Impact of formulation excipients on the thermal, mechanical, and electrokinetic properties of hydroxypropyl methylcellulose acetate succinate (HPMCAS)

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Abstract

Hydroxypropyl methylcellulose acetate succinate (HPMCAS) has been widely used in amorphous solid dispersions and as an enteric coating polymer. Under aqueous coating conditions and at elevated coating temperatures, HPMCAS particles tend to aggregate and clog the spray-nozzle, hence interrupting the coating process. This research focused on how plasticizers and surfactants, excipients used for aqueous coating, affect the properties and stability of HPMCAS. This information would be useful in identifying suitable excipients for developing a stable HPMCAS aqueous enteric coating formulation. Triethyl citrate was found to be the most compatible plasticizer with HPMCAS, and displayed suitable thermal and mechanical properties. PEG 4000, the co-plasticizer, provided dispersion stability by yielding a dispersible sediment without aggregation at the elevated processing temperatures. Zeta potential measurements indicated sodium lauryl sulfate (SLS) could be used as a potential stabilizing agent at concentrations above its critical micelle concentration (CMC). This study facilitated the understanding of the HPMCAS aggregation mechanism, in addition to identifying suitable stabilizing agents. These stabilizing excipients could potentially be used to develop a stable aqueous coating formulation that does not exhibit polymer aggregation and nozzle clogging during the coating process.

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