Standard Operating Procedure for Incorporation of Stabilizers in Nanoparticle-Based Formulations

1) Purpose

This SOP outlines the procedure for incorporating stabilizers into nanoparticle formulations to enhance the physical and chemical stability of the nanoparticles, preventing aggregation and degradation during storage and application.

2) Scope

This SOP applies to personnel involved in the preparation and stabilization of nanoparticles used in pharmaceutical, biomedical, and industrial applications.

3) Responsibilities

• Operators: Responsible for adding stabilizers to nanoparticle formulations as per the outlined procedure.
• QA: Ensures that the nanoparticle formulations meet stability requirements during storage and application.

4) Procedure

4.1 Selection of Stabilizers

4.1.1 Types of Stabilizers

• 4.1.1.1 Select stabilizers such as surfactants (e.g., Tween 80, Pluronic), polymers (e.g., PEG, PVP), or natural stabilizers (e.g., lecithin) to prevent nanoparticle aggregation and maintain stability.

4.1.2 Concentration Optimization

• 4.1.2.1 Optimize the concentration of the stabilizer to ensure effective protection against aggregation without interfering with the nanoparticle’s drug delivery or functional properties.

4.2 Incorporation of Stabilizers

4.2.1 Mixing Procedure

• 4.2.1.1 Dissolve the stabilizer in the nanoparticle suspension or add it during the nanoparticle synthesis process to ensure homogenous mixing and adequate coverage of the nanoparticle surface.

4.2.2 Sonication or Stirring

• 4.2.2.1 Use sonication or stirring to ensure proper dispersion of the stabilizer and nanoparticles, preventing aggregation.

4.3 Testing for Stability

4.3.1 Particle