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 |