SOP for Emulsification-Solvent Evaporation Technique in Nanoparticle Formulations

Standard Operating Procedure for Emulsification-Solvent Evaporation Technique in Nanoparticle Formulations

1) Purpose

This SOP outlines the emulsification-solvent evaporation technique for preparing nanoparticles. This method is widely used for encapsulating hydrophobic drugs into polymeric nanoparticles.

2) Scope

This SOP applies to all personnel responsible for preparing nanoparticle formulations using the emulsification-solvent evaporation technique.

3) Responsibilities

Operators: Responsible for following the emulsification-solvent evaporation method accurately.
QA: Ensures that the nanoparticle formulation meets particle size and encapsulation efficiency specifications.

4) Procedure

4.1 Polymer Dissolution

4.1.1 Solvent Selection

4.1.1.1 Select an appropriate organic solvent (e.g., dichloromethane) to dissolve the polymer (e.g., PLGA).

4.1.2 Drug Loading

4.1.2.1 Dissolve or suspend the drug in the polymer solution under gentle stirring.

4.2 Emulsification

4.2.1 Formation of Emulsion

4.2.1.1 Add the polymer-drug solution into an aqueous phase containing a surfactant (e.g., PVA) under high-speed stirring to form an emulsion.
4.2.1.2 Use a homogenizer to reduce the size of the emulsion droplets to achieve nanoscale particles.

4.3 Solvent Evaporation

4.3.1 Removal of Solvent

4.3.1.1 Evaporate the organic solvent under reduced pressure or constant stirring, leading to nanoparticle formation as the polymer solidifies.
4.3.1.2 Continue stirring until all solvent has evaporated.

4.4 Washing and Collection of Nanoparticles

4.4.1 Centrifugation

4.4.1.1 Centrifuge the nanoparticle suspension to collect the particles and discard the supernatant.
4.4.1.2 Wash the particles with distilled

water and repeat the centrifugation process as necessary.

4.5 Particle Size Measurement

4.5.1 DLS Analysis

4.5.1.1 Use dynamic light scattering (DLS) or another particle-sizing method to measure the nanoparticle size.

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)
PVA: Polyvinyl Alcohol
DLS: Dynamic Light Scattering

6) Documents, if any

Emulsification-Solvent Evaporation Logbook

7) References, if any

Formulation protocols for nanoparticles using the emulsification-solvent evaporation method

8) SOP Version

Version 1.0

Annexure

Emulsification-Solvent Evaporation Logbook Template


  
    Date
    Batch Number
    Polymer Type
    Particle Size
    Encapsulation Efficiency
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Polymer Name
    Size in nm
    % Encapsulation
    Operator Name
    QA Name

Date	Batch Number	Polymer Type	Particle Size	Encapsulation Efficiency	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Polymer Name	Size in nm	% Encapsulation	Operator Name	QA Name