Development the composition and technology for obtaining a dietary supplement “Cachinol” with the antioxidant activity in the form of granules used in the polycystic ovary syndrome

Abstract

Aim. To develop the composition and technology for obtaining a dietary supplement “Cachinol” with the antioxidant activity in the form of granules used in the polycystic ovary syndrome. Materials and methods. To achieve the goal, physical, physicochemical, pharmacotechnological and statistical research methods, as well as generally accepted research methods of the State Pharmacopoeia of Ukraine (SPhU) 2.0 were used in the work. Results and discussion. The rational dosage form is granules. The green tea leaf extract and myo-inositol were chosen as the active pharmaceutical ingredients of granules. For 3 batches of granules, the following parameters were determined: the fractional composition ranging from 13.2 to 17.9 % for 3-2 mm, from 45.3 to 56.2 % for 2-1 mm, from 20.1 to 26.1 % for 1-0.5 mm, from 8.1-12.4 for 0.5-0.25 mm, from 2.95-4.6 % for < 0.25 mm; the moisture content of granules ranging from 2.80-3.10 %; the bulk density – from 0.49 to 0.52 g/cm3, the tapped density – from 0.54 to 0.58 g/cm3; the flowability was in the range of 8.00-8.25 g/s; the angle of repose – from 30 to 33°; disintegration – from 41 to 45 s. Conclusions. The flowchart for obtaining granules in industrial conditions has been developed. The technological process for obtaining granules consists of 8 technological stages. The studies of the technological parameters of granules have been performed in accordance with the requirements of the SPhU 2.0. It has been found that the granules developed meet the requirements of the SPhU 2.0 and can be recommended for further research.