{"title":"Demonstrating scalability between two blender types using DEM","authors":"","doi":"10.1016/j.ijpharm.2024.124773","DOIUrl":null,"url":null,"abstract":"<div><div>Powder blending is a critical step in pharmaceutical manufacturing that can impact product quality such as tablet tensile strength. This study utilized the Discrete Element Method (DEM) to investigate blending in a 5-liter mini-batch and a 2-liter Turbula blender. DEM parameters were calibrated using small-scale powder characterization tests, so that the particle behavior in the DEM simulations matches the measured behavior. The research explored the effects of blender designs and process conditions on blending and lubricant dispersion. A predictive model for tablet tensile strength was developed. The model takes the lubricant’s dispersion via the lubrication energy into account. The model is then used to predict the tablet tensile strength depending on the chosen process parameters, blending speed, duration, and fill level. DEM simulations enabled scaling between the two blenders, providing valuable insights for a semi-continuous manufacturing process based on mini-batch blending. The findings contribute to a deeper understanding of blending mechanics, offering potential enhancements in pharmaceutical manufacturing efficiency and product consistency.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":null,"pages":null},"PeriodicalIF":5.3000,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S037851732401007X","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Powder blending is a critical step in pharmaceutical manufacturing that can impact product quality such as tablet tensile strength. This study utilized the Discrete Element Method (DEM) to investigate blending in a 5-liter mini-batch and a 2-liter Turbula blender. DEM parameters were calibrated using small-scale powder characterization tests, so that the particle behavior in the DEM simulations matches the measured behavior. The research explored the effects of blender designs and process conditions on blending and lubricant dispersion. A predictive model for tablet tensile strength was developed. The model takes the lubricant’s dispersion via the lubrication energy into account. The model is then used to predict the tablet tensile strength depending on the chosen process parameters, blending speed, duration, and fill level. DEM simulations enabled scaling between the two blenders, providing valuable insights for a semi-continuous manufacturing process based on mini-batch blending. The findings contribute to a deeper understanding of blending mechanics, offering potential enhancements in pharmaceutical manufacturing efficiency and product consistency.
期刊介绍:
The International Journal of Pharmaceutics is the third most cited journal in the "Pharmacy & Pharmacology" category out of 366 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.