Development of the Composition and Manufacturing Technology of a New Combined Drug: Lavaflam.

Abstract

Treatment of diseaes of the biliary system is one of the urgent problems of modern medicine. An original pharmaceutical drug "Lavaflam" in the form of combined tablets, which includes a composition of herbal components flamin (0.05 g) and lavender oil (0.02 g), was proposed for the complex treatment of diseases of the biliary system. Flamin is phytomedicine from the immortelle flowers [Helichrysum arenarium (L.) Moench, Asteraceae], which contains a complex of active substances from the flavonoids group (salipurposide, isosalipurposide, kaempferol, luteolin). It is applied as a choleretic and an anti-inflammatory agent in cholecystitis, cholangitis, and biliary dyskinesia. Tablets were prepared by pressing for separate granulation technology. The lavender oil granulate was prepared using the solid phase method, and β-cyclodextrin was used as an excipient substance. The flamin granulate was prepared by mixing with the spherical-shaped filler mannitol PARTECK M 200. On the basis of previous studies, the excipients of the designed composition tablet "Lavaflam" were β-cyclodextrin (0.27 g), mannitol PARTECK M 200 (0.20 g), croscarmellose sodium (0.03 g), potato starch (0.022 g), PEG 6000 (0.002 g), and magnesium stearate (0.006 g). The assay of the main components of lavender oil with the references linalol and linalyl acetate was performed using gas chromatography. The assay of the total flavonoids of flamin was performed using spectrophotometry with isosalipurposide as the reference. The new phytomedicine tablets "Lavaflam" meet European Pharmacopoeia requirements on the following parameters: appearance, geometric size, average weight, disintegration, friability, resistance of tablets to crushing, and quantification.