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Understanding the Sterile Filtration of Nanosuspensions

Introduction

 

Pharmaceutical nanosuspensions

 

Finely colloid, biphasic, dispersed, and solid drug particles in an aqueous vehicle, size below 1 μm, without any matrix material, stabilized by surfactants and polymers for drug delivery applications.

 

Advantages

 

  • Increased drug solubility, absorption and bioavailability
  • Reduces dosages and toxicity
  • Various routes for administration; e.g. oil-in-water nanosuspensions such as liposomes  and emulsions are used for topical oral and injectable drug delivery.

 

Manufacturing challenges for nanosuspensions

 

  • Time consuming processes/intensive labor
  • Process reproducibility and scale-up
  • Control of size/size distribution
  • Stability issues
  • Appropriate characterisation of nanosuspensions throughout manufacturing is critical/important

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