Mannitol is a frequently used diluent in the production of tablets due to its non-hygroscopic character and low drug interaction potential. Although the delta-polymorph of mannitol has superior tabletability in comparison to alpha- and beta-mannitol, the latter are most commonly used because large-scale production of delta-mannitol is difficult. Therefore, a continuous method for production of delta-mannitol was developed in the current study. Spray drying an aqueous solution of mannitol and PVP in a ratio of 4: 1 resulted in formation of delta-mannitol. The tabletability of a physical mixture of spray dried delta-mannitol with PVP (5%) and paracetamol (75%) was clearly superior to the tabletability of physical mixtures consisting of spray dried alpha- and beta-mannitol with PVP (5%) and paracetamol (75%) which confirmed the excellent tableting properties of the delta-polymorph. In addition, a coprocessing method was applied to coat paracetamol crystals with delta-mannitol and PVP. The tabletability of the resulting coprocessed particles consisting of 5% PVP, 20% delta-mannitol and 75% paracetamol reached a maximal tensile strength of 2.1 MPa at a main compression pressure of 260 MPa. Moreover the friability of tablets compressed at 184 MPa was only 0.5%. This was attributed to the excellent compression properties of delta-mannitol and the coating of paracetamol crystals with delta-mannitol and PVP during coprocessing.

• Ghent University

• Oral solid dose

1. Continuous production
2. Coprocessing
3. Delta mannitol
4. Direct compression
5. oral solid dose
6. paracetamol
7. Particle coating
8. Research Article
9. Spray - drying
10. Tabletability