An interlaboratory investigation of intrinsic dissolution rate determination using surface dissolution
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An interlaboratory investigation of intrinsic dissolution rate determination using surface dissolution. / Etherson, Kelly; Dunn, Claire; Matthews, Wayne; Pamelund, Henrik; Barragat, Camille; Sanderson, Natalie; Izumi, Toshiko; Mathews, Claudia da Costa; Halbert, Gavin; Wilson, Clive; McAllister, Mark; Mann, James; Ostergaard, Jesper; Butler, James; Khadra, Ibrahim.
In: European Journal of Pharmaceutics and Biopharmaceutics, Vol. 150, 2020, p. 24-32.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - An interlaboratory investigation of intrinsic dissolution rate determination using surface dissolution
AU - Etherson, Kelly
AU - Dunn, Claire
AU - Matthews, Wayne
AU - Pamelund, Henrik
AU - Barragat, Camille
AU - Sanderson, Natalie
AU - Izumi, Toshiko
AU - Mathews, Claudia da Costa
AU - Halbert, Gavin
AU - Wilson, Clive
AU - McAllister, Mark
AU - Mann, James
AU - Ostergaard, Jesper
AU - Butler, James
AU - Khadra, Ibrahim
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Intrinsic dissolution rate (IDR)
KW - Orbito
KW - Dissolution
KW - Fasted State Simulated Intestinal Fluid (FaSSIF)
KW - Surface Dissolution Imaging (SDI)
KW - Gastro Intestinal Tract (GIT)
KW - IN-VIVO PERFORMANCE
KW - BIOPHARMACEUTIC DRUG CLASSIFICATION
KW - MEDIATED PHASE-TRANSFORMATIONS
KW - INTESTINAL FLUIDS
KW - PHYSICOCHEMICAL PROPERTIES
KW - BIORELEVANT DISSOLUTION
KW - WEAK ACIDS
KW - SOLUBILITY
KW - DIFFUSION
KW - PH
U2 - 10.1016/j.ejpb.2020.02.005
DO - 10.1016/j.ejpb.2020.02.005
M3 - Journal article
C2 - 32061919
VL - 150
SP - 24
EP - 32
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
SN - 0939-6411
ER -
ID: 245618598