SOP for Optimization of Particle Size in Nanoparticle Formulations

Standard Operating Procedure for Optimization of Particle Size in Nanoparticle Formulations

1) Purpose

This SOP outlines the procedure for optimizing particle size in nanoparticle formulations. Particle size is a critical factor influencing drug release, stability, and bioavailability, and must be optimized to meet the therapeutic objectives of the formulation.

2) Scope

This SOP applies to personnel involved in the preparation and characterization of nanoparticle formulations, particularly those responsible for adjusting and controlling particle size during formulation.

3) Responsibilities

Operators: Responsible for optimizing and measuring particle size in nanoparticle formulations following this SOP.
QA: Ensures that particle size falls within the required specifications and meets stability and bioavailability targets.

4) Procedure

4.1 Methods for Optimizing Particle Size

4.1.1 Solvent Evaporation

4.1.1.1 Adjust the solvent evaporation process parameters (e.g., solvent type, evaporation rate) to control particle size during nanoparticle formation.

4.1.2 High-Pressure Homogenization

4.1.2.1 Utilize high-pressure homogenization to reduce particle size and create uniform nanoparticles, adjusting pressure and cycle number as necessary.

4.1.3 Sonication

4.1.3.1 Use sonication to break down larger particles and control the size of the nanoparticles, optimizing sonication time and power settings.

4.2 Particle Size Measurement

4.2.1 Dynamic Light Scattering (DLS)

4.2.1.1 Measure particle size using DLS to ensure the nanoparticles are within the desired size range, typically between

100–200 nm for drug delivery applications.

4.2.2 Scanning Electron Microscopy (SEM)

4.2.2.1 Use SEM to confirm the shape and size distribution of the nanoparticles, verifying uniformity and surface morphology.

4.3 Adjustments and Optimization

4.3.1 Process Optimization

4.3.1.1 Optimize the formulation process by adjusting the solvent, homogenization pressure, or sonication parameters to achieve the desired particle size and stability.

4.4 Stability Testing

4.4.1 Stability of Optimized Formulations

4.4.1.1 Conduct stability testing on the optimized nanoparticle formulations under various conditions (e.g., temperature, humidity) to ensure that the particle size remains stable over time.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
SEM: Scanning Electron Microscopy

6) Documents, if any

Particle Size Optimization Logbook

7) References, if any

Protocols for optimizing particle size in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Particle Size Optimization Logbook Template


  
    Date
    Batch Number
    Method Used
    Optimized Particle Size
    Stability Results
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Method (Sonication, Homogenization, etc.)
    Size in nm
    Pass/Fail
    Operator Name
    QA Name