Privatsphäre-Einstellungen

Brand-to-Brand and Batch-to-Batch Uniformity of Microcrystalline Cellulose in Direct Tableting with a Pneumohydraulic Tablet Press

Jessica Albers, Klaus Knop, and Peter Kleinebudde

Heinrich-Heine-University, Institute of Pharmaceutics and Biopharmaceutics, Düsseldorf (Germany)

Corresponding author: Prof. Dr. Peter Kleinebudde, Heinrich-Heine-University, Institute of Pharmaceutics and Biopharmaceutics, Universitätsstr. 1, Building 26.22.00, 40225 Düsseldorf (Germany), e-mail: kleinebudde@uni-duesseldorf.de

With the help of powder and tablet characteristics the uniformity of microcrystalline cellulose (MCC) type 101 was analysed. Therefore MCCs type 101 from five different manufacturers each represented by three batches were investigated in order to determine brand-to-brand and batch-to-batch variability. Tablets were pressed using a new type of instrumented pneumohydraulic single punch tablet press. This machine is suitable in the pharmaceutical development because of its flexible adjustability of the compression parameters. The aim of this work was to examine to what extent a change of the batch or the manufacturer in production has an influence on the powder and tablet properties. In the characterisation of the powders, only slight differences were observed, excluded with respect to the particle size, the specific surspezififace area and the flowability measured based on ring shear cell experiments. The 15 batches showed different tableting behaviour and tablet characteristics measured by the crushing strength, the friability and the disintegration time. Results of the analysis of variance confirmed both the variances between the five examined manufacturers and between the respective batches of one manufacturer.
Therefore it could be shown that the uniformity of microcrystalline cellulose from different manufacturers and even within a supplier is not given on the market. As the five manufacturers provide different MCCs, the production process should be adjusted when changing the batch or brand of MCC in a specific formulation.

Key words Batch-to-batch uniformity • Brand-to-brand uniformity • FlexiTab^TM • Microcrystalline cellulose • Pneumohydraulic tablet press • Ring shear cell • Tableting