Influence of technological properties of auxiliary substances on the quality of capsular masses on the basis of phytoextracts

Introduction. In the production of medicines with dry extracts of medicinal plant material a special place is occupied by such dosage form as capsules. The range of encapsulated drugs is diverse. So, among the dosage dosage forms of industrial production abroad medicines in capsules take the 3^d place after tablets and ampullated solutions [2, 3]. Thus, we were faced with the task of choosing the best auxiliary substances and rational technology to achieve the final result of our research – to obtain a medicine for the treatment of colds in the form of hard gelatin capsules based on extracts of medicinal plant material with quality parameters that meet the requirements of SPU [1].

A strategic approach to the creation of new medicines as vital goods requires a marketing justification in their implementation. Considerable attention and efforts are devoted to the study of the macro- and microenvironment of the target drug market segment, the definition of the social and medical need for a new drug, its competitiveness, innovation, economic efficiency and commercial attractiveness [3].

The last decade is characterized by a steady trend of increasing the volume of drug sales in Ukraine, with the consumption of domestically produced drugs in natural units reaching about 70 %, and in monetary terms it increased up to 40 % [2]. This was also contributed to not only by the crisis in the economy and a significant increase in the cost of foreign-made drugs, but also, in our opinion, public confidence in Ukrainian pharmaceutical products, high quality, efficacy and safety of domestic drugs.

Aim of the research. The study of the influence of auxiliary substances on the quality indicators of solid dosage forms for the treatment of colds.

Materials and methods. A small range of domestic internal dosage forms of expectorant action in the form of hard capsules containing the multicomponent composition of dry extracts became one of the determining factors in creating a drug based on phytoextracts. Capsule medicines have certain advantages over tableted ones: gelatin capsule is a kind of protective membrane against environmental factors for hygroscopic drugs, such as dry extracts of plant origin; it masks from unpleasant taste and smell.

The study of the technological properties of dry extracts on flowability, bulk weight, angle of repose and fractional composition allows concluding that it is necessary to use certain auxiliary substances to simplify the process and obtain the dosage form of the required quality [2-4]. To achieve the set goals, we needed to study the initial technological parameters of dry extracts of althea root and licorice for the development of a solid dosage form based on them. The bulk weight, flowability and moisture content of the substance have the highest effect on the encapsulation process of all the pharmaco-technological parameters. The results of the study of technological indicators of the substance presented in Table 1 show that, in aggregate, the values of all characteristics depend on the flowability, bulk weight of the powder and its moisture content, which in turn will impede the encapsulation process, since a very low flow rate of the substance into the capsule can reduce the dosing accuracy and uniform distribution of active substances.

Therefore, to prevent the occurrence of the above undesirable factors (effects), the introduction of auxiliary substances with good flowability and bulk density is necessary. The inclusion of the stage of mixing dry extracts and auxiliary substances will allow obtaining a more homogeneous mass for encapsulation. Given the hygroscopicity of dry extracts, as well as their dose for the introduction of the capsule, we selected auxiliary substances that will give the mass for encapsulation the desired technological properties, and also determined their technological characteristics (Table 2).

Table 1. Pharmaceutical and technological properties of dry extracts

Table 2. Technological characteristics of auxiliary substances used for the preparation of capsule mass

In our studies, we have accumulated experimental model mass samples for encapsulation using the studied auxiliary substances and the sum of extracts in the ratio (2:1). Analysis of the technological characteristics of the masses for encapsulation with the studied excipients showed that not all the compositions have excellent flowability. Among the studied samples, a relatively high flowability index of 11.3 g/s shows the composition with the use of Aerosil 300 and lactopress 260, which as a result was chosen for the further research.

Conclusion. Auxiliary substances for the industrial production of capsule masses based on phytoextracts were investigated. The results of a comparative analysis of the technological properties of the experimental samples showed that to ensure uniform dosing and satisfactory flowability of capsule masses, the following fillers are the most rational to be used: Aerosil 300, lactopress 260, microcrystalline cellulose MCC 102 - Avicel.

References.

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