Abstract
This study focused on the implementation of the stages of pharmaceutical development of a dosage form of eye drops based on the branched oligohexamethylene guanidine hydrosuccinate according to discrete and continuous optimization, followed by risk assessment and process validation. Experimental samples were developed, critical process and quality parameters were identified, technological characteristics were measured, parameters were normalized, a forecast was made, confirmatory experiments were conducted, the optimal composition was identified, risks in the production of eye drops were assessed, and partial validation was performed. During the implementation of the stages of pharmaceutical development of eye drops based on branched oligohexamethylene guanidine hydrosuccinate, three optimization cycles (discrete and continuous) were carried out, and the optimal ratio of active and auxiliary components was justified based on the results (branched oligohexamethylene guanidine hydrosuccinate 0.05%, polyvinyl alcohol 1%, phosphate-buffered saline 20%, sodium chloride 0.45%, and purified water up to 100%). After reviewing the technological process considering risk analysis, critical points were identified, and partial validation was performed, and the positive results verified and confirmed the optimal choice at this stage of pharmaceutical development. In general, a mixed type of optimization (discrete and continuous) can be used to implement pharmaceutical developments of eye drops based on branched oligohexamethylene guanidine hydrosuccinate, which is confirmed by a series of experiments and risk assessment, and the partial validation verified the data obtained. Thus, pharmaceutical development is a complex and time-consuming process, and limited functionality does not always allow quick identification of the optimal composition of a drug. As an effective solution for implementing the stages of pharmaceutical development, mathematical modeling methods and various types of optimization can be applied.