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European Journal of Pharmaceutics and Biopharmaceutics
Article . 2020 . Peer-reviewed
License: Elsevier TDM
Data sources: Crossref
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An interlaboratory investigation of intrinsic dissolution rate determination using surface dissolution

Authors: Etherson, Kelly; Dunn, Claire; Matthews, Wayne; Pamelund, Henrik; Barragat, Camille; Sanderson, Natalie; Izumi, Toshiko; +8 Authors

An interlaboratory investigation of intrinsic dissolution rate determination using surface dissolution

Abstract

The purpose of this study was to conduct an interlaboratory ring-study, with six partners (academic and industrial), investigating the measurement of intrinsic dissolution rate (IDR) using surface dissolution imaging (SDI) equipment. Measurement of IDR is important in pharmaceutical research as it provides characterising information on drugs and their formulations. This work allowed us to assess the SDI's interlaboratory performance for measuring IDR using a defined standard operating procedure (see supporting information) and six drugs assigned as low (tadalafil, bromocriptine mesylate), medium (carvedilol, indomethacin) and high (ibuprofen, valsartan) solubility compounds. Fasted State Simulated Intestinal Fluid (FaSSIF) and blank FaSSIF (without sodium taurocholate and lecithin) (pH 6.5) were used as media. Using the standardised protocol an IDR value was obtained for all compounds and the results show that the overall IDR rank order matched the solubility rank order. Interlaboratory variability was also examined and it was observed that the variability for lower solubility compounds was higher, coefficient of variation >50%, than for intermediate and high solubility compounds, with the exception of indomethacin in FaSSIF medium. Inter laboratory variability is a useful descriptor for understanding the robustness of the protocol and the system variability. On comparison to another published small-scale IDR study the rank ordering with respect to dissolution rate is identical except for the high solubility compounds. This results indicates that the SDI robustly measures IDR however, no recommendation on the use of one small scale method over the other is made.

Country
Denmark
Keywords

PH, Surface Properties, Drug Compounding, INTESTINAL FLUIDS, WEAK ACIDS, Intrinsic dissolution rate (IDR), IN-VIVO PERFORMANCE, BIOPHARMACEUTIC DRUG CLASSIFICATION, SOLUBILITY, Surface Dissolution Imaging (SDI), 510, Gastro Intestinal Tract (GIT), RS, Pharmacy and materia medica, Orbito, Humans, MEDIATED PHASE-TRANSFORMATIONS, Fasted State Simulated Intestinal Fluid (FaSSIF), DIFFUSION, Kinetics, BIORELEVANT DISSOLUTION, Models, Chemical, Pharmaceutical Preparations, Solubility, PHYSICOCHEMICAL PROPERTIES, Dissolution

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    16
    popularity
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    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
16
Top 10%
Average
Top 10%
Green
hybrid