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Discovery & Development Dosage Forms, Drug Delivery, Profession

Prizewinning Pillmaster

DFE Pharma’s Alberto Berardi is one of 10 winners of The Journal of Pharmaceutical Sciences’ 2021 Outstanding Early Career Scientists award. Berardi was recognized for “the most original and significant scientific findings”, based on his work on superdisintegrants – excipients that make tablets “burst” (1). Here, Berardi shares his journey in academia and pharma across Europe and the Middle East – and wonders where it will take him next.

Describe the path that led to your prize…
 

After completing my PhD in 2013, I started as an Assistant Professor in Pharmaceutical technology at the Applied Science Private University in Amman, Jordan, and was promoted to Associate Professor in 2018.

During my scientific journey I have been involved in a variety of different research projects, with the common denominator being oral solid dosage forms and oral drug delivery. To name a few projects, I’ve studied the stability of biopharmaceutical products in gastric and intestinal fluids, the formulation of oral solid dosage vaccines, and the development of controlled-release oral solid dosage forms using natural polymers.

Over the last three years my research has mainly focused on the development of a mechanistic understanding of the disintegration phenomenon, and on investigating the ranges of applications of conventional and non-conventional superdisintegrant excipients. Driven by my passion for oral solid dosage forms and the excipients within them, I joined DFE Pharma as a Product Application Specialist in 2021.

Since 2017, I have published a total of 28 scientific articles in international scientific journals within the fields of pharmaceutical technology and drug delivery.

Tell us about the work that won you this award…
 

The work published in The Journal of Pharmaceutical Sciences focused on the aforementioned topic of superdisintegrants – functional excipients used in oral solid dosage forms that cause a tablet to disintegrate in the gastric fluids of the stomach and thus enable prompt release of the drug. Superdisintegrants are often not interchangeable within a formulation and appropriate selection is key for effective disintegration performance. Specifically, the study shows that in a hydrophobic matrix tablet formulation, croscarmellose and sodium starch glycolate can provide rapid disintegration under harsh storage conditions, while crospovidone cannot.

Our work represents one step forward – or one more piece in the intricate puzzle of the disintegration phenomenon.

Why do you think your article stood out from the crowd?
 

Well, it was selected by the journal as the featured piece of that monthly issue, so that really helped it garner the attention of the scientific community. The article is also different from previous works thanks to the experimental design of my study.

Other previous studies have evaluated superdisintegrant performance in placebo, hydrophilic, and simplified formulations without considering the effect of storage on disintegration. Our study, on the other hand, compared superdisintegrants’ performance using more realistic conditions; for example, in the interest of increasing the practical relevance, we included aspects like hydrophobicity and storage effects in the design of the study.

How can your findings be applied?
 

The study shows how the three most commonly used superdisintegrants function and induce disintegration in hydrophobic tablets stored in harsh conditions. The article also provides a mechanistic explanation of why certain results were obtained.

Some findings of this study contradict traditional disintegration selection criteria – criteria that were derived from (overly) simplified systems. For instance, according to the conventional wisdom of formulation, croscarmellose sodium should be preferred as disintegrant in soluble matrices, but not in insoluble matrices.

But, on the contrary, in our work we showed that croscarmellose is also the disintegrant of choice in insoluble hydrophobic tablets, particularly when storage is a factor. Our work also highlighted the reduced disintegration performance of crospovidone – compared with croscarmellose and sodium starch glycolate – in hydrophobic tablets and after storage.

Our work represents one step forward – or one more piece in the intricate puzzle of the disintegration phenomenon. But one limitation of all studies on disintegration is that findings are often specific to the formulation and experimental conditions tested and cannot be generalized. Therefore, although our study provides indications on disintegrant selection in hydrophobic matrix tablets, extending our findings to different formulations should be done with care.

Overall, the study can serve as a guide for the selection of superdisintegrants in hydrophobic formulations. The work could also set an example for how the design of studies on superdisintegrants should be guided by the challenges of “real-life” pharmaceutical formulations.

What are you currently working on at DFE Pharma?
 

DFE Pharma is a really exciting place for me to work because it is at the forefront of research on pharmaceutical excipients. To give some examples, we are using our knowledge of current excipients to develop novel excipients optimized for particular applications, such as continuous manufacturing.

In another project, we are exploring excipients’ characteristics at a level that will enable us to predict whether or not their variability affects their functionality. In this way, we aim to provide a scientific approach to de-risk the use of our excipients in customer formulations.

 

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  1. KL Audus, “2021 Outstanding Early Career Scientists”, JPharmSci (2021). DOI: 10.1016/j.xphs.2021.11.012
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