Abstract
Mixtures of mannitol and microcrystalline cellulose (MCC) were investigated on a small-production scale by granulation in a high-shear mixer and compression into tablets. For both excipients only a few cases of incompatibilities with active ingredients are known. Tablets with only MCC as the filler excipient have mostly inferior strength and tablets of only mannitol disintegrate slowly. However, a combination of both excipients resulted in sufficiently rapid disintegrating tablets with acceptable strength. The composition of the tablet mixture and the process of tablet manufacturing were optimised using statistical techniques. Next to the effects of the amounts of MCC and hydroxypropylcellulose (HPC) in the composition, the effects of the amount of water and the granulation time were evaluated. For the production of tablets both the effects of moisture content in the granules and compression force were studied. Simultaneous optimisation of crushing strength, disintegration time and ejection force of the tablets was carried out to find optimal regions in the design space for these tablet properties. In conclusion, mannitol/MCC mixtures can be considered as an interesting alternative in case classical excipients cannot be selected in formulation development, due to chemical incompatibilities with active ingredients or inferior physical characteristics.
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