Process development for spray drying of sticky pharmaceuticals; case study of mucoad-hesive nicotine microparticles for compressed medicated chewing gum

Camilla Sander, Henrik Stillhof Nielsen, Susanne Roslev Søgaard, Celina Støving Jensen, Mingshi Yang, Jette Jacobsen, Jukka Rantanen

    2 Citationer (Scopus)

    Abstract

    Spray drying of pharmaceutical compounds with sticky properties is a challenging task and may require substantial time and resources. By including small-scale studies of single droplet drying kinetics a relatively high number of experiments with less material is allowed. This means one can construct a more robust design space according to Quality by Design (QbD) formulation development principles. In the current study we present a case study on the development of spray dried microparticles comprising nicotine bitartrate and hypromellose or alginate polymer, for incorporation into medicated chewing gum. By illustration of initial studies on single droplet drying kinetics, subsequent characterization of microparticles, and final characterization of compressed chewing gum this paper summarizes the entire development process.

    OriginalsprogEngelsk
    TidsskriftInternational Journal of Pharmaceutics
    Vol/bind452
    Udgave nummer1-2
    Sider (fra-til)434-437
    ISSN0378-5173
    DOI
    StatusUdgivet - 2013

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