Discrete optimization of the implementation stages of pharmaceutical development for a spray treatment for oral diseases

Introduction. All over the world more than 3.5 billion people suffer from oral diseases, which can lead to endogenous infectious diseases and create conditions for external infections. The growing antimicrobial resistance of bacterial strains is a global health threat. Oligoalkyleneguanidine polymers may be promising compounds to solve this problem. The spray form for the application of these substances is the most optimal.

The aim of the study is to apply discrete optimization to implement the stages of pharmaceutical development of a spray based on branched oligohexamethyleneguanidine for the treatment of oral diseases.

Material and methods. Experiments are carried out using various equipment and samples with different compositions have been developed. The implementation of the pharmaceutical development stages was carried out using a discrete optimization algorithm.

Results. When implementing discrete optimization in pharmaceutical development, it is necessary to prioritize criteria and limitations using the target quality profile of the drug being developed. As a result of the optimization cycles carried out, the optimal composition was selected, which corresponds to the target quality profile, including such parameters as pH, dynamic viscosity, sterilizing filtration, adhesion of the formulations to the oral mucosa and the spray torch. A discrete optimization was carried out, taking into account the wetting edge angle and particle size distribution. The optimal composition was sample No. 8, which has pseudoplastic properties, provides unhindered spraying and prevents the composition from draining from the mucous membrane of the oral cavity.

Conclusion. During the study, the optimal ratio of components was determined and the development of a spray based on oligohexamethyleneguanidine with the implementation of stages of pharmaceutical development for discrete optimization was proposed.