Bioavailability of Hydrocortisone From Commercial 20-mg Tablets
Abstract
The relative bioavailability of hydrocortisone was determined from four different 20-mg tablet formulations and one suspension in 15 healthy male volunteers; results were compared with in vitro dissolution rates. Plasma levels of hydrocortisone were determined by a liquid chromatography method developed in this laboratory. Dissolution of the tablet formulations, using the official USP test, varied from 7.8 to 93.8% in 30 min. Similar plasma profiles were obtained from all tablet products, and there were no differences among tablets in the cumulative percentage of drug absorbed. There were no clear trends in any pharmacokinetic parameter values among the tablet dosages, and the four products were considered bioequivalent. The suspension dosage yielded significantly higher plasma levels compared with some of the tablet formulations during the initial 30-min postdose, significantly higher cumulative absorption at 0.5 and 1.0 h compared with one tablet formulation, and significantly higher ka and Cmax, and shorter tmax values, compared with some of the tablets.
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The Cmax and Tmax for 20 mg hydrocortisone are in agreement with other previously published studies showing a range of 225-285 ng/ml after 1-1.4 h.
“The results for Cmax and Tmax for 20 mg hydrocortisone are also in agreement with other previously published studies showing a range of 225-285 ng/ml after 1-1.4 h [10].”
From Bioavailability of Oral Hydrocortisone Corrected for Binding Proteins and Measured by LC-MS/MS Using Serum Cortisol and Salivary Cortisone (2018) · cites this paper as [10]
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- Authors
- Patel, R. B., Rogge, M. C., Selen, A., Goehl, T. J., Shah, V. P., Prasad, V. K., & Welling, P. G.
- Affiliations
- University of Wisconsin–Madison (US)
- United States Food and Drug Administration (US)
- Corresponding author
- Patel, Rajni B.
- Welling, Peter G.
- ORCID
- Rogge, Mark C.
- Venue
- Journal of Pharmaceutical Sciences
- Publisher
- Elsevier BV
- Published
- 1984-07
- Volume
- 73
- Issue
- 7
- Pages
- 964-966
- ISSN
- 0022-3549 (ISSN-L)
- OpenAlex
- W2167556605
- Cited by
- 20
- References
- 13
- Citations by year
- 2026: 1 · 2025: 1 · 2023: 1 · 2021: 2 · 2019: 1 · 2018: 1 · 2016: 1 · 2014: 3
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Pharmaceutical Sciences (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Keywords
- cortisol, relative bioavailability, tablet formulation, bioequivalence, dissolution rate, plasma concentration, oral suspension, pharmacokinetics, absorption rate constant, healthy volunteers
- MeSH terms
- Adult, Biological Availability, Chromatography, High Pressure Liquid, Humans, Hydrocortisone, Kinetics, Male, Solubility, Spectrophotometry, Ultraviolet, Tablets
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