In Vitro-In Vivo Correlation Of Amorphous Solid Dispersion Enabled Itraconazole Tablets
To our knowledge, this is the first and only study that successfully developed an FDA level A IVIVC of an amorphous solid dispersion, which assessed the impact of grades of the same polymer, disintegrant level, and dry granulation processing on the performance of SDD tablets in humans.
Authors
- Samuel A. Krug (ORCID: https://orcid.org/0000-0001-6904-4851)
- Ana Luisa Coutinho (ORCID: https://orcid.org/0000-0002-3885-3709)
- Asmita Adhikari
- Maureen A. Kane (ORCID: https://orcid.org/0000-0002-5525-9170)
- James E. Polli (ORCID: https://orcid.org/0000-0002-5274-4314)
- Stephen W. Hoag (ORCID: https://orcid.org/0000-0003-0657-6951)
- R. Gary Hollenbeck
Institutions
- University of Maryland, Baltimore (US)
- Janssen (United States) (US)
Publication Details
- Journal
- Pharmaceutical Research
- Published
- 2025-03-01
- DOI
- https://doi.org/10.1007/s11095-025-03837-z
- Citations
- 5
- Primary Topic
- Drug Solubulity and Delivery Systems
- Type
- article
- Field-Weighted Citation Impact
- 3.95
Funders
- Deutsches Krebsforschungszentrum
- Georgia Clinical and Translational Science Alliance
- National Institutes of Health
- National Center for Advancing Translational Sciences