Starch Products as Candidate Excipients in a Continuous Direct Compression Line

Sonia M. Razavi, Yi Tao, James Scicolone, Tami Morker, Charles Cunningham, Ali Rajabi-Siahboomi, Douglas B. Hausner, Fernando J. Muzzio

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Direct compression (DC) remains the most preferred technique to produce tablets, and its effectiveness is directly influenced by raw material attributes. Therefore, the selection of specific grades of excipients to achieve desirable powder flow and compression properties is of importance. Shifting toward continuous manufacturing requires even more enhanced performance, quality, and consistency directly from the starting ingredients. Starch, as a well-known excipient with good compression characteristics in its native state, is poorly flowing and highly sensitive to lubrication. The objective of this study was to characterize the flow properties of different starch products and investigate the suitability of modified starch products for continuous manufacturing. Methods: The proposed methodology included techniques to characterize material flow properties and their feeding performance in a loss-in-weight feeder. Principal component analysis (PCA) was then applied to project material properties onto reduced dimensions and compare the flow behavior of starch products with other common excipients. Results: A newly developed starch product, StarTab®, was characterized and compared with two other starch products in terms of their flow behavior. StarTab showed desirable flowability and packing behavior, demonstrated by shear cell and compressibility results. During feeder refill studies, StarTab exhibited a low total deviation of material fed in excess of setpoint compared with the other two starch products. Additionally, it was observed that StarTab flow behavior was not sensitive to its moisture level. Conclusions: StarTab showed suitable characteristics compared with other starch products making it a potential candidate to design and develop pharmaceutical continuous direct compression (PCDC) formulations.

Original languageEnglish (US)
JournalJournal of Pharmaceutical Innovation
DOIs
StateAccepted/In press - 2021

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science
  • Drug Discovery

Keywords

  • Continuous manufacturing
  • Direct compression
  • Material properties
  • Powder flow
  • Starch

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