In order to achieve rapid disintegration rates, the tablet formulation must provide high porosity, low density and a low hardness ( Berthoumieu et al., 2010 Bandari et al., 2008). Orally disintegrating tablets are solid dosage forms which are formulated with the aim of improving the disintegrating and dissolution rates of a pharmaceutical product. José Ramón Ticó Grau, in Formulation Tools for Pharmaceutical Development, 2013 6.1 Introduction Thus, ODTs manufactured with FCC feature both high porosity and high levels of hardness ( Hamaidi, 2017). After milling and sieving, the granules are ready to be mixed with APIs and can be compressed into ODTs. This structure facilitates the production of granules by dry granulation. In contrast to other porous excipients, FCC has a lamellae morphology, which provides plenty of surface contact points among the particles, ensuring interlocking during dry granulation in roller compactors. FCC particles are characterized by an external lamellae structure and an internal network of interconnected pores ( Hamaidi, 2017).
This process can be controlled to obtain specific surface areas ranging between 30 and 180 m 2/g, a median particle size distribution of between 2 and 30 μm, and porosities of higher than 60%. FCC is manufactured from high-purity calcium carbonate that undergoes surface recrystallization. Functionalized calcium carbonate (FCC) offers the advantage of being a structured mineral comprising calcium carbonate and hydroxyapatite, both of which are monographed minerals. It can be difficult to find multifunctional excipients that do not add to the burden of an already extensive regulatory filing ( Bharawaj et al., 2010). Developing a dosage form with these properties requires an excipient that offers optimum cohesiveness for compaction.
The challenge, therefore, when compressing ODTs is ensuring a structure that enables fast disintegration without affecting the hardness of the tablets. However, the disintegration capacity of ODTs produced in this way is limited by the size and hardness of the resulting tablets. From the perspectives of cost and simplicity, the preferred method of preparing ODTs is direct compression. Orally disintegrating tablets (ODTs) are becoming increasingly important in the global pharmaceutical market for both prescription and over-the-counter medications because they can significantly improve patient compliance. Tekade, in Basic Fundamentals of Drug Delivery, 2019 2.4 Multifunctional Mineral Excipients
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