Optimization of the composition and technology of the solid dosage form "Romethine"

Abstract

Interferons (IFNs) are immunity mediators (cytokines) with a universally wide spectrum of biological activity, in particular, antiviral and immunomodulatory effects. The drug romethine, which is currently recommended as an antiviral agent for influenza, in particular, an interferon inducer, has the same effect. The aim of this paper is to find the optimal composition and develop a technology for an encapsulated dosage form of romethine. The object of the study was the substance romethine, obtained on the basis of gosiipol by means of synthesis. As a result of the studies, the following excipients were selected to ensure satisfactory encapsulation of the romethine substance: lactose (filler - a1); aerosil (sliding substance - b2); calcium stearate (lubricant - c2). As an oral dosage form, gastro-soluble capsule number 1 was selected, and also, the quality of the developed dosage form was assessed, which meets the regulatory and technical requirements of SP XIII.