharmaceutical development and quality assurance.

References

UV imaging of multiple unit pellet system (MUPS) tablets: A case study of acetylsalicylic acid stability
European Journal of Pharmaceutics and Biopharmaceutics, Volume 119, October 2017, Pages 447-453
Anna Novikova, Jens M. Carstensen, Thomas Rades, Claudia S. Leopold

The primary objective of this research is to investigate the design and size on particle coating thickness. Furthermore,  illustrate how the design, size, and configurations of fluid-bed coating machinery influence variations in pellet coating thickness. This parameter plays a crucial role in governing the release of medication in prolonged-release pellets. Initially, the scientists conducted a series of coating experiments where the pellet cores were coated with Tartrazine dye. The aim was to evaluate the performance of the coating equipment in terms of the distribution of coating thickness, which was assessed based on color hue.

In the subsequent set of experiments, drug-layered pellets underwent film-coating with prolonged-release material. Brezovar et al. conducted dissolution profile tests to gauge the uniformity and thickness of the coating among pellets of different sizes. Pellets of kind CELLETS® 700 (IPC Dresden, Germany) had been employed. This investigation encompassed both laboratory and pilot scale applications. Laboratory-sized fluid-bed coaters GPCG1 (Glatt GmbH, Germany and BX FBD10, Brinox d.o.o., Slovenia) and a pilot-sized (BX FBD30, Brinox d.o.o., Slovenia) fluid-bed coater are used for these tests. The group made comparisons between two types of distribution plates and various adjustments in the height of the draft tube.

The dye coating study yielded highly valuable insights. The results provided the basis for refining the process and optimizing the utilization of process equipment, especially in conjunction with the appropriate process parameters. On the laboratory scale, we observed a preference for film coating larger drug-containing pellets. However, on the pilot scale, we achieved a preferential coating of smaller pellets through judicious adjustments, a development that holds significance in achieving a drug release profile independent of particle size for prolonged-release dosage forms.

Link to publication:

The Effect of Design and Size of the Fluid‑Bed Equipment on the Particle Size‑Dependent Trend of Particle Coating Thickness and Drug Prolonged‑Release Profile
AAPS PharmSciTech (2023) 24, 93. doi:10.1208/s12249-023-02540-9
T. Brezovar, G. Hudovornik, M. Perpar, M. Luštrik, R. Dreu