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 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

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