Khaled Abdulhakim A A, Pervaiz Khalid, Khiljee Sonia, Karim Sabiha, Shoaib Qurat-ul-Ain, Murtaza Ghulam
Department of Mathematics, The Islamia University of Bahawalpur, Bahawalpur 63100, Pakistan.
Acta Pol Pharm. 2013 Sep-Oct;70(5):873-5.
The aim of this article was to assess and apply the in vitro to in vivo profiling (IVIVP), a new biowaiver approach, in designing a product with specific release pattern. The IVIVP was established by plotting the observed and predicted plasma drug concentrations. For IVIVP, convolution approach was employed to estimate plasma drug concentrations from in vitro dissolution profiles. The IVIVP for T1S exhibited a good correlation coefficient (R2 = 0.963) followed by the T2 (R2 = 0.682), T3 (R2 = 0.665), T1 (R2 = 0.616), and Mepresso (R2 = 0.345). Establishing an IVIVP, based on the convolution approach, can be more useful and practicable in the biowaiver studies, rather than present not useful practice of IVIVC estimated via deconvolution approach. This paper also elaborates that there is good correlation between the in vitro and in vivo profiles of the developed metoprolol tartrate formulations, particularly for T1S.
本文的目的是评估并应用体外到体内的特征分析（IVIVP）这一新型生物豁免方法来设计具有特定释放模式的产品。通过绘制观察到的和预测的血浆药物浓度来建立IVIVP。对于IVIVP，采用卷积法从体外溶出曲线估算血浆药物浓度。T1S的IVIVP显示出良好的相关系数（R2 = 0.963），其次是T2（R2 = 0.682）、T3（R2 = 0.665）、T1（R2 = 0.616）和美普洛尔（R2 = 0.345）。基于卷积法建立IVIVP在生物豁免研究中可能比目前通过反卷积法估算IVIVC的无用做法更有用且可行。本文还阐述了所研发的酒石酸美托洛尔制剂的体外和体内特征之间存在良好相关性，尤其是对于T1S。
