Isomalt and its diastereomer mixtures as stabilizing excipients with freeze-dried lactate dehydrogenase

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Tuderman , A-K , Strachan , C J & Juppo , A M 2018 , ' Isomalt and its diastereomer mixtures as stabilizing excipients with freeze-dried lactate dehydrogenase ' , International Journal of Pharmaceutics , vol. 538 , no. 1-2 , pp. 287-295 . https://doi.org/10.1016/j.ijpharm.2018.01.015

Title: Isomalt and its diastereomer mixtures as stabilizing excipients with freeze-dried lactate dehydrogenase
Author: Tuderman, Anna-Kaisa; Strachan, Clare J.; Juppo, Anne M.
Contributor organization: Faculty of Pharmacy
Division of Pharmaceutical Chemistry and Technology
Formulation and industrial pharmacy
Clare Strachan / Research Group
Preclinical Drug Formulation and Analysis group
Drug Research Program
Anne Juppo / Principal Investigator
Pharmaceutical Design and Discovery group
Date: 2018-03-01
Language: eng
Number of pages: 9
Belongs to series: International Journal of Pharmaceutics
ISSN: 0378-5173
DOI: https://doi.org/10.1016/j.ijpharm.2018.01.015
URI: http://hdl.handle.net/10138/309906
Abstract: The purpose of this research was to study isomalt as a protein-stabilizing excipient with lactate dehydrogenase (LDH) during freeze-drying and subsequent storage and compare it to sucrose, a standard freeze-drying excipient. Four different diastereomer mixtures of isomalt were studied. The stability of the protein was studied with a spectrophotometric enzyme activity test and circular dichroism after freeze-drying and after 21 days of storage at 16% RH. Physical stability was analyzed with differential scanning calorimetry and Karl Fischer titration. Statistical analysis was utilized in result analysis. LDH activity was almost completely retained after freeze-drying with sucrose; whereas samples stabilized with isomalt diastereomer mixtures had a considerably lower protein activity. During storage the sucrose-containing samples lost most of their enzymatic activity, while the isomalt mixtures retained the protein activity better. In all cases changes to protein secondary structure were observed. Isomalt diastereomer mixtures have some potential as protein-stabilizing excipients during freeze-drying and subsequent storage. Isomalt stabilized LDH moderately during freeze-drying; however it performed better during storage. Future studies with other proteins are required to evaluate more generally whether isomalt would be a suitable excipient for pharmaceutical freeze-dried protein formulations.
Subject: Isomalt
Freeze-drying
Protein stabilization
Lactate dehydrogenase
Sucrose
PHARMACEUTICALLY RELEVANT PROTEINS
HUMAN GROWTH-HORMONE
LYOPHILIZATE COLLAPSE
SOLID-STATE
ELEVATED-TEMPERATURES
FROZEN STATE
SUCROSE
FORMULATION
STORAGE
MECHANISMS
317 Pharmacy
Peer reviewed: Yes
Rights: cc_by_nc_nd
Usage restriction: openAccess
Self-archived version: acceptedVersion


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