Performance Evaluation of a High-Precision Low-Dose Powder Feeder
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Research Article Performance Evaluation of a High-Precision Low-Dose Powder Feeder Sara Fathollahi,1,2 Stephan Sacher,1 M. Sebastian Escotet-Espinoza,3 James DiNunzio,3 and Johannes G. Khinast1,2,4
Received 29 May 2020; accepted 29 September 2020 Abstract. Highly potent active pharmaceutical ingredients (APIs) and low-dose excipients, or excipients with very low density, are notoriously hard to feed with currently available commercial technology. The micro-feeder system presented in this work is capable of feeding low-dose rates of powders with different particle sizes and flow properties. Two different grades of lactose, dicalcium phosphate, croscarmellose sodium, silicon dioxide, a spray-dried intermediate, and an active ingredient were studied to vary material properties to test performance of the system. The current micro-feeder system is a volumetric feeder combined with a weighing balance at the outlet that measures feeder output rates. Feeding results are shown as a so-called “displacement-feed factor” curve for each material. Since the powder mass and volume are known in the micro-feeder system, in this work, we characterized an observed density variation during processing via a “displacement-feed factor” profile for each of the fed powders. This curve can be later used for calibrating the system to ensure an accurate, constant feed rate and in addition predicting feeding performance for that material at any feed rate. There is a relation between powder properties and feeding performance. Powders with finer particles and higher compressibility show densification during their feeding process. However, powders with larger particles and lower compressibility show both “densification” and “powder bed expansion,” which is the manifestation of dilation and elastic recovery of particles during the micro-feeding process. Through the application of the displacement-feed factor, it is possible to provide precise feeding accuracy of low-dose materials. KEY WORDS: continuous feeding; low-dose feeding; low-dose API; free flowing/cohesive powder.
INTRODUCTION Continuous feeding of small quantities of powder is a challenge in a wide range of processes and industries, including the pharmaceutical industry (1,2). Especially, in the context of continuous manufacturing, continuous feeding of materials is one of most critical unit operations in the entire line. While continuous feeding of fluids is a fairly easy challenge, creating a constant powder stream is challenging, especially for sticky and cohesive materials. Advantages of continuous manufacturing in terms of reduced footprint, advanced quality, and scalability are well known (3,4). In the last years, several modular continuous manufacturing implementations have been commercialized by different equipment companies, including GEA, Glatt, or Bosch to name a few. In addition, personalized, individualized, and small-scale manufacturing is increasingly important, also in the context of translational pharmaceutics. 1
Research Center Pharmaceutical Engineering (RCPE) GmbH, 8010,
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