Development and Study of Semi-Solid Preparations Containing the Model Substance Corticotropin (ACTH): Convenience Application in Neurodegenerative Diseases

Abstract

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.

Influence of Concentration on Release and Permeation Process of Model Peptide Substance-Corticotropin-From Semisolid Formulations

“…The results of the release test showed that ACTH is released the fastest from the preparation with the lowest concentration. Higher concentration may ensure prolonged release process [24]. A very short time of hormone release from the all formulations was also found.…”

“…From these preparation corticotropin was released the fastest from the ointment of the lowest concentration; with increasing concentration, the rate of ACTH release decreased. The highest correlation coefficient in determining kinetic models was recorded for the Higuchi model [24]. On the other hand, from all formulations based on glycerol ointment ACTH was released longer than 150 min and its amount increased with increasing concentration in the ointment.…”

“…There are no reports of release and permeation of ACTH from ointment formulations. So far only one semi-solid form containing ACTH has been tested [24]. In this study, the emulsion ointments have been prepared on the basis of creamy Lekobaza ® base with amphiphilic properties, containing corticotropin in various concentrations.…”

Pre-Formulation Studies: Physicochemical Characteristics and In Vitro Release Kinetics of Insulin from Selected Hydrogels

“…F2 was the maximum force value in the second cycle. Hardness corresponded to the maximum force value in the first pressing section [ 34 , 35 , 36 ]. The measurements were carried out at 25 ± 1 °C and 32 ± 1 °C.…”

Modelling and Control of Corticotropin Permeation from Hydrogels across a Natural Membrane in the Presence of Albumin

“…The amount of hormone released per unit time was calculated and release profiles were plotted. The method of corticotropin determination was described by Siemiradzka et al [11,12]. Measurements were made using a UV-VIS Cecil CE 3021 spectrophotometer (Cecil Instruments Limited, Cambridge, England).…”