WHITEPAPER – Case Study-Improving Bioavailability Using PBPK Modeling & Parallel Formulation Screening

Abstract: A team of bioavailability experts at Catalent used the in-house bioavailability enhancement platform, OptiForm® Solution Suite, to optimize and develop Phase 1 clinical formulation within a short timeline. Catalent’s global supply chain expertise was utilized for packaging and distributing clinical supplies to the site and, as a result, the target molecule went from early stage to Phase 1 in under 9 months. Download the whitepaper to learn more!

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  • Only 30g of drug substance was used and provided candidate formulation for toxicology studies in only 12 weeks
  • Two spray dry dispersions were developed; both showed equivalent bioavailability but one showed better PK
  • A finished dose capsule using the chosen spray dispersion was packaged and distributed to clinical sites