SOP for Preparation of Lipid-Based Nanoparticles

Standard Operating Procedure for Lipid-Based Nanoparticle Preparation

1) Purpose

This SOP outlines the process for preparing lipid-based nanoparticles (LNPs), which are commonly used for drug delivery systems. The objective is to standardize the preparation process, ensuring consistency and quality in the formulation.

2) Scope

This SOP applies to all operators involved in the preparation and formulation of lipid-based nanoparticles in the laboratory or production environment.

3) Responsibilities

Operators: Responsible for following the SOP to prepare lipid-based nanoparticles accurately and safely.
QA: Ensures that LNP preparation follows approved protocols and meets quality standards.

4) Procedure

4.1 Preparation of Lipid Solutions

4.1.1 Materials and Equipment

4.1.1.1 Prepare all lipid components, including phospholipids, cholesterol, and surfactants, as required by the formulation.
4.1.1.2 Ensure that all equipment (e.g., homogenizer, mixer) is cleaned and sanitized.

4.1.2 Solubilization of Lipids

4.1.2.1 Dissolve the lipid components in an organic solvent (e.g., ethanol) under gentle stirring.
4.1.2.2 Heat the solution slightly (if necessary) to ensure complete solubilization, but do not exceed the lipid stability limits.

4.2 Nanoparticle Formation

4.2.1 Emulsification

4.2.1.1 Slowly inject the lipid solution into an aqueous phase containing stabilizers or surfactants under high-speed mixing to form a stable emulsion.
4.2.1.2 Continue mixing for 10-15 minutes to ensure proper emulsification.

4.2.2 Particle Size Reduction

4.2.2.1 Use a high-pressure homogenizer or sonicator to reduce the particle size to the desired range (typically 100-200 nm).
4.2.2.2 Monitor the particle size using dynamic light scattering (DLS) or a similar technique.

4.3 Storage and Stability

4.3.1 Storage Conditions

4.3.1.1 Transfer the lipid-based nanoparticles into sterile, sealed containers for storage.
4.3.1.2 Store at 4°C or lower to maintain stability unless otherwise specified for the formulation.

4.3.2 Stability Testing

4.3.2.1 Periodically test the LNP formulations for particle size, encapsulation efficiency, and zeta potential to ensure stability over time.

5) Abbreviations, if any

LNP: Lipid-Based Nanoparticle
DLS: Dynamic Light Scattering

6) Documents, if any

Lipid-Based Nanoparticle Preparation Logbook

7) References, if any

Formulation protocols for lipid-based nanoparticles

8) SOP Version

Version 1.0

Annexure

Lipid-Based Nanoparticle Preparation Logbook Template


  
    Date
    Batch Number
    Formulation
    Particle Size
    Encapsulation Efficiency
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Formulation Code
    Size in nm
    % Encapsulation
    Operator Name
    QA Name

Date	Batch Number	Formulation	Particle Size	Encapsulation Efficiency	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Formulation Code	Size in nm	% Encapsulation	Operator Name	QA Name