EFFECT OF NONIONIC SURFACTANTS (DODECYL MALTOSIDE AND POLYSORBATE 20) ON PREVENTION OF AGGREGATION AND CONFORMATIONAL CHANGES OF RECOMBINANT HUMAN IFN β_1B INDUCED BY LIGHT

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MAHJOUBI NAJMEH; FAZELI AHMAD; DINARVAND RASSOUL; KHOSHAYAND MOHAMMAD REZA; SHEKARCHI MARYAM; FAZELI MOHAMMAD REZA

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Journal: Iranian Journal of Pharmaceutical Research Year:2017 | Volume:16 | Issue:1 Page(s): 103-111

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Title

EFFECT OF NONIONIC SURFACTANTS (DODECYL MALTOSIDE AND POLYSORBATE 20) ON PREVENTION OF AGGREGATION AND CONFORMATIONAL CHANGES OF RECOMBINANT HUMAN IFN β_1B INDUCED BY LIGHT

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Keywords

NONIONIC SURFACTANT

CIRCULAR DICHROISM (CD)

OXIDATION

ANTI- AGGREGATION

RHIFN β_1B

Abstract

Liquid protein formulations are prone to form aggregates. The effect of NONIONIC SURFACTANTs such as Polysorbate 20 (PS 20) and n-Dodecyl b-D-maltoside (DDM) on the prevention of aggregation and conformational changes of recombinant human IFN b-1b (rhIFN b_1b) was explored. Polysorbate has been used in formulations of protein pharmaceuticals. There have been concerns about using PS 20 due to its residual peroxide content which may negatively affect protein efficacy. n-Dodecyl b-D-maltoside has been of interest and shown to be highly effective in prevention of aggregation. Fresh bulk of rhIFN b_1b was formulated using DDM or different concentrations of PS 20. Formulations were exposed to light stress condition according to the ICH guideline of Q1b. The overall conformational integrity of individual samples was characterized by a combination of Circular dichroism (CD), Fluorescence spectroscopy and RP_HPLC techniques.The CD spectrum depicting the conformational integrity of rhIFN b_1b showed 31.9% and 31.2% decreases in a-helix content of protein samples with 0.2% or 0.02% of PS20 compared to only18.2% of that containing 0.2% DDM. The RP-HPLC analysis also showed that theoxidized impurity in formulation containing DDM is less than those contain PS 20.Complementary analysis of the liquid formulations using IFR and UV methods also was in compliance with the data obtained by CD.Compared to PS 20, the sample of rhIFN b_1b formulation with DDM was more resistant to the destruction effect of light. Results were in accordance with previous studies and couldsuggest DDM as a reliable anti-aggregation surfactant in biopharmaceutical formulations.

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APA: Copy

MAHJOUBI, NAJMEH, FAZELI, AHMAD, DINARVAND, RASSOUL, KHOSHAYAND, MOHAMMAD REZA, SHEKARCHI, MARYAM, & FAZELI, MOHAMMAD REZA. (2017). EFFECT OF NONIONIC SURFACTANTS (DODECYL MALTOSIDE AND POLYSORBATE 20) ON PREVENTION OF AGGREGATION AND CONFORMATIONAL CHANGES OF RECOMBINANT HUMAN IFN β_1B INDUCED BY LIGHT. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 16(1), 103-111. SID. https://sid.ir/paper/288833/en

Vancouver: Copy

MAHJOUBI NAJMEH, FAZELI AHMAD, DINARVAND RASSOUL, KHOSHAYAND MOHAMMAD REZA, SHEKARCHI MARYAM, FAZELI MOHAMMAD REZA. EFFECT OF NONIONIC SURFACTANTS (DODECYL MALTOSIDE AND POLYSORBATE 20) ON PREVENTION OF AGGREGATION AND CONFORMATIONAL CHANGES OF RECOMBINANT HUMAN IFN β_1B INDUCED BY LIGHT. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2017;16(1):103-111. Available from: https://sid.ir/paper/288833/en

IEEE: Copy

NAJMEH MAHJOUBI, AHMAD FAZELI, RASSOUL DINARVAND, MOHAMMAD REZA KHOSHAYAND, MARYAM SHEKARCHI, and MOHAMMAD REZA FAZELI, “EFFECT OF NONIONIC SURFACTANTS (DODECYL MALTOSIDE AND POLYSORBATE 20) ON PREVENTION OF AGGREGATION AND CONFORMATIONAL CHANGES OF RECOMBINANT HUMAN IFN β_1B INDUCED BY LIGHT,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 16, no. 1, pp. 103–111, 2017, [Online]. Available: https://sid.ir/paper/288833/en

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