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

1) Purpose

This SOP outlines the procedure for incorporating stabilizers into nanoparticle-based formulations to enhance their stability, prevent aggregation, and improve shelf life.

2) Scope

This SOP applies to laboratory personnel responsible for preparing nanoparticle formulations that require stabilizers to maintain physical and chemical stability.

3) Responsibilities

• Operators: Responsible for the accurate addition of stabilizers to nanoparticle formulations to prevent degradation or aggregation.
• QA: Ensures that the stabilizers used meet the required standards for nanoparticle stability and compatibility.

4) Procedure

4.1 Selection of Stabilizers

4.1.1 Stabilizer Types

• 4.1.1.1 Select appropriate stabilizers, such as PVA, PEG, or surfactants (e.g., Tween 80), based on the type of nanoparticle and desired stability properties.

4.2 Preparation of Stabilizer Solution

4.2.1 Solution Preparation

• 4.2.1.1 Dissolve the selected stabilizer in distilled water or an appropriate solvent at the required concentration (e.g., 0.1–2% w/v).
• 4.2.1.2 Stir until the stabilizer is fully dissolved and free of particulates.

4.3 Incorporation into Nanoparticle Formulation

4.3.1 Adding the Stabilizer

• 4.3.1.1 Add the stabilizer solution to the nanoparticle suspension during or after the particle formation process, depending on the formulation method.
• 4.3.1.2 Stir or sonicate the suspension to ensure uniform distribution of the stabilizer throughout the formulation.

4.4 Stability Testing

4.4.1 Physical Stability

• 4.4.1.1 Test the nanoparticle formulation for signs of aggregation, sedimentation, or phase separation over time using techniques like dynamic light scattering (DLS).

4.5 Storage of Nanoparticle Formulations

4.5.1 Storage Conditions

• 4.5.1.1 Store the stabilized nanoparticle formulations in sealed containers at 4°C or room temperature, based on stability data.

5) Abbreviations, if any

• PVA: Polyvinyl Alcohol
• PEG: Polyethylene Glycol
• QA: Quality Assurance

6) Documents, if any

• Stabilizer Usage Logbook

7) References, if any

• Formulation guidelines for nanoparticle stabilization

8) SOP Version

Version 1.0

Annexure

Stabilizer Usage Logbook Template

  

    
Date
    
Batch Number
    
Stabilizer Used
    
Concentration (%)
    
Stability Testing Results
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Stabilizer Type
    
Concentration %
    
Pass/Fail
    
Operator Name
    
QA Name