Content uniformity (CU) is a well-recognized challenge for low-dose direct compression (DC) tablet formulations. Using a dual particle engineering approach that involves a) forming a segregation-resistant drug-carrier composite to improve CU and b) nanocoating HPMC to enhance flowability, we have developed a platform DC formulation for preparing low-dose drug sustained-release (SR) tablets with excellent CU. In addition to demonstrated robustness in manufacturability, this platform formulation has the flexibility for modifying drug release rate. Thus, it is useful for expedited and material-sparing development of low dose SR tablets using the economical DC process.
Bibliographical noteFunding Information:
This work was supported by a grant from Eli Lilly and Company 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.
© 2018 Elsevier B.V.
- Direct compression
- Particle engineering
- Sustained release