Разработка и регистрация лекарственных средств (Nov 2019)

Development of Composition and Technology of Resveratrol Capsules

  • M. S. Sokurenko,
  • S. P. Krechetov,
  • S. A. Olifer,
  • I. I. Krasnyuk,
  • N. L. Solovyova,
  • M. A. Makarenko,
  • N. B. Demina

DOI
https://doi.org/10.33380/2305-2066-2019-8-4-16-19
Journal volume & issue
Vol. 8, no. 4
pp. 16 – 19

Abstract

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Introduction. Resveratrol is of scientific interest as a substance with a wide range of biological effects. However, its low bioavailability leads to limited use when administered orally. Therefore, the objective was to increase its solubility using various groups of excipients and create a solid dosage form. As a result of research, a group of twins was selected and the technology of manufacturing capsules containing 40 mg of resveratrol as a active substance was developed.Aim. The development of a solid dosage form – capsules containing resveratrol, tween 80 as a solubilizer and other excipients.Materials and methods. A composition with resveratrol, tween 80, glycerin, citric and ascorbic acids as stabilizers was developed. Methanol was used as a common solvent and was distilled off after complete dissolution of all components and obtaining a homogeneous mass. After adding olive oil (as a filler) to the resulting composition and a mixture of nipazole and nipagin (0.03 % by weight of the contents), the composition was manually mixed and poured into subsequently gelatin coated capsules for tightness. The quality indicators of the obtained capsules were studied in accordance with the requirements of the State pharmacopoeia XIV of Russian Federation (description, disintegration, dissolution, uniformity of dosage, residual organic solvents), as well as oxidation indicators.Results and discussion. During the research it was found that the obtained samples of capsules containing resveratrol 40 mg/caps. as an active substance, and tween 80 as a solubilizer, had a good disintegration. The substance is well soluble in hydrochloric acid condition, which indicates its high bioavailability.Conclusion. To produce capsules with resveratrol (40 mg/caps.) containing tween 80, glycerin, citric and ascorbic acids, excipients were selected according to studies that confirm the improvement of resveratrol bioavailability. The quality of the dosage form was assessed in accordance with the State Pharmacopoeia XIVth edition: it was shown that the use of Tween 80 as a solubilizer increases the release of resveratrol in the environment of gastric juice.

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