4.7 Article

Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel

期刊

PHARMACEUTICS
卷 14, 期 4, 页码 -

出版社

MDPI
DOI: 10.3390/pharmaceutics14040707

关键词

analytical quality by design; in vitro release test; USP apparatus IV with semi-solid adapter; topical gel; diclofenac sodium

资金

  1. Egis Pharmaceuticals Plc. [TKP2021-EGA-32]
  2. Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund [TKP2021-EGA]

向作者/读者索取更多资源

The aim of this study was to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter for diclofenac sodium hydrogel, by applying the analytical quality by design approach. The analytical target profile and critical method attributes were defined, and an initial risk assessment was conducted. High-risk parameters were identified and a test protocol was developed for the hydrogel system.
The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-high-performance liquid chromatography were defined; the critical method attributes (CMAs) (min. 70% of the drug should be released during the test, six time points should be obtained in the linear portion of the drug release profile, and the relative standard deviation of the released drug should not be over 10%) were selected. An initial risk assessment was carried out, in which the CMAs (ionic strength, the pH of the media, membrane type, the rate of flow, the volume of the SSA (sample amount), the individual flow rate of cells, drug concentration %, and the composition of the product) were identified. With the results, it was possible to determine the high-risk parameters of the in vitro drug release studies performed with the USP apparatus IV with SSA, which were the pH of the medium and the sample weight of the product. Focusing on these parameters, we developed a test protocol for our hydrogel system.

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