3PC-027 Optimisation of the liquid oral forms process: example of a semi-automated device and its qualification

<h3>Background and Importance</h3> The manual production of oral suspensions leads to the development of musculoskeletal disorders in operators and limits the size of batches. Faced with ever-increasing needs, the batch sizes of some oral formulations have been uprated. The pharmacy already has a mixer, which is used for mixing powders, and theoretically has the capacity to mix liquid forms. <h3>Aim and Objectives</h3> The study aimed to evaluate the ability of the equipment to produce oral suspensions by the optimisation and qualification of the semi-automated process. <h3>Material and Methods</h3> The frequent formulation that presented some non-conformities (uniformity of content issues) was chosen. A Topitec Touch mixer was used to perform the study. Melatonin powder (Inresa, France) and Syrspend (Fagron, the Netherlands) were selected. Firstly, for powder trituration, three speeds and three crushing times were tested in triplicates. Secondly, with optimum crushing parameters, the powder was mixed with the vehicle: two speeds and three times were evaluated in triplicates. Uniformity of content was performed by High-Performance Liquid Chromatography assay to study the homogeneity of the suspensions for all tested parameters. Statistical analyses of the variables were carried out using Excel software (alpha risk=5%). <h3>Results</h3> For the three trituration speeds and three trituration times, three samples were realised (top, middle, bottom). Statistical analysis of the results using a two-factor ANOVA test without repeating the experiment showed no difference between all samples (p-value=0.22) and between experiments (p-value=0.18). To limit container’s wear, trituration speed was set at 300 rpm, 1 minute. <h3>Second step</h3> Three mixing speeds and three trituration times, three samples were also performed. Statistical analysis showed no difference between all samples (p-value=0.87) and between experiments (p-value=0.36). To limit container’s wear, the mixing speed was set at 300 rpm for 4 minutes. To produce larger batches, parameters were progressively increased (mixing, speeds).Three batches were carried out by two technicians, were compliant and validated the qualification. Difficulties encountered included static electricity, which interfered with the proper mixing of the powder due to friction. <h3>Conclusion and Relevance</h3> The process for melatonin oral suspensions was optimised, qualified, and validated, enabling semi-automated production using the Topitec Touch. Applicability to other drugs and vehicles will be investigated. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest