Production of solid dosage forms of immunoglobulin products

Abstract

At the moment, there are no scientific publications devoted to the technological aspects of production of immunoglobulin solid dosage forms. The aim of the study was to review Russian and foreign literature on production of immunoglobulin solid dosage forms, and present the results of the authors’ own research. The authors analysed data of the National Register of Medicines of the Russian Federation as of mid-2021 on the authorised medicines with a generic name ‘globulin in a solid dosage form’, and summarised their characteristics. They reviewed data on the qualitative and quantitative composition of excipients used in lyophilisation, preparation of tablets and capsules. A number of examples were used to illustrate the effect of technological parameters of immunoglobulin solid form production on the quality of the finished products. It was demonstrated that the production of solid forms of immunoglobulin products prevents aggregation and fragmentation of proteins during storage, which affect the product’s specific activity, and also help to preserve the product’s target characteristics for a longer period of time as compared to liquid dosage forms of immunoglobulins. The results of the study may be used as a basis for development of a manufacturing technology for solid forms of immunoglobulin products.