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Small is Powerful: Demonstration of the Impact of Nanoformed Piroxicam in a Controlled Clinical Study

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Abstract

Purpose

New solutions are needed to enable the efficient use of poorly water-soluble drugs. Therefore, we aimed to demonstrate that decreasing particle size with a solution-to-particle method known as nanoforming can improve dissolution and thus bioavailability.

Methods

Piroxicam, a poorly water-soluble non-steroidal anti-inflammatory drug (NSAID), was used as a model compound. A Quality-by-Design (QbD) approach was used to nanoform piroxicam and a design space was established. The pharmacokinetics of piroxicam nanoparticles were compared to two marketed products in a clinical trial.

Results

Nanoformed tablets showed a 33% increase in exposure during the first hour after dosing (AUC0–1 h) compared with an immediate release tablet and was similar to a fast absorbing tablet incorporating complexation of piroxicam with β-cyclodextrin.

Conclusions

The results show that nanoforming enabled more rapid absorption in comparison to a typical marketed tablet and indicate that nanoforming is an alternative to complex formulation such as cyclodextrins based products. The study outcomes support the potential of nanoforming for producing fast-acting dosage forms of poorly soluble drugs.

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Change history

  • 01 January 2024

    Article has been updated to remove supplementary information citation on pages 2318 and 2324.

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Acknowledgements

The authors want to acknowledge all people who contributed to the study at Nanoform, Quotient Sciences, Medfiles, and Particle Analytical.

Funding

No funding to report.

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Authors and Affiliations

  1. Nanoform Finland Plc, Viikinkaari 4, 00790, Helsinki, Finland

    Satu Lakio, David J. Smith, Goncalo Andrade, Niklas Sandler & Edward Hӕggström

  2. School of Pharmacy, University of Eastern Finland, Kuopio, Finland

    Satu Lakio

  3. Quotient Sciences, Nottingham, UK

    Philip Evans, John McDermott & Chris Roe

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  1. Satu Lakio
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Lakio, S., Smith, D.J., Andrade, G. et al. Small is Powerful: Demonstration of the Impact of Nanoformed Piroxicam in a Controlled Clinical Study. Pharm Res 40, 2317–2327 (2023). https://doi.org/10.1007/s11095-023-03624-8

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