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The Right Excipient

The global empty hard capsules market is anticipated to increase at a compound annual growth rate of 7.2% and to reach $213 billion in revenues by 2022 (1). Over the past five years, about 12% of all prescription-based (Rx) and overthe- counter (OTC) pharmaceutical products were dosed with hard capsules, according to FDA documentation.

Despite being overlooked in the formulation of prescription drugs, the soft gels market is predicted to grow to $755 million by 2022 (2). This is mainly due to their popularity in the nutraceutical markets and added value in difficult Rx formulations, including very low-dose APIs (< 3mg), potent compounds, hormones and cytotoxic compounds (safe handling), oxygenlabile APIs, and, especially, poorly soluble or permeable APIs. As the market expands and new formulation technologies are adopted, selecting the right ingredient is essential to achieve optimum performance and functionality.

Choosing the Right Excipient

Favoured for its high functional capabilities, gelatine has been used in both hard and soft capsules in the pharma and nutraceutical industry for over 100 years. Capsule manufacturing started in 1834 thanks to gelatine, which has been the safe and only choice for decades. The first commercially feasible gelatine alternative entered the market in 2001: a soft gel shell alternative made of modified starches (hydroxypropyl starch) and carrageenans. Subsequently, hard gelatine capsule alternatives were commercialised, using hydroxypropyl methylcellulose (HPMC) as the main shell ingredient and carrageenans or gellan gum as gelling aids.

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Dr Bjorn Vergauwen is Principal Scientist at Rousselot. He currently coordinates R&D projects, aiming to unlock the unmet potential of gelatine. His main expertise relates to the biophysical and biochemical principles underpinning gelatine’s behaviour in food and pharma applications and to its use in dosage forms. Dr Vergauwen has a PhD in biochemistry from Ghent University, Belgium. Before joining Rousselot in 2014, he had several missions as Post-Doctoral Researcher at Ghent University where he conducted research in enzymology and structural biology for 17 years.
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Dr Bjorn Vergauwen
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