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Tytuł:
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Performance Evaluation of a High-Precision Low-Dose Powder Feeder.
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Autorzy:
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Fathollahi S; Research Center Pharmaceutical Engineering (RCPE) GmbH, 8010, Graz, Austria.; Institute of Process and Particle Engineering, Graz University of Technology, 8010, Graz, Austria.
Sacher S; Research Center Pharmaceutical Engineering (RCPE) GmbH, 8010, Graz, Austria.
Escotet-Espinoza MS; Oral Formulation Sciences and Technology, Merck & Co., Inc., Rahway, New Jersey, USA.
DiNunzio J; Oral Formulation Sciences and Technology, Merck & Co., Inc., Rahway, New Jersey, USA.
Khinast JG; Research Center Pharmaceutical Engineering (RCPE) GmbH, 8010, Graz, Austria. .; Institute of Process and Particle Engineering, Graz University of Technology, 8010, Graz, Austria. .
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Źródło:
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AAPS PharmSciTech [AAPS PharmSciTech] 2020 Nov 03; Vol. 21 (8), pp. 301. Date of Electronic Publication: 2020 Nov 03.
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Publication: New York : Springer
Original Publication: Arlington, VA : American Association of Pharmaceutical Scientists, c2000-
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MeSH Terms:
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Powders*
Technology, Pharmaceutical/*methods
Calibration ; Excipients ; Lactose/chemistry ; Particle Size
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References:
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Science. 2016 Apr 1;352(6281):61-7. (PMID: 27034366)
Int J Pharm. 2018 Mar 25;539(1-2):157-164. (PMID: 29366938)
Int J Pharm. 2012 Aug 20;433(1-2):42-50. (PMID: 22564779)
J Pharm Sci. 2015 Nov;104(11):3612-3638. (PMID: 26280993)
AAPS PharmSciTech. 2017 May;18(4):1177-1189. (PMID: 27422654)
Int J Pharm. 2019 Feb 25;557:342-353. (PMID: 30599227)
Eur J Pharm Biopharm. 2019 Feb;135:49-60. (PMID: 30582959)
Int J Pharm. 2017 Mar 15;519(1-2):314-322. (PMID: 27986476)
Int J Pharm. 2016 Jul 25;509(1-2):123-134. (PMID: 27210736)
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Contributed Indexing:
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Keywords: continuous feeding; free flowing/cohesive powder; low-dose API; low-dose feeding
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Substance Nomenclature:
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0 (Excipients)
0 (Powders)
J2B2A4N98G (Lactose)
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Entry Date(s):
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Date Created: 20201103 Date Completed: 20210111 Latest Revision: 20210111
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Update Code:
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20231215
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PubMed Central ID:
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PMC7609424
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DOI:
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10.1208/s12249-020-01835-5
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PMID:
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33141336
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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, di-calcium 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.