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.
Highlights
About 74% of drugs taken orally do not provide the expected therapeutic effect
The results showed that ointments containing different concentrations of profiles of the ointment formulations
The research material consisted of ACTH isolated from the pituitary glands, which is dissolved in water with activity of 90 IU/mg (Biochefa, Sosnowiec, Poland)
Summary
About 74% of drugs taken orally do not provide the expected therapeutic effect. In addition to its protective function, the skin, thanks to its large surface area of approximately 1–2 m2 (about 15% of the total body weight) [2,3] and good blood supply to the dermis (skin microcirculation) [4,5,6], can be perfectly used for the administration of therapeutic substances, both topical and systemic This non-invasive and convenient route of administration (transdermal route) seems to be a promising way of overcoming difficulties related to the use of peptide substances [1,2,4,7,8,9,10]. There are two Molecules 2020, 25, 1824; doi:10.3390/molecules25081824 www.mdpi.com/journal/molecules
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