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 |