TECHNOLOGY DEVELOPMENT AND ANALYSIS OF A PAEDIATRIC DOSAGE FORM WITH THE DIMEDROL (DIPHENHYDRAMINE)

Dimedrol is a first-generation H1-blocker. Doctors prescribe dimedrol for children under 14 years of age orally in the form of 0.02% solution. The industry produces dimedrol tablets for children over 14 years of age. Dimedrol is very easily soluble in water and has an unpleasant bitter taste. All this creates the need to create and use special corrected paediatric dosage form – а suspension. The aim of the present study was to develop the technology and analyse a paediatric corrected dosage form with dimedrol (diphenhydramine). To obtain a suspension, we transferred diphenhydramine from a soluble state to an insoluble complex with a cation-exchange resin (potassium polacryline). The aggregative stability of the suspension was increased by increasing the viscosity of the medium (we used carbopol 980 solution at pH 6.7-7.0), microbiological stability – through using of the preservatives. The taste of the suspension was adjusted using a sweetener. Substances in the suspension are: dimedrol -100 mg; potassium polacryline -150 mg; propylene glycol - 2000 mg; methylparahydroxybenzoate - 160 mg; carbopol 980 - 100 mg; xylitol - 100 mg; propyl parahydroxybenzoate - 20 mg; sodium hydroxide to pH 6.8-7.0 purified water to 100.0 g) The suspension of the dimedrol was a milky-white liquid with homogeneously distributed particles, odourless. The pH value was 6.8±0.1. We used UV-spectrophotometry at a wavelength of 258 nm for the quantitative analysis of the dimedrol. The content of the diphenhydramine hydrochloride was not less than 90.0 % and not more than 110.0 % of the claimed amount. The suspension remained stable during the observed shelf life of 1 year.