Lactose monohydrate flow characterization using shear cell method

Abstract

The flow properties of pharmaceutical powders have a great importance in the manufacturing of solid dosage forms. In order to ensure the performance in the production line this parameter must be determined. There are several methods described in European Pharmacopeia that are used to measure these properties. Some of them were used in this study and the results obtained from conventional methods (Conv) and shear cell using the powder flow tester (PFT) showed differences that were more evident in fractions with smaller particle size (F < 63) and for bulk powder (F_Total). The various powder behaviors showed to be related with the size of the particles. An increase of the ff_c (Flow Index) was observed with the increase of the particle size. It was also found for the different fractions that the ff_c always increases with increasing major principal consolidation stress (σ₁). This study shown to be predictive because it also allowed the behavior profiles of other LactMN fractions to be known by interpolation of the median size (Dv50) or σ₁ values ranged between the studied intervals. Furthermore, it was also observed that ff_c of the F_Total was similar to the F < 63, showing the same behavior under σ₁. The occurrence of caking was not observed.

Graphical Abstract

Keywords:

• Flow index
• flowing
• shear cell
• excipient
• diluent

Acknowledgments

The authors thank Dra. Teresa Malta and Atral, S.A., for the kindly supplying of the lactose monohydrate, that made this work possible.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This work was supported by the Applied Molecular Biosciences Unit-UCIBIO, which is financed by national funds from FCT/MCTES (UID/Multi/04378/2019).