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Abstract
Material science is the study of structural and chemical properties that give rise to bulk material properties. Understanding the fundamental structure-function relationship of materials enables the intentional manipulation of a material to achieve desirable traits for developing useful products. One such application is the development of immediate release pharmaceutical oral solid dosage forms (tablets) for treating illnesses. Tablets must function in accordance with rigorous standards to ensure adequate performance and safety for patients. Tablets must be mechanically strong enough to withstand production processing but weak enough to disintegrate and release active pharmaceutical ingredient (API) in a reasonable amount of time. This is just one example of the tension between desirable tablet attributes that a formulator must consider and engineer for. Explored in this work is the relationship between particle morphology and critical quality attributes such as flowability, tabletability, disintegration, and friability for the purpose of more efficiently developing formulations. By using materials science and small-scale-material-sparing test methods, the timeline and amount of API needed to produce a successful tablet formulation were drastically reduced compared to current industry practices.Additionally, a modified material-sparing granulation method was used to alter an API with an inherent tendency to segregate. The granulation work expanded on the more efficient formulation development approach, showing that even challenging APIs can be successfully formulated using minimal API and time. Lastly, an innovative technology for producing amorphous solid dispersion (ASD) tablets using injection molding was explored for the production of immediate release tablets. Injection molding is more efficient than the current production methods for ASD tablets. Furthermore, tablets produced via injection molding exhibited superior mechanical strength and content uniformity compared to tablets made via powder compression. This formulation development was also done using the rapid and material-sparing approach. Less than 10 g of API was needed to formulate and test tablets against industry standards. As these studies highlight, the implementation of materials science is a powerful tool for producing effective tablet formulations efficiently, which is beneficial for shortening the timeline for patients to gain access to life-saving drugs.