Dry heat stress stability evaluation of casein peptide mixture

D׳Hondt, Matthias; Demaré, Wim; Dorpe, Sylvia Van; Wynendaele, Evelien; Burvenich, Christian; Peremans, Kathelijne; Spiegeleer, Bart De

doi:10.1016/j.foodchem.2011.03.004

Cited by 15 publications

(6 citation statements)

References 28 publications

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“…In 120 addition, the influence of an oxidizing and reductive environment on its dry heat-induced 121 degradation profile was also evaluated by mixing β-artemether (3 parts) with potassium 122 permanganate and zinc, respectively (1 part), using mortar and pestle, thus obtaining two 123 different powder mixtures [13]. 124…”

Section: Materials and Methods 86mentioning

confidence: 99%

Relative response factor determination of β-artemether degradants by a dry heat stress approach

Spiegeleer

D׳Hondt

Vangheluwe

et al. 2012

Journal of Pharmaceutical and Biomedical Analysis

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Relative response factor determination of rmbeta-artemether degradants by a dry heat stress approach, Journal of Pharmaceutical and Biomedical Analysis (2010), doi:10.1016/j.jpba.2012 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. During the stability evaluation of -artemether containing finished drug products, a consistent 20 and disproportional increase in the UV-peak areas of -artemether degradation products, 21 when compared to the peak area decline of -artemether itself, was observed. This suggested 22 that the response factors of the formed -artemether degradants were significantly higher than 23 β-artemether. Dry heat stressing of -artemether powder, as a single compound, using 24 different temperatures (125 °C -150 °C), times (10 min -90 min) and environmental 25 conditions (neutral, KMnO 4 and zinc), resulted in the formation of 17 degradants. The vast 26 majority of degradants seen during the long-term and accelerated ICH stability study of the 27 drug product, were also observed here. The obtained stress results allowed the calculation of 28 the overall average relative response factor (RRF) of -artemether degradants, i.e. 21.2, 29 whereas the individual RRF values of the 9 most prominent selected degradants ranged from 30 4.9 to 42.4. Finally, Ames tests were performed on -artemether as well as a representative 31 stressed sample mixture, experimentally assessing their mutagenic properties. Both were 32 found to be negative, suggesting no mutagenicity problems of the degradants at high 33 concentrations. Our general approach and specific results solve the developmental quality 34 issue of mass balance during stability studies and the related genotoxicity concerns of the key 35 antimalarial drug -artemether and its degradants. 36

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Section: Materials and Methods 86mentioning

confidence: 99%

Relative response factor determination of β-artemether degradants by a dry heat stress approach

Spiegeleer

D׳Hondt

Vangheluwe

et al. 2012

Journal of Pharmaceutical and Biomedical Analysis

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“…The Maillard reaction refers to the nonenzymatic browning that was the outcome from a chemical reaction between an amino acid and a reducing sugar and commonly requires heat as an initiator. A previous study suggested that the possible reason for peptide degradation might be to the occurrence of a Maillard reaction and it has been reported that asparagine are among the amino acids that are sensitive to the Maillard reaction (D'Hondt and others ). This result agreed with those shown in Table where asparagine was absent in OD Ajwa dates compared to the FD Ajwa dates.…”

Section: Resultsmentioning

confidence: 99%

Influence of Different Drying Treatments and Extraction Solvents on the Metabolite Profile and Nitric Oxide Inhibitory Activity of Ajwa Dates

Abdul‐Hamid

Abas

Ismail

et al. 2015

Journal of Food Science

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The association between metabolite profiles and nitric oxide (NO) inhibitory activity of the various extracts of Ajwa dates was evaluated by utilizing partial least squares (PLS) model. The validated PLS model can be employed to predict the NO inhibitory activity of new samples of date fruits based on their NMR spectra which was important for assessing fruit quality. The information gained might be used as guidance for quality control, nutritional values and as a basis for the preparation of any food supplements for human health that employs date palm fruit as the raw material.

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“…An HPLC method was developed using a fusedcore silica stationary phase. 8 This hybrid technology, consisting of a 0.5-µm thick porous shell fused to a 1.7-mm inert core, w enables faster chromatographic separation with similar resolution to classic HPLC columns, which use fully porous particles. During method development, both stressed and unstressed solutions containing single triple intrathecal components and the mixture of all three components were analyzed using different linear gradient times, ranging from 5 to 30 minutes.…”

Section: Methodsmentioning

confidence: 99%

Stability of extemporaneously prepared cytarabine, methotrexate sodium, and methylprednisolone sodium succinate

D׳Hondt¹,

Vangheluwe²,

Dorpe

et al. 2012

American Journal of Health-System Pharmacy

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Dry heat stress stability evaluation of casein peptide mixture

Cited by 15 publications

References 28 publications

Relative response factor determination of β-artemether degradants by a dry heat stress approach

Relative response factor determination of β-artemether degradants by a dry heat stress approach

Influence of Different Drying Treatments and Extraction Solvents on the Metabolite Profile and Nitric Oxide Inhibitory Activity of Ajwa Dates

Stability of extemporaneously prepared cytarabine, methotrexate sodium, and methylprednisolone sodium succinate

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