SOP for Preparation of Nanoparticles for Transdermal Delivery

Standard Operating Procedure for Preparation of Nanoparticles for Transdermal Delivery

1) Purpose

This SOP outlines the procedure for preparing nanoparticles specifically designed for transdermal drug delivery. Transdermal delivery systems aim to deliver therapeutic agents through the skin, providing a controlled and sustained release.

2) Scope

This SOP applies to personnel involved in the formulation and characterization of nanoparticles intended for transdermal drug delivery, which requires optimized skin permeation properties.

3) Responsibilities

Operators: Responsible for preparing the nanoparticles and ensuring they meet the specifications for transdermal delivery.
QA: Ensures the nanoparticles are characterized for particle size, skin permeation, and stability.

4) Procedure

4.1 Selection of Materials

4.1.1 Polymer or Lipid Selection

4.1.1.1 Choose biocompatible polymers or lipids such as PLGA, chitosan, or phospholipids that enhance skin permeation while protecting the drug from degradation.

4.1.2 Permeation Enhancers

4.1.2.1 Incorporate permeation enhancers such as oleic acid or ethanol to facilitate the movement of nanoparticles through the skin barrier.

4.2 Nanoparticle Preparation

4.2.1 Solvent Evaporation or Nanoprecipitation Method

4.2.1.1 Prepare the nanoparticles using solvent evaporation or nanoprecipitation methods, aiming for a particle size below 300 nm to improve skin permeation.

4.3 Characterization and Testing

4.3.1 Particle Size and Zeta Potential

4.3.1.1 Measure the particle size and zeta potential using dynamic light scattering (DLS) to ensure uniform

size distribution and stability.

4.3.2 In Vitro Skin Permeation Studies

4.3.2.1 Perform in vitro skin permeation studies using Franz diffusion cells to assess the nanoparticles’ ability to penetrate through the skin.

4.4 Stability and Storage

4.4.1 Stability Testing

4.4.1.1 Conduct stability studies under different environmental conditions (e.g., temperature, humidity) to assess the long-term stability of the nanoparticles.

4.4.2 Storage Conditions

4.4.2.1 Store the nanoparticles in sterile containers at 4°C or room temperature based on stability data, ensuring protection from light and moisture.

5) Abbreviations, if any

PLGA: Poly(lactic-co-glycolic acid)
DLS: Dynamic Light Scattering

6) Documents, if any

Transdermal Nanoparticle Formulation Logbook

7) References, if any

Protocols for preparing nanoparticles for transdermal drug delivery

8) SOP Version

Version 1.0

Annexure

Transdermal Nanoparticle Formulation Logbook Template


  
    Date
    Batch Number
    Polymer/Lipid Type
    Permeation Enhancer
    Particle Size
    Permeation Test Results
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Polymer/Lipid Type
    Enhancer Used
    Size in nm
    Pass/Fail
    Operator Name
    QA Name

Date	Batch Number	Polymer/Lipid Type	Permeation Enhancer	Particle Size	Permeation Test Results	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Polymer/Lipid Type	Enhancer Used	Size in nm	Pass/Fail	Operator Name	QA Name