Konrád Sántha1, István Antal1
1 Department of Pharmaceutics, Semmelweis University, Budapest
Introduction: Efficient compression of coated pellets is a formidable task developed long since due to the considerable forces involved during procedures, as well as the rather frail nature of the coating. Solving the issues related, however, could provide us with an easy-to-use and flexible dosage form to use in therapy, such as multiple-unit pellet systems (MUPS).
Aims: Using microcrystalline cellulose (MCC) and a hydrophobic emulgent the formulation of a cushioning processing agent designed to mix freely with drug-containing pellets and able to prevent damage to pellet coating was proposed.
Methods: In comparison with the formulated material, MCC powder and granules were also used as a comparison. Texture analysis and physical characterisation of excipients were conducted, while homogeneity of compressed tablets was determined by microfocus X-ray imaging technique. Damage to pellet coating was examined via drug release test.
Results: Texture analysis showed the novel processing aid rating the highest in plasticity. Moreover, the drug dissolution profile was not altered significantly after compression based on similarity (f2 value) evaluation. While flowability and density of MCC granules surpassed that of the tested material, best homogeneity was observed in the tablets compressed from new processing agent.
Conclusion: The results of this study show that the formulation of a cushioning excipient able to protect the pellet coating while mixing homogeneously is possible. Further adjustment could provide manufacturers with a reliable, cost-effective method to produce pellets in tablet dosage forms.
Doctoral School: Pharmaceutical Sciences
Program: Modern Trends in Pharmaceutical Scientific Research
Supervisor: István Antal
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