Standard Operating Procedure for Preparation of Nanoemulsions
1) Purpose
This SOP outlines the procedure for preparing nanoemulsions, which are used as drug delivery systems to enhance the solubility of poorly soluble drugs. The aim is to ensure a consistent and controlled method for nanoemulsion preparation.
2) Scope
This SOP applies to all laboratory personnel involved in the formulation and preparation of nanoemulsions for drug delivery applications.
3) Responsibilities
- Operators: Responsible for following the SOP to accurately prepare nanoemulsions.
- QA: Ensures that the nanoemulsions meet quality and size specifications.
4) Procedure
4.1 Preparation of Oil Phase
4.1.1 Oil and Surfactant Selection
- 4.1.1.1 Select an appropriate oil phase based on the solubility of the drug and the desired application of the nanoemulsion.
- 4.1.1.2 Dissolve the drug in the oil phase under continuous stirring at room temperature.
4.2 Preparation of Aqueous Phase
4.2.1 Stabilizer Selection
- 4.2.1.1 Select a stabilizer or surfactant suitable for the formation of stable nanoemulsions.
- 4.2.1.2 Prepare the aqueous phase by dissolving the stabilizer in distilled water under gentle stirring.
4.3 Emulsification
4.3.1 Formation of Nanoemulsion
- 4.3.1.1 Add the oil phase to the aqueous phase under high-speed stirring to form an emulsion.
- 4.3.1.2 Continue stirring for 10–15 minutes to ensure proper emulsification.
4.3.2 Particle Size Reduction
- 4.3.2.1 Use a high-pressure homogenizer or ultrasonicator to reduce the particle size of the emulsion droplets to the nanoscale (typically less than 200 nm).
- 4.3.2.2 Monitor the particle size using dynamic light scattering (DLS).
4.4 Storage and Stability
4.4.1 Storage of Nanoemulsions
- 4.4.1.1 Store the prepared nanoemulsion in sterile, sealed containers at 4°C to maintain stability.
4.4.2 Stability Testing
- 4.4.2.1 Periodically test the nanoemulsion for particle size and physical stability (e.g., phase separation, creaming) to ensure the formulation remains stable over time.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
6) Documents, if any
- Nanoemulsion Preparation Logbook
7) References, if any
- Literature on nanoemulsion formulations and stability testing
8) SOP Version
Version 1.0
Annexure
Nanoemulsion Preparation Logbook Template
| Date | Batch Number | Oil Phase | Particle Size | Stability Test | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Oil Phase Used | Size in nm | Pass/Fail | Operator Name | QA Name |