Comparative evaluation of the powder and compression properties of various grades and brands of microcrystalline cellulose by multivariate methods

Abstract

The present work challenges a newly developed approach to tablet formulation development by using chemically identical materials (grades and brands of microcrystalline cellulose). Tablet properties with respect to process and formulation parameters (e.g. compression speed, added lubricant and Emcompress^® fractions) were evaluated by 2³-factorial designs. Tablets of constant true volume were prepared on a compaction simulator at constant pressure (approx. 100 MPa). The highly repeatable and accurate force-displacement data obtained was evaluated by simple ‘in-die’ Heckel method and work descriptors. Relationships and interactions between formulation, process and tablet parameters were identified and quantified by multivariate analysis techniques; principal component analysis (PCA) and partial least square regressions (PLS). The method proved to be able to distinguish between different grades of MCC and even between two different brands of the same grade (Avicel^®PH 101 and Vivapur^®101). One example of interaction was studied in more detail by mixed level design: The interaction effect of lubricant and Emcompress^® on elastic recovery of Avicel^®PH 102 was demonstrated to be complex and non-linear using the development tool under investigation.

Keywords::

• Microcrystalline cellulose
• direct compression
• brand variation
• multivariate analysis
• PAT