title: The rheological properties of self-emulsifying systems, water and microcrystalline cellulose.
abstract: The rheological properties of mixtures of equal parts of a range of ratios of a self-emulsifying system (MP) and water (W) added to microcrystalline cellulose (MCC), have been measured by an extrusion capillary rheometer. These measurements allow assessment of both the shear and tension components of flow plus the elastic behaviour of the wet powder masses, although the results for the estimation of shear stress require careful interpretation due to the limitation of the measuring system and the assumptions made in their derivation. The results indicate that there are three regions of behaviour of the systems, which are all significantly different from the mixtures containing only W and MCC. At low MP contents (1.5--23%), the masses increase in their resistance to shear and elongational flow and have lower elasticity. These similarities in behaviour occur in spite of considerable increase in the viscosity of the MPW mixtures and a change to non-Newtonian flow of the fluid. The behaviour of the 46% MP system is intermediate between these systems and the high MP concentrations (69, 80 and 92%). These latter systems show less resistance to shear and elongational flow than the first group of concentrations, but show considerably higher levels of elasticity. As the resistance to shear decreases, so does the impairment of the surface of the extrudate. There is clear evidence of a systematic change in behaviour of the wet powder masses as the values for the angle of entry of the wet mass into the die when plotted against the ratio of the resistance to die entry (upstream pressure loss) to the shear stress within the die, is linear on a log/log scale. Also, the values of compliance of the systems as a function of shear stress fall on a common curve. Changes in the ratio of the MPW to MCC for a system for a single level of MP (46%) resulted in a change in the values of the rheological parameters but not the type of behaviour. As all these wet powder masses had been shown previously to form pellets by the process of extrusion/spheronization, it is clear that systems with a wide range of rheological characteristics can be processed and no single rheological parameter can be used to provide complete characterisation of the processability of such systems.
authors.affiliation: The School of Pharmacy, University of London, Brunswick Square, London WC1N 1AX, UK. michael.newton@ams1.ulsop.ac.uk
authors.forename: J M
authors.initials: JM
authors.lastname: Newton
authors.forename: M
authors.initials: M
authors.lastname: Bazzigialuppi
authors.forename: F
authors.initials: F
authors.lastname: Podczeck
authors.forename: S
authors.initials: S
authors.lastname: Booth
authors.forename: A
authors.initials: A
authors.lastname: Clarke
mesh_terms: D002482:Cellulose / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004075:Diglycerides / Q000737:chemistry; D004655:Emulsions; D005079:Excipients / Q000737:chemistry*; D005989:Glycerides / Q000737:chemistry; D011136:Polysorbates / Q000737:chemistry; D012212:Rheology; D014867:Water / Q000737:chemistry*
chemical_list: D004075:Diglycerides; D004655:Emulsions; D005079:Excipients; D005989:Glycerides; D011136:Polysorbates; D014867:Water; D002482:Cellulose; C109691:microcrystalline cellulose