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A Brief Literature and Patent Review of Nanosuspensions to a Final Drug Product

Particle size reduction can be used for enhancing the dissolution of poorly water-soluble drugs in order to enhance bioavailability. In nanosuspensions, the particle size of the drug is reduced to nanometer size. Nanosuspensions after downstream processing into drug products have successfully shown...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2014-10, Vol.103 (10), p.2980-2999
Main Authors: Lim Chin, William Wei, Parmentier, Johannes, Widzinski, Michael, Tan, En Hui, Gokhale, Rajeev
Format: Article
Language:English
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Summary:Particle size reduction can be used for enhancing the dissolution of poorly water-soluble drugs in order to enhance bioavailability. In nanosuspensions, the particle size of the drug is reduced to nanometer size. Nanosuspensions after downstream processing into drug products have successfully shown its impact on formulation design, the augmentation of product life cycle, patent life, and therapeutic efficacy. Formulation considerations for the nanosuspension formulation, its processing into a solid form, and aspects of material characterization are discussed. Technology assessments and feasibility of upstream processes for nanoparticle creation, and subsequently transformation into a drug product via the downstream processes have been reviewed. This paper aims to bridge formulation and process considerations along with patent reviews and may provide further insight into understanding the science and the white space. An analysis of current patent outlook and future trends is described to fully understand the limitations and opportunities in intellectual property generation.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.24098