A mesoporous silica based platform to enable tablet formulations of low dose drugs by direct compression

Wei Jhe Sun, Aktham Aburub, Changquan Calvin Sun

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Achieving adequate content uniformity (CU) is a significant challenge in the development and manufacturing of low dose oral tablets. Using four model active pharmaceutical ingredients (APIs), we show that loading APIs into a grade of mesoporous silica, Aeroperl®, is effective for achieving excellent CU. All APIs in the Aeroperl® composites were amorphous. After six months under accelerated stability conditions, the drug-Aeoperl composites exhibited good physical stability for all four APIs. The performance of Aeroperl®-based formulations was robust since their good CU and manufacturability were insensitive to model APIs. In addition, the dissolution rate of composite-based formulations was higher than corresponding physical mixtures. Overall, the Aeroperl®-based platform formulation is a promising approach for successfully developing low dose oral tablet products.

Original languageEnglish (US)
Pages (from-to)184-189
Number of pages6
JournalInternational journal of pharmaceutics
Volume539
Issue number1-2
DOIs
StatePublished - Mar 25 2018

Bibliographical note

Funding Information:
This work was supported by a grant from Eli Lilly through the Lilly Research Award Program. W-J. Sun is grateful to the Department of Pharmaceutics, University of Minnesota for a David and Marilyn Grant Fellowship in Physical Pharmacy (2015-2017) and the Dane O. Kildsig Center for Pharmaceutical Processing Research (CPPR) for partial financial support.

Publisher Copyright:
© 2018 Elsevier B.V.

Keywords

  • Aeroperl®
  • Amorphous
  • Neusilin®
  • Particle engineering
  • Stability

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