Abstract
Dissolving microneedles (DMNs) are vital for the transdermal delivery of protein-based drugs due to their painless penetration, effective drug permeation, and safety characteristics. Thus, it is necessary to quantify the proteins encapsulated inside the DMNs. The classic BCA(c-BCA) assay is commonly employed for protein quantification. However, the presence of dextran (Dex, an excipient of DMNs) interferes with the quantification of ovalbumin (OVA) by the c-BCA assay, leading to erroneous results. Therefore, two new techniques, including modified BCA (m-BCA) and reversed-phase HPLC (RP-HPLC) were developed to accurately determine the protein concentrations in pharmaceutical formulations, compared with the c-BCA assay. The results showed that the m-BCA and RP-HPLC methods were reliable for protein quantification in DMNs, with linear responses for correlation coefficients of >0.99; the acceptable added samples recoveries of 100 ± 10 %; and the inter-day precisions for a relative standard deviation of <10 %. Herein, we describe these two methods for the rapid quantification of protein loaded in DMNs.
Published Version
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