SOP for Preparation of Liposomal Nanoparticles

Standard Operating Procedure for Preparation of Liposomal Nanoparticles

1) Purpose

This SOP outlines the procedure for preparing liposomal nanoparticles, which are lipid-based vesicles used for drug delivery, encapsulating hydrophilic and hydrophobic drugs for targeted therapy.

2) Scope

This SOP applies to personnel responsible for the preparation, formulation, and characterization of liposomal nanoparticles for pharmaceutical applications.

3) Responsibilities

Operators: Responsible for preparing liposomal nanoparticles as per the outlined procedures.
QA: Ensures that liposome formulations meet quality standards for particle size, encapsulation efficiency, and stability.

4) Procedure

4.1 Selection of Lipids

4.1.1 Lipid Types

4.1.1.1 Select appropriate lipids such as phosphatidylcholine (PC), cholesterol, or DSPE-PEG for preparing the lipid bilayer of the liposomes.

4.2 Preparation of Liposomes

4.2.1 Thin Film Hydration Method

4.2.1.1 Dissolve the selected lipids in a volatile organic solvent (e.g., chloroform) and evaporate the solvent to form a thin lipid film on the flask walls using a rotary evaporator.
4.2.1.2 Hydrate the lipid film with an aqueous solution containing the drug or therapeutic agent to form liposomes.

4.3 Size Reduction and Homogenization

4.3.1 Sonication or Extrusion

4.3.1.1 Reduce the size of the liposomes to the desired size (100–200 nm) using sonication or extrusion through polycarbonate membranes.

4.4 Characterization

4.4.1 Particle Size and Encapsulation Efficiency

4.4.1.1 Measure the particle size of the liposomes using dynamic light scattering (DLS) and evaluate the encapsulation efficiency using UV-Vis or HPLC analysis.

4.5 Storage

4.5.1 Storage Conditions

4.5.1.1 Store the liposomal nanoparticles in sterile containers at 4°C to maintain stability and prevent lipid degradation.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
PC: Phosphatidylcholine
DSPE-PEG: Distearoylphosphatidylethanolamine-Polyethylene Glycol

6) Documents, if any

Liposomal Nanoparticle Preparation Logbook

7) References, if any

Protocols for liposome preparation and characterization

8) SOP Version

Version 1.0

Annexure

Liposomal Nanoparticle Preparation Logbook Template


  
    Date
    Batch Number
    Lipid Composition
    Particle Size
    Encapsulation Efficiency
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Lipid Types and Ratios
    Size in nm
    Efficiency (%)
    Operator Name
    QA Name

Date	Batch Number	Lipid Composition	Particle Size	Encapsulation Efficiency	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Lipid Types and Ratios	Size in nm	Efficiency (%)	Operator Name	QA Name