A high-sensitivity HPLC-ELSD method for HPMC-AS quantification and its application in elucidating the release mechanism of HPMC-AS based amorphous solid dispersions

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Shan WangFeng Qian

Abstract

Hydroxypropyl methylcellulose acetate succinate (HPMC-AS) is one of the most widely used polymers used in amorphous solid dispersions (ASD) for solubility and bioavailability enhancement of poorly water-soluble drugs. Once released from ASDs, HPMC-AS was often found to be highly effective in maintaining drug supersaturation, and this capability is dependent on the concentration and substitution types of this pH-dependent polymer. Therefore, accurate quantification of different grades of HPMC-AS allows us to better understand the release and supersaturation mechanisms of HPMC-AS based ASDs. Since previously reported analytical methods were unable to quantify HPMC-AS in a complex medium with enough sensitivity, we hereby developed a high-sensitivity HPLC-ELSD (evaporative light scattering detector) method with satisfactory specificity, linearity, accuracy and precision, to quantify HPMC-AS down to 20 μg/mL in dissolution media, with the presence of various commonly used pharmaceutical excipients. With the assistance of this method, we compared the intrinsic dissolution rates (IDR) of both the drug and the polymer of posaconazole ASDs based on different types of HPMC-AS. We observed that: 1) For ASDs that were spray dried and unif...Continue Reading

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