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