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Influence of the Glidant on Diluent Flow Characterization Using Shear Cell Method

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Abstract

Purpose

The aim of this study was to compare the bulk lactose flow behavior with a defined fraction with smaller particles obtained by sieving from the bulk lactose and to evaluate the effect of a glidant addition on both samples. These powders showed, in a previous work, similar flow indexes (ffc) that motivated the addition of colloidal silicon dioxide in order to observe if there were any changes in their flow behaviors.

Methods

To evaluate this effect on the diluent flow behavior, the methods described in the European Pharmacopeia were used.

Results

The results obtained from conventional methods and shear cell methods (using the Powder Flow Tester) were compared, and they showed evident differences in the bulk and tapped densities values and flow classifications. The lactose monohydrate (FTotal) and lactose with particles smaller than 63 μm (F < 63) analyzed in a previous study presented similar ffc. To these pure powders a glidant was added, in increasing proportion (0.25—1.00%). The results obtained for all powders with colloidal silicon dioxide showed an improvement in its flow behaviors in comparison with pure powders.

Conclusion

All the parameters studied showed an evident effect of the glidant used. For the same amount of glidant, the F < 63 presented worse flow profiles than FTotal because its particles have a larger surface area. The FTotal + 0.25 flow profile was more similar to the F < 63 + 0.50 flow profile than F < 63 + 0.25 flow profile. For both powders, the maximum amount of glidant that produces effect was 1.00% for F < 63 and 0.75% for FTotal, respectively. In all powders, the occurrence of caking was not observed.

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Acknowledgments

The authors would like to thank Dra. Teresa Malta and Atral, S.A., for the kindly supplying of the lactose monohydrate, that made this work possible.

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Funding

This work was supported by the Applied Molecular Biosciences Unit-UCIBIO, which is financed by national funds from FCT/MCTES (UID/Multi/04378/2019).

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Authors and Affiliations

  1. Faculty of Pharmacy, Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), University of Lisbon, Av. Prof. Gama Pinto, 1649-003, Lisbon, Portugal

    Paulo José Salústio

  2. Faculty of Pharmacy, University of Lisbon, Av. Prof. Gama Pinto, 1649-003, Lisbon, Portugal

    Mafalda Machado

  3. Faculty of Sciences, University of Lisbon, Campo Grande, 1749-016, Lisbon, Portugal

    Telmo Nunes

  4. UCIBIO/REQUIMTE, MedTech-Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Rua Jorge Viterbo Ferreira, 228, 4050-313, Porto, Portugal

    José Paulo Sousa e Silva & Paulo Cardoso Costa

Authors
  1. Paulo José Salústio
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  2. Mafalda Machado
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  3. Telmo Nunes
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  4. José Paulo Sousa e Silva
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  5. Paulo Cardoso Costa
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Corresponding author

Correspondence to Paulo José Salústio.

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Highlights

Raw-materials flow properties are important for handling/ of the powders/granulates.

The glidants improve these powder/granulates characteristics.

Powder flow was measured according with European Pharmacopeia methods.

CSD improved the flow behavior of the powders analyzed.

CSD amount to produce maximum effect is different for two powders used.

Results from conventional methods are inconsistent.

Results from Powder Flow Tester methods are more complete and reliable.

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Salústio, P.J., Machado, M., Nunes, T. et al. Influence of the Glidant on Diluent Flow Characterization Using Shear Cell Method. J Pharm Innov 17, 60–70 (2022). https://doi.org/10.1007/s12247-020-09478-6

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  • DOI: https://doi.org/10.1007/s12247-020-09478-6

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