A key element in an individual's quality of life is undoubtedly maintaining an adequate state of health. In the case of the need to establish effective pharmacotherapy, we recognize that different patient populations require different dosing regimens and that individualized pharmacotherapies can increase both treatment success and patient adherence. For this reason, advanced formulation approaches are increasingly being developed, i.e. customized pharmaceutical forms to meet the individual needs of patients in the future. These approaches include the technology of applying active pharmaceutical ingredient (API) to biocompatible substrates using 2D printing method, which for active ingredients with low doses and/or narrow therapeutic window represent the possibility of individualized dosing and tailored therapy. Due to the need for a specific narrow particle size distribution, which after redispersion in the media for cartridges has the appropriate properties for successful 2D printing, the electrospraying method is suitable to produce such particles. By changing various formulation and process parameters, microparticles with different properties can be produced. Thus, we have attempted to use the electrospraying method to produce particles with a model drug in sufficiently small sizes suitable for subsequent use in cartridges for 2D printing.
In the research work, we studied the production process using the method of electrostatic spraying of chloroform solutions of the polymer and evaluated the size and morphology of the microparticles of the polycaprolactone (PCL) polymer itself. We then investigated spraying of a mixture of simvastatin and PCL and a mixture of simvastatin and combinations of PCL with different molecular weights. By changing the process parameters, we tried to find the optimal combination of process parameters to produce particles with the appropriate size and shape distribution. Spherical particles were obtained in all solutions of the polymer with the higher molecular weight. The difference in morphology is evident when a combination of polymers is used, forming particles with a higher proportion of morphological irregularities. Spherical microparticles with smooth surface were prepared by electrospraying solutions of polymer and active ingredient in the ratio of 9 : 1. In these solutions, we evaluated the influence of process parameters on the size of microparticles. The most suitable particles that we produced from this ratio of polymer and active ingredient at the most optimal process parameters, were then redispersed in the three media for cartridges. The cartridge media consisted of propylene glycol and water in different volume ratios (10 : 90, 50 : 50 and 90 : 10). The produced particles formed aggregates after redispersion, so it would be useful to apply a hydrophilic coating to the manufactured particles. The electrospraying method proved effective in the preparation of simvastatin and polycaprolactone scaffold microparticles, but the resulting particles are not suitable for use in 2D print cartridges.
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