Building a better particle: Leveraging physicochemical understanding of amorphous solid dispersions and a hierarchical particle approach for improved delivery at high drug loadings.

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ID: 66468
2019
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Abstract
Amorphous solid dispersions are a promising option for managing compounds with poor aqueous solubility. However, for compounds with high melting points, thermal stability limitations, or poor solubility in volatile solvents, conventional routes of hot melt extrusion or spray drying may not be viable. Co-precipitated amorphous dispersions (cPAD) can provide a solution. For the material studied in this paper, the cPAD material that was seemingly identical to spray dried material in terms of being single phase amorphous (as measured by DSC and XRD ) but showed slower dissolution behavior. It was identified that physical properties of the cPAD material could be improved to enhance wettability and improve dissolution performance. This was achieved by incorporating the cPAD material into a matrix of water soluble excipients generated via evaporative isolation routes. Importantly, this approach appears to offer another route to further increase the drug load in final dosage units and is significant as increased drug loading generally results in slower or incomplete release. Results showed successful proof of concept via in vitro biorelevant dissolution and confirmatory canine pharmacokinetic studies yielding comparable exposure for capsules comprised of conventional spray dried material as well as capsules with elevated drug load comprised of cPAD hierarchical particles.
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schenck2019buildinginternational Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Schenck, Luke;Mann, Amanda K P;Liu, Zhen;Milewski, Mikolaj;Zhang, Siwei;Ren, Jie;Dewitt, Kristel;Hermans, Andre;Cote, Aaron;
Journal International journal of pharmaceutics
Year 2019
DOI
S0378-5173(19)30035-3
URL
Keywords
spray drying bioavailability precipitation dissolution amorphous solid dispersion thin film evaporation

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