Influence of formulation composition and processing on the content uniformity of low-dose tablets manufactured at kilogram scale Content uniformity of low-dose tablets D.G. Morris et al.

Daniel G. Morris, Brett F. Truitt, Angela Kong, Norma Leyva, Paul E. Luner

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

The purpose of this study was to investigate the impact of processing, API loading, and formulation composition on the content uniformity of low-dose tablets made using direct compression (DC) and roller compaction (RC) methods at 1kg scale. Blends of 1:1 microcrystalline cellulose/lactose or 1:1 microcrystalline cellulose/dicalcium phosphate anhydrous with active pharmaceutical ingredient (API) at loadings of 0.2, 1 and 5% were processed either by DC or RC. A statistical analysis showed that DC produced comparable content uniformity results to RC. Microcrystalline cellulose/lactose formulations had improved average potency compared to microcrystalline cellulose/dicalcium phosphate anhydrous formulations for both DC and RC. The impact of segregation in the DC blends and adhesion to equipment surfaces was assessed to aid in understanding potency trends. DC may be as suitable as RC for low-dose regime (e.g. <1mg) when manufacturing clinical supplies at small scale provided the API has a suitable particle size and potency loss to equipment is negligible.

Original languageEnglish (US)
Pages (from-to)451-460
Number of pages10
JournalPharmaceutical Development and Technology
Volume14
Issue number5
DOIs
StatePublished - Nov 9 2009

Keywords

  • Content uniformity
  • Direct compression
  • Dry granulation
  • Low-dose tablets
  • Segregationd

ASJC Scopus subject areas

  • Pharmaceutical Science

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