Improvement of handling properties of naproxen using ordered mixing method

Study subject: A significant share of the raw materials used in pharmaceutical production are bulk materials. One of the key parameters affecting the quality of the manufacturing process and pharmaceutical product as well as determining the processing properties of raw materials in the manufacturing...

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Main Authors: Mateusz Przywara, Karolina Maria Leś, Marta Piwódzka, Marcin Chutkowski, Ireneusz Opaliński
Format: Article
Language:Polish
Published: Polish Pharmaceutical Society 2024-01-01
Series:Farmacja Polska
Subjects:
Online Access:https://www.ptfarm.pl/download/?file=File%2FFarmacja+Polska%2F2023%2F10%2F02_OG_Poprawa_wlasciwosci_przetworczych_naprok.pdf
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author Mateusz Przywara
Karolina Maria Leś
Marta Piwódzka
Marcin Chutkowski
Ireneusz Opaliński
author_facet Mateusz Przywara
Karolina Maria Leś
Marta Piwódzka
Marcin Chutkowski
Ireneusz Opaliński
author_sort Mateusz Przywara
collection DOAJ
description Study subject: A significant share of the raw materials used in pharmaceutical production are bulk materials. One of the key parameters affecting the quality of the manufacturing process and pharmaceutical product as well as determining the processing properties of raw materials in the manufacturing of solid drug forms is the flowability of the bulk powders. Flowability is important in the case of volumetric dosage of powder materials, in the production of tablets, capsules or granules. Research Objective: The purpose of this study was to develop a method for improving the flowability of naproxen using the ordered mixing process in the high–speed mixer–granulator. Naproxen was mixed with fumed silica. The process of adjusting interactive mixing parameters, i.e., the rotation speed of the main stirrer and the side stirrer, was performed and their effect on the flowability of naproxen was evaluated. A detailed analysis of the effect of process time on the tested material flowability was also carried out. Material and methods: In this study naproxen was doped with nanometric hydrophilic fumed silica under the trade name AEROSIL® 200. Interactive mixing was performed in the high–speed mixer–granulator. The flowability of the obtained mixtures was evaluated based on the selected Carr indices. Results: A reduction of about 20 deg in the angle of repose and the compressibility index by about 20% and an increase of about 8 deg in the angle of difference compared to the starting raw material were obtained. Significant improvement in the flowability of naproxen was obtained already after 5 min of mixing at the main stirrer speed of 150–300 rpm and side stirrer speed of 300–1500 rpm. Conclusions: The applied method makes it possible to reduce the amount of lubricant used compared to traditional mixing methods that involve mainly tumbling blenders. Improved flowability has a beneficial effect on further stages of production of pharmaceuticals containing naproxen, i.e. mixing with other components of the drug, tableting or encapsulation.
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spelling doaj.art-3d9e8dd7abbd461f80b9170cbe8b66c42024-04-19T11:51:42ZpolPolish Pharmaceutical SocietyFarmacja Polska0014-82612024-01-01791059560310.32383/farmpol/178520178520Improvement of handling properties of naproxen using ordered mixing methodMateusz Przywara0https://orcid.org/0000-0001-7009-7811Karolina Maria Leś1https://orcid.org/0000-0002-1112-8160Marta Piwódzka2https://orcid.org/0009-0001-3975-9132Marcin Chutkowski3https://orcid.org/0000-0001-8234-4963Ireneusz Opaliński4https://orcid.org/0000-0001-5887-2336Wydział Chemiczny/Katedra Inżynierii Chemicznej i Procesowej, Politechnika Rzeszowska im. Ignacego Łukasiewicza, PolskaWydział Chemiczny/Katedra Inżynierii Chemicznej i Procesowej, Politechnika Rzeszowska im. Ignacego Łukasiewicza, PolskaAbsolwentka Wydział Chemiczny/Katedra Inżynierii Chemicznej i Procesowej, Politechnika Rzeszowska im. Ignacego Łukasiewicza, PolskaWydział Chemiczny/Katedra Inżynierii Chemicznej i Procesowej, Politechnika Rzeszowska im. Ignacego Łukasiewicza, PolskaWydział Chemiczny/Katedra Inżynierii Chemicznej i Procesowej, Politechnika Rzeszowska im. Ignacego Łukasiewicza, PolskaStudy subject: A significant share of the raw materials used in pharmaceutical production are bulk materials. One of the key parameters affecting the quality of the manufacturing process and pharmaceutical product as well as determining the processing properties of raw materials in the manufacturing of solid drug forms is the flowability of the bulk powders. Flowability is important in the case of volumetric dosage of powder materials, in the production of tablets, capsules or granules. Research Objective: The purpose of this study was to develop a method for improving the flowability of naproxen using the ordered mixing process in the high–speed mixer–granulator. Naproxen was mixed with fumed silica. The process of adjusting interactive mixing parameters, i.e., the rotation speed of the main stirrer and the side stirrer, was performed and their effect on the flowability of naproxen was evaluated. A detailed analysis of the effect of process time on the tested material flowability was also carried out. Material and methods: In this study naproxen was doped with nanometric hydrophilic fumed silica under the trade name AEROSIL® 200. Interactive mixing was performed in the high–speed mixer–granulator. The flowability of the obtained mixtures was evaluated based on the selected Carr indices. Results: A reduction of about 20 deg in the angle of repose and the compressibility index by about 20% and an increase of about 8 deg in the angle of difference compared to the starting raw material were obtained. Significant improvement in the flowability of naproxen was obtained already after 5 min of mixing at the main stirrer speed of 150–300 rpm and side stirrer speed of 300–1500 rpm. Conclusions: The applied method makes it possible to reduce the amount of lubricant used compared to traditional mixing methods that involve mainly tumbling blenders. Improved flowability has a beneficial effect on further stages of production of pharmaceuticals containing naproxen, i.e. mixing with other components of the drug, tableting or encapsulation.https://www.ptfarm.pl/download/?file=File%2FFarmacja+Polska%2F2023%2F10%2F02_OG_Poprawa_wlasciwosci_przetworczych_naprok.pdfnaproxenflowabilityordered mixinghigh-speed mixer-granulator
spellingShingle Mateusz Przywara
Karolina Maria Leś
Marta Piwódzka
Marcin Chutkowski
Ireneusz Opaliński
Improvement of handling properties of naproxen using ordered mixing method
Farmacja Polska
naproxen
flowability
ordered mixing
high-speed mixer-granulator
title Improvement of handling properties of naproxen using ordered mixing method
title_full Improvement of handling properties of naproxen using ordered mixing method
title_fullStr Improvement of handling properties of naproxen using ordered mixing method
title_full_unstemmed Improvement of handling properties of naproxen using ordered mixing method
title_short Improvement of handling properties of naproxen using ordered mixing method
title_sort improvement of handling properties of naproxen using ordered mixing method
topic naproxen
flowability
ordered mixing
high-speed mixer-granulator
url https://www.ptfarm.pl/download/?file=File%2FFarmacja+Polska%2F2023%2F10%2F02_OG_Poprawa_wlasciwosci_przetworczych_naprok.pdf
work_keys_str_mv AT mateuszprzywara improvementofhandlingpropertiesofnaproxenusingorderedmixingmethod
AT karolinamariales improvementofhandlingpropertiesofnaproxenusingorderedmixingmethod
AT martapiwodzka improvementofhandlingpropertiesofnaproxenusingorderedmixingmethod
AT marcinchutkowski improvementofhandlingpropertiesofnaproxenusingorderedmixingmethod
AT ireneuszopalinski improvementofhandlingpropertiesofnaproxenusingorderedmixingmethod