Standard Operating Procedure for Optimization of Particle Size in Nanoparticle Formulations
1) Purpose
This SOP outlines the process for optimizing the particle size of nanoparticle formulations. Particle size is a critical parameter in determining drug release rate, biodistribution, and therapeutic efficacy.
2) Scope
This SOP applies to personnel involved in adjusting and optimizing the particle size of nanoparticles for pharmaceutical or industrial applications.
3) Responsibilities
- Operators: Responsible for optimizing particle size during nanoparticle preparation as per this SOP.
- QA: Ensures that the particle size of the final formulations meets required specifications.
4) Procedure
4.1 Selection of Methods
4.1.1 Method Selection
- 4.1.1.1 Choose an appropriate method to control particle size, such as high-pressure homogenization, ultrasonication, or microfluidization, depending on the desired size range.
4.2 Particle Size Reduction
4.2.1 Homogenization
- 4.2.1.1 Use high-pressure homogenization to reduce particle size to the nanoscale by applying shear forces to the nanoparticle suspension.
4.2.2 Ultrasonication
- 4.2.2.1 Apply ultrasonic waves to the suspension to break down larger particles and achieve the desired nanoscale dimensions.
4.3 Particle Size Measurement
4.3.1 Dynamic Light Scattering (DLS)
- 4.3.1.1 Measure the particle size at different stages of the formulation process using DLS to monitor size distribution and optimize the process parameters.
4.4 Stability Testing
4.4.1 Stability Assay
- 4.4.1.1 Perform stability tests to confirm that the optimized
nanoparticles maintain their size over time without aggregation or degradation.
4.5 Storage
4.5.1 Storage Conditions
- 4.5.1.1 Store the optimized nanoparticle formulations at 4°C in sealed, sterile containers to maintain stability.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
6) Documents, if any
- Particle Size Optimization Logbook
7) References, if any
- Guidelines for particle size optimization in nanoparticle formulations
8) SOP Version
Version 1.0
Annexure
Particle Size Optimization Logbook Template
| Date | Batch Number | Method Used | Particle Size | Stability Results | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Method Used | Size in nm | Pass/Fail | Operator Name | QA Name |
