Dynamic vapor sorption properties of sodium starch glycolate disintegrants

Paul M. Young, Stephen Edge, John N. Staniforth, D. Fraser Steele, Robert Price

Research output: Contribution to journalArticlepeer-review

24 Citations (Scopus)

Abstract

Dynamic vapor sorption (DVS) was used to determine the moisture sorption properties of sodium starch glycolates. The results were compared to similarly obtained data for potato starch, pregelatinized starch, microcrystalline cellulose (MCC), and crystalline lactose. As expected, sodium starch glycolates exhibit a large mass gain at 90% relative humidity (RH), compared to the other anhydroglucose-based excipients. However, the sorption capacities of potato starch and the modified starches between 10%–70% RH were similar. Analysis of the DVS data using the Brunauer-Emmett-Teller (BET) and Guggenheim, Anderson, and deBoer (GAB) theories to obtain the so-called monolayer (xm), as expected, showed that there was an increasing xm with apparent mass gain that is probably related to crystallinity, purity, and surface area and represents the number and accessibility of amorphous anhydroglucose units present. The value of xm was related to the degree of crystallinity or order as determined by X-ray diffraction, suggesting that xm can be used to further describe the amorphous nature of semicrystalline polymers containing anhydroglucose units, in particular the chemically modified sodium starch glycolate. Additionally, it appears that the sorption capacity between 10%–70% RH is not dramatically affected by the presence or type of cross-linking and sodium carboxymethylation (in sodium starch glycolates) and gelatinization (in pregelatinized starch) and that the superdisintegrant properties of the sodium starch glycolates are a consequence of some water-structure interaction that is well beyond the available number of hydration sites, as represented by xm. Further evaluation of the structure and sorption properties of excipients may aid the development of disintegrants for solid dosage forms.
Original languageEnglish
Pages (from-to)249-259
Number of pages11
JournalPharmaceutical Development and Technology
Volume10
Issue number2
DOIs
Publication statusPublished - 2005
Externally publishedYes

Keywords

  • Sodium starch glycolate
  • Moisture sorption
  • Disintegrant

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