Keywords
ferrous fumarate,
granulation
wet granulation,
dry granulation,
fluidized bed granulation,
physicomechanical properties,
tablets.
How to Cite
Abstract
The purpose of this study was to comparatively evaluate the influence of different granulation methods on the physicomechanical properties of Aferol granules and tablets containing a high proportion of ferrous fumarate. The methodology was based on a systematic review and meta-analysis of published scientific data, as well as extrapolation of findings obtained for analogous high-dose pharmaceutical formulations. Three granulation methods were compared: wet granulation in a high-shear mixer, dry granulation by roller compaction, and fluidized bed granulation. The results showed that wet granulation provided the most favorable flowability, mechanical strength, and dosage uniformity, whereas dry granulation was associated with increased granule friability and higher tablet abrasion. Fluidized bed granulation demonstrated balanced properties under conditions of strict process control. It was concluded that wet granulation is the most appropriate method for the industrial production of Aferol tablets.
References
Santiago P. Ferrous versus ferric oral iron formulations for the treatment of iron deficiency: A clinical overview. The Scientific World Journal. 2012; 2012:1–5. https://doi.org/10.1100/2012/846824
Nash CM, Allen VM. The use of parenteral iron therapy for the treatment of postpartum anemia. Journal of Obstetrics and Gynaecology Canada. 2015; 37:439–442. https://doi.org/10.1016/S1701-2163(15)30259-0
Mesías M, Seiquer I, Navarro MP. Iron nutrition in adolescence. Critical Reviews in Food Science and Nutrition. 2013;53(11):1226–1237. https://doi.org/10.1080/10408398.2011.564333
Nanjundan P. Comparison of various treatment modalities of iron deficiency anemia in pregnancy. World Journal of Anemia. 2017;1(1):23–26. https://doi.org/10.5005/jp-journals-10065-0005
Khan A, et al. Prediction of quality attributes (mechanical strength, disintegration behavior, drug release) of tablets on the basis of granule characteristics using SeDeM-ODT expert system. PLoS ONE. 2021;16(11): e0261051. https://doi.org/10.1371/journal.pone.0261051
Pharma Excipients. Comprehensive review of modern techniques of granulation in pharmaceutical solid dosage forms. Intelligent Pharmacy. 2024;2(5):609
Shanmugam S. Granulation techniques and technologies: Recent progresses. BioImpacts. 2015;5(1):55–63. https://doi.org/10.15171/bi.2015.04
Arndt OR, Kleinebudde P. Impact of different dry and wet granulation techniques on granule and tablet properties: A comparative study. Journal of Pharmaceutical Sciences. 2018;107(12):3145–3152. https://doi.org/10.1016/j.xphs.2018.08.025
Sekyi NKG, et al. Comparative analysis of granule properties in continuous twin screw granulation and batch granulation processes. Powder Technology. 2023; 423:118456. https://doi.org/10.1016/j.powtec.2023.118456
Jang EH, et al. Model-based scale-up methodologies for pharmaceutical granulation processes: A review. Pharmaceutics. 2020;12(5):453. https://doi.org/10.3390/pharmaceutics12050453
Государственная фармакопея Республики Узбекистан. 1-е изд. Ташкент: Министерство здравоохранения Республики Узбекистан; 2021. Т. I. 1548 с.
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