COPROCESSED EXCIPIENTS OF CROSSLINKED AMYLOSE AND XANTHAN GUM FOR USE IN CONTROLLED RELEASE DOSAGE FORMS
Objective: This study was aimed to obtain a new excipient that can be used as a polymer matrix for the formulation of controlled release dosage forms.
Methods: This study used coprocessing and crosslinking methods on amylose and xanthan gum (XG) to obtain a new excipient that can be used
for controlled release matrix of pharmaceutical dosage forms. The coprocessing step was conducted by drum drying, and the crosslinking step was
prepared using 6 and 12% sodium trimetaphosphate (STMP). The produced novel excipients were characterized in terms of infrared (IR) spectrum,
substitution degree, moisture content, swelling index, and gel strength.
Results: Our results showed that amyloseâ€“XG excipients crosslinked using 6% STMP have greater gel strength and better swelling indexes than
excipients crosslinked using 12% STMP. All coprocessed excipients exhibited no differences in their IR spectra, whereas the crosslinked excipients
did, indicating a structural change due to the addition of phosphate groups. Crosslinking amyloseâ€“xanthan-coprocessed excipients using 6% STMP
produced degrees of substitution (DSs) of 7â€“8 phosphates per 100 monomeric subunits. The excipients had a moisture content of 8.21â€“12.85%, and
the pH of a 1% solution of excipients was 6.21â€“6.43. In addition, the swelling index and gel strength of the excipient where both amylose and XG were
crosslinked together Were more than 1 where only amylose was crosslinked.
Conclusion: The crosslinking amyloseâ€“xanthan-coprocessed excipient using 6% STMP is more suitable for use in controlled release dosage forms,
particularly when the polymer ratio is 1:1.
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