SOP for Preparation of Nanoparticles for Brain Targeting

Standard Operating Procedure for Preparation of Nanoparticles for Brain Targeting

1) Purpose

This SOP outlines the procedure for preparing nanoparticles designed for brain targeting via the blood-brain barrier (BBB), enabling delivery of therapeutics to the brain with enhanced bioavailability.

2) Scope

This SOP applies to personnel responsible for preparing nanoparticles specifically designed to cross the BBB and target the brain for drug delivery.

3) Responsibilities

Operators: Responsible for preparing nanoparticles for brain targeting following this SOP.
QA: Ensures that the nanoparticles meet the size, stability, and drug delivery requirements for brain targeting applications.

4) Procedure

4.1 Selection of Materials

4.1.1 Polymer or Lipid Selection

4.1.1.1 Select biocompatible polymers or lipids, such as PEGylated lipids or PLGA, which can facilitate the crossing of the BBB and deliver drugs into the brain tissue.

4.2 Nanoparticle Preparation

4.2.1 Solvent Evaporation or Nanoprecipitation

4.2.1.1 Prepare the nanoparticles using solvent evaporation or nanoprecipitation methods, ensuring they are in the optimal size range (100–200 nm) for crossing the BBB.

4.3 Functionalization for Brain Targeting

4.3.1 Surface Modification

4.3.1.1 Functionalize the nanoparticle surface with targeting ligands (e.g., transferrin or lactoferrin) to improve brain-specific delivery.

4.4 Particle Size and Stability Testing

4.4.1 Dynamic Light Scattering (DLS)

4.4.1.1 Measure the particle size using DLS to ensure the nanoparticles are in the correct

size range for brain targeting.

4.4.2 Stability Testing

4.4.2.1 Conduct stability studies to ensure the nanoparticles maintain their integrity and drug loading during circulation and after crossing the BBB.

4.5 In Vitro and In Vivo Testing

4.5.1 In Vitro BBB Model

4.5.1.1 Perform in vitro studies using a BBB model to evaluate the nanoparticles’ ability to cross the BBB and deliver the therapeutic agent.

4.6 Storage

4.6.1 Storage Conditions

4.6.1.1 Store the brain-targeting nanoparticles at 4°C in sterile containers to preserve their functionality and targeting capabilities.

5) Abbreviations, if any

BBB: Blood-Brain Barrier
DLS: Dynamic Light Scattering
PEG: Polyethylene Glycol
PLGA: Poly(lactic-co-glycolic acid)

6) Documents, if any

Brain Targeting Nanoparticle Preparation Logbook

7) References, if any

Protocols for nanoparticle-based drug delivery systems targeting the brain

8) SOP Version

Version 1.0

Annexure

Brain Targeting Nanoparticle Preparation Logbook Template


  
    Date
    Batch Number
    Polymer/Lipid Type
    Targeting Ligand
    Particle Size
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Polymer/Lipid Type
    Targeting Ligand
    Size in nm
    Operator Name
    QA Name

Date	Batch Number	Polymer/Lipid Type	Targeting Ligand	Particle Size	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Polymer/Lipid Type	Targeting Ligand	Size in nm	Operator Name	QA Name