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Comparative studies of powder flow predictions using milligrams of powder for identifying powder flow issues.
Deng, Tong; Garg, Vivek; Pereira Diaz, Laura; Markl, Daniel; Brown, Cameron; Florence, Alastair; Bradley, Michael S A.
Afiliación
  • Deng T; Wolfson Centre for Bulk Solids Handling Technology, Faculty of Engineering & Science, University of Greenwich, Central Avenue, Chatham ME4 4TB, UK. Electronic address: t.deng@gre.ac.uk.
  • Garg V; Wolfson Centre for Bulk Solids Handling Technology, Faculty of Engineering & Science, University of Greenwich, Central Avenue, Chatham ME4 4TB, UK.
  • Pereira Diaz L; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, UK; EPSRC Future Continuous Manufacturing and Advanced Crystallisation Research Hub, Glasgow G1 1RD, UK.
  • Markl D; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, UK; EPSRC Future Continuous Manufacturing and Advanced Crystallisation Research Hub, Glasgow G1 1RD, UK.
  • Brown C; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, UK; EPSRC Future Continuous Manufacturing and Advanced Crystallisation Research Hub, Glasgow G1 1RD, UK.
  • Florence A; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, UK; EPSRC Future Continuous Manufacturing and Advanced Crystallisation Research Hub, Glasgow G1 1RD, UK.
  • Bradley MSA; Wolfson Centre for Bulk Solids Handling Technology, Faculty of Engineering & Science, University of Greenwich, Central Avenue, Chatham ME4 4TB, UK.
Int J Pharm ; 628: 122309, 2022 Nov 25.
Article en En | MEDLINE | ID: mdl-36270553
Characterising powder flowability can be challenging when sample quantity is insufficient for a conventional shear cell test, especially in the pharmaceutical industry, where the cost of the active pharmaceutical ingredient (API) used is expensive at an early stage in the drug product development. A previous study demonstrated that powder flowability could be predicted based on powder physical properties and cohesiveness using a small quantity of powder samples (50 mg), but it remained an open question regarding the accuracy of the prediction compared to that measured using industry-standard shear cell testers and its potential to substitute the existing testers. In this study, 16 pharmaceutical powders were selected for a detailed comparative study of the predictive model. The flowability of the powders was predicted using a Bond number and given consolidation stresses, σ1, coupled with the model, where the Bond number represents powder cohesiveness. Compared to the measurements using a Powder Flow Tester (Brookfield) and an FT4 (Freeman Technology) Powder Rheometer shear cell tester, the results showed a good agreement between the predictions and the measurements (<22 % difference) from the two shear cell testers with different consolidation stresses, especially for cohesive materials. The model correctly predicts the class of flowability for 14 and 12 of the 16 powders for the PFT and the FT4, respectively. The study demonstrated that the prediction method of powder flowability using a small sample (50 mg) could substitute a standard shear cell test (>15 g) if the available amount of sample is small.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Emolientes Tipo de estudio: Prognostic_studies / Risk_factors_studies Idioma: En Revista: Int J Pharm Año: 2022 Tipo del documento: Article Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Emolientes Tipo de estudio: Prognostic_studies / Risk_factors_studies Idioma: En Revista: Int J Pharm Año: 2022 Tipo del documento: Article Pais de publicación: Países Bajos