Flip-flop Pharmacokinetics – Delivering a Reversal of Disposition: Challenges and Opportunities During Drug Development

Yáñez, Jaime A; Remsberg, Connie M; Sayre, Casey L; Forrest, M Laird; Davies, Neal M

doi:10.4155/tde.11.19

Cited by 279Drug Solubulity and Delivery SystemsPharmaceutical studies and practicesPharmacogenetics and Drug Metabolism

Flip-flop Pharmacokinetics – Delivering a Reversal of Disposition: Challenges and Opportunities During Drug Development

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Yáñez, Jaime A, Remsberg, Connie M, Sayre, Casey L, Forrest, M Laird, Davies, Neal M·2011·Therapeutic Delivery

DOI 10.4155/tde.11.19PMC PMC3152312

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Abstract

Flip-flop pharmacokinetics is a phenomenon often encountered with extravascularly administered drugs. Occurrence of flip-flop spans preclinical to human studies. The purpose of this article is to analyze both the pharmacokinetic interpretation errors and opportunities underlying the presence of flip-flop pharmacokinetics during drug development. Flip-flop occurs when the rate of absorption is slower than the rate of elimination. If it is not recognized, it can create difficulties in the acquisition and interpretation of pharmacokinetic parameters. When flip-flop is expected or discovered, a longer duration of sampling may be necessary in order to avoid overestimation of fraction of dose absorbed. Common culprits of flip-flop disposition are modified dosage formulations; however, formulation characteristics such as the drug chemical entities themselves or the incorporated excipients can also cause the phenomenon. Yet another contributing factor is the physiological makeup of the extravascular site of administration. In this article, these causes of flip-flop pharmacokinetics are discussed with incorporation of relevant examples and the implications for drug development outlined.

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For immediate-release oral drug formulations, the absorption rate is faster than the elimination rate.
“Notably, for immediate-release oral drug formulations, the absorption rate is faster than the elimination rate [32].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [32]
In “Factors that affect rate constants > Drug physicochemical factors” (page not provided), the paper says GI absorption is generally believed to be faster than elimination for most immediate-release orally dosed drugs. The citing sentence omits “most” and states the relationship without qualification. (LLM, conf=0.87)
Experimental — accuracy not yet measured
The absorption rate of LAI antipsychotics is slower than the elimination rate, resulting in 'flip-flop' kinetics, whereby the time to steady state is a function of absorption, and the concentration at steady state is a function of elimination.
“Therefore, the absorption rate of LAI antipsychotics is slower than the elimination rate, resulting in “flip-flop” kinetics, whereby the time to steady state is a function of absorption, and the concentration at steady state is a function of elimination (Fig. 1) [32, 33].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [32]
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[24]Brindley C Practical deconvolution Pharmacokinetics in Drug Development: Clinical Study Design and Analysis Bonate P Howard D AAPS Press Arlington, VA, USA 479 500 2005

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“…by use of the very long-acting buprenorphine implant (Sixmo), 70 which exhibits flip-flop pharmacokinetics (where the absorption half-life predominates over the elimination half-life to determine duration of drug action) 71 and might allow gradual tapering by reducing the number of implants used.”

Authors: Yáñez, J. A., Remsberg, C. M., Sayre, C. L., Forrest, M. L., & Davies, N. M.
Affiliations: Alcon (United States) (US)
Washington State University (US)
University of Kansas (US)
ORCID: Yáñez, Jaime A
Remsberg, Connie M
Sayre, Casey L
Forrest, M Laird
Davies, Neal M
Venue: Therapeutic Delivery
Publisher: Informa UK Limited
Published: 2011-05
Volume: 2
Issue: 5
Pages: 643-672
ISSN: 2041-5990 (ISSN-L)
2041-6008
DOI: 10.4155/tde.11.19
PMC: PMC3152312
OpenAlex: W2114632070
Cited by: 279
References: 153
Citations by year: 2026: 28 · 2025: 35 · 2024: 24 · 2023: 24 · 2022: 25 · 2021: 32 · 2020: 18 · 2019: 11 · 2018: 20 · 2017: 15 · 2016: 7 · 2015: 12 · 2014: 14 · 2013: 13
FWCI: 0.89
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Therapeutic Delivery (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (R21CA132033)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
Keywords: absorption rate, elimination rate, sampling duration, dosage formulation, pharmaceutical excipients, drug development
MeSH terms: Humans, Pharmacokinetics, Drug Discovery

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Flip-flop Pharmacokinetics – Delivering a Reversal of Disposition: Challenges and Opportunities During Drug Development

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