The use of three-factor dispersion analysis to develop the composition of solutions for pharmaceutical printing of films dispersed in the oral cavity based on the substance 2-ethyl-6-methyl-3-hydroxypyridine succinate

Background. One of the main developing areas of medicine and pharmacy is the personification of pharmacological therapy. For the purpose of personification, dosage forms are being developed with the possibility of changing the dose during production, allowing for individual therapy for each patient. Currently, there are two main directions in the development of LF for individualized therapy: two-dimensional (2D) and three-dimensional (3D) printing methods that allow to obtain medicinal products of arbitrary size, shape and dose. Two-dimensional printing is additionally characterized by greater simplicity in the preparation of medicines (drugs) and allows you to obtain films dispersed in the oral cavity.

Aim. In this study, the composition of solutions (“ink”) containing the active pharmaceutical ingredient (API) 2-ethyl-6-methyl-3-hydroxypyridine succinate used in inkjet printing technology to produce films dispersed in the oral cavity is being developed. This API has antioxidant, antihypoxant and membrane protective effects and is used in many fields of medicine, in particular, cardiology, neurology, narcology, psychiatry.

Materials and methods. Viscosity measurement (EAC Pharmacopoeia 2.1.2.9. 201020009–2019) – VPJ-4 1.12 (Yancheng Jingwei Int’l Group Co., Ltd., China), Surface tension measurement – bubble Tensiometer (Sensadyne PC 900, M&H Technologies Inc., Flagstaff, USA), Relative density determination (EAEU Pharmacopoeia 2.1.2.5. 201020005–2019) – pycnometer; Canon PIXMA TS5040 thermal jet printer (Canon Inc, Tokyo, Japan) equipped with a QY6-0089-000000 printhead. In addition, methods for calculating the Onesorge number and the Z number were used, and full-factor three-level analysis of variance was used for the mathematical analysis of the data obtained.

Results. The development was carried out using the method of dispersion analysis to study the influence of composition factors on the studied pharmaceutical and technological characteristics of solutions. The type of viscosity and surface tension modifiers, the quantitative ratio of excipients and purified water, as well as the introduction of an additional surfactant are used as composition factors. Among the studied pharmaceutical and technological characteristics are viscosity, true density of solutions, surface tension, Onesorge number and solubility of API.

Conclusion. The analysis of the obtained data revealed the influence of each factor and their interactions, demonstrated their degree of exposure to pharmaceutical and technological characteristics of printing solutions, and also obtained average values of characteristics for particular factors of the composition of solutions to determine the most optimal excipients to achieve the target values of the Z number and the highest quantitative content of API in the composition.

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