title: A brief literature and patent review of nanosuspensions to a final drug product.
abstract: 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.
authors.affiliation: AbbVie Pte Ltd., Global Pharmaceutical Research and Development, 11 Biopolis Way, Helios #05-06, 138667, Singapore.
authors.forename: William Wei Lim
authors.initials: WW
authors.lastname: Chin
authors.forename: Johannes
authors.initials: J
authors.lastname: Parmentier
authors.forename: Michael
authors.initials: M
authors.lastname: Widzinski
authors.forename: En Hui
authors.initials: EH
authors.lastname: Tan
authors.forename: Rajeev
authors.initials: R
authors.lastname: Gokhale
mesh_terms: D036103:Nanotechnology; D010316:Particle Size; D010330:Patents as Topic; D004364:Pharmaceutical Preparations
chemical_list: D004364:Pharmaceutical Preparations
keywords: downstream processing; formulation; nanomilling; nanoparticles; nanosuspensions; nanotechnology; patents; poor solubility; processing; upstream processing