Dissolution Model Development: Formulation Effects and Filter Complications

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

Dissolution Model Development: Formulation Effects and Filter Complications. / Berthelsen, Ragna; Holm, Rene; Jacobsen, Jette; Kristensen, Jakob; Abrahamsson, Bertil; Mullertz, Anette.

In: Dissolution Technologies, Vol. 23, No. 1, 02.2016, p. 6-12.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Berthelsen, R, Holm, R, Jacobsen, J, Kristensen, J, Abrahamsson, B & Mullertz, A 2016, 'Dissolution Model Development: Formulation Effects and Filter Complications', Dissolution Technologies, vol. 23, no. 1, pp. 6-12. https://doi.org/10.14227/DT230116P6

APA

Berthelsen, R., Holm, R., Jacobsen, J., Kristensen, J., Abrahamsson, B., & Mullertz, A. (2016). Dissolution Model Development: Formulation Effects and Filter Complications. Dissolution Technologies, 23(1), 6-12. https://doi.org/10.14227/DT230116P6

Vancouver

Berthelsen R, Holm R, Jacobsen J, Kristensen J, Abrahamsson B, Mullertz A. Dissolution Model Development: Formulation Effects and Filter Complications. Dissolution Technologies. 2016 Feb;23(1):6-12. https://doi.org/10.14227/DT230116P6

Author

Berthelsen, Ragna ; Holm, Rene ; Jacobsen, Jette ; Kristensen, Jakob ; Abrahamsson, Bertil ; Mullertz, Anette. / Dissolution Model Development: Formulation Effects and Filter Complications. In: Dissolution Technologies. 2016 ; Vol. 23, No. 1. pp. 6-12.

Bibtex

@article{a7eb5be4fd754f84a52f8c425f58473a,
title = "Dissolution Model Development: Formulation Effects and Filter Complications",
abstract = "This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Several dissolutionapparatus and sample preparation techniques were tested. The flow-through cell apparatus (USP 4) was found unfit for dissolution testing of fenofibrate MeltDose formulations due to clogging of filters and varying flow rates. A mini paddledissolution setup produced dissolution profiles of the tested formulations that correlated well with clinical data. The work towards the mini paddle dissolution method demonstrates that sample preparation influenced the results. Theinvestigations show that excipients from the formulations directly affected the drug–filter interaction, thereby affecting the dissolution profiles and the ability to predict the in vivo data. With the tested drug–formulation combination, thebest in vivo–in vitro correlation was found after filtration of the dissolution samples through 0.45-μm hydrophobic PTFE membrane filters.",
keywords = "Dissolution, USP Apparatus 2, USP Apparatus 4, IVIVC, drug-filter interaction, fenofibrate",
author = "Ragna Berthelsen and Rene Holm and Jette Jacobsen and Jakob Kristensen and Bertil Abrahamsson and Anette Mullertz",
year = "2016",
month = feb,
doi = "10.14227/DT230116P6",
language = "English",
volume = "23",
pages = "6--12",
journal = "Dissolution Technologies",
issn = "1521-298X",
publisher = "Dissolution Technologies, Inc.",
number = "1",

}

RIS

TY - JOUR

T1 - Dissolution Model Development: Formulation Effects and Filter Complications

AU - Berthelsen, Ragna

AU - Holm, Rene

AU - Jacobsen, Jette

AU - Kristensen, Jakob

AU - Abrahamsson, Bertil

AU - Mullertz, Anette

PY - 2016/2

Y1 - 2016/2

N2 - This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Several dissolutionapparatus and sample preparation techniques were tested. The flow-through cell apparatus (USP 4) was found unfit for dissolution testing of fenofibrate MeltDose formulations due to clogging of filters and varying flow rates. A mini paddledissolution setup produced dissolution profiles of the tested formulations that correlated well with clinical data. The work towards the mini paddle dissolution method demonstrates that sample preparation influenced the results. Theinvestigations show that excipients from the formulations directly affected the drug–filter interaction, thereby affecting the dissolution profiles and the ability to predict the in vivo data. With the tested drug–formulation combination, thebest in vivo–in vitro correlation was found after filtration of the dissolution samples through 0.45-μm hydrophobic PTFE membrane filters.

AB - This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Several dissolutionapparatus and sample preparation techniques were tested. The flow-through cell apparatus (USP 4) was found unfit for dissolution testing of fenofibrate MeltDose formulations due to clogging of filters and varying flow rates. A mini paddledissolution setup produced dissolution profiles of the tested formulations that correlated well with clinical data. The work towards the mini paddle dissolution method demonstrates that sample preparation influenced the results. Theinvestigations show that excipients from the formulations directly affected the drug–filter interaction, thereby affecting the dissolution profiles and the ability to predict the in vivo data. With the tested drug–formulation combination, thebest in vivo–in vitro correlation was found after filtration of the dissolution samples through 0.45-μm hydrophobic PTFE membrane filters.

KW - Dissolution

KW - USP Apparatus 2

KW - USP Apparatus 4

KW - IVIVC

KW - drug-filter interaction

KW - fenofibrate

U2 - 10.14227/DT230116P6

DO - 10.14227/DT230116P6

M3 - Journal article

VL - 23

SP - 6

EP - 12

JO - Dissolution Technologies

JF - Dissolution Technologies

SN - 1521-298X

IS - 1

ER -

ID: 172886901