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Coupling biorelevant dissolution methods with physiologically based pharmacokinetic modelling to forecast in-vivo performance of solid oral dosage forms.
J Pharm Pharmacol. 2013 Jul; 65(7):937-52.JP

Abstract

OBJECTIVES

To summarize the basis for and progress with the development of in-vitro-in-silico-in-vivo (IV-IS-IV) relationships for oral dosage forms using physiologically based pharmacokinetic (PBPK) modelling, with the focus on predicting the performance of solid oral dosage forms in humans.

KEY FINDINGS

Various approaches to forecasting oral absorption have been reported to date. These range from simple dissolution tests, through biorelevant dissolution testing and laboratory simulations of the gastrointestinal (GI) tract, to the use of PBPK modelling to predict oral drug absorption based on the physicochemical parameters of the drug substance. Although each of these approaches can be useful for qualitative predictions, forecasting oral absorption on a quantitative basis with an individual approach is only possible for selected drug/dosage form combinations. By integrating biorelevant dissolution test results with the PBPK models, it has become possible to achieve quantitatively accurate as well as qualitative predictions of plasma profiles after oral dosing for both immediate and modified release formulations.

SUMMARY

With further refinement of both the biorelevant dissolution testing methods and the PBPK models, it should be possible to expedite the development and regulatory approval of optimized dosage forms and dosing conditions.

Authors+Show Affiliations

Goethe University, Frankfurt am Main, Germany; Takeda Pharmaceutical Company Limited, Osaka, Japan.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

23738721

Citation

Otsuka, Keiichi, et al. "Coupling Biorelevant Dissolution Methods With Physiologically Based Pharmacokinetic Modelling to Forecast In-vivo Performance of Solid Oral Dosage Forms." The Journal of Pharmacy and Pharmacology, vol. 65, no. 7, 2013, pp. 937-52.
Otsuka K, Shono Y, Dressman J. Coupling biorelevant dissolution methods with physiologically based pharmacokinetic modelling to forecast in-vivo performance of solid oral dosage forms. J Pharm Pharmacol. 2013;65(7):937-52.
Otsuka, K., Shono, Y., & Dressman, J. (2013). Coupling biorelevant dissolution methods with physiologically based pharmacokinetic modelling to forecast in-vivo performance of solid oral dosage forms. The Journal of Pharmacy and Pharmacology, 65(7), 937-52. https://doi.org/10.1111/jphp.12059
Otsuka K, Shono Y, Dressman J. Coupling Biorelevant Dissolution Methods With Physiologically Based Pharmacokinetic Modelling to Forecast In-vivo Performance of Solid Oral Dosage Forms. J Pharm Pharmacol. 2013;65(7):937-52. PubMed PMID: 23738721.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Coupling biorelevant dissolution methods with physiologically based pharmacokinetic modelling to forecast in-vivo performance of solid oral dosage forms. AU - Otsuka,Keiichi, AU - Shono,Yasushi, AU - Dressman,Jennifer, Y1 - 2013/03/25/ PY - 2013/01/10/received PY - 2013/02/11/accepted PY - 2013/6/7/entrez PY - 2013/6/7/pubmed PY - 2014/1/28/medline SP - 937 EP - 52 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 65 IS - 7 N2 - OBJECTIVES: To summarize the basis for and progress with the development of in-vitro-in-silico-in-vivo (IV-IS-IV) relationships for oral dosage forms using physiologically based pharmacokinetic (PBPK) modelling, with the focus on predicting the performance of solid oral dosage forms in humans. KEY FINDINGS: Various approaches to forecasting oral absorption have been reported to date. These range from simple dissolution tests, through biorelevant dissolution testing and laboratory simulations of the gastrointestinal (GI) tract, to the use of PBPK modelling to predict oral drug absorption based on the physicochemical parameters of the drug substance. Although each of these approaches can be useful for qualitative predictions, forecasting oral absorption on a quantitative basis with an individual approach is only possible for selected drug/dosage form combinations. By integrating biorelevant dissolution test results with the PBPK models, it has become possible to achieve quantitatively accurate as well as qualitative predictions of plasma profiles after oral dosing for both immediate and modified release formulations. SUMMARY: With further refinement of both the biorelevant dissolution testing methods and the PBPK models, it should be possible to expedite the development and regulatory approval of optimized dosage forms and dosing conditions. SN - 2042-7158 UR - https://www.unboundmedicine.com/medline/citation/23738721/Coupling_biorelevant_dissolution_methods_with_physiologically_based_pharmacokinetic_modelling_to_forecast_in_vivo_performance_of_solid_oral_dosage_forms_ L2 - https://doi.org/10.1111/jphp.12059 DB - PRIME DP - Unbound Medicine ER -