An interlaboratory investigation of intrinsic dissolution rate determination using surface dissolution

Research output: Contribution to journalJournal articleResearchpeer-review

  • Kelly Etherson
  • Claire Dunn
  • Wayne Matthews
  • Henrik Pamelund
  • Camille Barragat
  • Natalie Sanderson
  • Toshiko Izumi
  • Claudia da Costa Mathews
  • Gavin Halbert
  • Clive Wilson
  • Mark McAllister
  • James Mann
  • Østergaard, Jesper
  • James Butler
  • Ibrahim Khadra

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.

Original languageEnglish
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Volume150
Pages (from-to)24-32
Number of pages9
ISSN0939-6411
DOIs
Publication statusPublished - 2020

    Research areas

  • Intrinsic dissolution rate (IDR), Orbito, Dissolution, Fasted State Simulated Intestinal Fluid (FaSSIF), Surface Dissolution Imaging (SDI), Gastro Intestinal Tract (GIT), IN-VIVO PERFORMANCE, BIOPHARMACEUTIC DRUG CLASSIFICATION, MEDIATED PHASE-TRANSFORMATIONS, INTESTINAL FLUIDS, PHYSICOCHEMICAL PROPERTIES, BIORELEVANT DISSOLUTION, WEAK ACIDS, SOLUBILITY, DIFFUSION, PH

ID: 245618598