EXCIPIENTS IN THE TECHNOLOGY OF LYOPHILIZATION OF PEPTIDES AND PROTEINS

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DOI: https://doi.org/None
Issue: 
1
Year: 
2017

E.V. Blynskaya (1), PhD; S.V. Tishkov (1); Professor K.V. Alekseev (2), PhD; A.I. Marakhova (3), PhD 1-V.V. Zakusov Research Institute of Pharmacology; 8, Baltiyskaya St., Moscow 125315, Russian Federation; 2-Moscow Medical University REAVIZ; 2, Krasnobogatyrskaya St., Build. 2, Moscow 107564, Russian Federation; 3-Peoples’ Friendship University of Russia; 6, Miklukho-Maklai St., Moscow 117198, Russian Federation

Lyophilization of protein and peptide drugs is a promising method for designing stable and effective parenteral dosage forms. The paper considers the basic excipients used in the lyophilization of protein and peptide drugs, as well as their functional classification. It gives the characteristics of vehicles, cryoprotectants, lyoprotectants, tonicity modifiers, surfactants, and buffer systems. It also provides recommendations to solve the problems of preservation of the activity of a drug. The optimal combinations of excipients are proposed to improve the properties of lyophilisate tablets and to prevent their destruction.
Keywords: 
protein and peptide drugs
lyophilization
sublimation
excipients
lyoprotectants
cryoprotectants
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