SOP for Nanoprecipitation Method for Formulating Nanoparticles

Standard Operating Procedure for Nanoprecipitation Method in Nanoparticle Formulation

1) Purpose

This SOP outlines the nanonprecipitation method for preparing nanoparticles, typically used to create polymer-based nanoparticles for drug delivery. The technique allows for the formation of nanoparticles by precipitation from a solution.

2) Scope

This SOP applies to laboratory personnel responsible for the formulation of nanoparticles using the nanonprecipitation method.

3) Responsibilities

Operators: Responsible for following the nanonprecipitation protocol and ensuring accurate nanoparticle formation.
QA: Ensures the nanoparticles meet the required quality standards.

4) Procedure

4.1 Polymer Solution Preparation

4.1.1 Polymer Selection

4.1.1.1 Select an appropriate polymer (e.g., PLGA) and dissolve it in a water-miscible organic solvent (e.g., acetone or ethanol).
4.1.1.2 Stir until the polymer is completely dissolved.

4.2 Precipitation Process

4.2.1 Addition of Polymer Solution

4.2.1.1 Slowly add the polymer solution into an aqueous phase containing stabilizers under gentle stirring to form nanoparticles by precipitation.
4.2.1.2 Maintain the stirring rate until the nanoparticles have formed, typically over a period of 10–15 minutes.

4.2.2 Particle Size Control

4.2.2.1 Monitor particle size using dynamic light scattering (DLS) to ensure the nanoparticles are within the desired size range.

4.3 Washing and Purification

4.3.1 Centrifugation

4.3.1.1 Centrifuge the nanoparticle suspension at 10,000 g to collect the nanoparticles and discard the supernatant.
4.3.1.2 Wash the nanoparticles with distilled water

and repeat the centrifugation process.

4.4 Drying and Storage

4.4.1 Drying

4.4.1.1 Freeze-dry or vacuum-dry the nanoparticles, depending on the formulation requirements.

4.4.2 Storage

4.4.2.1 Store the dried nanoparticles in sterile containers at 4°C or room temperature.

5) Abbreviations, if any

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

6) Documents, if any

Nanoprecipitation Process Logbook

7) References, if any

Guidelines for nanoprecipitation methods in nanoparticle formulation

8) SOP Version

Version 1.0

Annexure

Nanoprecipitation Process 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