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Novel copolymers of poly(sebacic anhydride) and poly(ethylene glycol) as azithromycin carriers to the lungs

Kwiecień Konrad, Knap Karolina, Heida Rick, Czajkowski Jonasz, Gorter Alan, Ochońska Dorota, Mielczarek Przemysław, Dorosz Agata, Niewolik Daria, Reczyńska-Kolman Katarzyna, Jaszcz Katarzyna, Brzychczy-Włoch Monika, Sosnowski Tomasz R., Olinga Peter, Pamuła Elżbieta

Biocybernetics and Biomedical Engineering

2025

Vol. 45, iss. 1

114--136

By many chronic lung diseases, there is a problem of recurrent bacterial infections that require frequent usage of antibiotics. They can be more effective and cause fewer side effects when administrated directly via the pulmonary route. For such purposes, various types of inhalers are used of which dry powder inhalers (DPIs) are one of the most common. Formulations such as dry powders usually consist of an active pharmaceutical ingredient (API) and a carrier material that is supposed to provide adequate properties to deliver the bioactive molecules to the site of action, effectively. Copolymers of sebacic acid (SA) and poly(ethylene glycol) (PEG) have been regarded as suitable materials for such formulations. Here, we present a study about the manufacturing of microparticles from such materials dedicated to inhalation which have been loaded with azithromycin (AZM). The microparticles (MPs) were 0.5 to 5 μm in size, presenting either a spherical or elongated shape depending on the material type and composition. The encapsulation efficiency (EE) of the MPs were almost complete with the drug loading up to 23.1 %. The powders had fair or good flowability based on Carr’s index and Hausner ratio. Due to the presence of the drug, the tendency to agglomerate decreased. As a result, up to 90 % of the obtained powders showed diameters below 5 μm. Also, the fine particles fraction (FPF) of the chosen formulation reached 66.3 ± 4.5 % and the mass median aerodynamic diameter was 3.8 ± 0.4 μm. The microparticles degraded quickly in vitro losing up to 50 % of their mass within 24 h and up to 80 % within 96 h of their incubation in phosphate-buffered saline (PBS). They were also nontoxic up to 100 μg/ml when added to cultures of A549 and BEAS-2B lung epithelial cells as well as to rat lung tissue slices tested ex vivo. The microparticles showed bactericidal effects against various strains of Staphylococcus aureus in lower than cytotoxic concentrations.

Dynamics of aerosol generation and flow during inhalation for improved in vitro–in vivo correlation (IVIVC) of pulmonary medicines

Dorosz Agata, Moskal Arkadiusz, Sosnowski Tomasz R.

Chemical and Process Engineering : New Frontiers

2023

Vol. 44, nr 4

art. no. e39

Chemical and process engineering offers scientific tools for solving problems in the biomedical field, including drug delivery systems. This paper presents examples of analyzing the dynamics of dispersed systems (aerosols) in medical inhalers to establish a better relationship between the test evaluation results of these devices and the actual delivery of drugs to the lungs. This relationship is referred to as in vitro-in vivo correlation (IVIVC). It has been shown that in dry powder inhalers (DPls), the aerosolization process and drug release times are determined by the inhalation profile produced by the patient. It has also been shown that inspiratory flow affects the size distribution of aerosols generated in other inhalation devices (vibrating mesh nebulizers, VMNs), which is due to the evaporation of droplets after the aerosol is mixed witha dditional air taken in by the patient. The effects demonstrated in this work are overlooked in standard inhaler testing methods, leading to inaccurate information about the health benefits of aerosol therapy, thus limiting the development of improved drug delivery systems.