Development of technology for obtaining tablets by double granulation method with Pipsissewa (Chimaphila Umbellata) extract
Authors: Kovregin Oleksiy , Soldatov Dmytro , Kukhtenko Oleksandr , Vladymyrova Inna 
Published: December 2024

The use of the therapeutic potential of medicinal plants is currently considered a physiological method of prevention and treatment, which affects the normalization of metabolic processes and the restoration of the body's functional capabilities. Medicinal products created based on plants can be used for a longer period, including in the treatment of chronic diseases.
The aim of the work is to select a technology to produce tablets containing wintergreen umbrella herb liquid extract, considering the pharmaco-technological properties of the resulting dosage form.
Materials and methods. The objects of the study were pipsissewa herb liquid extract and experimental model samples of mixtures of this plant substance with excipients permitted for medical use. The research on the analysis of the liquid extract and pharmaco-technological indicators of test samples of tablet mass and tablets was carried out according to the methods of the State Pharmacopoeia of Ukraine (SPhU).
Determination of the optimal technology for obtaining and quantitative composition of excipients of tablets from pipsissewa herb liquid extract was carried out using mathematical design of experiments (MDE) by the method of a four-factor experiment based on the Greco-Latin square.
Results. The analysis of the liquid extract of pipsissewa showed the presence of 47.0±1.0 % of extractive (dry residue) substances. It was determined that the use of Liquid-Solid technology in the technology of obtaining tablets with plant extract based on the amorphous form of magnesium aluminometasilicate (Neusilin US2) requires the use of a combined approach that will ensure the quality of the finished product. During experimental studies, the use of three interrelated production strategies was proposed. In the process of applying the proposed strategy, it was determined that microcrystalline cellulose effectively performs the function of an adsorbent and filler; the consistency of the mixtures significantly depends on the ratio of MCC 101:extract. It was investigated that the use of double granulation will allow for the increase of the amount of active ingredient in the granulate without changing the volume of MCC 101, which will allow for the achievement of a higher extract content in the finished tablets. The use of double granulation technology can also ensure uniform distribution of the active ingredient and maintain the necessary flowability of the mixture for subsequent tabletting. The use of mathematical, experimental planning in the development of double granulation (drying) technology and the composition of excipients based on studies of the fluidity of the tabletting mass; attrition, disintegration, resistance of tablets to crushing, and organoleptic indicators became the basis for the development of the composition of the medicinal product in the form of tablets containing pipsissewa liquid extract.
Conclusions. The adsorption property and its influence on the tabletting process of the synthetic amorphous form of magnesium aluminometasilicate (Neusilin US2) and microcrystalline cellulose 101 (MCC 101) were determined when using these substances as a carrier for pipsissewa grass liquid extract. The possibility of conducting a double granulation process using microcrystalline cellulose 101 (MCC 101) according to a given amount of liquid extract was proven. Using mathematical planning of the experiment, the drying conditions of the granulate and the quantitative composition of excipients were selected