Rheological evaluation of inter-grade and inter-batch variability of sodium alginate |
| |
Authors: | Fu Shao Thacker Ankur Sperger Diana M Boni Riccardo L Velankar Sachin Munson Eric J Block Lawrence H |
| |
Institution: | (1) Graduate School of Pharmaceutical Sciences, Duquesne University, 600 Forbes Avenue, Pittsburgh, Pennsylvania 15282, USA;(2) Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas 66047, USA;(3) Department of Chemical and Petroleum Engineering, Swanson School of Engineering, University of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA;(4) Department of Pharmaceutical Sciences, University of Kentucky, Lexington, Kentucky 40536, USA; |
| |
Abstract: | 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. |
| |
Keywords: | |
本文献已被 PubMed SpringerLink 等数据库收录! |
|