Abstract

Apremilast is an anti-inflammatory agent. It has been a flourishing molecule in the field of dermatology. In the year 2014, Apremilast got its approval for treatment of psoriatic arthritis. Presently it is known to treat a number of other conditions, including atopic dermatitis and plaque psoriasis. Apremilast a phthalimide derivative, is non-hygroscopic in nature. It is practically insoluble in water. Apremilast acts by inhibiting the activity of phosphodiesterase 4 (PDE4), an intracellular enzyme. Analytical method plays a key role to understand the physio-chemical properties of a drug molecule. Because of poor solubility and low permeability, analytical method development and formulation becomes challenging. Till date, there are no standard test methods available to analyze Apremilast. So, a critical review of the analytical techniques of Apremilast was carried out. The literature search was done by screening the papers reporting analytical techniques of Apremilast from year 2014 to 2019. Methodologies particularly UV spectroscopy, HPTLC, HPLC, X-ray diffraction, NMR, LC-MS were collected and reviewed. Interminable efforts are made by the researchers to develop simple, accurate, robust and cost-effective methods of analysis. In pharmaceutical research, this information will aid in the development of new delivery systems. The review will prove beneficial and advantageous pre-formulation studies and will guide the formulation development.

摘要

阿普斯特是一种抗炎剂。它一直是皮肤病学领域蓬勃发展的分子。2014年，阿普司特获批用于治疗银屑病关节炎。目前已知治疗许多其他病症，包括特应性皮炎和斑块状银屑病。阿普司特是一种邻苯二甲酰亚胺衍生物，本质上是非吸湿性的。它实际上不溶于水。阿普司特通过抑制细胞内酶磷酸二酯酶 4 (PDE4) 的活性起作用。分析方法在了解药物分子的理化特性方面起着关键作用。由于溶解性差和渗透性低，分析方法的开发和制定变得具有挑战性。迄今为止，没有可用于分析阿普司特的标准测试方法。所以，对 Apremilast 的分析技术进行了严格审查。文献检索是通过筛选 2014 年至 2019 年报告阿普司特分析技术的论文来完成的。收集和审查了方法学，特别是紫外光谱、HPTLC、HPLC、X 射线衍射、NMR、LC-MS。研究人员付出了不懈的努力来开发简单、准确、稳健且具有成本效益的分析方法。在药物研究中，这些信息将有助于开发新的给药系统。该审查将证明有益和有利的制剂前研究，并将指导制剂开发。收集并审查了 HPLC、X 射线衍射、NMR、LC-MS。研究人员付出了不懈的努力来开发简单、准确、稳健且具有成本效益的分析方法。在药物研究中，这些信息将有助于开发新的给药系统。该审查将证明有益和有利的制剂前研究，并将指导制剂开发。收集并审查了 HPLC、X 射线衍射、NMR、LC-MS。研究人员付出了不懈的努力来开发简单、准确、稳健且具有成本效益的分析方法。在药物研究中，这些信息将有助于开发新的给药系统。该审查将证明有益和有利的制剂前研究，并将指导制剂开发。