Development and application of a micro-capillary rheometer for in-vitro evaluation of parenteral injectability.

A micro-capillary rheometer was developed to determine the rheology and injectability of parenteral formulations. The rheometer consisted of a micro-capillary and a glass syringe attached to an Instron that drove the syringe plunger at predetermined speeds and measured resulting forces on the plunger. The cross-head speed and the measured force were used to calculate the shear rate and the shear stress respectively, according to the Hagen-Poiseuille equation. The resulting rheograms of several Newtonian standards showed excellent linearity over a broad range of about 10 x 10(3) to 160 x 10(3) s(-1) and produced accurate and reproducible viscosity determinations over the viscosity range of about 10 x 10(-3) to 100 x 10(-3) Pa.s. The developed methodology focussed primarily on the minimization of errors associated with the determination of the wall frictional force using both direct measurement and linear regression to determine this parameter from the data. The effect of micro-capillary diameter, syringe cross-sectional area and micro-capillary length was explored in an effort to increase the measured force so that wall frictional force errors could be minimized. The micro-capillary rheometer gave reproducible and accurate rheograms over a range of shear rates consistent with the shear rate range used in clinical practice, and showed that Newtonian and non-Newtonian rheological behaviours could be evaluated quantitatively. Copyright 2004 The Authors