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

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 fact...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2019-11, Vol.53 (8), p.748-754
Main Authors: Lomkova, E. A., Shitikova, V. O., Tsukur, A. A., Sozonova, A. A., Ryakhovskaya, A. M.
Format: Article
Language:English
Subjects:
Biological products
Drug Synthesis Methods and Manufacturing Technology
Ethylenediaminetetraacetic acid
Immunoglobulin G
Medicine
Monoclonal antibodies
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
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Summary: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.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-019-02073-1