The uniformity of active pharmaceutical ingredient (API) is a main challenge associated with manufacturing low dose tablets. Here, we present a binder enhanced API-microcrystalline cellulose (BEAM) approach to address this challenge. In the BEAM approach a powder is prepared by spraying a PVP hydro-alcoholic solution, which contains API at an appropriate concentration, onto a powder bed of microcrystalline cellulose (MCC) under high shear. BEAM powders of 5 model APIs, with solubility spanning a range of 5 orders of magnitude, all exhibited excellent flowability, tabletability, and low ejection force. Therefore, all BEAM powders could be directly compressed into tablets with excellent API uniformity and fast disintegration without using any other excipients. Compared to traditional ways to address content uniformity problems, this formulation strategy is much more robust and simpler, making it a potential platform technology for manufacturing tablets of potent APIs.
Bibliographical noteFunding Information:
Part of this work was carried out in the Characterization Facility, University of Minnesota, which receives partial support from NSF through the MRSEC program.
© 2020 Elsevier B.V.
- Content uniformity
- Low dose
- Microcrystalline cellulose
PubMed: MeSH publication types
- Journal Article