| Abstract [eng] |
Master's thesis of K. Prazarkevičiūtė's "Production of capsules and tablets with turmeric root extract and evaluation of qualitative properties". Scientific supervisor assistant Dr. Rasa Kalėdaitė; Vilnius University, Faculty of Medicine, Institute of Biomedical Sciences (Pharmaceutical Centre), Vilnius 2023. Aim of the study: To investigate the antibacterial effect of dry Curcuma L. root extract against Escherichia coli and Streptococcus pyogenes and to determine the qualitative properties of capsules and tablets made with dry Curcuma L. root extract. Objectives: 1. To evaluate the flowability of dry Curcuma L. root extract and granules with dry Curcuma L. root extract using Carr's index and Hausner's ratio methods. 2. To evaluate the fractional composition of granules produced with dry Curcuma L. root extract. 3. To investigate the antibacterial effect of dry Curcuma L. root extract against Escherichia coli and Streptococcus pyogenes. 4. To choose appropriate manufacturing technologies and excipients for the manufacturing of capsules and tablets with dry Curcuma L. root extract. 5. To assess the quality of the capsules and tablets by determining uniformity of mass, disintegration time and friability of the capsules and the tablets. Methodods: The flowability of the dry Curcuma L. root extract and manufactured granules was evaluated using Carr index and Hausner ratio according to European Pharmacopoeia. For the manufacturing of capsules and tablets, the diluent of choice was Avicel® PH 102, the lubricants Aerosil® 200 and magnesium stearate was chosen to improve the flowability of the granules. Granules were produced by wet granulation using a 3 % solution of acacia gum as a wetting agent. Fractional composition of the granules was determined by analytical sieving method. 5 batches of capsules with CE were manufactured using a capsule filling machine and 5 batches of tablets with CE were produced by compression. The quality of manufactured capsules and tablets was evaluated according to the European Pharmacopoeia methods for uniformity of mass, disintegration time and friability of the capsules and the tablets. The effect of turmeric dry rhizome extract on E. coli and S. pyogenes strains was investigated by the dilution method in 96-well flat-bottomed microplates. Results and conclusions: CE and MKC (Avicel® PH 102) powders were fine with poor flowability. The addition of acacia resin as granulation liquid during the production of granules improved the flowability of the granules, with higher liquid content in the granules improving the flowability. The narrowest distribution of granules was observed in the second series, with more than half of the granules being 1,4 - 1 mm in diameter. The most even distribution of pellets was observed in the third series of pellets. The second and fourth series of manufactured capsules did not correspond to the Ph. Eur. requirements, with a maximum mass deviation of more than 10 %. The second series of capsules had a maximum deviation of 10,77 % and the fourth series 14,197 %. The capsules of series 1,3,5 and all the vbatch of tablets complied with the requirements for the mass uniformity test. The capsules of five series disintegrated in less than 4 minutes. The tablets did not meet the Ph. Eur. requirements. All tablet batches met the Ph. Eur. requirements for abrasion and. All batches were within the 1 % abrasion limit. The antibacterial test on turmeric revealed the following CE concentrations: 12.5μl/ml, 25μl/ml, 50μl/ml, 100μl/ml, 400μl/ml, 800μl/ml, which have an effect on both E.coli and S.pyogenes. |
