Study of the influence of excipients on the technological parameters of raw materials and the stability of the active substance in the process of manufacturing a solid dosage form

Abstract

A theoretical study of approaches to solving problems related to the uniformity of the mixture for tableting and the stability of the active substance was carried out. A study of data on the influence of excipients on the properties of the mixture for granulation was carried out. As a result of reference to literary sources, works were found that consider the relationship between the composition, fluidity of the mixture, and mixing time. In addition, work in the field of stability of substances, which is associated with the excipients used, is considered. As a result of the review, various options for influencing the technological characteristics of the mixture, such as dissolution, flowability, segregation, are shown. Observing the relationship between process parameters helps to understand the dependence of quality control parameters on them. Thus, for example, the homogeneity of dosing is highly dependent on segregation and, accordingly, on the fluidity of the mixture. Excipients also have an effect on the stability of the active substance. They should be inert to it, but with the help of excipients it is possible to regulate the required pH level, the percentage of moisture. In some cases, excipients reversibly bind to the active substance to reduce degradation. In conclusion, it was concluded that in the course of developing the technological composition of a solid dosage form, it is necessary to take into account the influence of excipients. When developing the composition, it is possible to select the optimal combination of excipients, which will improve the technological parameters of the mixture, the quality and shelf life of the medicinal product. For the production of generic drugs, this issue is most relevant, since the development of the composition of the drug requires the repetition of the characteristics of the original drug. In this case, it is possible to use an alternative placebo composition, which allows to increase the economic efficiency of production.