Study of the quantitative factors influence on pharmaco-technological properties of powder masses and tablets with plant extracts and essential oil

Abstract

The available range of phytopreparations for topical use in the oral cavity does not fully meet the needs of patients as mainly medicinal plant raw materials and tinctures of domestic production represent it. Therefore, we developed a pharmaceutical composition in the form of tablets based on dry extracts herb of Geranium sanguineum L., Geranium sibiricum L. and essential oil of Salvia sclare. To optimize the composition of the tablets it is necessary to study and select the necessary excipients and their quantities, which was the purpose of the work. In order to study the influence of 10 quantitative factors on the properties of powder masses and the main quality indicators of tablets with plant extracts and essential oil, the method of random balance was used. The obtained powder mixtures and tablets based on them were subjected to the determination of the following pharmaco-technological parameters: bulk density, tapped density, flowability, the angle of repose, the uniformity of weight, tablet hardness testing, the friability test, disintegration time, desirability function. The pharmaco-technological index of bulk density improves with an increase in the amount of Pregelatinized Starch, Mannitol 60, Emcompress, as well as a decrease in the amount of Neusilin UFL2 and Neusilin US2. Regarding the tapped density, Neusilin US2 significantly affects it, with the increase of which this indicator decreases. With the introduction of more Neusilin US2, Mannitol 60, Pregelatinized Starch, Ludipress, Emcompress and Magnesium Stearate, the value of the angle of repose is improved. The average mass has the greatest influence on fluidity, at its decrease this indicator improves. The same happens with the introduction of Neusilin UFL2, Neusilin US2, Pregelatinized Starch and Magnesium Stearate. The uniformity of weight of all series of tablets fluctuates within ± 5%, and friability to 1%, which meets the requirements of the State Pharmacopoeia of Ukraine. Also, despite the results obtained, all series of tablets were very strong, with the lowest tablet hardness testing – 159 N. The disintegration of the tablets varies within 6 minutes. After evaluating the results of the scattering diagrams of all pharmaco-technological parameters as well as the desirability function, Neusilin US2, МCC 102, Sodium croscarmellose, Mannitol 60 and Magnesium Stearate were selected for further research. The average weight of tablets should be increased to 0.55 g.

Keywords

• tablets
• excipients
• pharmaco-technological indicators
• direct compression
• mathematical planning