Department of Pharmaceutical Technology, School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia in Katowice, 41-200 Sosnowiec, Poland.
"Biochefa" Pharmaceutical Research and Production Plant, 41-200 Sosnowiec, Poland.
Molecules. 2020 Apr 16;25(8):1824. doi: 10.3390/molecules25081824.
Corticotropin (ACTH, previously an adrenocorticotropic hormone) is used in the diagnosis and treatment of pituitary gland disorders, adrenal cortex disorders, and other diseases, including autoimmune polymyositis, systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, and ulcerative colitis. So far, the ointment dosage form containing ACTH for use on the skin is unknown. Therefore, it seems appropriate to develop a semi-solid formulation with corticotropin. Emulsion ointments were prepared using an Unguator based on the cream base Lekobaza containing corticotropin in different concentrations, and then the physical and chemical parameters of the ointment formulations, such as pH, spreadability, rheological properties, and texture analysis, were evaluated. In addition, a USP apparatus 2 with enhancer cells was utilized to study the in vitro drug release characteristics of the selected formulations. All the ointments obtained were characterized by good spreadability and viscosity. An analysis of the ointment texture was performed and the dependence of the tested parameters on the ACTH content in the ointment was demonstrated. Examination of the structure of the ointment showed that a high concentration of ACTH increases the hardness and adhesiveness of the ointment. In turn, it adversely affects the cohesiveness and elasticity of the ointments tested. The results of the release study showed that ACTH is released the fastest from the formulation with the lowest concentration, while the slowest from the ointment with the highest concentration of ACTH.
促皮质素（ACTH，以前称为促肾上腺皮质激素）用于诊断和治疗垂体腺疾病、肾上腺皮质疾病和其他疾病，包括自身免疫性多发性肌炎、系统性红斑狼疮、类风湿性关节炎、克罗恩病和溃疡性结肠炎。到目前为止，还不知道含有 ACTH 的用于皮肤的软膏剂型。因此，似乎有必要开发一种含有促皮质素的半固体制剂。基于含有促皮质素的 Lekobaza 乳膏基质，使用 Unguator 制备乳剂软膏，然后评估软膏制剂的物理化学参数，如 pH 值、铺展性、流变学特性和质地分析。此外，还使用 USP 装置 2 带有增强细胞来研究所选制剂的体外药物释放特性。获得的所有软膏均具有良好的铺展性和粘性。对软膏的质地进行了分析，并证明了测试参数与软膏中 ACTH 含量的依赖性。对软膏结构的检查表明，ACTH 浓度越高，软膏的硬度和粘性越大。反过来，这会对所测试软膏的内聚性和弹性产生不利影响。释放研究的结果表明，ACTH 从浓度最低的制剂中释放最快，而从 ACTH 浓度最高的软膏中释放最慢。
