ArticlePharmaceutical research2012
Elucidating the role of dose in the biopharmaceutics classification of drugs: the concepts of critical dose, effective in vivo solubility, and dose-dependent BCS.
Article in Pharmaceutical research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Norfloxacin-NSAID Pharmaceutical Salts: Structure-Property Relationships for Enhanced Solubility and Stability.Crystal growth & design · 2026Article
- Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023.International journal of pharmaceutics: X · 2024Article
- Coupling Drug Dissolution with BCS.Pharmaceutical research · 2024Article
- Re-writing Oral Pharmacokinetics Using Physiologically Based Finite Time Pharmacokinetic (PBFTPK) Models.Pharmaceutical research · 2022Article
- Untangling Absorption Mechanisms and Variability in Bioequivalence Studies Using Population Analysis.Pharmaceutical research · 2021Article
- Mathematical Models to Explore Potential Effects of Supersaturation and Precipitation on Oral Bioavailability of Poorly Soluble Drugs.The AAPS journal · 2015Article
- A report from the pediatric formulations task force: perspectives on the state of child-friendly oral dosage forms.The AAPS journal · 2013Review
- Oral delivery of ionic complex of ceftriaxone with bile acid derivative in non-human primates.Pharmaceutical research · 2013Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo develop a dose dependent version of BCS and identify a critical dose after which the amount absorbed is independent from the dose.
methodsWe utilized a mathematical model of drug absorption in order to produce simulations of the fraction of dose absorbed (F) and the amount absorbed as function of the dose for the various classes of BCS and the marginal cases in between classes.
resultsSimulations based on the mathematical model of F versus dose produced patterns of a constant F throughout a wide range of doses for drugs of Classes I, II and III, justifying biowaiver claim. For Classes I and III the pattern of a constant F stops at a critical dose Dose(cr) after which the amount of drug absorbed, is independent from the dose. For doses higher than Dose(cr), Class I drugs become Class II and Class III drugs become Class IV. Dose(cr) was used to define an in vivo effective solubility as S(eff) = Dose(cr)/250 ml. Literature data were used to support our simulation results.
conclusionsA new biopharmaceutic classification of drugs is proposed, based on F, separating drugs into three regions, taking into account the dose, and Dose(cr), while the regions for claiming biowaiver are clearly defined.
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22760660What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.