Appropriate selection of excipient grade during tablet formulation development depends on thorough knowledge in their compaction and flow properties. Each chemically unique pharmaceutical excipient is usually available in several commercial grades that are widely different in powder properties, which influence their performance for a specific formulation application. In this work, 11 grades of mannitol were systematically characterized, in terms of their particulate, flow and tableting properties, and compared against 5 grades of lactose. Principal component analysis (PCA) identified significant correlations among selected variables, such as particle size, surface area, flowability, wall friction, plasticity parameter, tensile strength, and tablet brittleness. PCA also revealed similar grades of the two excipients, which may be used to select replacement grade, if needed, based on similarity in their overall properties.
Bibliographical noteFunding Information:
We thank Sara Solin for the particle surface area measurements. Roquette, Merck, and DFE Pharma are acknowledged for providing Pearlitol, Parteck, and lactose samples, respectively. A portion of this work was carried out in the Minnesota Nano Center which receives partial support from the NSF through the NNCI program. Appendix A
© 2018 Elsevier B.V.
- Direct compression
- Powder flow
- Principal component analysis