Kaminskaitė, Miglė

Background: During the production of water-dispersible tablets with dry guarana extract, poor physical, chemical, and mechanical properties such as high hygroscopicity, stickiness, bulkiness and compressibility are observed [1]. To solve these problems, magnesium aluminum metasilicate can be used, which is characterized by good compressibility, it improves the technological properties of powders with plant extracts, the time of disintegration, and the hardness of tablets [2]. Aim: To produce guarana dry extract water-dispersible tablets using the multifunctional material magnesium aluminum metasilicate and to evaluate the quality of the tablets. Methods: Appropriate concentrations of magnesium aluminum metasilicate were chosen. When studying the properties of the tablet mixture, flowability, angle of repose, tapped density, bulk density, compressibility index and Hausner ratio were determined. Quality tests of tablets were performed: uniformity of mass, friability of tablets, resistance to crushing of tablets and disintegration of tablets were determined. Results: After adding different amounts of magnesium aluminum metasilicate to the mixtures, the properties of the powder improved. Based on the obtained results, it was decided to apply direct compression method to produce tablets. The optimal concentration of magnesium aluminum metasilicate to produce water-dispersible tablets with guarana dry extract is 30%. It was found that with this concentration of magnesium aluminum metasilicate, the tablets meet the requirements of the European Pharmacopoeia for mass uniformity, resistance to crushing – 32.6 N, friability – 99%, disintegration time – 01:06 minutes. The mass deviation of the manufactured tablets is within the permissible limits of ±7.5%, the resistance to crushing is between 30-40 newtons, the resistance to dilution is at least 99%, the disintegration time is up to 3 minutes. Conclusion: The insertion of magnesium aluminum metasilicate into powder mixtures with dry guarana extract improved the technological properties of the powder mixtures, because of which high-quality water-dispersible tablets were produced.

Introduction: Tablets are one of the most used pharmaceutical forms, characterized by high physical, chemical and microbiological stability, and an acceptable way of administration. However, patients with dysphagia may find it difficult to swallow regular tablets. For this reason, dispersible tablets are produced, which are dispersed in water before use. In the production of dispersible tablets with plant extracts, inappropriate physical, chemical, and mechanical properties of dry extracts are encountered, such as their high hygroscopicity, stickiness, poor flowability and compressibility in the tablet pressing process. To solve these problems, various excipients are proposed that improve the technological properties of dry extracts. One such material is magnesium aluminum metasilicate, which has good compressibility, improves the technological properties of the powder mixture with plant extracts, improves the disintegration time, and mechanical strength of the produced tablets. As a model material, we chose guarana dry extract, which has stimulating and antioxidant properties. Aim: To produce guarana dry extract dispersible tablets using the multifunctional material magnesium aluminum metasilicate and to evaluate the quality of the tablets. Methods: Based on the scientific literature and research conducted, it was decided to use appropriate amounts of magnesium aluminum metasilicate, i.e., 15%, 20%, 25%, 30%, 35%. When studying the properties of the mixture of tablets with guarana dry extract, the flowability, angle of repose, tapped density, bulk density, compressibility index and Hausner ratio were determined. Based on the results of these studies, it was decided to use the direct pressing method to produce dispersible tablets. Quality tests of tablets were performed: uniformity of mass, friability of tablets, resistance to crushing of tablets and disintegration of tablets were determined. Results: To choose a suitable method for tableting, first the properties of the powder were determined. The sample without magnesium aluminum metasilicate had rather poor bulkiness, its angle of repose was 33°. After adding different amounts of magnesium aluminum metasilicate to the mixtures, the properties of the powder improved, the angle of repose prevailed between 25° – 29°, the compressibility index was between 19.2 - 22.5, and the Hausner ratio – from 1.2 to 1.3. Based on the obtained results, it was decided to apply direct compression method to produce tablets. According to the conducted research, it was observed that the optimal concentration of magnesium aluminum metasilicate to produce water dispersible tablets with guarana dry extract is 30 percent. It was found that with this concentration of magnesium aluminum metasilicate, the tablets meet the requirements of the European Pharmacopoeia for mass uniformity, resistance to crushing – 32.6 N, friability – 99%, disintegration time – 01:06 minutes. The mass deviation of the manufactured tablets is within the permissible limits of ±7.5%, the resistance to crushing is between 30-40 newtons, the resistance to dilution is at least 99%, the disintegration time is up to 3 minutes. Conclusions: According to the conducted research, it was established that the insertion of aluminum metasilicate into powder mixtures with dry guarana extract improved the technological properties of the powder mixtures. Flowability, angle of repose, tapped density and bulk density improved, which is why it was decided to apply the direct compression method for tablets production. Based on the analysis of the scientific literature and the conducted research, it was determined that the appropriate concentration of magnesium aluminum metasilicate should be used in the production of water-dispersible tablets with dry guarana extract. The composition of the tablets, in which the concentration of magnesium aluminum metasilicate was 30%, had the best properties and met the requirements of the European Pharmacopoeia.