Standard Operating Procedure for Preparation of Nanoparticles for Transdermal Delivery
1) Purpose
This SOP outlines the procedure for preparing nanoparticles for transdermal drug delivery, enhancing drug penetration through the skin and providing controlled release for improved therapeutic efficacy.
2) Scope
This SOP applies to personnel involved in the formulation and preparation of nanoparticles for transdermal administration in drug delivery applications.
3) Responsibilities
- Operators: Responsible for following the procedures to prepare nanoparticles for transdermal delivery.
- Quality Assurance (QA): Ensures that the nanoparticles meet quality specifications.
4) Procedure
4.1 Selection of Materials
4.1.1 Polymer or Lipid Selection
- 4.1.1.1 Select a biocompatible polymer or lipid such as PLGA, chitosan, or liposomes suitable for drug encapsulation and skin penetration.
- 4.1.1.2 Ensure that all materials are of pharmaceutical grade and compatible with the drug being delivered.
4.2 Nanoparticle Preparation
4.2.1 Solvent Evaporation Method
- 4.2.1.1 Dissolve the polymer and drug in an organic solvent (e.g., dichloromethane).
- 4.2.1.2 Add the solution to an aqueous phase containing a surfactant under stirring to form an emulsion.
- 4.2.1.3 Evaporate the solvent under reduced pressure to form nanoparticles.
4.3 Drug Loading
4.3.1 Drug Incorporation
- 4.3.1.1 Load the active pharmaceutical ingredient (API) into the nanoparticles during the preparation or post-formation via adsorption or covalent attachment.
4.4 Size Reduction
4.4.1 Homogenization
- 4.4.1.1 Reduce the particle size using high-pressure homogenization or ultrasonication to achieve the desired nanoscale size range.
4.5 Particle Size and Drug Release Testing
4.5.1 Size Measurement
- 4.5.1.1 Measure the particle size using dynamic light scattering (DLS) to ensure the nanoparticles are in the size range of 50–500 nm.
4.5.2 Drug Release Studies
- 4.5.2.1 Conduct in vitro release studies to evaluate the controlled release of the drug from the nanoparticles.
4.6 Storage of Nanoparticles
4.6.1 Storage Conditions
- 4.6.1.1 Store the nanoparticles in sterile containers at 4°C to maintain stability.
5) Abbreviations, if any
- PLGA: Poly(lactic-co-glycolic acid)
- DLS: Dynamic Light Scattering
6) Documents, if any
- Nanoparticle Preparation Logbook
7) References, if any
- Guidelines for transdermal drug delivery using nanoparticles
8) SOP Version
Version 1.0
Annexure
Nanoparticle Preparation Logbook Template
| Date | Batch Number | Polymer/Lipid Type | Particle Size | Drug Release Rate | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer/Lipid Type | Size in nm | Rate (mg/hr) | Operator Name | QA Name |