Physical Stability of Freeze-Dried Isomalt Diastereomer Mixtures
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Physical Stability of Freeze-Dried Isomalt Diastereomer Mixtures. / Koskinen, Anna-Kaisa; Fraser-Miller, Sara J.; Bøtker, Johan P.; Heljo, Ville P.; Barnsley, Jonathan E.; Gordon, Keith C.; Strachan, Clare J.; Juppo, Anne M.
I: Pharmaceutical Research, Bind 33, Nr. 7, 2016, s. 1752–1768.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Physical Stability of Freeze-Dried Isomalt Diastereomer Mixtures
AU - Koskinen, Anna-Kaisa
AU - Fraser-Miller, Sara J.
AU - Bøtker, Johan P.
AU - Heljo, Ville P.
AU - Barnsley, Jonathan E.
AU - Gordon, Keith C.
AU - Strachan, Clare J.
AU - Juppo, Anne M.
PY - 2016
Y1 - 2016
N2 - PurposeIsomalt is a sugar alcohol used as an excipient in commercially available solid oral dosage forms. The potential of isomalt as a novel freeze-drying excipient was studied in order to increase knowledge of the behavior of isomalt when it is freeze-dried.MethodsIsomalt was freeze-dried in four different diastereomer compositions and its physical stability was investigated with differential scanning calorimetry, Fourier-transform infrared and Raman spectroscopy, X-ray powder diffraction, Karl-Fischer titration and thermogravimetric analysis in order to verify the solid state form of isomalt after freeze-drying and observe any changes occurring during storage in three different relative humidity conditions.ResultsIsomalt was successfully transformed into the amorphous form with freeze-drying and three diastereomer combinations remained stable as amorphous during storage; one of the diastereomer compositions showed signs of physical instability when stored in the highest relative humidity condition. The four different crystalline diastereomer mixtures showed specific identifiable solid state properties.ConclusionsIsomalt was shown to be a suitable excipient for freeze-drying. Preferably a mixture of the diastereomers should be used, as the mixture containing only one of the isomers showed physical instability. A mixture containing a 1:1 ratio of the two diastereomers showed the best physical stability in the amorphous form.
AB - PurposeIsomalt is a sugar alcohol used as an excipient in commercially available solid oral dosage forms. The potential of isomalt as a novel freeze-drying excipient was studied in order to increase knowledge of the behavior of isomalt when it is freeze-dried.MethodsIsomalt was freeze-dried in four different diastereomer compositions and its physical stability was investigated with differential scanning calorimetry, Fourier-transform infrared and Raman spectroscopy, X-ray powder diffraction, Karl-Fischer titration and thermogravimetric analysis in order to verify the solid state form of isomalt after freeze-drying and observe any changes occurring during storage in three different relative humidity conditions.ResultsIsomalt was successfully transformed into the amorphous form with freeze-drying and three diastereomer combinations remained stable as amorphous during storage; one of the diastereomer compositions showed signs of physical instability when stored in the highest relative humidity condition. The four different crystalline diastereomer mixtures showed specific identifiable solid state properties.ConclusionsIsomalt was shown to be a suitable excipient for freeze-drying. Preferably a mixture of the diastereomers should be used, as the mixture containing only one of the isomers showed physical instability. A mixture containing a 1:1 ratio of the two diastereomers showed the best physical stability in the amorphous form.
U2 - 10.1007/s11095-016-1915-3
DO - 10.1007/s11095-016-1915-3
M3 - Journal article
C2 - 27059921
VL - 33
SP - 1752
EP - 1768
JO - Pharmaceutical Research
JF - Pharmaceutical Research
SN - 0724-8741
IS - 7
ER -
ID: 160798354