Mota-Aguilar, David A.

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    Effect of operational and design parameters on the early stages of high shear wet granulation processes
    (2014) Mota-Aguilar, David A.; Velázquez-Figueroa, Carlos; College of Engineering; Méndez Román, Rafael; Curet-Arana, María C.; Córdova-Figueroa, Ubaldo M.; Department of Chemical Engineering; Macchiavelli, Raúl E.
    The development of new technologies, active ingredients and regulatory initiatives, has increased the need for a scientific understanding of the pharmaceutical manufacturing processes. In this context, solid dosage forms (i.e., tablets, capsules, etc.) receive special attention since they represent more than 66% of the medications in the market, due to their ease of administration, handling and production. This work is focused on the study of high shear wet granulation, a widely used intermediate operation in the production of solid dosage forms. The main objective is to contribute to the understanding of the effect of initial formulation conditions (i.e., hydrophobicity), operational parameters (i.e., impeller velocity), and design factors (i.e., impeller blade design) on the early stages of granule growth. The effect of the dry premixing stage in the initial wettability of hydrophobic formulations was studied. Results indicate that the concentration of the hydrophobic component and the applied premixing shear strain affect significantly the hydrophobic conditions of the formulation. They also suggest that the mixing mechanism of the hydrophobic ingredient should be taken into account in the design and analysis of these systems. Those findings were further explored carrying out an experimental design to study the high shear granulation of lubricated formulations. Although this is not a common practice in the industry, the results show that the addition of small amounts of lubricant can help as an internal controller of the granulation, decreasing the growth velocity and reducing the amount of over-granulated material. Another study was developed to determine the influence of the impeller velocity and blade angle on the granulation behavior. The analysis of the granulated material confirmed that both factors impact significantly the growth kinetics and can be used to modify the performance of a high shear granulation process. The data also allowed the generation of useful processing maps and dimensionless groups to describe the process. In general, this research provides scientific elements to analyze high-shear granulation processes and demonstrates the applicability of those elements in formulation and process design. Experimental conditions and data sets are also valuable for the development of theoretical models and simulations.