Drug development and industrial pharmacy · 2025
An in vitro release test method with Immersion Cells for evaluation of drug release performance of butenafine hydrochloride cream.
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Li Ping, Zhang Rongqin, Li Xin, Chen Hong, Zheng Ping, Xie Li
Аннотация
OBJECTIVE: To establish an in vitro release (IVR) method for butenafine hydrochloride cream using Immersion Cells and compare the drug release characteristics of commercial samples.
SIGNIFICANCE: Reevaluating post-listing semisolid drug products based on quality attributes of IVR performance is crucial for guaranteeing clinical efficacy.
METHODS: An in vitro release testing (IVRT) method using Immersion Cells was developed and validated for sensitivity, linearity, and reproducibility. It was adapted for use with Vertical Diffusion Cells (VDCs) to compare two devices. Univariate tests were conducted to assess the effect of excipients on in vitro release rates (IVRRs). Three regulatory guidelines recommended by FDA, NMPA and EMA for IVR performance consistency assessment were compared to evaluate the sameness of marketed samples.
RESULTS: For IVRT of butenafine hydrochloride cream, Immersion Cells exhibited the same functionality as VDCs. Stearyl alcohol which serves as oil phase matrix and thickener in the cream had a significant impact on IVRRs. Regarding the consistency of marketed samples, FDA guidelines supported a consistent conclusion, while NMPA and EMA guidelines reached the opposite conclusion, which were primarily attributed to different acceptance criteria outlined in the three regulatory guidelines.
CONCLUSIONS: Additional strategies are needed to ensure consistent therapeutic outcomes of butenafine hydrochloride cream throughout its life cycles, such as stricter control of stearyl alcohol dosage during manufacturing. Further research is needed to explore appropriate limits for consistency assessment of it. Immersion Cells offers the advantage of lower cost in routine quality control and its application in IVRT for semisolid formulations merits further expansion.
SIGNIFICANCE: Reevaluating post-listing semisolid drug products based on quality attributes of IVR performance is crucial for guaranteeing clinical efficacy.
METHODS: An in vitro release testing (IVRT) method using Immersion Cells was developed and validated for sensitivity, linearity, and reproducibility. It was adapted for use with Vertical Diffusion Cells (VDCs) to compare two devices. Univariate tests were conducted to assess the effect of excipients on in vitro release rates (IVRRs). Three regulatory guidelines recommended by FDA, NMPA and EMA for IVR performance consistency assessment were compared to evaluate the sameness of marketed samples.
RESULTS: For IVRT of butenafine hydrochloride cream, Immersion Cells exhibited the same functionality as VDCs. Stearyl alcohol which serves as oil phase matrix and thickener in the cream had a significant impact on IVRRs. Regarding the consistency of marketed samples, FDA guidelines supported a consistent conclusion, while NMPA and EMA guidelines reached the opposite conclusion, which were primarily attributed to different acceptance criteria outlined in the three regulatory guidelines.
CONCLUSIONS: Additional strategies are needed to ensure consistent therapeutic outcomes of butenafine hydrochloride cream throughout its life cycles, such as stricter control of stearyl alcohol dosage during manufacturing. Further research is needed to explore appropriate limits for consistency assessment of it. Immersion Cells offers the advantage of lower cost in routine quality control and its application in IVRT for semisolid formulations merits further expansion.