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 |