Rheological Evaluation of Inter-grade and Inter-batch Variability of Sodium Alginate
Open accessAbstract
Polymeric excipients are often the least well-characterized components of pharmaceutical formulations. The aim of this study was to facilitate the QbD approach to pharmaceutical manufacturing by evaluating the inter-grade and inter-batch variability of pharmaceutical-grade polymeric excipients. Sodium alginate, a widely used polymeric excipient, was selected for evaluation using appropriate rheological methods and test conditions. The materials used were six different grades of sodium alginate and an additional ten batches of one of the grades. To compare the six grades, steady shear measurements were conducted on solutions at 1%, 2%, and 3% w/w, consistent with their use as thickening agents. Small-amplitude oscillation (SAO) measurements were conducted on sodium alginate solutions at higher concentrations (4-12% w/w) corresponding to their use in controlled-release matrices. In order to compare the ten batches of one grade, steady shear and SAO measurements were performed on their solutions at 2% w/w and 8% w/w, respectively. Results show that the potential interchangeability of these different grades used as thickening agents could be established by comparing the apparent viscosities of their solutions as a function of both alginate concentration and shear conditions. For sodium alginate used in controlled-release formulations, both steady shear behavior of solutions at low concentrations and viscoelastic properties at higher concentrations should be considered. Furthermore, among batches of the same grade, significant differences in rheological properties were observed, especially at higher solution concentrations. In conclusion, inter-grade and inter-batch variability of sodium alginate can be determined using steady shear and small-amplitude oscillation methods.
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Because alginate is biologically derived, its mechanical properties are subject to lot-to-lot variability.
“However, because alginate is biologically derived, its mechanical properties are still subject to lot-to-lot variability110.”
From Towards organoid culture without Matrigel (2021) · cites this paper as [110]
There have been a number of studies showing that organoids can be grown on unmodified surfaces such as alginate, but this requires more research.
“There have been a number of studies showing that organoids can be grown on unmodified surfaces such as alginate, but this requires more research103,105,110,175,183.”
From Towards organoid culture without Matrigel (2021) · cites this paper as [110]
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- Authors
- Fu, S., Thacker, A., Sperger, D. M., Boni, R. L., Velankar, S., Munson, E. J., & Block, L. H.
- Affiliations
- Duquesne University (US)
- University of Kansas (US)
- University of Pittsburgh (US)
- University of Kentucky (US)
- Corresponding author
- Block, Lawrence H.
- Venue
- AAPS PharmSciTech
- Published
- 2010-11-24
- Volume
- 11
- Issue
- 4
- Pages
- 1662-1674
- ISSN
- 1530-9932 (ISSN-L)
- PMC
- PMC3011064
- OpenAlex
- W2141819905
- Cited by
- 67
- References
- 44
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 2 · 2023: 8 · 2022: 6 · 2021: 7 · 2020: 4 · 2019: 4 · 2018: 6 · 2016: 4 · 2015: 3 · 2014: 6 · 2013: 4
- FWCI
- 1.96
- Type
- journal article
- Language
- en
- Update notices
- erratum (2011-01-07)
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- AAPS PharmSciTech (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Polysaccharides Composition and Applications
- Physical Sciences › Chemical Engineering › Fluid Flow and Transfer Processes › Rheology and Fluid Dynamics Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Medicine › Hydrogels: synthesis, properties, applications
- Keywords
- sodium alginate, polymeric excipients, batch-to-batch variation, rheology, steady shear flow, small oscillations, apparent viscosity, viscoelasticity, thickening agents, quality by design
- MeSH terms
- Alginates, Calcium, Delayed-Action Preparations, Drug Compounding, Excipients, Hexuronic Acids, Rheology, Viscosity, Pharmaceutical Solutions, Glucuronic Acid, Shear Strength
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