Kinetic Monitoring of in vitro Release Testing Using UV-Vis Spectrophotometry with Hydrocortisone Creams.

IF 2.8 4区 医学 Q2 DERMATOLOGY
Kelsey Leach, Lola Sibaud, Bradley Towey
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引用次数: 0

Abstract

Introduction: A new method for conducting in vitro release testing (IVRT) was developed by adapting Higuchi's square root approximation for use with UV-Vis spectrophotometry, and over the counter hydrocortisone formulations at 0.5% and 1.0% concentrations. This IVRT method was investigated for the required validation elements as specified by abbreviated new drug applications (ANDAs) and USP General Chapter <1724> for linearity and range, precision and reproducibility, and discrimination sensitivity, specificity, and selectivity.

Methods: IVRT kinetic experiments were conducted using UV-Vis spectrophotometer, a quartz cuvette, with measurements collected every 15 s for 5 min, and methanol as the receptor solution. Six measurements of the 1% hydrocortisone formulation were conducted over 3 different days, for a total of 18 measurements. The 0.5% formulation was measured 6 times over 1 day. Release rates were obtained by plotting the slope of Abs242 vs. √t. HPLC was used to demonstrate specificity via an alternate analytical technique and to show membrane inertness.

Results: The hydrocortisone cream formulations demonstrated specificity via HPLC compared to a USP traceable hydrocortisone reference standard. IVRT sensitivity and selectivity were demonstrated by the statistically different release rates (slopes) of the 0.5% vs. the 1% hydrocortisone formulations at 90% confidence interval (75-133.33%). Linearity throughout the duration of the assay was demonstrated through a r2 value of ≥0.97 for each experiment and for each formulation. All intra-run and inter-run precision calculations relating to the IVRT experiments had %CV values of ≤15%.

Conclusion: IVRT experiments were conducted using UV-Vis spectrophotometry kinetic monitoring of 0.5% and 1% hydrocortisone formulations. This IVRT method was validated for specificity, selectivity, sensitivity, linearity and range, precision and reproducibility following the guidance for ANDAs and USP General Chapter <1724>, thus demonstrating the capability of UV-Vis spectrophotometry as a reliable way of discerning release rates of semisolid formulations. This novel approach can be conducted in a matter of minutes as opposed to hours, a vast improvement over conventional IVRT studies.

紫外可见分光光度法测定氢化可的松乳膏体外释放的动力学监测。
介绍:采用Higuchi平方根近似法,在0.5%和1.0%浓度的非处方氢化可的松制剂中,建立了一种新的体外释放试验(IVRT)方法。根据简略新药申请(anda)和USP通章的规定,对该方法的线性和范围、精密度和重现性、鉴别灵敏度、特异性和选择性进行了必要的验证元素研究。方法:采用石英试管紫外-可见分光光度计,以甲醇为受体溶液,每隔15 s采集5 min,进行IVRT动力学实验。在3天内对1%氢化可的松制剂进行了6次测量,总共进行了18次测量。0.5%配方在1天内测量6次。通过绘制Abs242相对于√t的斜率得到释放率。高效液相色谱通过一种替代分析技术证明了特异性,并显示了膜惰性。结果:氢化可的松乳膏配方通过高效液相色谱法与USP可追溯的氢化可的松参比标准品相比显示出特异性。在90%的置信区间(75-133.33%)内,0.5%氢化可的松制剂与1%氢化可的松制剂的释放率(斜率)有统计学差异,证明了IVRT的敏感性和选择性。在整个检测过程中,每个实验和每个配方的r2值均≥0.97,证明了线性。所有与IVRT实验相关的组内和组间精度计算的%CV值≤15%。结论:采用紫外可见分光光度法对0.5%和1%氢化可的松制剂进行了动态监测。该方法的特异性、选择性、灵敏度、线性和范围、精密度和重现性均按照ANDAs和USP通章的指导进行了验证,从而证明了紫外可见分光光度法作为识别半固体制剂释放速度的可靠方法的能力。这种新颖的方法可以在几分钟内完成,而不是几小时,这是对传统IVRT研究的巨大改进。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Skin Pharmacology and Physiology
Skin Pharmacology and Physiology 医学-皮肤病学
CiteScore
5.20
自引率
7.40%
发文量
23
审稿时长
>12 weeks
期刊介绍: In the past decade research into skin pharmacology has rapidly developed with new and promising drugs and therapeutic concepts being introduced regularly. Recently, the use of nanoparticles for drug delivery in dermatology and cosmetology has become a topic of intensive research, yielding remarkable and in part surprising results. Another topic of current research is the use of tissue tolerable plasma in wound treatment. Stimulating not only wound healing processes but also the penetration of topically applied substances into the skin, this novel technique is expected to deliver very interesting results.
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