Compactibility of mixtures of calcium carbonate and microcrystalline cellulose.

A patented coprocessed mixture of microcrystalline cellulose (MC) and calcium carbonate (CC) is claimed to perform, as a pharmaceutical excipient, equal or better than pure MC. To investigate it, the tensile strength (T) of tablets made of mixtures of MC type 102, CC, magnesium stearate (MS) and polyvinylpyrrolidone (PVP) and formed under a compaction pressure (P(c)) ranging up to 618 MPa has been determined. The compactibility of the mixtures was defined through regression parameters obtained with ln(-ln(1-T/T(max)))=slope x lnP(c) + intercept. MC/CC mixtures, P(c)=618 MPa, show a small decrease in tablet tensile strength with CC proportions up to about 20%, falling considerably thereafter. Lower compaction pressures, P(c)< or =332 MPa, show a continuous decrease in tensile strength as the CC proportion increases. A MC drastic fall in tablet tensile strength due to 2%-MS, P(c)=487 MPa, was recovered to 35% of its original value admixing about 25% CC. This maximal value of recovery showed a shift to lower proportions of CC, up to 10%, as compaction pressure decreased. This was attributed to lower CC-particles fragmentation or agglomerates spreading at lower compaction pressures. Mixtures with increased plasticity (MC/CC/PVP and MC/CC/PVP/MS) showed an increased compactibility, which was more evident at higher compaction pressures and higher CC proportions, presumably due to higher deformation and erosion of PVP particles. Inclusion of about 40% CC in a MC/PVP/MS mixture showed 60% recovery of the original MC tablet tensile strength. Lower MS proportions are expected to allow a higher recovery.