Разработка и регистрация лекарственных средств (May 2022)

Рharmaceutical-technological Study of Adsorbed Liquid Plant Extract of Antimicrobial Activity

  • A. S. Gulenkov,
  • P. G. Mizina,
  • E. O. Bakhrushina,
  • A. I. Bardakov,
  • A. V. Nyudochkin

DOI
https://doi.org/10.33380/2305-2066-2022-11-2-94-101
Journal volume & issue
Vol. 11, no. 2
pp. 94 – 101

Abstract

Read online

Introduction. The use of a combined herbal extract of chamomile flowers, calendula flowers and yarrow herb (patent RU 1 561 262 C) can be effective against various microbial strains, including those causing inflammatory diseases of the oral cavity. The article presents the results of a comparative pharmaceutical and technological study of an adsorbed liquid plant extract on sorbents of various nature for subsequent introduction into the composition of orodispersible tablets.Aim. To select the optimal sorbent of liquid plant extract of chamomile flowers, calendula and yarrow herb ensuring the suitability of the active pharmaceutical ingredient for direct compression, by analyzing using the SeDeM expert system method.Materials and methods. Active pharmaceutical ingredient was adsorbed on organic (microcrystalline celluloses of various brands) and inorganic (colloidal silicon dioxide of various brands) sorbents, a liquid combined plant extract of anti-inflammatory and antibacterial action of chamomile flowers, calendula flowers and yarrow herb. Pharmaceutical-technological analysis included the study of such technological parameters as: Bulk Density (Da = m/Va), Tapped Density (Dc = m/Vc), Inter-particle Porosity (Ie = (Dc – Da)/(Dc · Da)), Carr index (IC = (Dc – Da)/(Dc · 100)), Cohesion Index (Icd), Hausner Index ratio (IH = Dc/Da), Angle of Repose (Tgα = h/r), Powder Flow (t), Loss of Drying (%LoD), Hygroscopicity (%H), Particles <50 μm (%Pf), Homogeneity Index (IΘ = Fm/100 + ∆Fmna).Results and discussion. A comprehensive pharmaceutical-technological study of sorbents of liquid plant extract before and after adsorption was carried out, the results of which were processed and presented by the SeDeM expert system method. It was found that the adsorption of the extract has a positive effect on the Dimension (ID = (Da · Dc)/2) of all studied sorbents which may be related to change in the fractional composition due to the aggregation of small particles during adsorption and destruction of large ones when sifting the finished mixtures through a sieve with a mesh diameter of 200 μm (recommended insoluble particle size for use in the oral cavity). A negative effect on the Stability (IS = (%LoD · %H)/2) was also recorded for all samples, regardless of their nature, which is probably explained by residual moisture after drying and high hygroscopicity of adsorbed plant bioactive substances. Changes in the Compressibility (IC = (Ie · IC · Icd)/3), Flowability (IF = (IH · α · t)/3) and Dosage (IDos = (%Pf · IΘ)/2) are individual.Conclusion. The SeDeM expert system method makes it possible to characterize bulk materials from the point of view of suitability for direct compression, to establish the factors that need to be primarily corrected by the introduction of auxiliary substances. As a result of the conducted studies, Aeroperl 300 (inorganic sorbent) and Pharmacel 112 (organic sorbent) can be recommended for the introduction of liquid plant extract of chamomile flowers, calendula flowers and yarrow herb into the composition of orodispersible tablets.

Keywords