Case Study

Less than 1 min
Author name: Jerry Mizell

A Case Study of Using Common Low Moisture Fillers in the Roller Compacted Tablets

OBJECTIVE
The aim of this study was to compare the benefit of using common low moisture grade
pharmaceutical excipients: Mannitol, NF (Grades: Pearlitol® 300 DC, Pearlitol® 160c) (Roquette)
and/or Microcrystalline Cellulose, NF (Grades: Avicel® PH-200 LM, Avicel ® PH 112) (FMC Corp.)
as fillers in a tablet formulation to limit the moisture uptake by a model hygroscopic drug
manufactured with a roller compaction process.

INTRODUCTION
The model compound (X) is highly compressible with poor flow properties. Moreover, it is not
suited for a direct blend process, without increasing the tablet size to one larger than deemed
acceptable.

Amongst the means used to affect densification of a blended formulation are various forms of
granulation: notably low-shear or high-shear wet granulation or roller compaction. In the cases
where the Active Pharmaceutical Ingredient (API) has exhibited chemical or polymorphic
instability in water or other common wet granulation solvents, the process of roller compaction
is preferred.

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