Improved preparation of Abraxane ® I.V. Infusion (paclitaxel nanoparticles)

Abstract

Objective

Abraxane^® intravenous infusion (albumin-bound paclitaxel nanoparticles; Abraxane^® or paclitaxel nanoparticles) is a lyophilized cake formulation containing paclitaxel and human serum albumin in nanoparticulate form. Before use, it must be uniformly dispersed in saline. However, this reconstitution process often leads to foaming, necessitating careful handling and prolonging preparation time. This study aimed to investigate shaking conditions for rapid, uniform paclitaxel nanoparticle dispersion while minimizing foam formation. Additionally, we evaluated whether shaking affects nanoparticle size.

Methods

After adding 20 mL of saline to a vial containing 100 mg of lyophilized cake, the vial was placed either vertically or horizontally on a shaker. Two shaking types were examined: linear reciprocal and orbital shaking. We varied shaking intensity and recorded the dispersion time and foam formation. Particle size was analyzed under the following three conditions: (1) control, (2) minimal dispersion time without foaming, and (3) the condition causing the most severe foaming.

Results

When the vial was placed horizontally and subjected to orbital shaking at 100 rpm, uniform dispersion was achieved within 6.25 min without foaming. This was approximately one-third the time required under control conditions. Further, when particle size was measured under different shaking intensities in the horizontal setup, no significant change in nanoparticle size was observed regardless of shaking strength or time after preparation.

Conclusion

In the reconstitution of Abraxane^®, the optimal shaking condition identified in this study was demonstrated to not only preserve nanoparticle integrity but also reduce the time and effort required for healthcare professionals.