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A Comparative Study of Directly Compressible Orally Disintegrating Tablet Platforms

The world’s population is widely acknowledged to be ageing, resulting in the demand for geriatric medicines increasing, and this trend will continue. Plenty of evidence shows that children are not just small-sized human beings, a child’s metabolism is significantly different to that of an adult, and ageappropriate formulations have to be developed. In fact, since 2007, it has been compulsory for a paediatric investigational plan to be submitted to the Paediatrics Committee at the EMA at the end of the first phase of testing a new drug in adults (1). Thus, a need to develop formulations targeting these two population groups is clear. Since children and elderly people are not easily persuaded to take medicines, compliance is a significant challenge. Orally disintegrating tablets (ODTs) can overcome this because, since they are usually smaller, they disintegrate rapidly in the mouth and they have a pleasant mouthfeel and flavour, making them, overall, easier to take.

ODTs: A Challenging Oral Dosage Form

The combined ODT markets in the US, the EU, and Japan doubled in size over the past four years. According to reports, the global ODT market is predicted to grow at a significant pace: revenue growth is anticipated to rise from an estimated US $11.4 billion in 2017 to about US $27 billion by the end of 2025 (2). As a result, more than 450 over-thecounter and prescription ODT products are now available on the market. ODTs can be produced by different technologies, including direct compression (DC), lyophilisation (freeze drying), moulding, mass extrusion, and spray-drying (3). All these technologies have their own disadvantages, such as relatively slow disintegration, poor mouthfeel or taste masking, cost-ineffective manufacturing, a requirement for special packaging due to hygroscopicity, or low chemical and/ or mechanical stability. However, DC platforms have clear advantages in terms of cost-effectiveness and ease of ODT manufacturing compared to other technologies. Figure 1 shows the key performance attributes expected in a DC ODT platform. In addition to fast disintegration, an ODT platform must also be stable, have a good level of inertness, good flowability and compactability, and must contribute to the pleasant mouthfeel of the final formulation.



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Dr Carolina Diaz Quijano is Head of Technical Services for consumer goods at Omya, joining the company in 2013. Prior to her current position, Carolina has worked as Senior Scientist for Mineral Surface Chemistry and as Manager for Technical Services and Innovation. She has also previously worked as a research collaborator in protein engineering at the University of Zurich, Switzerland, and in diagnostics and genetic profiles at the start-up Stab Vida in Portugal. She earned a PhD in life sciences from ETH Zurich, Switzerland.
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