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Development of a Pharmaceutical Composition and Stablity of Liquid Dosage Forms Based on Monoclonal IgG1 Antibodies

  • DRUG SYNTHESIS METHODS AND MANUFACTURING TECHNOLOGY
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Pharmaceutical Chemistry Journal Aims and scope

A scheme for developing an excipient composition for liquid dosage forms based on monoclonal antibodies(mAbs) is proposed and used to develop a stable formulation of an active pharmaceutical ingredient (API) and finished dosage form (FDF) for s.c. injection of mAbs IgG1 against a tumor necrosis factor (TNF-α) with API concentrations from 50 to 150 mg/mL.

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Authors and Affiliations

  1. BIOCAD Biotechnology Co., Strelna, St. Petersburg, 198515, Russia

    E. A. Lomkova, V. O. Shitikova, A. A. Tsukur, A. A. Sozonova & A. M. Ryakhovskaya

  2. St. Petersburg State Chemical Pharmaceutical Academy, St. Petersburg, 197376, Russia

    A. A. Tsukur

Authors
  1. E. A. Lomkova
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  2. V. O. Shitikova
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  3. A. A. Tsukur
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  4. A. A. Sozonova
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  5. A. M. Ryakhovskaya
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Corresponding author

Correspondence to E. A. Lomkova.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 53, No. 8, pp. 34 – 40, August, 2019

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Lomkova, E.A., Shitikova, V.O., Tsukur, A.A. et al. Development of a Pharmaceutical Composition and Stablity of Liquid Dosage Forms Based on Monoclonal IgG1 Antibodies. Pharm Chem J 53, 748–754 (2019). https://doi.org/10.1007/s11094-019-02073-1

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  • DOI: https://doi.org/10.1007/s11094-019-02073-1

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