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Achieving faster formulation of solid oral dosage forms for first-in-human supplies using drug in capsule approach

The pharmaceutical industry is increasingly looking for approaches that shorten drug development timelines and save on cost, especially virtual biotech companies who rely heavily on key milestone payments. Consequently, it is imperative that new chemical entities can be quickly manufactured into clinical drug products.

Across the industry there are two principle approaches to formulation development of solid oral dosage forms for First-In-Human (FIH) studies, namely the “commercial formulation approach” which produces a clinical formulation that will bear resemblance to commercially acceptable formulations and the “exploratory formulation approach” which favours the use of the simplest possible formulation such as powder-in-capsule (PIC) / drug-in-capsule.

This whitepaper explores both of these two principle approaches and is broadly broken-down into two areas; the direct and indirect cost savings associated with the “exploratory formulation approach”, and how systems such as the Xcelodose® 600S mitigate against some of the risks associated with using the “commercial formulation approach” in early development.

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Almac Pharmaceutical Drug Product Development

Addressing the increasing pressure on pharmaceutical companies to bring clinical candidates through their pipeline faster and with greater efficiency, Almac Pharma Services provide expert pharmaceutical drug product development solutions.

Our scientists can develop clinical candidates into optimum formulations and manufacture solid oral dose products for all stages of clinical trials.

From developing a fit-for-purpose formulation for First-in-Human trials, to scaling up for late phase trials.

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