SOP for Solvent Evaporation Method for Nanoparticles

Standard Operating Procedure for Solvent Evaporation Method for Nanoparticles

1) Purpose

This SOP provides the detailed steps for the solvent evaporation method used in nanoparticle preparation. The purpose is to ensure consistency and control in the formation of nanoparticles for drug delivery applications.

2) Scope

This SOP applies to laboratory staff involved in the formulation of nanoparticles using the solvent evaporation method.

3) Responsibilities

Operators: Responsible for carrying out the solvent evaporation technique as per this SOP.
QA: Ensures quality control by verifying particle size and encapsulation efficiency.

4) Procedure

4.1 Polymer Dissolution

4.1.1 Solvent Selection

4.1.1.1 Select a suitable organic solvent (e.g., dichloromethane) and dissolve the polymer (e.g., PLGA) under gentle stirring.

4.1.2 Drug Loading

4.1.2.1 Dissolve or suspend the drug in the polymer solution based on its solubility profile.

4.2 Formation of Emulsion

4.2.1 Emulsification

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

4.3 Solvent Evaporation

4.3.1 Solvent Removal

4.3.1.1 Evaporate the solvent under reduced pressure or stirring at room temperature, leading to nanoparticle formation as the polymer solidifies.
4.3.1.2 Continue until no solvent remains in the suspension.

4.4 Washing and Collection of Nanoparticles

4.4.1 Centrifugation

4.4.1.1 Centrifuge the nanoparticle suspension to collect the solid particles and discard the supernatant.
4.4.1.2 Wash the particles with distilled water and repeat the centrifugation process.

4.5 Particle Size Measurement

4.5.1 Dynamic Light Scattering (DLS)

4.5.1.1 Use DLS or another method to measure the particle size of the nanoparticles and ensure they meet the desired specifications (e.g., 100–200 nm).

4.6 Storage

4.6.1 Storage Conditions

4.6.1.1 Store the nanoparticles in sterile, sealed containers at 4°C or freeze-dry them for long-term stability.

5) Abbreviations, if any

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

6) Documents, if any

Solvent Evaporation Method Logbook

7) References, if any

Formulation protocols for nanoparticles using solvent evaporation

8) SOP Version

Version 1.0

Annexure

Solvent Evaporation Method Logbook Template


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

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