Specific Excipient Requirements in Continuous Tablet Manufacturing

Abstract

Continuous Manufacturing Technology continues to gain importance in pharmaceutical manufacturing.
Although traditional processes like direct compression, roller compaction, or wet granulation are used within the continuous lines, the requirement for ingredients may differ from traditional batch processing.
This whitepaper analyzes the various steps of a continuous process in the light of excipient properties.

The evaluation shows that multifunctional excipients such as PROSOLV® SMCC and PROSOLV® EASYtab SP may be particularly well-suited for continuous processes.

Introduction

While the actual granulation and tableting steps within a continuous process have great similarity with traditional processes, the major difference lies in the feeding and mixing of the ingredients, as well as in the inline monitoring of the blend uniformity. This article aims to identify specific requirements resulting from these differences.

Picture 1 shows the set-up of the research production line used at the University of Eastern Finland in Kuopio. The line consists of a primary feeding and blending unit with three feeders, a roller compactor, a secondary feeding and a blending unit for the addition of extragranular ingredients and a tablet press. The content of active ingredient in the powder blend is constantly monitored by NIR measurement. In addition, segmented conveyor systems enable an off-line analysis of samples representing well-defined time intervals of the blender´s output.

See the complete research overview in the brochure
(click to open the brochure)

Conclusion

PROSOLV® EASYtab SP presents a set of properties that make it well-suited for continuous processing. Its multifunctionality enables production with just two feeders, since it acts as a filler/binder, flow aid, disintegrant and lubricant at the same time.

PROSOLV® EASYtab´s unique surface structure and good flowability enable fast and segregation-free blending with APIs. Its all-in-one structure, using sodium steary fumarate as a lubricant, provides outstanding robustness in terms of blending times.

Source: JRS brochure “Specific Excipient Requirements in Continuous Tablet Manufacturing”