IVIVC Revised

Alimpertis, Nikolaos; Simitopoulos, Antony; Tsekouras, Athanasios A.; Macheras, Panos

doi:10.1007/s11095-024-03653-x

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Pharm Res

2024

DOI: 10.1007/s11095-024-03653-x

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IVIVC Revised

Nikolaos Alimpertis,

Antony Simitopoulos,

Athanasios A. Tsekouras

et al.

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2024

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Cited by 3 publications

References 41 publications

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Coupling Drug Dissolution with BCS

Simitopoulos,

Tsekouras,

Macheras

2024

Pharm Res

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Purpose The purpose of this study is to develop a Temporal Biopharmaceutic Classification System (T-BCS), linking Finite Dissolution Time (F.D.T.) and Mean Dissolution Time (M.D.T.) for Class I/III drugs and Mean Dissolution Time for saturation (M.D.T.s.) for Class II/IV drugs. Methods These parameters are estimated graphically or by fitting dissolution models to experimental data and coupled with the dose-to-solubility ratio (q) for each drug normalized in terms of the actual volume of dissolution medium (900 mL). Results Class I/III drugs consistently exhibited q values less than 1, aligning with expectations based on their solubility, while some Class II/IV drugs presented a deviation from anticipated q values, with observations of q < 1. This irregularity was rendered to the dissolution volume of 250 mL used for biopharmaceutical classification purposes instead of 900 mL applied as well as the dual classification of some sparingly soluble drugs. Biowaivers were also analyzed in terms of M.D.T., F.D.T. estimates and the regulatory dissolution time limits for rapidly and very-rapidly dissolved drugs. Conclusions The T-BCS is useful for establishing correlations and assessing the magnitude of M.D.T., F.D.T., or M.D.T.s. for inter- and intra-class comparisons of different drugs and provide relationships between these parameters across all the models that were utilized. Graphical Abstract

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Coupling Drug Dissolution with BCS

Simitopoulos,

Tsekouras,

Macheras

2024

Pharm Res

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Application of the Finite Absorption Time (F.A.T.) Concept in the Assessment of Bioequivalence

Tsekouras,

Macheras

2024

Pharm Res

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A floating 3D printed polypill formulation for the coadministration and sustained release of antihypertensive drugs

Zgouro,

Katsamenis,

Moschakis

et al. 2024

International Journal of Pharmaceutics

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IVIVC Revised

Cited by 3 publications

References 41 publications

Coupling Drug Dissolution with BCS

Coupling Drug Dissolution with BCS

Application of the Finite Absorption Time (F.A.T.) Concept in the Assessment of Bioequivalence

A floating 3D printed polypill formulation for the coadministration and sustained release of antihypertensive drugs

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