FreeThink Technologies, Inc., Branford, CT, USA.
Pharm Dev Technol. 2022 Jul;27(6):740-748. doi: 10.1080/10837450.2022.2112223. Epub 2022 Aug 18.
An accelerated stability model approach was demonstrated to accurately predict the long-term shelf life of example drug substances and drug products (indigo carmine tablets and L-ascorbic acid powder) where appearance changes were shelf life-limiting. The products were exposed outside of packaging to conditions from 50 to 90 °C and 0-80% relative humidity for up to one month to accelerate appearance changes. The appearance changes of stressed samples were quantitated using the CIELAB color scale (calculated Δ*), where a visual assessment of appearance changes likely to be noticeable was used to assign a Δ* specification limit. ASAP software was employed to create an isoconversion paradigm, modeled in packaging by the moisture-modified Arrhenius equation, that predicted the color changes of the products within the error bars of the model to nine months at 25 °C/60% RH, 30 °C/65% RH, and 40 °C/75% RH. Overall, these case studies indicate that the ASAP approach for accelerated stability studies are a fast, accurate approach to modeling appearance changes.
加速稳定性模型方法可用于准确预测示例药物物质和药物产品（靛蓝胭脂红片和 L-抗坏血酸粉末）的长期货架寿命，这些药物物质和药物产品的外观变化是货架寿命的限制因素。将产品在包装外暴露于 50 至 90°C 和 0-80%相对湿度的条件下长达一个月，以加速外观变化。使用 CIELAB 颜色标度（计算的Δ*）定量评估受应力样品的外观变化，其中使用外观变化的视觉评估来指定Δ*规格限制。ASAP 软件用于创建等转化率范例，该范例通过水分修正的 Arrhenius 方程在包装中建模，可预测产品在 25°C/60%RH、30°C/65%RH 和 40°C/75%RH 下的颜色变化，模型的误差范围内可预测到九个月。总体而言，这些案例研究表明，ASAP 用于加速稳定性研究的方法是一种快速、准确的建模外观变化的方法。
